eubios journal of asian and international bioethics · surrogacy discussed by kodama is in ......

Eubios Journal of Asian and International Bioethics

EJAIB Vol. 27 (2) March 2017 www.eubios.info

ISSN1173-2571(Print)ISSN2350-3106(Online)OfficialJournaloftheAsianBioethicsAssociation(ABA)Copyright©2017EubiosEthicsInstitute(Allrightsreserved,forcommercialreproductions).

Content page Editorial:EthicalTherapy-DarrylMacer 37Obituarytoadearfriend,ProfessorDr.JayapaulAzariah-DarrylMacer 38ObituarytoProfessorDr.JayapaulAzariah 39-IrinaPollardTheworldhaslostaBridgebetweenBioethicsandourFutureProf.Dr.UmarAnggaraJenie-DarrylMacer 39RisksPresentintheCambodianSurrogacyBusiness40-MasayukiKodamaConsiderationofAppropriateClinicalInternshipsforOccupationalTherapyStudentsinJapan-K.Yamano44LackofethicalreasoningintheinnovationnarrativeofOccupationalTherapyandOccupationalScienceLiterature-SamanthaSirianni,andGregorWolbring48OnBeingtheHippocraticDoctor:ViewsofHouseofficersinaNigerianTeachingHospital–O.Okoye,F.Maduka-Okafor,A.Udeaja,A.IChuku59UnethicalClinicalTrialsinIndia:ASelectivepreliminaryoverview-AnkitaChakravartyandAmbedkarBhavan66ABARenewalandEJAIBSubscription(69online)

EJAIBEditor:DarrylMacerAssociate Editor: Nader Ghotbi (Ritsumeikan AsiaPacificUniversity(APU),Japan)EditorialBoard:AkiraAkabayashi(Japan),SahinAksoy(Turkey), Martha Marcela Rodriguez-Alanis (Mexico),Angeles Tan Alora (Philippines), Atsushi Asai (Japan),Alireza Bagheri (Iran), Gerhold Becker (Germany),Rhyddhi Chakraborty (India/UK), Shamima Lasker(Bangladesh), Minakshi Bhardwaj (UK), Christian Byk(IALES;France),KenDaniels(NewZealand),OleDoering(Germany), Amarbayasgalan Dorjderem (Mongolia),Hasan Erbay (Turkey), Soraj Hongladarom (Thailand),Dena Hsin (Taiwan), Rihito Kimura (Japan), AbbyLippman (Canada), Umar Jenie (Indonesia), NobukoYasuhara Macer (Japan), Masahiro Morioka (Japan),Anwar Nasim (Pakistan), Jing-Bao Nie (China, NewZealand), Pinit Ratanakul (Thailand), Qiu Ren Zong(China), Hyakudai Sakamoto (Japan), Sang-yong Song(RepublicofKorea),TakaoTakahashi(Japan),NoritoshiTanida(Japan),AnanyaTritipthumrongchok(Thailand),YanguangWang (China),DanielWikler (USA), JeongRoYoon(RepublicofKorea).

Editorial:EthicalTherapy?Twooftheethicalfoundationsofourlifearelovinglife,andlovinggoodorbeneficence.Thearticlesinthisissueaddresstherapy,tryingtomakethelifeofpeoplebetterthantheyarebecauseofadiseaseorcondition. There are two papers on occupationaltherapy, which is an applied health scienceincreasinglybeingdiscussed.YamanolooksatwhattypeofclinicalinternshipcanbeeffectiveinJapan,andSirianni andWolbringpresent the resultsof aliteratureanalysis.Thereislittlementionofethicsinthatliteraturetodate,yetitclearlyraisesethicalissues. Surrogacy discussed by Kodama is incontrastahotissueofbioethicalreflection.Therearetwodescriptivebioethicspapers,onefromNigeriaandonefromIndia,thathelpfillinsome practical circumstances that we need topay attention to. Practical ethics is required.This issue includes obituaries to two leadingfigures in Asian Bioethics. I hope that I do notneed to write anymore this year. They bothwereactive andsupportedEJAIB,and JayapaulAzariah was a founding associate editor of theEJAIB–soafter threedecadeshewillbesorelymissed. In this issue I announce theappointment of Prof. Nader Ghotbi as associateeditorwhohas offered to help, and thankProf.Masahiro Morioka who served as associateeditor for 3 decades also. He joins the othermembersoftheeditorialboard.-DarrylMacerEJAIB welcome papers! EJAIB charges no fees forpublication and the on-line version has been openaccesssince1990Editorialaddress,andallcorrespondenceto:Prof.DarrylMacer,Ph.D.,Hon.D.President, American University of Sovereign Nations(AUSN),Arizona,USAEmail:[email protected]://www.eubios.infoRegistered address of EJAIB: P.O. Box 16 329, Hornby,Christchurch8441,NewZealand(Donotpost itemshere;pleaseuseemailforallcommunication)

Eubios Journal of Asian and International Bioethics 27 (March 2017)

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Obituary to a dear friend, Professor Dr. Jayapaul Azariah (1939-2017) -DarrylMacer,Ph.D.,Hon.D.President,AmericanUniversityofSovereignNationsSecretary,AsianBioethicsAssociationDirector,EubiosEthicsInstitute Iamsosadtohearofthepassingofmydearfriend,colleague, partner in Indian and Asian Bioethicsdevelopment, and teacher, Professor Dr. JayapaulAzariah.

He is survived by his loving daughters, andfamily, and many dear friends, colleagues andstudentsallaroundtheglobe.

Jaywrotemanypapersandbooksonzoology,ecologyandbioethics.Wewereinseparablefriendssincewemetin1992inChennai(Madrasasitwascalledinthosedays),intenselydiscussingbioethicsandtogetherweworkedtodevelopbioethicsinthe1990s.Twenty-fiveyearslaterthetermbioethicsiswidelyknown;manyofourstudentsareprofessorsthemselves developing a global understanding ofbioethics. Bioethics is widely known in India andothercountriesinAsia,thankstohim.

JayalsoservedontheBoardofDirectorsoftheInternational Association of Bioethics, on theBioethicsCommissionoftheInternationalUnionofBiological Sciences (IUBS), and numerous otherbodies. In 1998 he was the founding President ofthe All India Bioethics Association (AIBA). Weshared the common understanding that love wasthe critical message of bioethics, hence theabbreviation “Ai” Bioethics Association, withreference to the Japanese (also the Chinese)wordfor love. He was dedicated to cross culturalunderstanding and exploration of bioethics,

throughhisdeepChristianfaith.HewasdevotedtoChristianserviceaswellasacademiclife.Jaywas the first Vice-President for India of the

Asian Bioethics Association, and served also asPresident of Asian Bioethics Association. He wasformer Professor of Zoology and Former Dean ofLife Sciences,UniversityofMadras, thoughhehadtofollowthemandatoryretirementatage60years,fromhencehetaughtatmanyinstitutionsinIndia.Jay passed away while also serving as VisitingProfessor of Zoology and Bioethics (AmericanUniversityofSovereignNations);VisitingProfessorof Kumamoto University, Japan; and FoundingAssociate Editor of Eubios Journal of Asian andInternationalBioethics(EJAIB).

Through some joint publications, jointresearchworksince1993,andspreadingbioethicsin India, Japan, Israel, Korea, Turkey, Indonesia,Chinaandmanyother countries, there is adeeperunderstanding of bioethics. In the joint book,Bioethics in India, in 1998, we published onehundredscholars’papersonbioethicsacrossIndia.There are numerous papers of his on the EubiosEthicsInstitutewebsite(www.eubios.info).Jay,yoursmile,love,

loyalty, support,wisdom and intellectwill be sadly missed.May you be togetherwith dear Hilda, withso much workaccomplished towardsmaking our world amore ecologically andethical one. I willremember Jaywithhisfavourite sweater andsmile. There are also several youtube videos of hisbioethicslectureson:https://www.youtube.com/watch?v=KvxDyY-Obo0(2003, TRT8, Eighth Tsukuba InternationalBioethicsRoundtable,Japan)https://www.youtube.com/watch?v=S6LA-_u9iNY(2005BBRT1,UNESCOBangkok)https://www.youtube.com/watch?v=jDYM-V6S7ZE&t=3s(2007ABC8,Bangkok)https://www.youtube.com/watch?v=Xggih-rhfTc(2007ABC8,Bangkok)https://www.youtube.com/watch?v=x2qJQySZxBA&t=195s(2009ABC9, Indonesia, includesProf. Azariah andProf.UmarJenie,whoalsopassedawayin2017)


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Obituary to Professor Dr. Jayapaul Azariah (1939-2017) -IrinaPollard,Ph.D.DepartmentofBiologicalSciences,FacultyofScienceandEngineering,MacquarieUniversity,N.S.W.Australia,2109Email:[email protected] feel a need to express my deep sadness at thepassing of a close friend Dr. Jayapaul Azariah – aprecious friendshipthatreachedbackoverseveraldecades. Our first social contacts took place atABA’sannualmeetingsduring theearly1990sbutsoon expanded over a range of other enjoyableevents – so friendship was regularly renewedduring subsequent meetings and as an invitedcolleagueatBiologicalSciences,MadrasUniversity.

Being with Jay meant sharing a variety ofactivities that include literature, science,philosophy, bioethics, politics, religion as well asenjoyablegastronomiclifeexperiences.Writingthishas brought a strong characteristic memory thattookplaceat aprestigiousmeeting inPariswheretheprojectorwouldnotwork,butknowinglyofmydiscomfort,Jaymaterializedfromtheaudienceandwithonepowerfulknockmyproblemwasresolved(Inowexclusivelyusepowerpoint!)

Jay, I miss your humanity, ethical insights,positivityandfriendship.

The world has lost a Bridge between Bioethics and our Future Prof. Dr. Umar Anggara Jenie, Apt, Msc (22 August 1950 – 26 January 2017) -DarrylMacer,Ph.D.,Hon.D.President, American University of SovereignNations(AUSN),USASecretary,AsianBioethicsAssociationFormerUNESCORegionalAdviser forAsiaand thePacific The world has lost a leading scientist andbioethicist, and I have lost a teacher and friend.Professor Umar as he was fondly known tothousands of scholars around the world, was thepublic face of bioethics from Indonesia. Umar andhis wisdom, inquiring mind, love and mediation,willbedeeplymissedbyhiscolleaguesaroundtheworldinmanydisciplines.

In his position as Chairman of the IndonesianInstitute of Sciences (LIPI), founding Chairman ofthe Indonesian National Commission on Bioethics,andalsoasVice-PresidentforSouth-EastAsia,andVice-PresidentforIndonesia,oftheAsianBioethicsAssociation, Professor Jenie acted as a centralbridgebetweendevelopmentofresearchpolicyandpractice for the development of bioethics throughAsia and as an interface between Asia and theGlobal Community. For a decade he was theinterface of Indonesia and Asian Bioethics, alsochairingtheAnnualMeetingsoftheAsianBioethicsAssociation in Indonesia in 2008 and 2016. Heattendedtheannualmeetingsallaroundtheworldinspiringhiscolleagues fromdifferentcountriestowork together, and to conduct research of glocal(global and local) relevance. In discussion ofinternational policy, we have to articulate andrediscovervaluesofIndonesiatotakealeadingrolein amoderate approach tobuilding a global orderthat is fair to all countries, not one dominated bythe formercolonialpowersand the richcountries,hebelieved.Umaralwayssupportedandmentoredyoung scholars to look to themselves and theirculture to find solutions that are enduring andequitable.

Umar also served as a bridge between thenatural science and social science fields that iscriticalforsoundpolicymakingintheemerginguseof science and technology. Several of hisinformativetalksareavailableforalltolearnfromonyoutube;healso,anprovidedhistimefreelyforpublic service as AUSN Visiting Professor inMedicinal Chemistry and Bioethics. Experts,


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students and the public could all learn from himhow to share wisdom from diverse fields ofgenomics,medicinalchemistry,history,philosophy,and cross cultural communication and policymaking.

Prof.Jenie’sservicetoUNESCOasamemberofUNESCO’s Intergovernmental Committee onBioethics, as well as in numerous roles as aninternational expert on science, was instrumentaltotheimplementationoftheUniversalDeclarationon the Human Genome and Human Rights, intolaws in Indonesia, ASEAN and globally. As formerUNESCO Regional Adviser to Asia and the Pacific,andtheformerandfoundingmemberofUNESCO’sInternational Bioethics Committee from NewZealand, I had thepleasure toworkwithUmaronthe translationofmerewordsofgovernmentsandtheUnitedNationsintopracticesthatsavethelivesof vulnerable people, and protect our biodiversityand biosphere. Future generations will appreciatethe foresight of policies that he helped formulate.He not only fought to protect people, but alsoanimals andplants that ourworld is blessedwith.Umar served us all, and theworldwas blessed tohave himwith us for 67 years – still too short forhis friends and colleagues. God has blessed us tohave Umar among us, and may you rest in peacesure that your wisdom will continue to inspireothers.

Jogyakarta2008

Beppu,Japan,2015

Risks Present in the Cambodian Surrogacy Business -MasayukiKodama,Ph.D.ProfessorEmeritusatNationalInstituteofFitnessandSportsinKanoya,Japan;13-237-6Honmachi,Higashiyama-ku,KyotoCity,Japan,605-0981Email:[email protected] Abstract TheThai temporaryNationalAssemblypassed theProtection for Children Born through AssistedReproductive Technologies Act, 2015 on February19,2015.ThepassingofThailand’s law regulatingreproductivemedicine(surrogacy)wasfollowedbyanenactmentwiththeapprovalof thecabinetandKingBhumibolAdulyadej in July2015. Since then,some surrogacy mediation agencies based inThailand, including Japanese surrogacy agencies,haveshiftedtheirattentionfromThailandtootherAsian countries, such as Cambodia, Georgia andothers.ThispaperdiscussesthebackgroundoftherapidgrowthoftheCambodiansurrogacyindustryas well as the government’s announcement of acomplete ban on commercial surrogacy, and alsothe risks inherent in Cambodian surrogacybusiness. This paper aims to provide relatedinformation to Japanese surrogacy patients andresearchersinreproductivemedicine.1. Introduction TheNewLife GlobalNetwork (NLGN) has been inthe midst of international expansion since thepassage of Thailand's Protection for Children Bornthrough Assisted Reproductive Technologies Act(พ.ร.บ.คุ้มครองเด็กที่เกิดโดยอาศัยเทคโนโลยีช่วยการเจริญพันธุท์างการแพทย์พ.ศ.2558)onJuly30,2015throughthetimeofthiswriting(January2017).LedbyMariamKukunashvili (MD, PhD), the organization hasspread its operations from Thailand, where itestablished its initial foothold, to the neighboringcountriesofCambodia,Laos,andMyanmar.1FollowingbeingshutoutofThailandin2015due

tonationallaw,thefirstalternativehostcountrytowhich NLGN expanded its operations wasCambodia, which lacked laws concerningreproductive medicine, in particular assisted 1 NLGN is a commercial organization that handles egg provision and surrogacy services. Headquartered in Georgia, this intermediary agency for reproductive medicine services also has offices in India, South Africa, Poland, Armenia, and Ukraine, Mexico, Kenya, and Southeast Asia, and claims on its website to have helped over 7000 couples and individuals to build their families. (https://www.newlifeasia.net/)


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reproductivemedicine(ART)orsurrogacy.Alreadyfacing “more than 50 surrogacy brokers...advertising online for services in Cambodia” as ofAugust 2016 2 , the Cambodian governmentannounced a complete ban on commercialsurrogacyinNovember2016.3Despite the proclamation, neither NLGN nor

Japanese surrogacy brokers have suspendedbusiness operations in Cambodia as of the time ofthiswriting (January2017), insteadwaiting toseethe government's next moves. Such businessestargeted by the complete ban on commercialsurrogacy can still be easily accessed, but clientsriskpayinganextremelyhighpriceforcontractingtheirservices.Towhatrisksaresurrogacypatientsexposed as a result of the business priorities ofCambodian surrogacy agencies? This manuscriptaims to identify the risks inherent in surrogacybusinessesthathavespreadfromThailandtootherneighboringnations. 2. The Rapid Growth of the Cambodian Surrogacy Industry, and the Government’s Announcement of a Complete Ban on Commercial Surrogacy Thailand’sinterimlegislaturepassedtheProtectionfor Children Born through Assisted ReproductiveTechnologiesAct,2015onFebruary19,2015.Itwassoon followedby theNepalese government,whichtook the step of completely banning commercialsurrogacyinthecountryinSeptember2015.Somesurrogacy mediation agencies responded to thesemovesbyconsideringalternativehostcountriestoThailand for surrogacy operations: one of these isneighboring Cambodia, which permits surrogacytreatmentandlackslegislationregardingsurrogacyand other forms of reproductive medicine (forexample, the reproductivemedicine agencyNLGN,headquartered in Georgia and operating inThailand, opened a Cambodian branch in March2015). Following Dr. Sean Sokteang’s opening ofthe country’s first IVF clinic, Fertility Clinic ofCambodia, in September 2014, the country hasexperienced rapid growth in the field ofreproductivemedicine, and nowhas 16 surrogacyclinics. Concerned about the physical and mentalhealth of Cambodian surrogate mothers andsurrogate children, the Cambodian governmentannouncedabanonsurrogacy inNovember2014,but the activities of surrogacy brokers havecontinuedunabated.

2 As Surrogacy Trade Grows, Government Charts Course (The Cambodia Daily, August 27, 2016). 3 Cambodia bans commercial surrogacy by Xavier Symons [BioEdge, 5 Nov 2016].

In addition, the Indian government’sannouncement of measures to completely bancommercial surrogacy drove an exodus of gaycouples to Thailand in 2013. This triggered theinterim military junta of Prayuth Chan-ocha toimplementtheProtectionforChildrenBornThroughAssisted Reproductive Technologies Act, 2015,whereupon the preferred destinations of gaysurrogacy tourists changed to Nepal and theMexican state of Tabasco. The authorities werebewilderedbythelegionsofgaycouples,drivenoutof country after country in their search forinternational surrogacy, and by the end of 2015both Nepal and Mexico had adopted measures toban commercial surrogacy by the end of 2015,ultimatelyleadingthesegroupstoCambodia.

Two major home countries from which gaysurrogacy tourists have flocked to Thailand since2013areAustralia4andIsrael5.InAustralia,neithersurrogacy nor adoption for gay couples isrecognized. According to the AustralianDepartment of Foreign Affairs and Tradedocumentation 6 , the number of Indian-bornchildrenapplying forcitizenshiprose rapidly from126inthe2008financialyear(2007-2008)to519in the 2012 financial year (2011-2012); amongthese, the number of Australians born in Indiaaveraged around 50 per year; similarly, Thai-bornchildrenapplyingforAustraliancitizenshipjumpedfrom 294 to 459. In the 2013 financial year, thenumber of Thai-born Australian citizenshipapplicationsincreasedevenfurther.Theproportionof gay and straight parents in these figures isestimated to be half and half. Even if theywanted

4 Commercial surrogacy is banned in Australia, but altruistic surrogacy is permitted for both opposite-sex and same-sex couples. Passed in Tasmania in 2012, Surrogacy Act No. 34 and Surrogacy (Consequential Amendments) Act No. 31 permit same-sex couples to have surrogate children as well as opposite-sex couples. Tasmania passes gay, de facto surrogacy bill (ABC NEWS, August 30, 2012). 5 While compensated surrogacy has been legal in Israel following the 1996 enactment of the Embryo Carrying Agreements Law, applicants are restricted to opposite-sex couples. Moreover, religious law permits surrogacy only when the commissioning mother and father (whether married or not) as well as the surrogate mother are Jewish (80% of the Israeli population is Jewish). Israel lacks civil marriage: only religious marriage exists, which is ordained by rabbis based on religious law. As a result, there are many de facto married couples in the country who are not legally married. In January 2014, Israel’s High Court of Justice recognized a gay couple’s adoption of a surrogate child genetically related to one of the parents (High Court orders Israel to recognize gay adoption of child born through surrogacy; The Jerusalem Post, January 28, 2014). However, a 2014 amendment bill to the Embryo Carrying Agreements Law, intended to extend the ability to commission commercial surrogacy to same-sex and de facto married couples and single men and women, failed to pass. 6 More parents defy law with overseas surrogacy (The Sydney Morning Herald, September 14, 2013)


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to,gaycouples fromAustraliaand Israelcouldnotchange course and commission surrogacy inGeorgia (the location of NLGN headquarters),because Georgian law restricts those who cancommission surrogacy to married heterosexualcouples; instead, they headed to Thailand’sneighboringcountryofCambodia.

Flooded with the influx of gay couples, theCambodian government gave notice of a comingcrackdown on commercial surrogacy in aNovember 11, 2015 article in the Khmer Times7,warning that “Governmentofficialsplan toclassifysurrogacyasaformofhumantrafficking”.8Despitethe announcement, the number of surrogacybrokers working clandestinely in Cambodiacontinued to increase. Concerned about themassiveinfluxofnotonlyopposite-sexcouples,butalso same-sex couples and single persons fromforeign countries seeking surrogacy, the U.N.Population Fund’s representative to CambodiawarnedinAugust2016:“There is currently no legal framework regulatingsurrogacy inCambodia,eventhoughmorethan50surrogacy brokers are advertising online forservices in Cambodia, and Australian couples aretravelinghereseekingsurrogateservices.Theyneedatleastalegalframeworktoavoidmalpractices.Inthe absence of a legal framework, there is muchmoreriskofhavingabuseandmalpractice.”9

In September 2016, the Ministry of Women’sAffairs in Cambodia held a conference about theeffectsofunregulatedsurrogacy,andannounced itwouldtakemeasuretoprotectthehumanrightsofCambodianwomen and children. On November 3,2016, the Cambodian government subsequentlynotified all medical institutions in Phnom Penh ofan impending complete ban on commercialsurrogacy.

Despitethisthreat,NLGNclaimsthattherearenolawsrelatedtoARTorsurrogacyregulationsinCambodia,andthereforesurrogacy isnot illegal inthe country. Based on this determination, NLGNcontinuestorecruitandmanagesurrogatemothersinThailandandCambodia,andtoactasamediatorbetween Cambodian clinics and medical refugees

7 Gov’t to Crack Down on Surrogacy Clinics (Khmer Times, November 11, 2015) 8 The legal basis for this crackdown is Cambodian domestic law: specifically Article 332 of the Penal Code: Intermediary between an Adoptive Parent and a Pregnant Woman referring to “Ban on Human Trafficking”. In addition, Cambodia is party to the UN's Trafficking Protocol, written in November 2000 to supplement the Convention against Transnational Organized Crime. However, the reality remains that impoverished Cambodian women and children still become victims of human trafficking. 9 As Surrogacy Trade Grows, Government Charts Course (The Cambodia Daily, August 27, 2016)

fromaroundtheworld.Atthesametimeasitpaysoff authorities to defend itself from repeatedinvestigations by the Cambodian socialistadministration, NLGN is fostering new surrogacymarkets in the cities of Vientiane (Laos) andNaypyidaw (Myanmar) as a back-up plan for itssurrogacyprogram.Despite their opaque future, parties seeking

surrogacy are directed to these Cambodiansurrogacy clinics by advertisements posted on thewebsites of some Japanese surrogacy agencies(Company A and Company B). NLGN transfersembryosfertilizedviaIVFandfrozeninThailandtoCambodian clinics, where they are implanted inThai and Cambodian surrogate mothers. 10 TheJapanesesurrogacyagenciesworkinasimilarway:e.g.CompanyAinspectschromosomesfromfrozenembryospreparedinJapanatapartnerThaiclinicusing a next-generation sequencer (NGS).11 Onlythehealthyfrozenembryosthatpassinspectionarethen brought to a partner clinic in Cambodia by aJapanese surrogacy agent, where a local doctorimplantsthemintosurrogatemothers.

What are the risks to the patients of possiblesuffering due to the business priorities andattitudesofCambodiansurrogacyagents?3. Risks Inherent in the Cambodian Surrogacy Business WhilebothThailandandCambodia areTheravadaBuddhistcountries,therearestrikingdifferencesintheir attitudes towards the surrogacy industry. Incontrast to Thailand, where there is a strongtendencytoviewsurrogacyasthamboon(ทําบุญ)or‘apiousact’forextendingahelpinghandtopeoplewith reproductivedisabilities, thiswayof thinkingis rare inCambodia.Asa result, amarriedwomandeliveringachildbelongingtosomeoneotherthanher spouseappearsquiteabnormal to theaverageCambodian. The national sentiment to stop thesurrogacy industry as a form of prostitution orchild trafficking (i.e. in violation of Article 332 ofthe Penal Code: Intermediary between an AdoptiveParentandaPregnantWomanreferringto“BanonHuman Trafficking”) has made searching for

10 Some companies specialize in the transport of biological materials. For example, Cryoport, Inc. has recently expanded its business to not only the Czech Republic, a country with many egg donors, but also Cambodia, hailed as an alternative to Thailand for surrogacy tourists. The company uses specialized “cold chain” technology, a low-temperature distribution system for transporting gametes and fertilized eggs, whereby cells cryogenically frozen at –151 °C and a calcium silicate sponge soaked in liquid nitrogen are placed in a Dewar flask and transported to the destination. 11 The Japan Society of Obstetrics and Gynecology does not permit

pre-implantation genetic screening (PGS) or whole-chromosome NGS.


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surrogatemothersamoredifficulttaskforbrokersthan in Thailand. Accordingly, the majority ofwomen who undertake surrogate motherhood inCambodian society are inevitablydivorcedwomenin financial distress or poor foreign women fromneighboringcountries.

Moreover,Cambodian lawregardsthewomanwhogivesbirth toa childas its legalmother.Thismeansthatwhenasurrogatemothergivesbirthtothe child of a commissioning couple, she isrecognized as the child's legal mother simply bylending her uterus, even if she lacks a geneticrelationship with the child. This legal situationmeans that commissioning couples from Japanmust jump over several hurdles in order to bringhomeasurrogatechildgeneticallyrelated to thembut born in Cambodia between a Japanese fatherand a Cambodian surrogate mother. First, thesurrogatemothermust undergo legal proceedingsto relinquishherparental rights; second, the childmust be recorded in the couple's family registry,andobtainJapanesecitizenship;andthird,thechildmust be issued both a passport by the Japanesegovernment and an exit visa by the Cambodiangovernment.Aretheseexpectationsrealistic?

Because of its November 3, 2016announcement of a complete ban on commercialsurrogacy to all medical institutions in PhnomPenh, theCambodiangovernment isunlikely tobeable to publicly issue exit visas to surrogatechildrenborninviolationofit.12Moreimportantly,Japan lacks legislation regarding reproductivemedicine, particularly surrogacy; therefore, theEmbassy of Japan in Cambodia cannot issue aJapanese passport to a surrogate child born inCambodia if it is to respect the officialgovernmental positions of both countries. 13 Thelegalizationof an international adoption system inCambodianotwithstanding,theannouncementofacomplete ban on commercial surrogacy makes itimpossible not only for the Embassy of Japan inCambodia to issuepassports to surrogate childrenborn in Cambodia, but also for the Cambodian

12 Immediately after the distribution of the Notification of a Complete Ban on Commercial Surrogacy on November 3, 2016, anti-human-trafficking police in Phnom Penh arrested three surrogacy providers (Tammy Davis-Charles, the Australian founder of a surrogacy agency, and two Cambodians) on suspicion of violation of Penal Code Article 332: Intermediary between an Adoptive Parent and a Pregnant Woman referring to “Ban on Human Trafficking”. (Surrogacy in Cambodia Faces First Official Charges, accessed November 22, 2016 at: http://www.sensiblesurrogacy.com/ surrogacy-in-cambodia-comes-to-end-amidst-arrests/) 13 A surrogate child could potentially be granted Japanese citizenship and a passport through extra-legal measures, if the genetic relatedness of the child and its Japanese parent(s) (i.e., the commissioning couple) could be certified via DNA screening.

government to grant exit visas to such children,since there is no legal system for transferring thesurrogate child to a commissioning couple atpresent. In short, it will likely become impossiblefor a surrogate child to be transferred to acommissioningcouple.

However, Cambodia is a country where onecan purchase citizenship. Aware of the culture of“legal flexibility” in thecountry, surrogacybrokershavetraditionallybeenabletoresolvemost issuesbybribingauthoritiesinsecret.Ifcitizenshipcanbepurchased,certainlythereisachancethatexitvisascanbeboughtaswell.AbrokercanbriberelevantCambodian hospital officials to omit the surrogatemother’s name from the “Mother” field of asurrogatechild'sbirthcertificate, therebyavoidingany trouble when the commissioning coupleregistersitsbirthattheircityofficeuponreturningto Japan. This workaround is made possible by aMinistry of Justice directive issued in 1961,whichnotes no special scrutiny for screening marriedcouples upon their return home with a newbornchild, assuming the women commissioningsurrogacyisunder50yearsold.14

The hard reality is that bribery is widelytolerated in Cambodia, as it is in many poorsocialistcountries.Thisfactandtheloopholeabovenotwithstanding, voices such as the Ministry ofWomen’s Affairs are loudly calling for theprotection of the human rights of women andchildren. Combinedwith the recent notification tobancommercialsurrogacy,thistrendsuggeststhatthe influence of bribery, traditionally effective inages past, may lose some of its potency. In otherwords, theNovember3,2016notificationmustbetaken as a sign that with Cambodian medicalinstitutions waiting for the government’s nextmoves, theabilityofsurrogatechildrenborntheretoemigratethecountryisinjeopardy.4. Conclusion Despitethis,somesurrogacyagenciesinJapanhaveyet to withdraw their Cambodian surrogacyrecruitment advertisements from their website asof the time of thiswriting (January 2017).Why isthis?

Ontheirwebsites,CompanyAandCompanyBclaim to “performsurrogacy inCambodia”, layoutthetimelineofeachCambodiansurrogacyprogram,and state that “the child is transferred to themarriedcoupleimmediatelyupondelivery.”

However, even as the Cambodia governmentmakes explicit its policies to ban commercial

14 “[Authorities must] Check the facts of the birth when the mother is 50 years or older.” (Ministry of Justice directive, 1961)


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surrogacy, the above-mentioned surrogacyagencies have maintained a uniform silenceconcerning the expected risks facing the return ofthe surrogate child to Japan. As of January 2017,Cambodia as a surrogacy destination exposessurrogate children born there to inherent risks.There is only one word for the behavior of theseJapanesesurrogacyagencieswhichsendsurrogacy-seeking couples to Cambodia while feigningignoranceoftherisksinvolved:dishonest.Note:ThispaperisbasedonapaperpresentedattheTenthKumamotoUniversityInternationalBioethicsRoundtable,November2016. Consideration of Appropriate Clinical Internships for Occupational Therapy Students in Japan -KatsuakiYamano,Ph.D.,OTRDepartmentofRehabilitation,FacultyofHealthScience,KumamotoHealthScienceUniversityEmail:[email protected] 1. Introduction The purpose of this study was to determine theappropriate clinical internship for occupationaltherapystudentsbycomparingtwodifferentstyles:“inchargeofclientstyleandclinicalclerkship”.

All occupational therapy students in Japanmust practice clinical internship for more than1000 hours in order to qualify for the nationalexam for occupational therapists. Since 1965, aphysical and occupational therapist law has beenestablished in Japan stipulating that studentspracticean internshipwhere theyare in chargeofclientsandwritecasereportsunderasupervisor’sguidance. However, a number of occupationaltherapists have been practicing clinical clerkshipfromthe2000sonward.

In the clinical education for occupationaltherapy students, it is important to compare incharge of client style with the clinical clerkshipstyle and to considerwhich of these two styles ofclinicalinternshipappropriately. 2. Occupational therapy process in Japan OccupationaltherapistsinJapanneedprescriptionsfrom a physician to practice therapy in order tohave compliance with the law. Once they haveprescriptions,occupationaltherapistscompletethefollowing steps: 1. Evaluate the clients using a

variety of methods. 2. Determine the state offunctioning and the real problem. 3. Plan anoccupational therapy intervention, set long-termand short-term goals, and select and establish thecourse for occupational therapy. 4. Practiceoccupational therapy.Mostof thetherapysessionsrange from 20 minutes to an hour. 5. Therapistsroutinelyreevaluatetheclient(Table1).

Occupational therapists assess the effect oftherapy by comparing previous and currentevaluation data results. If the client completes thegoal,itmaybetheendoftherapydependingontheassessment by the physician. If not, therapistsrepeattheprocessbypracticingsteps1to5again.

Table1:OccupationalTherapyProcessinJapan0.Prescriptionbyphysician1.Evaluation:interview,observation,collecting

information,andmeasurementforclients2.Problemdefinition:InternationalClassificationof

Functioning(ICF)isusedtoassesstheresultsofevaluationanddefineproblemsthataretobetargetedthroughoccupationaltherapyinterventions

3.Interventionplanning:goal(longorshort-term)setting;selectandestablishthecourseoftherapy.

4.Interventionimplementation:verificationoftheeffectseverytherapy

5.Re-evaluation:systematicallyre-collectinitialevaluationdataandcompareevaluationandre-evaluationdatatodetermineifoutcomeshavebeenmetandifdiscontinuationisappropriate;ifnot,determinesubsequentaction.

6.Completion

3. Legal regulations for clinical internship in occupational therapy in Japan The rules for educational facilities of physical andoccupationaltherapists(universitiesandvocationalcolleges offering a major in physical andoccupational therapy) are outlined in Article3-2,notified by the Ministry of Education, Culture,Sports,ScienceandTechnologyandbytheMinistryof Health, Labour and Welfare and stipulate thatphysical and occupational therapy students mustpractice a clinical internship of more than 25credits (810 hours: 45 hours per credit) andcompletemore than two-thirds of the credits in amedicalsetting(theMinistryofEducation,Culture,Sports,ScienceandTechnologyandTheMinistryofHealth,LabourandWelfare,1966).


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Besides, the Japanese Association ofOccupational therapists (JAOT) requires aninternship of more than 1000 hours includinginternships of more than six consecutive weeks(Japanese Association of Occupational Therapists,2014). This criterion is based on the internationaleducational standards of the World Federation ofOccupational Therapists (WFOT). Specifically, it isnecessary tomeet these criteria in order to attainthe standard, which is necessary if Japaneseoccupational therapists desire to work or studyabroad(Hockingetal.2002,p.1).

The guide for teaching physical andoccupational therapy at training institutions asstated by the Ministry of Health, Labour andWelfare lists the following four points asqualifications for the supervisor and the facility ofthepracticeofoccupationaltherapyinternship:1) An experienced occupational therapist (clinicalexperience of over 3 years since licensure)supervises the student. 2) It is desirable that thefacility is located near the training school. 3) It isdesirable that the proportion of students tosupervisor is approximately 2:1. 4) The facilitymust have adequate equipment to practice theinternship (the Ministry of Health, Labour andWelfare,1999).4. The significance and purpose of clinical internship for occupational therapy students The Japanese Association of OccupationalTherapists (JAOT) published the fourth edition ofits guidelines for the occupational therapy clinicalinternship in 2010. JAOT has defined thesignificanceandpurposeof a clinical internship inthe guidelines (Japanese Association ofOccupationalTherapists,2010).

According to the JAOT, the significance of aclinical internship is that occupational therapystudents experience occupational therapy practiceinthefacilityandlearntheappropriateknowledge,technology, skills, and attitude in the trainingcourse. The purpose of a clinical internship is foroccupational therapy students to develop anunderstanding of the perspective of the client, aswell as the knowledge, technology, skills, andattitude of a therapist through occupationaltherapyplanningandtreatment,andofferguidanceand support to clients under the supervisor’sguidance, which will improve their understandingas a healthcare professional (Japanese AssociationofOccupationalTherapists,2010,p.10).5. Charge of client style internship for occupational therapy students in Japan

Inthechargeofclientstyleinternship,occupationaltherapystudentspracticeclient-basedoccupationaltherapyandwritecasereportsunderasupervisor’sguidance.

The JAOT defines the goals of the clinicalinternship as follows: “occupational therapystudents are able to practice occupational therapyforgeneralclientsunderthesupervisor’sguidance,and act as a therapist professionally” (JapaneseAssociationofOccupationalTherapists,2010,p.17).In other words, the JAOT recommends aninternshipcongruentwiththechargeofclientstyle.

The strength of the charge of client styleinternship is that students are able to repeatedlyexperience the occupational therapy process, andtodeveloptheskillsofclinicalreasoningthrougharelationship with the client. Additionally, thesupervisor can allocate time for guidance, and,students are able to thoroughly study the client’sclinicalcondition.6. Criticisms of the charge of client style internship The charge of client style has been practiced inmany occupational therapy training settings inJapan since occupational therapy training coursesbeganin1963.TherewerefewJapanesetherapistswith a license in those days. Therefore, it wasnecessarytotrainmanytherapists.Thenumberofregisteredoccupational therapists is insufficient inJapan today to meet the needs of an agingpopulation. It could be argued that training moreoccupational therapists is one of the importantstrengthsofthechargeofclientstyle.

However, some therapists have criticismsconcerning the charge of client style internship.Sato, an occupational therapist, notes that thecharge of client style internship has sevenlimitations. 1. Insufficient internship facilities. 2.Insufficientguidancetimes.3.Thestudent’s“powerof clinical reasoning” does not develop whenwriting case reports. 4. The main guidance of thesupervisors is often restricted to the contents ofcase report because they cannot directly lead thestudent’spractice.5.Thenumberofclientswhodonotconsenttobetreatedbystudentshasincreased.6. There is an increase in students’ physical andmental fatigue in practicing the internship all day.7.Supervisor’sinabilitytolead(Sato,2015,pp.6-9).

Nakagawa, a physical therapist, has alsocriticized the charge of client style internship forphysicalandoccupationaltherapystudents,makingthe following six points: 1.The supervisor cannotjudge the student’s development in the affectiveandpsychomotordomainsbecause it isdependentonthestudent’sabilitytowriteacasereport.2.The


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student has to practice client therapy despite notpossessinga license.3.Thestudent isonlyable toobserve the cases of high-risk clients. Therefore,thestudentcannotexperiencethecompleteclinicalreality. 4. Clients do not receive enough therapy,quantitatively and qualitatively, from students. 5.Supervisorshavelimitedtimeforstudents,becausethehealthservicecarefeeforoccupationaltherapyhas slowly decreased, whereas the number ofclients is increasing. 6. It is understandable thatmany clients do not consent to treatment by thestudent(Nakagawa,2011a,pp.21-4).

Aida, an occupational therapist, argues thatstudents with little clinical experience are toonervous and not skilled to practice, and cannotwrite case reports that meet supervisor'sexpectations(Aida,2015).

7. Legal interpretation of the clinical internship in Japan It is important to consider the criticism byNakagawa that the student with no licensepractices therapy on clients in the course of theinternship. Students who have no license topracticetherapyare,intheirclinicalinternships,inviolation of physical therapist and occupationaltherapist law and of those pertaining to fee forhealthcare services in Japan (Nakagawa, 2011b,pp.13-4).

The most important law for Japaneseregistered occupational therapists is the physicaltherapist and occupational therapist lawestablished in 1965. Article 2-4 states, “the termoccupational therapist as used in this actmeans aperson that is qualified with a license by theMinistry of Health, Labor, and Welfare, uses thestyle of ‘Occupational Therapist’, and practices inoccupational therapy with a physician’sprescription”.

On the other hand, the ministry ordinanceconcerning fee for healthcare services in Japanestablishes that “it is performed under the directguidance of the physician, and the occupationaltherapy considers it as being performed under aphysician or the monitoring of an occupationaltherapist”.

One member of the Diet submitted a writteninquiry inMarchof2016asking if it isviolationofthe law for non-licensed students to practicephysicaloroccupationaltherapyininternships,andifhospitalsandfacilitiesreceiveamedicalfeefromtreatmentperformedbystudents.Thegovernmentanswered that “these practices are not a problembasedontheinterpretationofthelaw,ifaphysicianorexperiencedtherapistalwaysprovidesguidance,ensures client safety, and the client consents to

practicebyastudent,anditisalsonotaproblemifadequate guidance is provided by a physician orexperienced therapist based on the interpretationofthelaw.”ThisisbasedonaninterpretationoftheMedicalPractitionersActbytheMinistryofHealthand Welfare in 1991 (Ministry of Health andWelfare,1991).

8. Clinical clerkship style internship for occupational therapy students As discussed in the preceding section, it is notagainst the law for a student with no license topractice therapy. However, it is doubtful whetherthe student’s therapy is themost effective for theclientaswellastherapist(supervisor).Therefore,itisnotsurprisingeveniftheclientdoesnotconsentto receive therapy froma student. If so, itwillnotbe possible for the student to practice internship.Thus, some therapistshaveemphasizedonclinicalclerkshipstyleinternshiptomanagethisissue.

TheclinicalclerkshipstyleinternshipinJapanhasbeenpracticedbyphysiciansincearound2004(Japan Society for Medical Education, 2005, p.11).ItsprevalenceamongphysiciansinJapanhasbeenaffected by the clinical training system,which hasmadeitalegalobligationin2004(JapanSocietyforMedicalEducation,2005,p.11).

According to the Japan Society for MedicalEducation,intheclinicalclerkshipstyleinternship,medical students participate in medicalexaminationsasateammember.Theyassistinthemedicalexaminationbyengaginginalimitedrangeof medical practices under a supervisoryphysician’s guidance, and develop the knowledge,technology,skills,andattitudeofaphysician.Theyhave responsibility for the patients because theirpracticeisonthemedicalrecord(JapanSocietyforMedicalEducation,2005,p.65).

The clinical clerkship style internship forphysical and occupational therapy was alsointroducedaround2000(Nakagawa&Kano,2001).Nakagawadefinesthatintheclinicalclerkship,thestudentparticipatesintherehabilitationteamasanassistant, which facilitates the development ofprofessional skills and attitudes and ethicalreasoning(Nakagawa,2011c,p.37).

There are three steps in the practice of theclinical clerkship style internship: 1. Observation:the studentobserves the supervisor’spracticeandreceives explanations concerning therapy. 2.Imitation: the student practices therapy under thesupervisor’s guidance. 3. Practice: the student isabletoexplainriskfactorstoclients,andpracticestherapyindividuallyaspermittedbythesupervisor(Nakagawa,2011c,pp.38-9).


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9. Strengths of the clinical clerkship style internship Nakagawaintroducessevenstrengthsoftheclinicalclerkship. 1. The students do not write the casereport, which reduces their physical and mentalexhaustion.2.Supervisorsare freed fromcheckingthe report, and are thus able to devote additionaltimetoleadingthestudentsandpracticingtherapy.3.Thestudentinteractswiththesupervisoralldayas an assistant, and is therefore always able topracticeundersupervision.4.Thestudentisabletoexperience various clinical situations, and learnsuitable actions. 5. Supervisors are able to have adialoguewithstudents,andeffectivelyguidethem.6.Supervisorsareabletoensureadequatetherapytime for the client as well as guidance for thestudent. 7. Clients are likely to consent to thestudent being a part of their treatment team(Nakagawa,2011c,pp.37-41).10. Criticisms of the clinical clerkship style internship There are also some criticisms of the clinicalclerkshipstyleinternship.Aidamentionsthatthereare few educational facilities that recommendclinicalclerkships,andmanytherapistsdonothavea good understanding of clinical clerkships (Aida,2015).

AlthoughHanafusa(occupational therapist forphysical dysfunction) and Uda (occupationaltherapist for psychiatric dysfunction) practice thethree-step clinical clerkship, there are severalpoints that differ because of the difference inclinical specialization. They demand that studentsproduce a planning report and occupationaltherapysummaryfortheclientandcaseconferencematerial for the other team staff if necessary(Hanafusa2016;Uda2016).11. Discussion It can be a valuable experience for students topractice current occupational therapy processesthrough the charge of client style internship.However, this stylemay cause the students to usetheir energy unproductively in producing casereports.Mostofthestudentsarenotskilledenoughto practice occupational therapy with the littleclinical experience they gain. For example, thesupervisor’s guidance time with the student islimited to the time allowed practicing therapy assetbythehealthcareservicefee(max60minutes).Therefore, they have minimal discussion withclientsandtherapists,resulting ininsufficienttimefor guiding the students while providing therapyformany clients. In this situation, the students donot have adequate time to acquire the necessary

skillsastherapistsandtowritecasereportsduringtheclinicalinternship.Asaresult,studentsarenotabletolearnabouttheprofessionalresponsibilitiesofanoccupationaltherapist.

In comparison, clinical internship enablesstudentstoenhancetheirprofessionalqualitiesandprovides the experience needed to gain the truemeaning of the occupational therapy profession.Consideringtheseviewpoints,theclinicalclerkshipis a better style of clinical internship than thecharge of client style for occupational therapystudents.However, the clinical clerkship style alsohas some problems. Some of the students arelimited to observation or imitation in theinternship. There are reasons for this: 1. Many oftheoccupationaltherapystudentscannotactintheinternship because they are not skilled enough. 2.The supervisor does not set internship planningandmaynothaveastrategyforleadingbecauseofa lackofunderstandingof the clinical clerkship.3.The educational facility may not establishattainment goals for every step.The studentsmaylose focus if their only purpose is to earn enoughcredits, and they cannot acquire occupationaltherapy clinical thinking skills if theydonotwritecase reports. In other words, it is easy for theinternship to become a mere label rather than aproductiveexperience.

Supervisorsneedabetterunderstandingoftheclinical clerkship type of internship. Furthermore,lecturers in the occupational therapy trainingsettingandsupervisorsneed tocooperativelyplanthe clinical internship, and explain to students thepurpose, passing level, and contents of the clinicalclerkshipstyleinternship. 12. Conclusion It is desirable that occupational therapy studentspracticemore in the clinical clerkship styleduringthe clinical internships. However, it is hard to saythat supervisors have an adequate understandingoftheneededclinicalclerkship.Thereneedstobeasupervisor instruction course concerning theclinicalclerkshipstyleinthefuture.Note:ThispaperisbasedonapresentationattheTenthKumamotoUniversityInternationalBioethicsRoundtable,November2016.References Aida T. 2015. Kurinikarukurakusippu ni motodukurinsyoukyouiku toha (What is clinical education basedonclinicalclerkship?).JJOT49(11):1114-20.

Hanafusa K. 2016. rinshoujissyuusidousya no tachibakara, shintaisyougai ryouiki (kyuuseiki) (From a pointof view of a supervisor – specialized for physical


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dysfunction (acute stage)). Japan Journal ofOccupationalTherapy50(1):80-4.

Hocking C, Ness NE. 2002. World Federation ofOccupationalTherapistsRevisedMinimumStandardsforthe Education of Occupational Therapists 2002, Thecouncil of the World Federation of OccupationalTherapists.

Japan Society for Medical Education. 2005.shinryousankagata rinnshoujissyu gaido (Guideline ofclinical clerkship style internship), shinohara-shuppansya.

Japanese Association of Occupational Therapists. 2010.Sagyoryoho rinshojissyu no tebiki dai4pan (Theguideline of occupational therapy clinical internship,fourth edition). http://www.jaot.or.jp/wp-content/uploads/2012/08/rinshoujisshuVer.422203251.pdf(Accessedon2016.11.14�

JapaneseAssociation ofOccupational Therapists. 2014.sagyoryohoshi kyouiku no saitei kijun kaitei dai 3 pan(theminimum standard of education for occupationaltherapist). (Accessed on 2017.1.30)http://www.jaot.or.jp/wp-content/uploads/2013/12/OTmimimumstandard-3nd1.pdf>.

Ministry of Health and Welfare. 1991. Rinsyojissyukenntou iinkai saisyu houkoku 2 (The Final Report bythe committee on consideration of clinical internshipfor physician 2). (Accessed on 2017.1.13)http://www.mext.go.jp/a_menu/koutou/iryou/__icsFiles/afieldfile/2013/03/13/1329799_02.pdf>

MinistryofHealth,LabourandWelfare.1999.Theguideto teaching for physical and occupational therapytraining institutions. (Accessed on 2017.1.6)https://kouseikyoku.mhlw.go.jp/kantoshinetsu/shokan/kankeihourei/documents/yoryo_rigaku.pdf>

MinistryofHealth,LabourandWelfare.2016.Heisei28nendosinryohosyukaiteinitsuite,(TheGuidanceof thehealthcare service fee in 2015-6) (Accessed on2017.1.25)http://www.mhlw.go.jp/file.jsp?id=335763&name=file/06-Seisakujouhou-12400000-Hokenkyoku/0000114819.pdf>

Nakagawa N, Kano K. 2001. Evaluation Method on aClinicalClerkship.PhysicalTherapyJapan28 (4):198-202.

Nakagawa N (a). 2011. rinshojissyu no kennsyo – kanjatanntosei jissyu no houkai (Inspection of clinicalinternship- collapse of the charge of client style).Nakagawa N (ed.) Serapisutokyouiku no tamenoKurinikarukurakusippu no susume dai2han,(Recommendation of clinical clerkship for therapisteducation,secondedition),Miwa-shoten,pp.20-5.

Nakagawa N (b). 2011. serapisuto kyoiku ni okerurinshojissyunokiki(acrisisofclinicalinternshipintheeducation for physical and occupational therapists).Nakagawa N (ed.) Serapisutokyouiku no tamenoKurinikarukurakusippu no susume dai2han,(Recommendation of clinical clerkship for therapisteducation,secondedition),Miwa-shoten,pp.12-9.

Nakagawa N (c). 2011. serapisuto kyoiku ni okerukurinikaru kurakusippu no souzou (A Creation ofclinical clerkship in the education for physical andoccupational therapists). Nakagawa N (ed.)Serapisutokyouiku no tameno Kurinikarukurakusippu

no susume dai2han, (Recommendation of clinicalclerkship for therapist education, second edition),Miwa-shoten,pp.37-42.

Rogers JC, Holm MB. 2009. Occupational TherapyProcess.CrepeauEB,CohnES,schellBAB(eds.)Willardand Spackman’s Occupational Therapy 11th edition,LippincottWilliams&Wilkins,p.480.

Sato A. 2015. Ima naze kurinikarukurakushippujissyunanoka? (Why is clinical clerkship style internshipnow?)Aomorisagyoryohokenkyu24(1):5-15.

Uda H. 2016. Rinshojissyusidosya no tachiba kara,seishinsyogai ryoiki (from a point of view of asupervisor – specialized for psychiatric dysfunction).JJOT50(3):272-8.

Lack of ethical reasoning in the innovation narrative of Occupational Therapy and Occupational Science literature

-SamanthaSirianni,CummingSchoolofMedicine,UniversityofCalgary,CalgaryT2N4N1,Alberta,CanadaEmail:smsirian@ucalgary.ca-GregorWolbringDepartmentofCommunityHealthSciences,CummingSchoolofMedicine,StreamofCommunityRehabilitationandDisabilityStudiesCummingSchoolofMedicine,TRWbuilding3D31UniversityofCalgary,3330HospitalDriveNW,Calgary,Alberta,Canada(Correspondence)Email:[email protected]

Abstract Occupational therapyandoccupationalsciencearetwofieldsthatareimpactedbyinnovationsandareseen as innovative. Ethical reasoning is seen asessential for guiding innovative processes such asthedevelopmentofnewscientificandtechnologicalproducts. At the same time it is reported thatethicists“lacktheappropriate intellectualtools forpromotingdeepmoral change inour society” andthat members of the public such as parents ofchildren with disabilities do not necessarily useethical theories and ethical reasoning to highlighttheir problems. The purpose of this study was toinvestigate how the fields of occupational therapyandoccupationalscienceengagewithethicswithintheir innovation-covering academic literature andwhether occupational therapy and occupationalsciencewerementioned in academic journals thatcontained words starting with “ethic” in the title.Wefound littleconceptualengagementwithethicsprinciplesandnoemploymentofethicaltheoriesinthe academic literature covered. We also foundlittle engagement with occupational therapy oroccupational science in academic journals that


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contained words starting with “ethic” in the title.Ourfindingsareanotherexampleofthelimiteduseof the term ethics and limited uptake of ethicalreasoning using ethical theories giving furtherweighttotheconcernsSherwinvoiced. Key words: ethics, ethical theories, ethical reasoning, innovation, science, technology, occupational therapy, occupational science; 1. Introduction Occupational therapy and occupational sciencefocus on improving the health and well-being ofpeople by enabling people to participate in theactivities of everyday life [4]. Occupationaltherapists are responsible to remain current withnew developments in the profession and tomaintain excellence in their practice [5].Occupational therapy and occupational science asfieldsandoccupational therapistsarecontinuouslyimpactedbyscientific,technologicalandinnovation(STI)developments[6].Ethical theoriesandethicalreasoning are employed with local and globalscopes when one discusses for example thegovernance of scientific, technological andinnovation(STI)developments[2,7-25].

Ethicsisaboutwhatoneoughttodo.However,as Sherwin stated, “we [ethicists] lack theappropriate intellectual tools for promoting deepmoral change in our society” ([1] quoted in[2]).Furthermore one study revealed that members ofthe public such as parents of children withdisabilities do not use ethical theories and ethicalreasoningtohighlighttheirproblems[3].Ourstudyinvestigatedhowthefieldsofoccupationaltherapyandoccupationalscienceengagewithethicswithintheir academic literature covering innovation andwhether occupational therapy and occupationalscience were mentioned in academic journalscontainingwordsstartingwith“ethic”inthetitle.1.1. Occupational Therapy and Occupational Science AccordingtotheWorldFederationofOccupationalTherapy, “Occupational therapy is the art andscienceofenablingengagement ineveryday living,throughoccupation;ofenablingpeople toperformthe occupations that foster health and well-being;andofenablinga justand inclusivesocietyso thatall peoplemayparticipate to theirpotential in thedailyoccupationsoflife”[4].

Occupational therapistsworkwithpeopleandcommunities “toenhance theirability toengage inthe occupations they want to, need to, or areexpected to do, or bymodifying the occupationorthe environment to better support their

occupational engagement” [26]. In recent yearsoccupational therapy added concepts such asoccupational justice [27-29], ecologicalsustainability of occupations [30], occupationalsatisfaction [31,32], occupational enablement [33]and other areas [34] to its focus. According toYerxa,oneofthefoundersofthefieldoccupationalscience in the 1990’s, occupational science is anemergingbasicsciencewhichsupportsthepracticeof occupational therapy [35].Occupational scienceisseentoassistindevelopingtheunderstandingofthe occupational nature of humans [36,37] as amethodofachievingsocialjusticeandsocialreform[38] and it engages with many occupationalconcepts(Table3in[39]).1.2. Occupational Therapy, Occupational Science and Innovation Thefieldsofoccupationaltherapyandoccupationalscience both have narratives around innovation.Forexample,innovationislistedasonevalueoftheCanadian Association of Occupational Therapists[40]. The Canadian Association of OccupationalTherapists has an award for innovative practicewhich is given for “exceptional leadership andinnovation in the application of evidence-basedprinciples of occupational therapy to clinicalpractice” which includes “client service, consumeradvocacy, policy development, communitydevelopment,educationand/orfieldwork”[41].Onthe webpage of the Canadian Association ofOccupational Therapists it is stated that the“nominees shall have had a positive impact onclients, thecommunityand/ortheadvancementofoccupational therapy clinical practice” [41].Occupational scientists are seen to “studyways ofmeasuring participation, develop new andinnovative methods of intervention to helpindividuals engage in activities, and examine theimpact of participation on an individual’s healthandwell-being”[42].1.3. Code of Ethics and Occupational Therapy Organizations Codes of ethics are documents that are developedto give guidance to organizations and groupsworkingunder them.TheCanadianFrameworkforEthical Occupational Therapy Practice addressestheethicsprinciplesofautonomy,beneficence,non-maleficence, and justice [43]. Ethics is used as anumbrellaterm,combiningelementsof identityandknowledge, as an everyday way of behaving andwhat each person values and considers important[43]. The framework primarily discusses theprofessionalethicalconductsthatareimportantforoccupational therapists to follow in a way that is


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“technically proficient and honors the stories andlived experience of both the therapist and theclient”[43].

Occupational therapists are furthermoreexpected to be courageous, competent, mindful,respectful, sensitive, and reflective when they areworkingwithclients,asoccupationaltherapistsareaccountabletothosetheyserveandtosociety[43].According to theWorldFederationofOccupationalTherapy Code of Ethics, occupational therapistsmust maintain many personal attributes such asintegrity, reliability, openmindedness, and loyalty[44] . Occupational therapists must respect theirclients and their unique situation as well as notdiscriminate against their clients and keep theclient information confidential [44]. Occupationaltherapists must be able to collaborate with otheroccupationaltherapistsaswellasotherprofessions[44]. A combination of knowledge, skills andevidence must be acquired by the occupationaltherapist to help their clients in the best way aswell as to improve their professional field [44]. Italsostatesthattheoccupationaltherapyfieldhastobe promoted to the public, other professionalorganizationsandgovernmentbodies inanethicalway[44].1.4 Ethics and Innovation Therearemanydiscoursesaround innovationandethics for example medical technology [45],inclusive innovation [46], critical social innovation[47], tripartite innovation for global health [48],sticky ethics and corporate responsibility [49],ethical considerations in the innovation business[50], thepolitics of bloodethics [51], the ethics ofclinical innovation in psychopharmacology [52],legal ethics and technological innovation [53],ethical technology management and innovation[54],and theethicsof innovation [55].93%of thearticles in the Journal of Responsible Innovationmention words starting with ethic [56]. Empiricalethics and responsible innovation are linked [57]and ethics education is seen as useful forresponsibleinnovation[58].

Giventhatethicalreasoningisseenasessentialfor guiding scientific, technological and innovationdevelopments, given Sherwin’s concern thatethicists“lacktheappropriate intellectualtools forpromoting deepmoral change in our society” ([1]quotedin[2])andthatmembersof thepublicsuchasparentsofchildrenwithdisabilitiesdonotperseuse ethical theories and ethical reasoning tohighlight their problems [3] and given thatoccupational therapy andoccupational science seeinnovationas important for their respective fields,thepurpose of this studywas to investigatedhowthefieldsofoccupationaltherapyandoccupational

science engagewith ethicswithin their innovationcovering academic literature and whetheroccupational therapy and occupational sciencewere mentioned in academic journals thatcontainedwordsstartingwith“ethic”inthetitle.2. Data Source and Sampling We employed three approaches accessing threetypes of sources to generate descriptivequantitative and qualitative data answering thequestionsthestudyposed.

Approach 1: We accessed five occupationaltherapy journals of different backgrounds(American Journal of Occupational Therapy, BritishJournal of Occupational Therapy, Canadian Journalof Occupational Therapy, Scandinavian Journal ofOccupational Therapy, and Hong-Kong Journal ofOccupational Therapy) and the Journal ofOccupationalScience.

Wesearchedthewebsitesearchenginesofthefive occupational therapy journals and theoccupational science journal for the term“innovation” in the abstracts of articles onMay 5,2015. We identified n=121 articles from theAmerican Journal of Occupational Therapy, n=129articles from the British Journal of OccupationalTherapy, n=142 from the Canadian Journal ofOccupationalTherapy, n=19 from theScandinavianJournal of Occupational Therapy and n=6 articlesfrom the Hong-Kong Journal of OccupationalTherapy and n=41 articles from the Journal ofOccupational Science. The articles weredownloadedasPDFanduploadedintoAtlas-Ti.7,aqualitative analysis software, for descriptivequantitativeandqualitativecontentanalysis.

Approach 2: We accessed three academicdatabases (EBSCO All - an umbrella database thatconsists of over 70 other databases includingMedline; Scopus andWeb of Science) that containjournals that cover a wide range of topics. Thesedatabases include many journals that haveoccupationaltherapyinthetitleofthejournalsuchas:Britishjournalofoccupationaltherapy;Americanjournal of occupational therapy; Australianoccupational therapy journal; Physical &occupational therapy in pediatrics; Occupationaltherapy in health care; Physical & occupationaltherapy in geriatrics; Canadian journal ofoccupational therapy; Scandinavian journal ofoccupational therapy; Occupational therapy inmental health; Indian journal of physiotherapy &occupational therapy; Occupational therapyinternational; Indian journal of occupationaltherapy; Mental health occupational therapy;Occupational therapy journal of research; South


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African journal of occupational therapy; NewZealand journal of occupational therapy; Journal ofoccupational therapy, schools & early intervention;Hong Kong journal of occupational therapy; IrishjournalofoccupationaltherapyandPhysiotherapy&occupationaltherapyjournal.

We searched (May 19, 2015) the threeacademic databases for the terms “occupationaltherapy” and “innovation” in the abstract (EBSCOALL), abstract, title, keyword (Scopus), Web ofScience (topic: meaning Title, Abstract, AuthorKeyword and Keywords Plus®) limiting thesearches to articles, editorialmaterial, review andproceedingpapers(WebofScience);review,article,conference paper, editorial (Scopus) and scholarlypeer reviewed journals (EBSCO ALL). Of thepositive hits n=108 were duplicates from thesearchconductedinApproach1anddiscarded.Then=71newarticles foundweredownloadedasPDFuploaded into Atlas-Ti a qualitative analysissoftware for descriptive quantitative andqualitativecontentanalysis.

Approach 3:Wesearched for thepresenceof theterms “occupational science” and “occupationaltherapy” in the abstract of articles from journalswithwords startingwith “ethic” in the title of thejournal that are listed in EBSCO All and Scopus(March3,2016).WedidnotuseWebofScienceasitdoes not generate a hit count for all publicationswithwordsstartingwith“ethic”inthejournaltitle.3. Data Analysis To obtain descriptive quantitative data weemployedthreeapproaches.

Approach 1: We searched all the downloadedarticles obtained as described under section 2.1.Approaches 1 and 2 for terms and phrasecontaining words starting with “ethic” and usingtheadvancedsearchfeatureofthesoftwareAdobeAcrobatXProtorecordthenumbersofhowoftenagiventermorphraselinkedtoethicswaspresentinagivenarticleandinhowmanyarticles(Table1).

Approach 2: We searched all the downloadedarticles obtained as described under sectionapproach 1 and 2 for containing words startingwith “ethic”, the following n=14 ethics terms:“value”, “philosoph*”, “justice”, “moral*”,“autonomy”, “bioethics”, “dignity”, “care ethics”,“virtue ethics”, “feminist ethics”, “human ethics”,“public health ethics”, “beneficence”, “maleficence”and n=19 ethical theories: “Kant”, “Socialist”,“Egalitarian”, “Moral Relativism”, “IndividualRelativism”, “Cultural Relativism”, “PsychologicalHedonism”, “PsychologicalAltruism”, “FemaleCareBased Ethics”, “Virtue Theories”, “Samuel

Pufendorf”, “Rights Theory”, “WD Ross”,“Consequentialism”, “Deontology”, “Utilitarianism”,“Preference Utilitarianism”, “Libertarian” and“Feminist Approach”. The 34 terms were takenfrom Beauchamp and Childress’ 1979 paper“Principle of Biomedical Ethics” [59] as well asencyclopediaorwebsources[60-63].

Weusedagain theadvancedsearch featureofthe software Adobe Acrobat X Pro to record thenumbers of how often a given term or phraselinkedtoethicswaspresentinagivenarticleandinhow many articles (Table 2). We also used theadvanced search feature of the software AdobeAcrobatXProtorecordhowoftenatermlinkedtoethics was present in an article within 20 wordsfromawordstartingwith“inno”(Table2).

Approach 3: We recorded how often the terms“occupational science” and “occupational therapy”were present in the abstract of articles fromjournalswithawordthatstartswith“ethic” inthetitleof the journal thatare listed inEBSCOAll andScopus(March3,2016)(section3.1.3.).Thedescriptivequantitativedatageneratedby thethree approaches was generated by both authorsandnodiscrepancywasevidentincountsobtainedbythetwoauthors.

To obtain qualitative data the downloadedarticles were auto-coded for words starting with“inno”whichgeneratedn=1075hitsandforwordsstartingwith “ethic”whichgeneratedn=1442hits.A co-occurrence code was then generated thatindicated the co-occurrence of the two wordswithin20words(n=21quotes).Athematicanalysiswasperformedontheco-occurrence(n=21quotes)and the n=1442 ethics-related quotes. Bothresearchers performed the analysis and resultswere compared between the researchers. Nodisputeoccurredpartlyduetothefewarticlesthatlinkedcontenttoethicsandrelatedterms.4. Limitations Only documents that were in English wereconsidered. Wedidnot cover all theoccupationaltherapy journals in existence and all academicdatabases that might have articles that coveroccupational therapy and occupational science. Assuch our conclusions are linked to the sourcescoveredandcannotbegeneralized.5. Results Inafirststepwegenerateddescriptivequantitativedata on which phrases were linked to wordsstarting with “ethic” (Table 1), which of the n=34ethics terms mentioned in the section 2.1 werepresentinthesourcescovered(Table2)andhow

Table1.Thehitcountandthearticlecountforeachethicsdiscourseterm,orderedby“NumberofArticlesinOTJournals”(Secondcolumn)

Phraselinkedtowordsstartingwithethic

OTJournalsHitCounts

OTJournalsNumberofArticles(n=417)

OSJournal

HitCounts

OSJournalNumberofArticles(n=41)

DatabaseJournalHitCounts(excludingOTjournalsalreadycovered)

DatabaseJournalNumberofArticles

(n=71)(excludingOT

journalsalreadycovered)

Ethic* 1442 160 56 16 45 23Ethicsapproval 530 70 1 1 6 6Researchethics 212 53 2 2 1 1Ethicscommittee 225 46 0 0 4 3Codeofethics 98 32 0 0 3 2Ethicalconsideration 34 18 0 0 1 1Ethicsboard 16 15 3 3 0 0Ethically 25 13 3 2 1 1Ethicaldilemma 14 12 0 0 0 0Workethic 11 8 13 2 0 0Ethicalimplications 13 8 0 0 0 0Ethicsreview 11 7 0 0 1 1Ethicalprinciples 8 7 0 0 0 0Ethicalobligation 7 7 0 0 0 0Ethicalguideline 8 7 0 0 0 0Ethicspermission 6 6 0 0 0 0Ethicalconcern 5 5 0 0 0 0Ethicaldecisions 6 5 0 0 0 0Ethicalreasoning 9 4 0 0 0 0Professionalethics 3 3 0 0 0 0Ethicalstandard 5 3 1 1 1 1Ethicalpractitioner 2 2 0 0 0 0Ethicalconduct 2 2 0 0 0 0Ethicalquestion 1 1 0 0 0 0Ethicalbelief 1 1 0 0 0 0Ethicaluse 1 1 0 0 0 0Ethicalconstraints 0 0 1 1 0 0ProtestantEthics 0 0 2 2 0 0Interactiveethics 0 0 3 1 0 0AfricanEthics 0 0 3 1 0 0often occupational therapy and occupationalscienceshowupinethicsjournals.Quantitative Data: Table 1 shows how the termethicswasusedinthen=417occupationaltherapyand n=41 OS articles. Words and phrasescontaining words starting with “ethic” werementionedn=1442 in n=160 occupational therapyarticles and n=56 in n=16 OS articles. “Ethicalapproval” had the highest counts with n=530 inn=70occupationaltherapyarticles.

Table 2 shows with the hit count and thearticle count for eachof then=34ethicsdiscourseterms. It demonstrated thatmany ethical theorieswere not employed in the literature investigated,and also that key bioethics principles such asbeneficenceandmaleficencewerenotemployed.

Mentioning of Occupational Therapy andOccupational Science in Ethics Journals: Of the45,588 articles found in the databases that havewords startingwith “ethic” in the title of journals,n=5articlesmentionedoccupationaltherapyinthe

abstract. Not one article mentioned occupationalscienceintheabstract.

Qualitative Analysis: Most of the quotationsgenerated for the articles uploaded into Atlas Ti7contained content that did not engage in ameaningful or conceptual way if at all with then=34 ethics-related terms in question. As suchweonly recap here our findings for the quotesgenerated with words and phrases containingwords starting with “ethic”. First, we will discusstheonesnotlinkedtoinnovationwithina20-worddistance, and then we will discuss the quotationsthatco-occurredwith“inno*”.

Ethic* and Occupational Therapy: Althoughn=1442 quotations were generated for wordsstartingwithethicmostof thequotationsreflectabureaucraticuseofwordscontainingethic,suchasethics approval or using a term without givingcontent. Only seven articles were found to havesomecontent.

Table2.Thehitcountandthearticlecountforeachofthen=34ethicsdiscourseterms

Term OTjournalsHitCounts

OTjournalsNumberofArticles(n=417)

Numberofhits/articleswithtermsinproximity(20words)ofterminnovationinthedatabaseOTarticles

OSHitCounts

OSjournalNumberofArticles(n=41)

Numberofhits/articlewithtermsinproximity(20words)ofterminnovationintheOSjournal

DatabaseHit

Counts(n=71)

DatabaseOTNumberofArticles(n=71)

Numberofhits/articlewithtermsinproximity(20words)ofterminnovationinthedatabaseOTarticles

EthicsConceptethic* 1442 160 21/8 56 16 0 45 23 0Value 1978 269 78/21 254 33 5/2none

linkingvaluewithinnovation

495 61 0

Philoso* 721

146

2/1

105 22 2/1(notlinkingphilosotoinnovation

236 35 0

Harm 216 92 0 40 15 0 110 29 0Autonomy 185 76 13/6 8 4 0 26 11 1Justice 177 58 2/1 64 14 0 74 18 0moral* 151 61 4/2 35 17 0 67 22 0Dignity 49 22 0 4 3 0 4 4 0Beneficence 0 0 0 0 0 0 0 0 0Maleficence 0 0 0 0 0 0 0 0 0careethics 2 2 0 0 0 0 0 0 0virtueethics 0 0 0 0 0 0 0 0 0feministethics 0 0 0 0 0 0 0 0 0publichealthethics 0 0 0 0 0 0 0 0 0

bioethics 21 3 0 0 0 0 0 0 0EthicalTheories

Egalitarian 7 6 0 3 2 0 0 0 0

Socialist 0 0 0 0 0 0 4 3 0Hedonism 1 1 0 0 0 0 0 0 0Libertarian 1 1 0 0 0 0 0 0 0FeministApproach

1 1 0 0 0 0 0 0 0

MoralRelativism 0 0 0 0 0 0 0 0 0IndividualRelativism

0 0 0 0 0 0 0 0 0

CulturalRelativism

1 1 0 1 1 0 4 4 0

PsychologicalHedonism

0 0 0 0 0 0 0 0 0

PsychologicalAltruism

0 0 0 0 0 0 0 0 0

FemaleCareBasedEthics

0 0 0 0 0 0 0 0 0

VirtueTheory 0 0 0 0 0 0 0 0 0SamuelPufendorf 0 0 0 0 0 0 0 0 0RightsTheory 0 0 0 0 0 0 0 0 0WDRoss 0 0 0 0 0 0 0 0 0Consequentialism 0 0 0 0 0 0 0 0 0Deontology 0 0 0 0 0 0 0 0 0Utilitarianism 0 0 0 0 0 0 0 0 0PreferenceUtilitarianism

0 0 0 0 0 0 0 0 0


54

Abernethy, inher2010 articleTheassessmentand treatment of sensory defensiveness in adultmentalhealth:a literaturereview,stated that noneof the articles in her literature review coveredethicalimplications[64].Twoarticlesengagedwiththephrase“ethicalreasoning”.Onelinkedissuesofsustainability with occupational therapyphilosophy and discusses how employing asustainability lenswithprofessional reasoning canhelppractitionersintegratesustainabilityintotheirpractice [65]. The authors stated: “In addition toaddressingissuesrelatedtoindividualclientcareinour day-to-day practice, occupational therapypractitioners should also consider ethicaldimensions of the issues by utilizing thesustainabilitylensdiscussedinthispaper.Thislensencourages practitioners to focus on theconsequences of our actions and consider ourduties, responsibilities, and the morally correctactiontobetaken,which isanextensionofethicalreasoning”[65].

WendyWood’s article covered the process ofcurriculum redesign of an occupational therapyMaster’s degree in which Wood engages with theterm “ethical reasoning”. Wood states “Ethicalreasoningisdefinedinthecurriculumasprocessesofenactingthehigheststandardsofethicalconductand of generating solutions to problems on thebasisof a systematic studyofmorality.Thearticleexamined current threats to the field “in light ofpast compromises that weakened occupationaltherapy’ssociopoliticalpositionanddiminisheditspower to meet the occupational needs of peopleandsociety”[66].

Taff et al assessed “how contemporarychallengesandaneedforethicalidentityrequireaphilosophical shift”[67] and their article has asection called “Occupational Rights and HumanDignity: Defining Ethics and Accountability” [67].Thephrase“ethicalconsiderations”wasmentionedin n=25 articles. However, the phrase was mostlylinked to ethics approval. Again, Taff et al providesome content: “There is some debate in recentyears about the core values as well as the ethicalconsiderations in the definition and practice ofoccupationaltherapy”[67].Ethicaldilemmaswerebrought to light in one paper where they are“related to an inability to offer new technology toall clientsdue to fundingshort falls” [68]wherebythe lack of access was seen as being able to beaddressedandresolvedthroughpublicopinionandclientexperience[68].

Vincent reported on a survey saying thatpeoplesayethicsisimportant[69].However,itwasnotexplainedwhatismeantwithethics.Althoughthe term “ethical implication” was mentioned inn=8 articles in only one case was it not linked to

ethics approval. Castro et al. stated “As culture isdifficult to define, and has political and ethicalimplications, an investigation into its usage iswarranted” [70]and flagged thepossibility that “alackof critical insight intoprofessional knowledgeincreases the risk that occupational therapy willremainsatisfiedwiththecurrentunderstandingofculture, based on the dominant knowledge. Thedisciplinecouldfailtoaddressthepolitical,ethical,and theoretical issues required to reach thetargeteddiversityinitspractice”[70].

Taff et. al in their article The Accountability–Well-Being–Ethics framework: A new philosophicalfoundation for occupational therapy, engage withRortyian thoughts and they have “particularrelevanceinoccupationaltherapy,wherethefocuson possibilities and local meanings resonatesheavily with people’s lived experience. Hiscontextualism differs from most philosophicalperspectivesbecauseitisnotconcernedwithgreattruths. Instead, it is a ‘‘lowercase’’ philosophy thatponders the joys, dilemmas, and improvement ofdaily life. The discoveries of science are crucial tosupport the continued growth of professionalknowledge. No less important, though, is thephilosophicalviewofthepersonasanactiveagentinachievingagoodlife,anditisequallycriticalthatthis facet of occupational therapy be sustained tofacilitate both local and global influence. Theperson-centredphilosophymustbenourished,anditisherewhereRortyplaysakeyrole.Rortybringsphilosophy out of the realm of scientists andacademics and presents it as a tool for solvingproblems and achieving equity in everydayexperience. This ‘‘lower-case’’ philosophy requirescollaboration, promotes capabilities, and isavailabletoeveryone.Assuch,itisavaluableallytooccupational therapyas theprofessionseekswaysto address the new challenges of changing healthcare policies, globalization, and sociopolitical andclimate-driven determinants of health. TheRortyian concepts of hope, solidarity, andcontingency provide new and needed conceptsupon which occupational performance,participation, and well-being can be addressed aswemovethroughthe21stcentury”[67].

Ethic*andOccupational Science:Wordsstartingwith ethic were mentioned in n=16 articles n=56times with n=6 articles having some content. Onearticle stated that occupational science needs toengagewithethicalconsiderationsinorderforittobeasociallyresponsible[71].

According to Rudman, it is important toconsider “how occupational science is ethically,morally and politically responsible for theknowledge it generates” which “challenges


55

occupational scientists to redefine the boundariesbetween ‘professional’ (sometimes framed asapplied) and ‘scientific’ (sometimes framed asbasic) knowledge and practices” [72] and the“broader dialogue addressing the types ofknowledge production falling within the domainandpracticesofoccupationalscienceisessentialtooptimize relevance and ethical and socialresponsibility”[72].Willis linkProtestantethics tosocialhistoryofdeadlines[73].

Halahan states “competence can be regardedasaprocess*notmerelyasanoutcome*andusedtoenrich practices by opening the arena of humanaction to its ethical, or value-laden, nature.Participants in occupation become agents of safe,effective, lifegiving, meaningful pursuits, not meretechniciansofaction,becausecompetenceconsistsasmuch in people’s ability to articulate why theyactthewaytheydoasitdoesintheircapacitytoactin the first place” [74]. In an article by ElelwaniRamugondo, an ethics idea governing humanengagement called Ubuntu, an interactive ethicsalsocalledAfricanethics, isdiscussedasit ismoreof a community based ethics rather than justconcerning the individual [75]. In this article theUbuntu “raises consciousness around theresponsibilityofbothindividualsandcommunitiesto allow meaningful existence for all” [75]. Thisform of ethics governing is concerned with howeachindividualimpactsotherindividuals[75].

Dickie et al make a case for “TransactionaloccupationalsciencebasedonDeweyandhisallies”whichtheyassertis“asolidfoundationonwhichtoplace the concept of occupation” as it “provides aphilosophical basis for the importance ofoccupationineverydaylifeandbecauseit“enablesoccupationtobedirectlyrelatedtoawiderrangeofexperience and inquiry, from ethics to culturalanalysis to political issues such as occupationaljustice”[76].

Ethic* and Innov*: N=21 quotations in n=8occupational therapy articles were generated forthe presence of “inno*” and “ethic*” within 20words. All but two articles used the term “ethicsapproval” and did not use ethics in relation toinnovation.Noarticlewasobtainedfor“inno*”and“ethic*” within 20 words distance in theoccupationalsciencearticles.

As to the two occupational therapy articlesmentioning “ethic*” and “inno*” within 20 wordsdistance; Hoffmann in a 1979 article ContinuingEducation: An Answer to Professional Obsolescencerecognized “that new innovations have alsofostered a host of problems” [77], stating furtherthat“Organtransplants,forexample,haveopenedaPandora's Box in terms of ethical questions. The

debate of prolonging life by mechanical meanswhen there is virtually no hope for recovery, hasfosteredamajordebateof theright todie issue.AgoodexampleofthissituationistheKarenQuinlancase in New Jersey. Another example is biologicalresearch on recombinant DNA. It is now possiblefor scientists to combine genetic material fromdifferentmolecules and generatebiologicalmatterin the laboratory that are not found in nature.Another example is the recent debate concerningtesttubefertilization”[77].However,Hoffmandoesnot explicitly statewhat the ethical issues are andhe does not employ ethical reasoning to discusssomeofthespecificinnovationshighlighted.

AnitaAtwal’spaperstatedthat“Thechallengefor action researchers is to act ethically. Wheninstigating change in the health service,investigators must let professionals drive changeinnovationseven though the investigatormay findhimself or herself challenging assumptions. Actionresearchers have to ensure that the quality, valueand honesty of their inquiries are not jeopardisedbyunrecognisedbiasandinfluence”[78].6. Discussion Based on the articles investigated, our findingssuggest that the occupational science andoccupational therapy academic literature aroundinnovation did not engage with ethics in asubstantial matter such as employing ethicaltheories or ethics principles. Further, we foundlittleengagementwithoccupationaltherapyandnoengagement with occupational science in ethicsjournalssearched.Wepositthatthisisproblematicgiven that occupational therapy and occupationalscience is seen to be in constant need to innovate[40-42] and given that science and technologyproducts are an area of interest to occupationaltherapyandoccupationalscience[79-86],productsthat constantly are influencedbyadvancements inscience and technology. Furthermore, advances inscienceand technologyare seenas innovativeandthey influence innovation discourses includingsocialinnovation.AsJarvisstates:“AsstatedinourCodeofEthics,itisourobligationtokeepuptodatewithchangesinourfield”[87].Thisquoteistryingto show the connection that ethics has withinnovationintheoccupationaltherapyfield[87].

Itisalsoaproblemfromtheperspectiveoftheethics field. Ethicists want to influence social andpoliticalchange;butsomeseeproblemswithdoingso. Sherwin recently stated: “We lack theappropriate intellectual tools for promoting deepmoral change in our society. To find ways ofaddressing these difficult questions, we need tolearnabouttheleversofsocialandpoliticalchange.


56

We probably need also to develop skills incommunicating effectively with the public and toengage in some version of political lobbying. Inother words, we must develop new types ofunderstanding and new ways of practice” ([1]quotedin[2]).Ourfindingsprovideevidencefortheproblem Sherwin outlines. Ethical theories, one ofthemain tools used in academic ethics discoursestojustifycertainreasoningandconclusionsarenottaken up by the occupational therapy andoccupationalscienceacademicliterature.Givenourfindings, it is reasonable to assume thatoccupational therapists do not employ ethicaltheoriesintheirreasoning.

Sherwinasksforthere-orientationoftheoretictools used in bioethics to guide the field in a newdirection [1]. She asks for adopting an ethics ofresponsibility;explorationoftheresponsibilitiesofvarious kinds of actors and relationships amongthemandtheexpansionofthetypesofparticipantsengaged in bioethics ([1] quoted in [2]).We positthatoccupationaltherapyandoccupationalsciencebasedontheirfocusonoccupationdealwithmanyissues that raise ‘ethical issues’. As such we positthat the active and knowledgeable involvement ofoccupational therapy scholars, students,practitionersandoccupationalsciencescholarsandstudentsisfittingSherwin’sdemand.Thisinclusionhowever demands that occupational therapyscholars, students and practitioners andoccupationalsciencescholarsandstudentsemployethicaltheoriesandethicalreasoningbeyondwhatwe foundwhichwepositmeans thata curriculumchange is needed that trains occupational therapyand occupational science students how to useethicaltheoriesandethicalreasoning.Indeedgivencertain emerging science, technology andinnovation development such as using robots foremployment [88] it seems fruitful to develop acommunity of practice around an “ethics ofoccupation”aphrasewhichso faronlyhas41hitsinGooglescholarwherebythe focus isnoton jobsand being busy but occupation of ones space byothers.

To develop an ethics of occupation as in job,work, and being busy fits with the goal ofoccupational therapy and occupational science. Italsoisanpressingissue,givenanticipatedtrendsinrobotics [88], 3D printing [89-91] and molecularmanufacturing(StarTrekfoodreplicator)aprocesswhereamachinebuildsupproductsatombyatom[92] and areas such as the body enhancements ofhumans which will impact ability expectations ofhumans linked to occupation and with that theeducationofhumans[93].

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Call for Papers: The Eleventh Kumamoto University International Bioethics Roundtable: Philosophy and practice of bioethics across and between cultures,

18-19 November 2017, Kumamoto University, Japan; Contact: Kimiko Tashima, Email: [email protected]

On Being the Hippocratic Doctor: Views of House officers in a Nigerian Teaching Hospital -OnochieOkoyeDepartmentofOphthalmology,CollegeofMedicine,UniversityofNigeria,PMB01129,Enugu,NigeriaEmail:onochie.okoye@unn.edu.ng-FerdinandMaduka-OkaforDepartmentofophthalmology,CollegeofMedicine,UniversityofNigeria-AnthoniaUdeajaDepartmentofophthalmology,AnambraStateUniversityTeachingHospital,Awka,AnambraState,Nigeria-AbaliIChukuFederalMedicalCenter,Umuahia,Nigeria Abstract Medicalstudents inmanycountriestakeamedicaloathongraduationfrommedicalschool.Giventhatthereislittleornoformalmedicalethicseducationin many Nigerian medical schools, the currentrelevance of swearing to these medical oaths isbeing questioned. This study determined mainlythe views of pre-registration house officers(PRHOs)ontherelevanceoftheHippocratic-basedmedical oaths and some selected issues related tothe ideals espoused therein. Using self-administered questionnaires, a cross-sectionalsurveyofPRHOswas conducted in2013as apre-orientation workshop activity in Nigeria.Respondents were simply required to indicate ifthey agreed/disagreed with 29 perceptionstatements related to the medical oaths and theirideals. Simple descriptive analysiswas done usingthe Statistical Package for Social Sciences version19.Thesample included63malesand41 females,whohadallsworntothePhysician’sOathattheir9respective medical schools. Though only tworespondents (1.9%)were confident about recitingthe Physician’s oath/any medical oath frommemory or recalling all the specific detailscontainedinit,themajorityofthemagreedwithallthe traditional ideals espoused in theHippocratic-basedoaths,includingtheprohibitionsonabortion,euthanasia/physician-assisted suicide and sexualmisconduct. Contemporary issues like doctors’strikeactions, jobsecurity/self-preservationissuesand demand for payment of hospital fees beforeservice were shown to be contentious issues forwhich there was no explicit guidance from themedical oaths. For these oaths to gain greaterrelevance and priority among these doctors, theyshouldberecitedwithin thecontextofareformed


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undergraduatemedicaleducationalsystemwithanintegrated medical ethics curriculum and afunctionalhealthcaresystemthatisresponsiveandsensitivetosocietalneedsandchanges.1. Introduction Althoughoathtakingiscommoninmanysocieties,its importanceand impactvariesamongthemajorprofessions,withthetakingoftheHippocraticoathbeing widely invoked in the popular medicalculture as being contributory to conveying adirection to medical practice and the medicalprofession [1].Mostmedical graduateswill take amedical oath to inspire them to take their properplaceinthecomradeshipofphysiciansandremindthem of their obligations to their patients, societyand their profession [2]. The recitation of such anoath is a laudable tradition that provides a link tothehistory ofmedicine, affirms the solemnity of amedicalcareer,andacknowledgesthepublic’strustindoctors[3].

Included in the classical Hippocratic Oath arecontent domains espousing loyalty to colleagues,profession and teachers, protecting patientconfidentiality, avoiding sexual misconduct, non-exploitation of patients, prohibition of abortion,prohibition of physician assisted suicide oreuthanasia, putting the patient’s welfare first,acting with beneficence or non-maleficence,professional integrity, acknowledgement of limitsof competence and willingness to refer tospecialized colleagues, furthering a just society,respecting the law and/or laws of humanity,avoiding bias or prejudice, and commitment topeace[4]. With growing attention and interest inmedical oaths, the medical profession haswitnessedthecreationanduseofbothHippocraticandnon-Hippocraticbasedoaths,withsomeofthelatter often times being authored by medicalstudents and/or clinical faculty and projectingsomeof the ideals in theoriginalHippocraticoath[4]. One such variant, generally considered as themodernversionoftheHippocraticoathandwidelyused, is the World Medical Association (WMA)Declaration of Geneva’s Physicians Oath [5].Embodiedinthisdeclarationaretheguidelinesforbehavioral interaction between practitioners andtheir patients, practitioners and their teachers,practitioners and their colleagues, as well aspractitionersandhumanity/societyasrepresentedbylawandthegovernment.

In Nigeria, all fresh medical graduates onformal induction into the medical profession arerequiredtopubliclydeclaretheirreadinesstoobeythe professional rules and regulations (Code ofMedicalEthicsinNigeria)oftheMedicalandDental

Council Of Nigeria (MDCN-the regulatory body formedicalanddentalpractice)andallother lawsforthe control of the medical profession, as well assubscribe to the Physicians’ Oath [6], these beingthe core of medical ethics and professionalism inthe country. All the newly inducted doctors areconsequently given personal copies of the Code ofMedical Ethics booklet together with theirprofessional temporary registration licenses but itis doubtful if this actually generates acommensuratelevelofinterestinmedicalethics.

Incidentally, there is no documented formalundergraduatemedical ethics and professionalismeducation program that is actively beingimplemented in most Nigerian medical schools.Undergraduate medical education remains largelyfocused on traditional clinical and basic medicalscience components, leaving students to developmoral attitudespassively throughobservation andintuition [7], a situationworthy of note given thatpaternalism is still very much alive and well inmany of the routine doctor-patient interactions intheNigeriansociety.Evenwhenethicsinstructionshadbeengiven,anecdotalevidencepointstothesebeingveryinconsistentandthespecificteachingonthesemedicaloathsbeinghighlyvariable.

Againstthisbackdrop,thecurrentrelevanceofswearing to these medical oaths is beingquestioned,particularlywhentheseyoungdoctorsare compelled into participating in these oathtaking ceremonies. There is paucity of evidence inoursettingsonhowmuchofthesedeclarationsareretained, recalled and applied by these youngdoctors in the course of their duties. As apreliminary step to developing a curriculum forundergraduatemedicalethics inNigeria,ourstudydetermined the views of pre-registration houseofficers (PRHOs) on the relevance of the medicaloaths and some selected issues explicitly orimplicitly related to the ideals espoused in theseHippocratic-basedmedicaloaths. 2. Methods A descriptive cross-sectional survey of pre-registration house officers(PRHOs)was conductedin 2013 as a pre-workshop activity for theorientation workshop on the ‘’Doctor-PatientRelationship” organized for the fresh intake ofPRHOs for a teaching hospital in Nigeria. Self-administered 37-item anonymous questionnairesweredistributedamongall theeligibleandwillingworkshop participants and, the completed oneswere consequently retrieved on-the-spot by theresearchassistantsafter30minutes.


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Table 1: The views of 104 PRHOs on statements regarding medical oaths Perception statement Agree

(%) Disagree (%)

Not sure (%)

Hippocratic oath or the physician’s oath are still relevant to modern medicine The current medical oaths should be revised in the face of emerging & evolving trends in medicine & society

75(72.1) 68 (65.4)

14(13.5) 21 (20.2)

15(14.4) 15 (14.4)

Medical schools should abrogate the medical oaths Graduating doctors should write their personal oaths Oath taking ceremonies automatically commit doctors to ethical conduct & practice

17 (16.4)

14 (13.5)

52 (50)

64 (61.5)

79 (75.9)

41 (39.4)

23 (22.1)

11 (10.6)

11 (10.6)

A pan-professional oath for all health workers is desirable, since modern health care is multidisciplinary

68 (65.4) 22 (21.1) 14 (13.5)

Respondentsweresimplyrequiredto indicate

if they agreed/disagreed with 29 perceptionstatements related to the relevanceof themedicaloathsandtheidealsespousedintheseHippocratic-based medical oaths (specifically the Physician’sdeclaration and the Hippocratic Oath). Theresponses to these statementswere initiallybasedon a 5 point Likert scale: 1=strongly disagree,2=disagree, 3=not sure, 4=agree and 5=stronglyagree,andsubsequentlygroupedinto3categories:1 and 2=disagree, 3=not sure, and 4 & 5=agree.Frequencies, proportions and percentages weregeneratedon these responses, using the StatisticalPackage for Social Sciences SPSS Version 19.Questionnaires with incomplete entries wereexcludedfromanalysis.Approvalforthestudywasobtained from the Health Research EthicsCommittee of a university Teaching Hospital inNigeria.

Table 2: The views of 104 Pre-registration house-officers on statements on certain ideals guiding professional practice Perception statement Agree

(%) Disagree (%)

Not sure (%)

A doctor’s life should be entirely consecrated to the service of humanity devoid of any other considerations

80 (76.9)

11 (10.6)

13 (12.5)

Medicine must be practiced always with respect, conscience, dignity, integrity & honour Doctors should only undertake interventions within their professional competence

102 (98.1)

96 (92.3)

Nil

6 (5.8)

2 (1.9)

2 (1.9)

Job security and self-preservation should be of secondary concern to doctors

39 (37.5)

37 (35.6)

28 (26.9)

Doctors should never embark on industrial strike actions

37

(35.6)

31

(29.8)

36 (34.6)

Doctors should always abstain from any mischief or corruption

103 (99)

Nil 1 (1)

3. Results Thesampleincluded63malesand41females,witha response rate of 94.6% (104/110). All therespondents had trained in 9 different medicalschoolswithinNigeria.Themean(SD)agewas26.2(2.7) years. All the respondents identifiedChristianityastheirreligion.Allhadparticipatedina mandatory medical oath-taking ceremony, ongraduation from their respective medical schools.Though all stated that they were aware of theoriginal Hippocratic Oath and/or the Physician’sOath,onlytworespondents(1.9%)wereconfidentabout reciting the Physician’s Oath/any medicaloath from memory or recalling all the specificdetailscontainedinit.Tables1to4showtheviewsof the 104 respondents on the 29 perceptionstatementspresentedinthequestionnaire.


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Table 3: The views of 104 pre-registration house-officers on statements on ideals related to the doctor-patient relationship Perception statement Agree

(%) Disagree (%)

Not sure (%)

A doctor must act in the best interests of the patient always

95 (91.3)

4 (3.9)

5 (4.8)

A doctor must act to avoid causing any form of harm to the patient always

93

(89.4)

4

(3.9)

7

(6.7)

A doctor should not use his medical knowledge to assist in the termination of a patient’s life(Euthanasia etc)

87

(83.6)

4

(3.9)

13

(12.5)

A doctor should not act to terminate a viable pregnancy

78 (75)

8

(7.7)

18

(17.3) A doctor must hold all information about his patients in confidentiality always, even after death

87

(83.6)

6

(5.8)

11

(10.6)

A doctor should not insist on payment before attending to any patient

38

(36.5)

30

(29)

36

(34.6)

A doctor should not issue a certificate of medical fitness without conducting the necessary examinations

91 (87) 8 (7.7)

5 (4.8)

A doctor should not issue a sick leave certificate to any undeserving patient, irrespective of the situation A doctor should not prescribe treatment over the telephone or email without first seeing and examining the patient A doctor should avoid all intimate relationships with one’s patients

89

(86)

77 (74)

98 (94)

6

(5.8)

17 (16)

2 (1.9)

9(8.6)

10 (9.6)

4 (3.9)

4. Discussion

With significant shifts in the traditionalmoralgrounds of the society against the background ofscientific/technological advances, the medicalprofession is increasingly being required to facehard choices in patient care and to re-examine itsownroleinhealthcareandthenatureofitsvalues[8]. The medical oaths, be it the modernizedHippocratic oath, Declaration of Geneva, Prayer of

Maimonides, oath of Louis Lasagna or othervariants[9],arethusbeingre-appraisedafreshforboth moral and professional guidance. The mainintentionof amedical oath seems tobe todeclarethe core values of the medical profession and tostrengthen the necessary resolve in doctors toexemplifyprofessionalintegrity[8].However,withincreasing consideration of religious andgovernmentalissueswhichimpingeonprofessionalbehavior, concerns over the moral nature ofmedical education and practice are being broughtto prominence by students, practitioners, andfaculty. Oaths are deontological in that they bindthe oath-taker to certain kinds of duties andobligations,andpartaking in such is regardedasasymbolic, integral and shared aspect ofprofessionalization [4]. By providing the oath-taking young doctor with a set of general ethicalprecepts and prohibitions, he is then expected toapply such to situations arising in daily medicalpracticeandinteractions. Table 4: The views of the 104 PRHOs on perception statements regarding relationship with teachers, colleagues & students/trainees. Perception statement Agree

(%) Disagree(%)

Not sure(%)

A doctor should show all his teachers unconditional respect & gratitude, which is their due

91 (88)

6 (5.8)

7 (6.7)

A doctor should help all his teachers in professional matters, if & when required

89

(85)

4

(3.8)

11

(10.6)

A doctor should help all his teachers in other matters, if & when required.

72

(69)

15

(14)

17

(16) A doctor should relate with all other doctors as family, & not merely as colleagues

77

(74)

9

(8.7)

18

(17)

A doctor should impart medical knowledge only to those students, trainees & colleagues he considers responsible and serious

19 (18)

65 (63)

20 (19)

A doctor should impart medical knowledge to any student, trainee or colleague wishing to learn

97 (93)

3 (2.9)

4 (3.8)

A doctor should avoid intimate relationships with one’s students or trainees.

91 (88)

4 (3.8)

9 (8.7)


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Oath–taking among professionals is aubiquitous practice and even among Africans, theconcept isenshrined inthe ideathat it isusuallyaceremony of great solemnity and a publicattestation of the veracity and sincerity of theswearer’swordsandactions.Yet,as theuseof themodern medical oaths has burgeoned, theircontents have veered away in somanyways fromtheoriginaloath’sbasictenets.Manycontemporaryoaths seem diluted and the lack of enforceablesanctions for defaulters seemingly render themtoothless in their impact. A growing number ofpractitionershadcometo feel thattheHippocraticOath is inadequate to address the realities of amedical world that has witnessed huge scientific,economic,politicalandsocialchanges;andthattheprinciplesenshrinedintheoathdonotconstituteasharedcoreofmoralvalues foradherentsofotherreligions, considering its pagan origins. With alltheseinmind,somedoctorsseeoath-takingaslittlemore than a pro-forma nostalgic ritual with littlevalue beyond that of upholding tradition, being anear-meaninglessformalitydevoidofanyinfluenceonhowmedicineistrulypracticedintherealworld[10].

Our study demonstrated that all the medicalschoolsattendedby the respondentsadministeredthePhysician’sOathtotheirgraduates,inlinewiththerequirementsoftheMedicalandDentalCouncilofNigeria(MDCN).ThoughthePhysician’sOathisamodernized formof theclassicalHippocraticOath,it differs mainly from the original version in notmaking reference to God or any deity, sexualmisconduct, abortion, euthanasia/physician-assistedsuicideandpossibilityofconsequencesforfailure to live up to the stated ideals. This use ofonly the Physician’s Oath in these oath-takingceremonies is very much unlike the situation insomeotherpartsoftheworld,wherevariousformsof oaths were used, with some versions beingauthored by the students and some schools evenofferingtheirstudentsamenuofoathstopickfromfor use in graduation ceremonies and otherrelevantevents[4].

Studieshaveshownthatoverthelastcoupleofdecades the prevalence of oath taking in U.Smedical schools had grown remarkably from only28% in 1928 to involve all allopathic schools andosteopathicschoolsby1993[11],withonly1.6%of100 allopathic schools using the Declaration ofGenevaand21.3%usingamodifiedDeclarationofGeneva in 1993 [4]. On another note, acontemporarymedical ritual called thewhite coatceremonyisnowbeingpracticedatmorethan100American medical schools, in which first yearmedical students publicly vow to abide by the

medical oaths occasionally authored by thestudentsand/orfaculty[12].

The degree of importance which thesegraduating students attach to thesemedical oathshadalsobeencalledtoquestionatvarioustimes.Inour study, virtually none of the PRHOs wasconfidentaboutrecitingthecontentsofanymedicaloathbymemoryorrecallingallthespecificdetails,a situation corroborated in other studieswhere itwas stated that the contents of the medical oathsworntowereoftensoonforgotten[13,14].Onthecontrary, thosestudentswhohad formallystudiedthemedicaloathwereshowntohaveabetterrecallofitsprinciples[14].Inlinewiththatfinding,itwassuggested that, at a minimum, the last hours ofmedical school education be devoted to a formalstudyoftheHippocraticOath[14].Thus,theroleofmedical oaths in the ethical education ofundergraduatemedicalstudentswillneedtobere-assessed in our medical schools, if these youngdoctors are to stop regarding these oath-takingexercises as mere ritualistic recitations. The needforformal instructionsisbuttressedfurtherbytheassertions ofmajority of our respondents that themedicaloathsarestillrelevanttomodernmedicineandassuch,shouldnotbeabrogated.

Furtheranalysisof theirviewson themedicaloaths(TableI)showsapreferenceforarevisionofthe medical oath to align with evolving trends inmedicineandsociety,withoutnecessarilyexpectinggraduating doctors to write their personal orpreferredoaths.Theuseofnon-standardoathsmaymake oaths and oath taking more relevant andusefulasmeansofpromotingprofessionalismbutitmayalsoleadtofragmentationandconfusionabouttheethicalvaluesofthemedicalprofession,therebydilutingthevalueofaprofessionallybindingoath.

At our level ofNationaldevelopment, offeringstudentsamenuofoathstoselectfromaspracticedin the western world may further worsen thesituation as mixed messages will be sent out tothese students from time to time, erroneouslyconveying the impression that medical oaths areflexible documents which can be framed in anyformtosuittheoath-taker[4].Suchasituationmaynot augur well for the ethical and professionaldevelopment of these young doctors, given thattheyhadlittleornoformalmedicalethicsteachingas undergraduates. With respect to possiblerevisions required on the currently usedPhysician’s oath and the oath-taking ceremony,furtherqualitativestudiesareimperative,involvingthe MDCN, medical educators, policy makers,administrators, medical practitioners, patients aswellasthestudents.Thedevelopmentanduseofamore socio-culturally sensitive and relevant oath


64

mayalsoenhancetheimportanceandrelevanceofthesemedicaloathstothesegraduatingdoctors.

Also, worthy of note is the view held by themajorityof respondentsabout thedesirabilityofapan-professionalcode.Ifsuchweretopromoted,itcouldengenderapositivedegreeofmoralcohesionbetweenall caringprofessions,across institutionalboundaries, influencing perhaps even theorganization of health care [8]. The hope is that asingleoathforallhealthcareprofessionscouldhealsplit loyalties and ameliorate existing moraltensionsinhealthcare[8].However,thismayonlybe worthy consideration with the activecooperation of all the other stakeholders in thehealth care sector, and may not be currentlyfeasible inNigeria considering the prevailing levelof inter-professional disharmony in the healthsector.

The Hippocratic Oath’s timelessness as atouchstoneofmedicalcarerestsinanemphasisonthevaluesofan‘’idealphysician’’[15],eventhoughonemaynotknowtowhatextentthesevaluesareactually taught in themedical schools.There isnoreference in it or other variants to the facts andskills that a doctor must know, only to thebehaviorsexpectedinthepracticeofmedicine[15].Although there is paucity of data on the impact ofmedicaloathsuponoath-takers’behaviors,astudyinIsraelshowedthatthemedicalstudentsdoubtedthe oath’s influence [16]. Analysis of the views ofthePRHOsontheperceptionstatements(Tables2to 4) in our study indicate a reasonable level ofagreeabilitywiththeidealsespousedinthemedicaloaths.Thoughoathsmaynotcompelbehavior,theymay serve to sensitize the oath-taker to theethically or professionally appropriate choicesinherent in any interaction. There may be adiscrepancybetween therespondents’ standpointson the perception statements and their actualbehavior in their everyday practice. Though thequestionnaires were self–administered andanonymous,itisstillpossiblethatthefrequencyofagreementwiththosestatementsinsupportoftheideals espoused in these oaths might be over-estimatedduetosocialdesirabilityeffect.

GiventhatthePhysician’sOathdoesnotmakeany explicit references to sexual misconduct,abortion and euthanasia unlike the classicalHippocratic Oath, their responses on the relatedperception statementsareapparently indicativeofthesedoctors’beliefthattheirfirstresponsibilityisto care for their patients, acting as a fiduciary forthe patient and keeping with the traditionalHippocratic moral obligation of providing netmedicalbenefittothepatientwithoutcausingharmin any form. In addition, theunderlying influencesof their Christian and socio-cultural beliefs

regarding the sanctity of life and the fact thatabortion and euthanasia are illegal in Nigeria areobviously contributory to the views expressed.Regarding sexual relationships between doctorsandpatientsorbetweendoctorsandtheirstudents,these issues are still subjects of ethical and legalanalysis inmany places and their inclusion in themodernmedicaloathsisstillbeingdebatedglobally[17].

One criticism somepeople have againstmanyof the medical oaths is their perceived failure tokeep up with contemporary issues in society andthe medical profession. Legally, however, medicaldoctorsinNigeriaarenotheldstrictlyaccountableasfiduciariesastheymayalsohaveobligationsandallegiance to other parties such as the NigerianMedicalAssociationandtheNationalAssociationofResident Doctors. In a society grappling withchanges characterized by unionization of themedical profession, institutionalization anddepersonalization of health care, incessantindustrialstrikeactionsandcompetitionwithinthehealth sector, advertising/commercialization ofpractice, and specialization in medicine, it isbecomingmoreimperativethatgraduatingdoctorsbeprovidedwiththerequisiteknowledgeandskillsfor navigating through this emerging and evolvinglandscapeofethicalandprofessionalchallenges.

The pattern of responses (evenly distributedacrossthethreecategoriesofresponses)observedin relation to 3 perception statements on doctors’involvement in strike actions, job security/self-preservation issues (Table 2) and demand forpayment of hospital fees before service(Table 3)shows a gap in knowledge and some level ofconflict among the significant proportions of thestudy sample with respect to identifying theexpected behavior in those circumstances asprescribedbythetenetsofthemedicaloathsorthecodeofmedicalethics,giventhattheseoathsdonotalso make any explicit reference to these threeissues.

In Nigeria, as in so many other developingcountries, strike actions had been carried out inprotestoverawidearrayofreasonsincludingpoorremuneration, staff welfare/job security issues,healthinfrastructuraldeficiencies,andpoorqualityof health services. There is still no single bestanswer against or in favour of doctors’ strikeactions[18].Utilitariansmayjustifysuchactionsonthe basis of potential long-term benefits to thedoctor, patient and the health care deliverysystems. Others would, nevertheless, argue thatunder the Hippocratic-based oaths, care of thepatientismainlyasocialcontractualobligationforthe doctors and should have primacy over otherconsiderations[18].


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Regarding payment for services, some mayarguethatthehistoricalruleisthatadoctorisnotboundtoacceptapatientregardlessoftheseverityof the condition, but that it becomes ethicallyindefensibletodosuchoncethecontractualdoctor-patientrelationshipisestablished.ThedemandforcashdepositsinNigerianhospitalsbeforeapatientis treated has become a dangerous trend in thehealthcaresector[19].TheproprietyorotherwiseofthispracticeisstilldebatableasthereisnoclearlegalreferencepointinNigeriatocompelamedicalpractitionertotreatapatientwhoisunabletopay,unlike in some jurisdictions like America whichrequireapractitionertoacceptanindigentpatientfor treatment, this being predicated on theprinciple of preserving life atwhatever costs [19].Onarelatednote,medicalstudentsinNigeriawereshown in another study to have identified issuesrelated to payment of medical bills as among theleading ethical challenges confronting medicaldoctors in Nigeria [7]. There is no doubt that thisissue along with other debatable issues arechanging the entire construction of medicalpracticeandeducationinthecountry.

As a curricular event required for theprofessional development of these fresh medicalgraduates, the tradition of taking ofmedical oathsat formal ceremonies should be sustained bymedicalschools.Althoughall thetraditional tenetsand ideals espoused in these oaths continue toresonatewith these juniordoctors, there isaneedto review the contents with a view of addressingthe emerging and evolving realities of themedicalenvironment in Nigeria, an environment that haswitnessedsignificantsocial,economic,culturalandpolitical changes. For these oaths to gain greaterrelevance and priority among these doctors, theyshouldberecitedwithinthecontextofareformed,robust undergraduate medical educational systemwithanintegratedmedicalethicscurriculumandafunctionalhealthcaresystemthatisresponsiveandsensitivetosocietalneedsandchanges. References 1) JotterandF.TheHippocraticOathandcontemporaryMedicine: Dialectic between past ideals and presentreality. Journal of Medicine and Philosophy 2005;30:107-128

2)MeffertJJ.”ISwear!’’Physicianoathsandtheircurrentrelevance. Clinics in Dermatology 2009; 27:411-415.doi:10.1016/j.clin.dermatol.2009.02.016.

3) Newman A, Park IR. An oath for entering medicalstudents.AcademicMedicine1994Mar;69(3):214.

4) Kao AC, Parsi KP. Content analyses of oathsadministeredatU.S.medicalschoolsin2000.AcadMed2004;79(9):882-887.

5) The World Medical Association. Declaration ofGeneva.Geneva,Switzerland.AdoptedSeptember1948

and amended 1968, 1983, 1994.www.wma.net/en/30publications/10policies/g1/WMA_DECLARATION-OF-GENEVA_A4_EN.pdf (accessedDecember20,2016).

6)AbegundeB.Legalimplicationsofethicalbreachesinmedical practice: Nigeria a case study. Asian JHumanitiesandSocialSciences2013Nov;1(3):69-87.

7) Ogundiran TO. Adebamowo CA. Medical EthicsEducation:AsurveyofopinionofmedicalstudentsinaNigerianuniversity.JAcadEthics.2010;8(2):85-93.

8) Hurwitz B, Richardson R. Swearing to care: theresurgence in medical oaths. BMJ 1997;315:1671-1674.

9) Jonsen A. A short history of medical ethics. Oxford:OxforduniversityPress,2000:4

10) Tyson P. The Hippocratic Oath today. NOVA.www.pbs.org/wgbh/nova/body/hippocratic-oath-today.html.AccessedDecember23,2016.

11)OrrRD,PangN,PellegrinoED ,SieglerM.UseoftheHippocratic Oath :a review of twentieth centurypractice and a content analysis of oaths administeredinmedical schools in the U.S. and Canada in 1993. JClinEthics1997;8:377-388.

12)HuberSJ.TheWhitecoatceremony:acontemporarymedical ritual. J Med ethics 2003;29:364-366doi:10.1136/jme.29.6.364.

13)LoudonI.TheHippocraticOath.BMJ1994;309:414.14)MofficHS,BayerT,CoverdaleJ.TheHippocraticOathandmedical students.AcadMed 1990 Feb;65(2):100-101.

15)SternDT.Practicingwhatwepreach?Ananalysisofthe curriculum of values in medical education. Am JMed1998;104:569-575.

16)YakirA,GlickSM.Medicalstudents’attitudestothePhysician’sOath.MedEduc1998;32:135.

17)PerezSG,GelpiRJ,RancichAM.Doctor-patientsexualrelationships in medical oaths. J Med Ethics2006;32:702-705doi:10.1136/jme.2005.014910

18)AbbasiIN.Protestofdoctors:abasichumanrightoran ethical dilemma. BMC Med Ethics 2014,15:24.http://www.biomedcentral.com/1472-6939/15/24

19) Obidimma EOC, Obidimma AE. Legal and ethicalissuesinthedemandforpaymentbeforetreatmentinNigerian hospitals .Journal of law, policy andglobalization2015;38:176-181.


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Unethical Clinical Trials in India: A Selective preliminary overview -AnkitaChakravartyWest Bengal National University of JuridicalSciences,No.12,LBBlock,-AmbedkarBhavanSector III, Salt Lake City, Kolkata, West Bengal700098,India Abstract This paper attempts to study the phenomena ofclinical trials in India with a specific focus on theconduct of unethical trials. There has been awidespread chronicling of the rise of the greatpharmaceutical power, the triumphs leading toimprovements in life expectancy along withtreatments and cures for numerous diseases. Butthere has also been the equally fascinating tale ofthe appalling usage of power in the form ofcoercion and deceit, with human beings exploitedand subjugated tohorrific formsof torture for theadvancement of scientific knowledge and financialgains. 1. Introduction There are legal and ethical provisions relating tothe clinical trials sector and theseprovisions havebeen formulated both at the international andnational levels and one of their major aims is toprovide protection to the participants of clinicaltrials.However, despite the existenceof a numberofethicalguidelinesaswellasthelegalstipulations,there have been numerous instances of clinicaltrials being conducted unethically and illegally inIndia. While such trials have been reported fromother parts of the world as well, there have beenquiteafewIndiancasesrecentlywhichcontinuetobe in focus- thereby providing the basis for thisresearchwork.

India has been hailed as an emerging clinicaltrial location over the last decade or so and thedifferentadvantagesitoffershavebeenrepeatedlyhighlighted (Yee2012).Pharmaceutical companiesarethemajorsponsorsofclinicaltrialsandasmoreand more of these companies venture into drugdevelopment and clinical trials, there is a need tohave access to a large pool of participants for thetrials. Along with the population advantages andtheavailabilityoflowercostoflabourandexpertiseavailable in India, the facilities promised by theGovernmenthavealsoplayedan important role insettingupIndiaasanattractivelocation.However,the reports of trials being repeatedly carried outunethically and illegally have raised certain

questionsaboutthefunctioningoftheclinicaltrialssectorinIndia.

This study seeks to investigate the clinicaltrialssectorinIndiaas,overthelastfewyears,thequestion of clinical trials in India has been acontentious one. This is largely because a numberof trials were found to have been conducted onIndian patients without following the necessarylegal and ethical principles (recently, for instance,the HPV Vaccine trial, Indore Public Hospital andBhopal Memorial Hospital trials). It is this areawithin the clinical trials sector which forms thefocusofthiswork-however,thescopeofthispaperisonlylimitedtoanoverviewofsomeoftheearlierreportsofunethicaltrialsinIndia.Forthispurpose,the publication of the ICMREthical Guidelines hasbeentakenastheintegraldevelopment,andhence,only trials which were reported prior to thedevelopment of the guidelines have been includedinthisshortreview.2. The ethical questions: unethical clinical trials in India In order to gain an insight into the clinical trialssector in India,weneedto tryandunderstandthecontext in which it was established and thesubsequent path of its development. Thisnecessitates identifying the historical cases ofunethicaltrialsinIndiaalongwithdocumentingtherecentcases.

The cervical dysplasia trial was perhaps thefirst well documented case of trials beingconductedinIndia.In1970sand1980sresearchersat the Institute for Cytology and PreventiveOncology which is an institute under the IndianCouncil ofMedical Research (ICMR) inNewDelhi,carried out a study on women patients whopresentedwithdifferentstagesofcervicaldysplasiaorwhatweresuspectedtobeprecancerouslesionsof the cervix. Thewomenwere not informed thattheywere participating in a trial, andhence, noneof them were asked for consent. Nonetheless, itshouldbenotedthattheresearcherssaidthattheytook verbal consent from the women who wereilliterate. They also argued that the study wasjustified in that therewas ‘noconclusiveevidence’that all severe dysplasias develop into cancer.However, while the studywas underway, amajorNorth American medical journal published thefindingsofalongitudinalstudyofcervicalcancer.

The study concluded that cervical dysplasiawas indeed a precursor for cervical cancer, andthusthatall formsofdysplasiaweretobetreated.However, despite these new findings, the Indianresearchers continuedwith the study. The subjectparticipants were left untreated to see howmany


67

lesions progressed to cancer and how manyregressed. By the end of the study seventy-onewomenhaddevelopedmalignanciesand lesions innine of them had progressed to invasive cancer.Sixty-two women were treated only after theydevelopedlocalisedcancer.Itwaslargelyduetothecontroversy that erupted after the study washighlighted in the 1990s, that the ICMR EthicalGuidelines for Biomedical research in Humanwasformulatedin2000(Srinivasan,2005).

Although India adopted Schedule Y andScheduleXAoftheDrugsandCosmeticsRules1945which relates to clinical trials in 1988, the studyhighlights the ethical issues that can emerge inclinical trials, and therefore establishes why suchtrials need to be closely regulated. Further, theprinciples enshrined in the Helsinki Guidelineswere not adhered to. While the investigatorsasserted that they had acquired verbal consent,there was no evidence that the women had beeninformed about their potential participation in aclinical research study. Further, despite the factthat the research published in the journal clearlyestablished that all forms of dysplasia warrantedtreatment, the Indian investigators continuedwiththestudy.ThisisclearlynotinkeepingwithArticle7 of the Helsinki Guidelines (1964) whichestablishes that ‘physicians should abstain fromengaging in research projects involving humansubjects unless they are satisfied that the hazardsinvolvedarebelieved tobepredictable.Physiciansshould cease any investigation if the hazards arefoundtooutweighthepotentialbenefits’.Further,ithad been clearly stated in the introduction to theguidelinesthatthemissionofthephysicianwastosafeguardthehealthofthepeople.

It also needs to be clarified that in thepresentation of this case as well as the othersubsequentcases, theterm‘subjectparticipant(s)’is being used. What is being referred to is, theprocessoftheconstitutionofthetrialparticipantasa ‘subject participant’ rather than merely avolunteerparticipant.Thisisespeciallytrueincaseof unethical trials where the patients may not beaware of or fully comprehend their status asexperimentalsites. However,theintrinsicunequalpowerrelationsbetweenthetrialorganizerandtheparticipant also constitute her/him as a subjectparticipantevenifshe/heisawareofthetrial.Thevulnerability and defenselessness of their positionis more markedly revealed since it is their ownresource of life which is leased out as resourcematter for trial activitieswhich are carried out toostensibly improve life existence and yet, mayparadoxically lead to diminishing of their own lifeexistence.

Thesecondcasebeingpresentedhere is fromthe1990s.Ahugemulti-countryunauthorizedtrialwas carried out on thousands of illiterate IndianandBangladeshiwomenwhereintheanti-malarialcompoundmepacrinewasused inpellet formasameans of female sterilization. Once inserted intothewomen’suterinecavity,itcausedinflammationand scar tissue formation which closed off thefallopian tubespermanently.15While the trials hadbeenstoppedintheWest,thecompoundhadbeendirectly distributed to medical practitioners inIndia.More than30,000women in Indiahadbeensterilisedusingthisillegalanduntestedmethod,atleast 10,000 in West Bengal alone. This trialdemonstrates the differing ethical standardsapplied in different country settings. In what wasclearlyanillegalmove,althoughthetrialshadbeenstopped in thewest, the interventionwas directlydistributed to medical practitioners instead ofbeing properly approved for testing. The SupremeCourt banned the use and sale of this drug but itcontinued tobeavailable in ruralBengal forup tofiveyearsafterthat(Dasgupta,2005).

TheM4NANDG4N trial is another importantcaseintheaccountofIndia’sclinicaltrialhistory.In1999, 2716people with oral cancer were undertreatment at the government-run Regional CancerCentre in Thiruvananthapuram. Although therewere established protocols of treatment includingsurgery, chemotherapy and radiation options, thepatients were given first-in-human experimentaldrugs, tetra-O-methyl nor-dihydro-guaiaretic acid(M4N) or tetraglycinyl nor-dihydro-guaiaretic acid(G4N). The aim was to determine whether thesechemicals could arrest the growth of oral cancer.Although the subject participants were made tosign consent forms, they were not informed thattheywereparticipating inaresearchstudyor thattherewereotherapprovedmeansoftreatmentfortheir condition.While approval for theanti-cancer

15Mepacrine is the name of the compound, but it wasbetter known by its commercial name Quinacrine.Although its use in sterilization has passed throughseveral small trials, therehasbeennooveralldismissalof its link to cancers and ectopic pregnancy and hence,WHO convened a technical consultation which decidedthat Quinacrine should not be used for sterilizationpurposes in women, either in research or therapeuticsettings.(WHOTechnicalConsultation,2009) 16Whilethequestionsontheethicalconductofthetrialarenumerous, therealsoappears tobesomeconfusionon the total number of trial participants. The RCC hadinitially acknowledged 27 patients but later releaseddata on only 23 of them. Subsequently, only 18 casesweretakenintoaccount.


68

drugtrialwastakenfromtheIndiandrugregulatoronly after the trial was underway (Srinivasan,2005), ethical clearance from the collaboratingorganization-JohnHopkinsUniversityhadalsonotbeenprovided.

The trial was only thrust into the mediaspotlight after a radiotherapist from the centreraisedseriousquestionsontheconductofthetrial.WhiletherewasanenquiryestablishedinIndiaaswell as in the US, only ‘procedural lapses’ werefoundtohaveoccurred.However,itmustbenotedthattheUniversitybarredtheprincipalinvestigatorfrom conducting any further research on thechemicalentitiesandalsoprovidedthatanyfurtherhuman clinical research to be carried out by theinvestigator would have to be supervised bysomeone from the Universitywho had experienceindealingwithhumantrials(Frontline,Vol.22Dec.2005). Subsequently, animal testing was done onthesechemicalsbeforethe launchofPhase1trialsonhumansinUSA.Moreover,thevolunteersintheUS trial were patients who did not have anytherapyoptionavailable to them.Thiswasnot thecase with the Indian subject participants. Thisparticular trial also serves to highlight thereprehensibleprocessinwhichtrialsareorganizedin India. Firstly, the subject participants were notinformed that theywere participating in a clinicaltrial,andtherebyreceivingexperimentaltherapyasopposed to approved therapy, thereby effectivelyamountingtodenyingthemtreatment.

Moreover, the trial was initiated beforepermission was sought, which was illegal as perSection 1.2 of Schedule Y of the Drugs andCosmetics Act, 1945 (GSR 944 (E) 1988). Further,theethicalcommitteeclearanceofthecollaboratingbody should also have been obtained as no suchclearancehadbeenacquired.Itmaybepertinenttopoint out that one of the possible reasons for theethical clearance not being sought from JohnHopkinsUniversity,mighthavebeen that itwouldhave been unlikely that permission would havebeen granted because of the serious ethicalquestion on the study itself. Hence, the questioncannotbelookedatinisolation-whatalsoneedstobe focussed upon is the undeniable role of thecontext of such a trial. This refers to the fact thatthe trial was being carried out in a third worldnation-statewhichhasahistoryofpoorregulatoryoversight;alsothelackofethicalclearancefromtheUS (first world) makes it an intriguing case andraises the pertinent question of elitism and even,worryingly,racism.

These three trials are illustrative cases of thenature and extent of unethical as well as illegalpracticesthatarewidelyprevalentinthepursuitofclinical research in India. To state clearly, all of

thesestudiesviolatedthefourbasictenetsofethicsas per the ICMR Ethical Guidelines- autonomy(respect for person /participant), beneficence (actfor the benefit of person/participant), non-maleficence(donoharm)andjustice(ICMREthicalGuidelines). Subjects were not informed that theywere participating in clinical research and actualinformedconsentwasnottaken.Participantsweresubjected to the trials while being deliberatelydeceived that they were receiving standardizedtherapyasopposedtoexperimentalinterventions.

The three cases of unethical trials that werepresented- the cervical dysplasia trial, themepacrine pellet trial and the G4N & M4N trialswere all conducted before the ICMR EthicalGuidelines for Biomedical research in HumanSubjects was presented in 2000, although the'Policy Statement on Ethical Considerationsinvolved in Research on Human Subjects' had infact, been published in 1980. The ICMR EthicalGuidelinesforBiomedicalresearchinHumanwerepublished first in 2000while the CDSCOpreparedthe Indian Good Clinical Practice (GCP) guidelinesin 2001. It is to be expected that after thecategorical formulation of ethical and clinicalconsiderations necessary for conducting clinicalresearchinIndia,thesituationwouldbesomewhatdifferent.

However,reportsoverthe last fewyearshavenot been positive and instead brought to lightfurther examples of unethical conduct of clinicaltrials. However, that is beyond the scope of thispaper.3. References Dasgupta,R. (2005)‘Quinacrine Sterilization in India:Women’s Health and Medical Ethics Still at Risk’http://www.global-sisterhood-network.org/content/view/237/59/

Krishnakumar, R. ‘Trial and Errors’ Frontline, Volume22 - Issue 25, Dec. 03 - 16, 2005http://www.hindu.com/thehindu/thscrip/print.pl?file=20051216005102200.htm&date=fl2225/&prd=fline&

ICMREthicalGuidelines,2006HelsinkiGuidelines,WMA,1964Srinivasan, S. (2005) ‘Some Questionable trials’http://infochangeindia.org/public-health/features/some-questionable-drug-trials.html

WHO Technical Consultation (2009)http://whqlibdoc.who.int/hq/2009/WHO_RHR_09.21_eng.pdf

Yee,A.(2012)‘RegulationfailingtokeepupwithIndia’strialboom’.TheLancet,Volume379,Issue9814,Pages397–398.


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