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Postgraduate Studies, Research Development & Ethics Sefako Makgatho University Research Ethics Committee (SMUREC) APPLICATION FORM: NEW STUDY (1) PARTICULARS OF APPLICANT/CHIEF RESEARCHER Surna me First names Title Staff /Student No Gende r fema le male Schoo l Department Tel Internal Box No Cell No: E-mail address (Researcher) E-mail address (Supervisor, if applicable) (2). DETAILS OF RESEARCH PROJECT (Tick appropriate block(s) with an ‘x’) 1 (i) New project or : Continuation of project (ii ) Independent research or : Contract research 1

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Page 1: APPLICATION FORM FOR PROPOSED RESEARCH ...€¦ · Web viewParticipant photography Recording of participants using photographic images and illustration that include digital (video

Postgraduate Studies, Research Development & EthicsSefako Makgatho University Research Ethics Committee (SMUREC)

APPLICATION FORM: NEW STUDY

(1) PARTICULARS OF APPLICANT/CHIEF RESEARCHER

Surname First namesTitle Staff /Student NoGender female maleSchool DepartmentTel Internal Box NoCell No:E-mail address (Researcher)E-mail address (Supervisor, if applicable)

(2). DETAILS OF RESEARCH PROJECT (Tick appropriate block(s) with an ‘x’)

1 (i) New project or : Continuation of project (ii) Independent research or : Contract research (iii) Post-graduate research or : Undergraduate research (iv) Laboratory study or: Sub-study

Degree

Year of study

2 (i) Provide the study title and synopsis of the research envisagedTitle (be as succinct as possible and place study geographically where possible – no abbreviations)

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Synopsis (provide only a summary of maximum 350 words under the following headings: Introduction, Aims & Objectives, Innovation, Methods (including data analysis), Plan for dissemination of results)

(ii) Co-investigator/s (in the case of independent or contract research) Name Department/Institution Signature

Email:

(iii) Co-workers (in the case of independent research - see guidelines) Name Department/Institution Signature

Email:

(iv) Research Coordinator (in the case of independent or contract research)Name Department/Institution Signature

Email:

(v) Supervisor (in the case of post-graduate or undergraduate research)Name Qualification/s Department/

InstitutionSignature

Email:2

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(vi) Co-supervisor (in the case of post-graduate or undergraduate research)Name Qualification/s Department/Institution Signature

Email:

(vii) Hospital Superintendent/ Health Care Manager Name Department/Institution Signature

(viii) Other involved departmental heads Name Department/Institution Signature

(3). SPECIAL REQUIREMENTSYes No Yes No

Statistical analysis Has a statistician been consulted? If yes, attach form. (Appendix 2) If no explain.

Special apparatus Available at Sefako Makgatho University?

Electron microscopy Completed Electron Microscope form attached (Appendix 3)

Special laboratory facilities Available at Sefako Makgatho University? If no, where can this be accessed? Insert a letter from the laboratory/ facility..

Radio isotopes Completed Radioisotopes form attached (Appendix 4)

Health care services Signature of health care manager attached. Refer section 5 Facility indemnity.

(4). PROCEDURES INVOLVED

Questionnaire or data collection sheets or interview schedule to be included

Material Transfer Agreement of Human Biological Materials to be completed

Radiographs Biobank Physical examination Biopsy materialsRecord review Genetic studiesInterview (self-administered)Interview form (researcher administered) Blood draw (venous)Focus group discussions(no confidentiality, provide anonymity)

Blood draw (arterial)

MCC/ SAHPRA Approval if not registeredDatabases Drug administration (include name, dose

and frequency of administration)Other: (specify)Ministerial Consent for non-therapeutic research Isotope administration

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Minors Medical Devices

(5) ETHICAL ISSUES

Yes NoFacility Indemnity If a hospital (human, dental or veterinary) will be involved,

please attach the written approval of the Superintendent. Should the use of the service laboratories be required, attach an approval letter from the hospital/ laboratory management that this is in order.

Patient Participant Information Brochure

This leaflet or brochure explains what will be investigated and what would be involved for the participants if they choose to take part. Please adapt the standard template for your particular investigation.

Consent Forms Will patients’ / human volunteers be invited to participate in the research? If so, kindly select and modify the attached standard forms (Appendix 1) in the appropriate language for the study.

(a) Parental/Guardian Consent A standard parental/ guardian consent form is available. Will minors or other vulnerable population groups be invited to participate in the research study? Then kindly use and modify the form as applicable for your research.

(b) Assent An assent form is available when children will be invited to participate in the study. Please modify the form so that it will be age appropriate for the minors.

(c) Participant photography Recording of participants using photographic images and illustration that include digital (video and still), film and radiographs. If yes, include Appendix 5.

(d) Voice recordings Clearly indicate in your protocol the informed consent, privacy and confidentiality measures (anonymity) related to voice recordings for interviews or focus group discussions

Use of medical information or biobanks

In cases where retrospective studies are performed by accessing medical information, biobanks or other stored samples (e.g. histology specimens), it may not be possible to obtain individual consent. Please refer to specific guidelines.

(e) Case Report/ Series A template is supplied to report on a case study (1-2) or case series (3-10) for publication or presentation purposes. Where possible consent must be obtained from individual patients, alternatively please motivate why this is not possible.

(f) Biobank/ Tissue Application An application cover is available for details of biobanks as needed. Also complete the Gazetted Material Transfer Agreement where necessary.

(g) Waiver of consent In cases where a retrospective record review involving medical information is to be done, the consent process may be waived. In these cases, a very clear motivation must be supplied as to why individual consent cannot be obtained. In such cases, delinking of patient information is required to provide anonymity and confidentiality. Please see guidelines for waiver of consent.

Other studies not including human participants

Review of information in public domain

Provide title of review and motivation that no human participants are included

Secondary analysis of datasets There are several publically available health-related electronic databases that can be used to address a variety of research topics. Kindly complete the SMU notification for external datasets.

In vitro laboratory study for non- Cell lines, bacterial cultures or any materials - confirm that no

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degree purposes humans, human data or human tissues will be included. Provide a motivation and research protocol.

In vitro laboratory study for degree purposes, not part of project with ethics approval

Cell lines, bacterial cultures or any materials -confirm that no humans, human data or human tissues will be included. Provide a motivation and research protocol.

In vitro laboratory study for degree purposes, within an approved umbrella study

Cell lines, bacterial cultures or any materials - confirm that no humans, human data or human tissues will be included. Kindly provide umbrella study information and a copy of the Ethics Clearance certificate.

Environmental impact Do you anticipate that your research may have an environmental impact? Please discuss this under ethical considerations.

Studies involving animals

Experimental animals or capturing of animals

Approval from Animal Research Ethics Committee required. (Also complete the separate AREC application form). Outcome to be submitted to SMUREC for Ethics Clearance Certificate to be issued.

(6) STATISTICAL ANALYSIS (What software will be used for analysis of data)SAS SPSS MS ExcelSTATA STATISTICA EpiInfoNVivo ATLAS ti Other

(7) BUDGET (Who will finance this project? Tick appropriate block with an ‘x’)

Sefako Makgatho Health Sciences University

Health Department Self Other (specify)

Please indicate the institutions where application has been made for financial support or where it is intended to apply for financial support. Kindly indicate (X)

Applied and awaiting outcomes

Not yet applied, but intends to apply

Single Source

MRC NRF CSD Other (specify)

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Multiple sources

MRC NRF CSD Other (specify)

Funding cycle I II III IV VTOTAL AMOUNTFunding source

Amount

NB: Approval of the research project does NOT imply that the requested funds will be made available to the applicant.

(8) DISSEMINATION OF RESULTS (Please discuss the anticipated dissemination of results)

(1) Which journal do you plan to publish in?

(2) Is this journal DHET/SAPSE accredited? YES NO

(3) If No, please discuss why this journal was selected

(9) DATA SHARING How do you intend to make your datasets available to the scientific community? Please discuss.

(10) DISCLOSURES OR CONFLICT OF INTEREST

(Any disclosures or Conflicts of Interest regarding the anticipated research, e.g. non-dissemination agreements with sponsor)

(10) DECLARATION BY RESEARCHER(S)

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Should this project be approved, I/we fully understand the conditions under which I am/we are authorised to carry out the above-mentioned research. I/we guarantee to ensure compliance with these approved conditions. Furthermore, I/we undertake not to change the procedure as detailed in the protocol but will submit a further application to the Research Committee if changes do become necessary (please add additional lines if required).

1. TITLE, INITIALS & SURNAME CHIEF RESEARCHER

SIGNATURE DATE

2. TITLE, INITIALS & SURNAME HEAD OF DEPARTMENT SIGNATURE DATE

3. TITLE, INITIALS & SURNAME CHAIRPERSON: SCHOOL RESEARCH COMMITTEE SIGNATURE DATE

4. TITLE, INITIALS & SURNAME DEAN OF SCHOOL

SIGNATURE DATE

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CHECK LIST FOR PROPOSED RESEARCH PROJECT AT THE SEFAKO MAKGATHO HEALTH SCIENCES UNIVERSITY

Documents to be submitted Yes No1. Completed research protocol2. Completed research application form

2.1 Signature of Chief Researcher2.2 Signature of Head of Department2.3 Signature of Chairperson: School Research Committee2.4 Signature of Dean of School2.5 Appendix 1: Completed Consent form (English version)2.6 Appendix 1: Completed Consent form (Translated local language version)2.7 Appendix 1: Assent Form2.8 Appendix 1: Parental/ Guardian Consent Form2.9 Participant information brochure2.10 Site approval Dr George Mukhari Academic Hospital2.11 Other approvals/ forms e.g. Ministerial consent for non-therapeutic

research form, Material Transfer Agreement form, Proof of registration on National Clinical Trials Register (see guidelines for submission of protocols to SMUREC, SAPHRA application etc.)

3. Appendix 2: Completed statistical analysis form with statistician’s signature4. Data collection tool (including questionnaire) plus permission to use where required.5. Appendix 3, 4 or 5 for Electron Microscope Unit, Radioisotopes or Patient

Photography6. Other recruitment material e.g. posters; brochures and flyers7. If animals form part of the research, has the Animal Ethics Application been completed?

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SEFAKO MAKGATHO HEALTH SCIENCES UNIVERSITYSuggested format for research protocols

The research protocol should be typed in double spacing. The title or research question should be clearly stated, including the details of the chief researcher, supervisor and co-supervisor, where applicable.

Length of protocol: It is unlikely that a protocol shorter than three pages (including references, but excluding data collection forms and questionnaires) will contain enough information for Research Committee to assess the merits of a research project. A long protocol does not necessarily convince the Committee either. Most importantly be concise about your planning. Protocols of ten pages (including references, excluding data collection forms and questionnaires) are ideal. For higher degree candidates, a longer protocol is acceptable but should not exceed 20 pages ((including references, excluding data collection forms and questionnaires). If your department requires a longer protocol, it will have to be shortened for the Research Committees.

The following headings are suggested, although some studies may require a slightly different format:

1. The study problem (or, rationale of the study). In a paragraph or two, explain what the problem is.

2. Literature Review (or background to the study): In half to three pages, explain what is known from the literature.

3. Aim & objectives of study: State the aim of study and 1 to 4 objectives. These must be short, succinct and exact behavioural statements. (e.g. To determine the length of hospital stay of paediatric patients with HIV infections)

.4. Methods:

4.1 Give a brief account of the methods you intend to employ, including the study design.4.2 The sample: How are potential subjects identified, and how is the sample drawn?4.3 Materials, Apparatus and Instruments (give a concise and systematic list).4.4 Data collection: How will data be collated? Which tests will be done and which research instruments

(psychosocial) will be used?4.5 Data analysis: How will data be collated and analyzed, including statistical analysis, if appropriate?4.6 Reliability and validity of study: How will these be accomplished in the study?4.7 Bias: What types of bias will be encountered? How will they be minimized?4.8 Ethical considerations: Informed consent must be included and indicate all authorities to be contacted for

permission to conduct the study. There is a standard consent form available*, which must be adapted to include only the relevant particulars for your study e.g. focus group discussions, interviews, voice recordings etc. and attach to the protocol.

4.9 References: A recognized system is preferred e.g. Vancouver or Harvard. Please be consistent in its use. Six to ten references are usually appropriate - this is not a thesis

4.10 Appendices: All Data collection forms and questionnaires: should be attached, where relevant. If designed for this study, questionnaires should be attached. If questionnaires are extremely well known, they need not be attached. If in doubt, it should be attached.

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APPENDIX 1

SEFAKO MAKGATHO HEALTH SCIENCES UNIVERSITY ENGLISH CONSENT FORM

You are hereby kindly invited to participate in a Clinical Trial/Research Project*

Name of Project / Study / Trial*

.............................................................................................................................................................................…….

.....................................................................................................................................................................................

.....................................................................................................................................................................................

I have read the information on */heard the aims and objectives of* the proposed study and was provided the opportunity to ask questions and given adequate time to rethink the issue. The aim and objectives of the study are sufficiently clear to me. I have not been pressurized to participate in any way.

I know that photographs / electronic images / sound recordings* will be taken of me. I am aware that this material may be used in scientific publications which will be electronically available throughout the world. I consent to this provided that my name / and hospital number* is / are* not revealed. Regarding images of the face, I understand that it may not be possible to disguise my identity, and I consent to the use of these images*.

I understand that participation in this Clinical Trial / Study / Project* is completely voluntary and that I may withdraw from it at any time and without supplying reasons. This will have no influence on the regular treatment that holds for my condition neither will it influence the care that I receive from my regular doctor.

I know that this Trial / Study / Project* has been approved by the Sefako Makgatho University Research Ethics Committee (SMUREC), Sefako Makgatho Health Sciences University / Dr George Mukhari Hospital. I am fully aware that the results of this results of this Trial / Study / Project* will be used for scientific purposes and may be published. I agree to this, provided my privacy is guaranteed.

I hereby give consent to participate in this Trial / Study / Project*.

............................................................ ........................................................Name of patient/volunteer Signature of patient or guardian

................................ .................................... ................................................Place Date Witness___________________________________________________________________________Statement by the Researcher

I provided verbal and/or written* information regarding this Trial / Study / Project*I agree to answer any future questions concerning the Trial / Study / Project* as best as I am able.I will adhere to the approved protocol.

....................................... .................................... ...............……Name of Researcher Signature Date Place

*Delete whatever is not applicable.

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AANHANGSEL 1

SEFAKO MAKGATHO HEALTH SCIENCES UNIVERSITY AFRIKAANS CONSENT FORM

U word hiermee vriendelik genooi om deel te neem aan 'n Kliniese Eksperiment/ Navorsingsprojek*

Naam van Projek/Studie/Eksperiment*

.............................................................................................................................................................................…….

.....................................................................................................................................................................................

.....................................................................................................................................................................................

Ek het die inligting in verband met die beoogde studie gelees*/het die doelwitte en oogmerke van die beoogde studie aangehoor* en is die geleentheid gegun om vrae te stel asook voldoende tyd toegelaat om oor die aangeleentheid te besin. Die doelwit en oogmerke van die studie is duidelik genoeg vir my. Ek is geensins onder enige druk geplaas om deel te neem nie.

Ek verstaan dat deelname aan hierdie Kliniese Eksperiment/Studie/Projek* geheel en al vrywillig is en dat ek te eniger tyd daarvan kan onttrek sonder om enige redes aan te voer. Dit sal geen invloed hê op die gereelde behandeling van my toestand nie, en sal ook nie die behandeling wat ek van my eie dokter ontvang, beïnvloed nie.

Ek is bewus daarvan dat hierdie Eksperiment/Studie/Projek* goedgekeur is deur die 'Sefako Makgatho University Research Ethics Committee (SMUREC)', Sefako Makgatho Health Sciences University /Dr George Mukhari Hospitaal. Ek is ten volle bewus daarvan dat die uitslae van hierdie Eksperiment/Studie/Projek* aangewend sal word vir wetenskaplike doeleindes, en gepubliseer mag word. Ek stem daartoe in, met dien verstande dat my privaatheid gewaarborg is.

Hiermee verleen ek toestemming om deel te neem aan hierdie Eksperiment/ Studie/Projek*

............................................................ .......................................................Naam van pasiënt/ vrywilliger Handtekening van pasiënt of voog

................................ .................................... ................................................Plek Datum Getuie___________________________________________________________________________Verklaring deur Navorser

Ek het mondelingse en/of skriftelike* inligting ten opsigte van hierdie Eksperiment/Studie/Projek* voorsien.Ek verklaar myself bereid om enige toekomstige vrae ten opsigte van die Eksperiment/Studie/Projek* na die beste van my vermoë te beantwoord.Ek sal myself onderwerp aan die goedgekeurde protokol.

....................................... .................................... .............…… ……………………..Naam van Navorser Handtekening Datum Plek

*Skrap waar nie van toepassing nie.

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APPENDIX 1

SEFAKO MAKGATHO HEALTH SCIENCES UNIVERSITY SETSWANA CONSENT FORM

Lo lalediwa go tla go tsaya karole ngo porojekeng ya dileko tsa mafaratlhatlha (research project) le a di patlisiso mo mererongya ‘science’ (clinical trials) *

Leina la Porojeke / Patlisiso / Tekelelo*

.............................................................................................................................................................................…….

.....................................................................................................................................................................................

.....................................................................................................................................................................................

Ke buisitse tshedimosetso mo */ke utlwile maitlhomo le maikemisetso a* patlisiso e e tshitshintsweng mme ke filwe tšhono ya go botsa dipotso le go fiwa nako e e lekaneng ya go akanya gape ka ntlha e. Maitlhomo le maikemisetso a patlisiso e a tlhaloganyega sentle. Ga ke a patelediwa ke ope ka tsela epe go tsaya karolo.

Ke tlhaloganya gore go tsaya karolo mo Tekopatlisisong e / Patlisiso / Porojeke* ke boithaopo le gore nka ikgogela morago mo go yona ka nako nngwe le nngwe kwa ntle ga go neela mabaka. Se ga se kitla se nna le seabe sepe mo kalafong ya me ya go le gale ya bolwetsi jo ke nang le jona e bile ga se kitla se nna le tlhotlheletso epe mo tlhokomelong e ke e amogelang mo ngakeng ya me ya go le gale.

Ke a itse gore Tekopatlisiso / Patlisiso / Porojeke* e e rebotswe ke Patlisiso le Molao wa Maitsholo tsa Khampase ya Sefako Makgatho University Research Ethics Committee (SMUREC), Yunibesithi ya Sefako Makgatho Health Sciences / Bookelo jwa Ngaka George Mukhari. Ke itse ka botlalo gore dipholo tsa Tekelelo / Patlisiso / Porojeke* di tla dirisetswa mabaka a saentifiki e bile di ka nna tsa phasaladiwa. Ke dumelana le seno, fa fela go netefadiwa gore se e tla nna khupamarama.

Fano ke neela tumelelo ya go tsaya karolo mo Tekelelong / Patlisiso / Porojeke* e.

............................................................ ........................................................Leina ka molwetse/moithaopi Tshaeno ya molwetse kgotsa motlamedi

................................ .................................... ................................................Lefelo Letlha Paki___________________________________________________________________________Seteitemente ka Mmatlisisi

Ke tlametse tshedimosetso ka molomo le/kgotsa e e kwadilweng malebana le Tekelelo / Patlisiso / Porojeke* e. Ke dumela go araba dipotso dingwe le dingwe mo nakong e e tlang tse di amanang le Tekelelo / Patlisiso / Porojeke* ka moo nka kgonang ka teng. Ke tla tshegetsa porotokolo e e rebotsweng.

....................................... .................................... ...............……….. ………………………..Leina la Mmatlisisi Tshaeno Letlha Lefelo

*Phimola sengwe le sengwe se se seng maleba.

TLALELETŠO 1

Sefako Makgatho Health Sciences University SEPEDI CONSENT FORM

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Setatamente mabapi le go tšea karolo ka go Protšeke ya Dinyakišišo tša Teko ya Klinikhale *

Leina la Protšeke / Dinyakišišo / Teko*

.............................................................................................................................................................................…….

.....................................................................................................................................................................................

.....................................................................................................................................................................................

Ke badile/ke kwele ka ga tshedimošo mabapi le *maikemišetšo le morero wa* dinyakišišo tšeo di šišintšwego gomme ke ile ka fiwa monyetla wa go botšiša dipotšišo gomme ka fiwa nako yeo e lekanego gore ke naganišiše ka ga taba ye. Ke tloga ke kwešiša maikemišetšo le morero wa dinyakišišo tše gabotse. Ga se ka gapeletšwa go kgatha tema ka tsela efe goba efe.

Ke a kwešiša gore go kgatha tema Protšekeng/Dinyakišišong tše tša Teko ya Klinikhale* ke ga boithaopo gomme nka tlogela go kgatha tema nakong efe goba efe ntle le gore ke fe mabaka. Se se ka se be le khuetšo efe goba efe go kalafo yaka ya ka mehla ya maemo a ka gape e ka se huetše le ge e ka ba tlhokomelo yeo ke e humanago go ngaka yaka ya ka mehla.

Ke a tseba gore Teko/Protšeke/Dinyakišišo tše* di dumeletšwe ke Sefako Makgatho University Research Ethics Committee (SMUREC), Yunibesithi ya Limpopo (Khamphase ya Medunsa) / Dr George Mukhari Hospital.Ke tseba gabotse gore dipoelo tša Teko/Dinyakišišo/ Protšeke tše * di tla dirišetšwa merero ya saense gomme di ka phatlalatšwa. Ke dumelelana le se, ge fela bosephiri bja ka bo ka tiišetšwa.

Mo ke fa tumelelo ya go kgatha tema Tekong/Dinyakišišong/ Protšekeng *.

............................................................ ……………………………………………….. ........................................................

Leina la molwetši/ moithaopi Mosaeno wa molwetši goba mohlokomedi

................................ .................................... ................................................Lefelo Letšatšikgwedi Tlhatse___________________________________________________________________________Setatamente ka Monyakišiši

Ke fana ka tshedimošo ka molomo le/goba yeo e ngwadilwego * mabapi le Teko/Dinyakišišo/ Protšeke ye .*Ke dumela go araba dipotšišo dife goba dife tša ka moso mabapi le Teko/Dinyakišišo/ / Protšeke ka bokgoni ka moo nka kgonago ka gona.Ke tla latela melao yeo e dumeletšwego.

....................................... .................................... ...............…… ……………..Leina la Monyakišiši Mosaeno Letšatšikgwedi Lefelo

*Phumola tšeo di sego maleba.

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ISITHASISELO 1

SEFAKO MAKGATHO HEALTH SCIENCES UNIVERSITY ISIZULU CONSENT FORM

Isitatimende esimaqondana nokuhlanganyela oHlolweni Lokwelashwa/kuPhrojekthi Yocwaningo*

Igama lePhrojekthi/loCwaningo/loHlolo*

.............................................................................................................................................................................…….

.....................................................................................................................................................................................

.....................................................................................................................................................................................

Ngilufundile ulwazi*/ngizizwile izinhloso nezinjongo* zocwaningo oluhlongoziwe futhi nganikezwa nethuba lokubuza imibuzo nganikezwa nesikhathi esanele sokuphinde ngicabange ngodaba. Inhloso nenjongo yocwaningo kucace ngokwanele kimi. Azange ngicindezelwe ukuthi ngihlanganyele nganoma iyiphi indlela.

Ngiyaqonda ukuthi ukuhlanganyela kulolu Hlolo/Cwaningo/ kule Projekthi* yoHlolo ngokokuzithandela ngokuphelele nokuthi ngingahoxa kulo noma nini ngaphandle kokunikeza izizathu. Lokhu angeke kube nomthelela ekwelashweni okuvamile kwesimo sami futhi angeke kube nomthelela ekunakekelweni engikuthola kudokotela wami ovamile.

Ngiyazi ukuthi lolu Hlolo/Cwaningo/le Projekthi* igunyazwe yi-Sefako Makgatho University Research Ethics Committee (SMUREC), Sefako Makgatho Health Sciences University / Dr George Mukhari Hospital. Nginolwazi olugcwele lokuthi imiphumela yalolu Hlolo/Cwaningo/yale Projekthi* izosetshenziselwa izinhloso zesayensi futhi ingashicilelwa. Ngiyakuvuma lokhu, uma nje ingasese lami liqinisekisiwe

Lapha nginikeza imvume yokuhlanganyela kulolu *.

............................................................ ..................................................... Igama lesiguli/levolontiya Isignesha yesiguli noma yomgadi

................................ .................................... ................................................Indawo. Usuku. Ufakazi___________________________________________________________________________Isitatimende somCwaningi

Nginikezele ngolwazi ngomlomo kanye/noma olubhaliwe* maqondana nalolu Hlolo/Cwaningo/nale Phrojekthi*. Ngiyavuma ukuphendula nanoma yimiphi imibuzo yesikhathi esizayo maqondana noHlolo/Cwaningo/ne Phrojekthi* kahle kakhulu kangangoba ngikwazi. Ngizobambelela kusivumelwano senqubo esigunyaziwe

....................................... .................................... ...............………. …………………………….Igama loMcwaningi Isignesha Usuku Indawo

* Cisha noma yini engasebenzi.

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APPENDIX 2

STATISTICAL ANALYSES

The Chairperson,Sefako Makgatho University Research Ethics Committee (SMUREC),Box 163SEFAKO MAKGATHO HEALTH SCIENCES UNIVERSITY

Dear Sir/Madam

STATISTICAL ANALYSES

I have studied the research protocol of

__________________________________________________________________________________

titled: _____________________________________________________________________________

___________________________________________________________________________________

___________________________________________________________________________________

___________________________________________________________________________________

and I agree/do not agree * to assist with the statistical analyses.

Yours sincerely,

______________________________________Signature: Statistician

_______________________________________Name in block letters

____________________Date

* Please delete which is not applicable. If you do not agree to assist with the statistical analyses, please provide reasons on a separate sheet.

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APPENDIX 3

ELECTRON MICROSCOPE UNIT

A. Outline requirements_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

B. Give estimation of cost (this should be discussed with the Director of the Electron Microscope Unit)

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

SIGNATURE: ______________________________________ DATE: ______________

DIRECTOR: ELECTRON MICROSCOPE UNIT

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APPENDIX 4

RADIO ISOTOPES

a) Will isotopes be used during the course of the experiment: __________

b) If affirmative, state the isotopes to be used _____________________________________________________________________________

_____________________________________________________________________________

c) State the quantity of radioactive materials to be stored: _____________________________________________________________________________

_____________________________________________________________________________

For what period? _______________________________________________________________

Used at any given moment? ______________________________________________________

d) State the name of the registered laboratory where the work will be conducted___________________________________________________________________

e) Do you have previous experience in the handling of radioactive material? If affirmative, please qualify_____________________________________________________________________________

_____________________________________________________________________________

f) Do the laboratory personnel have any experience in the handling of the radioactive material: Please qualify _____________________________________________________________________________

g) State the method of disposal after use _____________________________________________________________________________

_____________________________________________________________________________

SIGNATURE: ______________________________________ DATE: ______________

RADIATION PROTECTION OFFICER

(Approval of above-mentioned information must be obtained before submission to SMUREC)

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