The Institutional Review Board The Institutional Review Board (IRB) and its functions(IRB) and its functions

Anthony K. Wutoh, Ph.D., R.Ph.ProfessorSchool of PharmacyCollege of Pharmacy, Nursing and Allied Health SciencesCo-Chairman, Institutional Review Board

Howard University IRBHoward University IRB

What is your image of What is your image of the IRB?the IRB?

Why were/are IRBs Why were/are IRBs needed?needed? Tuskegee Syphilis Study (Alabama, 1932-Tuskegee Syphilis Study (Alabama, 1932-

1972)1972) Nazi Experiments (1930s-1940s)Nazi Experiments (1930s-1940s) Stanley Milgram's Stanley Milgram's

experiment .experiment .""Obedience and Individual Obedience and Individual Responsibility" (Yale, 1961-1963)Responsibility" (Yale, 1961-1963)

Willowbrook Study (New York, 1963-1966)Willowbrook Study (New York, 1963-1966) Tearoom sex (Washington Univ., 1960s)Tearoom sex (Washington Univ., 1960s) Research conducted in prisoners, children Research conducted in prisoners, children

and other vulnerable populationsand other vulnerable populations

Recent ViolationsRecent Violations

In a totally unprecedented flurry of enforcement In a totally unprecedented flurry of enforcement activity, the National Institutes of Health (NIH) Office for activity, the National Institutes of Health (NIH) Office for Protection from Research Risks (OPRR) stopped Protection from Research Risks (OPRR) stopped research at Rush-Presbyterian-St. Luke's Medical Center research at Rush-Presbyterian-St. Luke's Medical Center (AP 1998), the West Los Angeles Veterans Affairs (AP 1998), the West Los Angeles Veterans Affairs Medical Center (Monmaney 1999; Hilts 1999a), Duke Medical Center (Monmaney 1999; Hilts 1999a), Duke University (Stout 1999; Weiss 1999), the University of University (Stout 1999; Weiss 1999), the University of Illinois at Chicago (Guerrero and Herguth 1999; Grahnke Illinois at Chicago (Guerrero and Herguth 1999; Grahnke and Ritter 1999), the University of Colorado (Hubler and Ritter 1999), the University of Colorado (Hubler 1999), Virginia Commonwealth University (Mathews 1999), Virginia Commonwealth University (Mathews 2000), and most recently, the University of Alabama at 2000), and most recently, the University of Alabama at Birmingham (Hansen and Spencer 2000; Hilts 2000). Birmingham (Hansen and Spencer 2000; Hilts 2000).

While there have been some substantive concerns While there have been some substantive concerns relating to subject enrollment and informed consent, relating to subject enrollment and informed consent, most of these sanctions have been levied because of most of these sanctions have been levied because of sloppy and inadequate operation of institutional review sloppy and inadequate operation of institutional review boards (IRBs) and slow or inadequate response to boards (IRBs) and slow or inadequate response to OPRR's concerns.OPRR's concerns.

ViolationsViolations

Researchers at Stanford University were permitted by the Researchers at Stanford University were permitted by the state in 1997 to test the use of Depakote in incarcerated state in 1997 to test the use of Depakote in incarcerated adolescent males to see if the drug would reduce adolescent males to see if the drug would reduce aggressive behavior (Weber 1999). aggressive behavior (Weber 1999).

Researchers at the New York State Psychiatric Institute, the Researchers at the New York State Psychiatric Institute, the Mount Sinai School of Medicine, and the Research Mount Sinai School of Medicine, and the Research Foundation of the City University of New York came under Foundation of the City University of New York came under fire for giving fenfluramine to young children, many of fire for giving fenfluramine to young children, many of whom were Hispanic or African American. The children whom were Hispanic or African American. The children were at-risk younger siblings of child offenders identified were at-risk younger siblings of child offenders identified by the researchers through court records (Hilts 1998a; by the researchers through court records (Hilts 1998a; Waldman 1999; Bernstein 1999). Waldman 1999; Bernstein 1999).

In the early 1990s, plastic surgeons at the Manhattan Eye, In the early 1990s, plastic surgeons at the Manhattan Eye, Ear, and Throat Hospital performed a study in which Ear, and Throat Hospital performed a study in which different surgical face-lift techniques were used on the different surgical face-lift techniques were used on the opposite sides of patients' faces without securing IRB opposite sides of patients' faces without securing IRB approval and without express patient consent (Hilts approval and without express patient consent (Hilts 1998b1998b). ).

Jesse Gelsinger and Jesse Gelsinger and Gene Therapy (U. of Gene Therapy (U. of Penn.)Penn.) In 1999-2000 the Food and Drug Administration stopped all In 1999-2000 the Food and Drug Administration stopped all gene therapy trials at the University of Pennsylvania, gene therapy trials at the University of Pennsylvania, because of alleged shortcomings and violations of protocols, because of alleged shortcomings and violations of protocols, revealed in an audit .prompted by the death of Jesse revealed in an audit .prompted by the death of Jesse Gelsinger Gelsinger

Gelsinger suffered from Ornithine transcarbamylase (OTC) Gelsinger suffered from Ornithine transcarbamylase (OTC) deficiency, a rare metabolic disorder.deficiency, a rare metabolic disorder.

Gelsinger's death also prompted a revelation of at least six Gelsinger's death also prompted a revelation of at least six deaths in other gene therapy trials that had not been deaths in other gene therapy trials that had not been reported to the NIH, in violation of the law, because the reported to the NIH, in violation of the law, because the investigators determined the deaths were caused by the investigators determined the deaths were caused by the subjects' disease and not the experimental therapy. subjects' disease and not the experimental therapy.

Several institutions and foundations sponsoring genetic Several institutions and foundations sponsoring genetic therapy research halted trials because of concerns about therapy research halted trials because of concerns about patient safety. The public hearings also spurred the reporting patient safety. The public hearings also spurred the reporting to NIH of 652 adverse events in trials using modified to NIH of 652 adverse events in trials using modified adenoviruses (as used in the Penn trial), compared to only adenoviruses (as used in the Penn trial), compared to only 39 that had been reported promptly as required by law. 39 that had been reported promptly as required by law.

Issues - Conflict of interest, did not meet the inclusion Issues - Conflict of interest, did not meet the inclusion criteria, consent forms did not adequately discuss risks.criteria, consent forms did not adequately discuss risks.

Research RegulationsResearch Regulations

In 1979, the federal government developed regulations of In 1979, the federal government developed regulations of ethical principals underlying the current regulations and ethical principals underlying the current regulations and standards that are contained in the Belmont Report.standards that are contained in the Belmont Report.

It was the capstone of the National Commission for the It was the capstone of the National Commission for the Protection of Human participants of Biomedical and Protection of Human participants of Biomedical and Behavioral Research. It outlines the ethical principals upon Behavioral Research. It outlines the ethical principals upon which the ethics of a research study are evaluated in the which the ethics of a research study are evaluated in the United States. United States.

The Belmont Report embodies the moral consensus upon The Belmont Report embodies the moral consensus upon which stand our present US Federal regulations governing the which stand our present US Federal regulations governing the ethics of human participants research conduct with Federal ethics of human participants research conduct with Federal funds from the majority of Federal agencies. funds from the majority of Federal agencies.

Our present regulations formulize The Belmont Report's Our present regulations formulize The Belmont Report's requirements for informed consent and establish another requirements for informed consent and establish another Commission recommendation that formalized and extended Commission recommendation that formalized and extended the existing peer review system of that time, which has the existing peer review system of that time, which has matured into the Institutional Review Board (IRB) system that matured into the Institutional Review Board (IRB) system that we have today.we have today.

Historical OverviewHistorical Overview

The protection of the rights and privacy of The protection of the rights and privacy of human participants involved in research human participants involved in research activities is mandated by federal law.  activities is mandated by federal law. 

The National Research Act Public Law 99-158, The National Research Act Public Law 99-158, The Health Research Extension Act of 1985, and The Health Research Extension Act of 1985, and the National Commission for the Protection of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Human Subjects of Biomedical and Behavioral Research provide guidelines for research with Research provide guidelines for research with human participants to ensure their protection in human participants to ensure their protection in the design and conduct of research. the design and conduct of research.

These federal regulations require that any These federal regulations require that any institution requesting and receiving funds from a institution requesting and receiving funds from a federal department or agency for research federal department or agency for research involving human participants must assure that involving human participants must assure that such research is reviewed and approved by the such research is reviewed and approved by the institution's institutional review board (IRB). institution's institutional review board (IRB). 

IRB Review ProcessIRB Review Process

Purpose of the IRB at Purpose of the IRB at Howard UniversityHoward University Review research proposals, projects,

and activities that involve human participants;

Determine for each activity or proposed activity if human participants will be placed at risk;

if risk is involved, determine if the importance of the knowledge to be gained warrants allowing the participant to accept the risks;

Oversee protection of rights and welfare of participants.

Assess whether the researcher(s) is/are qualified to conduct research involving human participants.

In GeneralIn General

Applies to funded and unfunded Applies to funded and unfunded researchresearch

Submission of a protocol and Submission of a protocol and approval by the IRB is mandatory for approval by the IRB is mandatory for any faculty, staff or student who will any faculty, staff or student who will interact with a human being for interact with a human being for purposes of conducting researchpurposes of conducting research

Research may not begin before Research may not begin before approval from the IRB is givenapproval from the IRB is given

IRB MembershipIRB Membership

EachEach IRB shall have at least five members, with varying IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. research activities commonly conducted by the institution.

Each IRB shall include at least one member whose primary Each IRB shall include at least one member whose primary concerns are in the scientific area and at least one member concerns are in the scientific area and at least one member whose primary concerns are in nonscientific areas. whose primary concerns are in nonscientific areas.

Each IRB shall include at least one member who is not Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the the immediate family of a person who is affiliated with the institution. institution.

No IRB may have a member participate in the IRB's initial or No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a continuing review of any project in which the member has a conflicting interest, except to provide information requested conflicting interest, except to provide information requested by the IRB. by the IRB.

Every nondiscriminatory effort will be made to ensure that no Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one of gender. No IRB may consist entirely of members of one professionprofession..

Howard University IRB Howard University IRB MembershipMembership

Frank BoldenFrank Bolden EducationEducation

Vernon Bond, Ed.DVernon Bond, Ed.D Exercise PhysiologyExercise Physiology

Alfonso Campbell, Alfonso Campbell, Ph.D. Co-ChairPh.D. Co-Chair

PsychologyPsychology

Vincent Hollis, Jr., Ph.D.Vincent Hollis, Jr., Ph.D. BiologyBiology

Alicia Horton, JD,MPHAlicia Horton, JD,MPH Education, LegalEducation, Legal

Leslie Jones, MDLeslie Jones, MD OphthalmologyOphthalmology

Charles Mouton, MD, Charles Mouton, MD, ChairmanChairman

MedicineMedicine

Jacqueline Smith, Ph.D.Jacqueline Smith, Ph.D. Social WorkSocial Work

Anthony Wutoh, Ph.D.Anthony Wutoh, Ph.D. Pharmacy Pharmacy AdministrationAdministration

Henry Ferry, Ph.D.Henry Ferry, Ph.D. ReligionReligion

Robert Taylor, MDRobert Taylor, MD MedicineMedicine

Non-affiliated

Non-affiliated

Leave of absence

What type of research What type of research requires review?requires review? Research which involves the administration of drugs Research which involves the administration of drugs

or other substances to participants or other substances to participants Research involving pregnant women and/or fetuses in Research involving pregnant women and/or fetuses in

utero utero Research involving participants with life-threatening Research involving participants with life-threatening

physical conditions physical conditions Research involving physically intrusive procedures Research involving physically intrusive procedures Research which previous experience (by the particular Research which previous experience (by the particular

investigator or other investigators) has shown to investigator or other investigators) has shown to create a potential of risk to participants create a potential of risk to participants

Research which potentially could put the participant at Research which potentially could put the participant at risk for legal or civil liability or invade a participant's risk for legal or civil liability or invade a participant's privacy in regard to sensitive aspects of his/her privacy in regard to sensitive aspects of his/her behavior (e.g., illegal conduct, drug use, sexual behavior (e.g., illegal conduct, drug use, sexual behavior, alcohol use). behavior, alcohol use).

What about survey What about survey research or research or questionnaires?questionnaires? Research which involves the interviewing of participants Research which involves the interviewing of participants

requires review by the IRB for several reasons;requires review by the IRB for several reasons;– The IRB must insure the risks do not outweigh the The IRB must insure the risks do not outweigh the

benefits of this researchbenefits of this research– The IRB must review potential questionnaires and The IRB must review potential questionnaires and

items for inappropriate or potentially harmful itemsitems for inappropriate or potentially harmful items– Certain populations may be at risk for psychological Certain populations may be at risk for psychological

harm (for example; crime/rape victims, Post harm (for example; crime/rape victims, Post traumatic stress disorder (PTSD), etc.traumatic stress disorder (PTSD), etc.

– The investigator must be qualified to administer The investigator must be qualified to administer these items.these items.

– Potential risk of disclosure of identity/confidentialityPotential risk of disclosure of identity/confidentiality

What types of Research What types of Research could possibly be could possibly be exempted?exempted? Research in which the risks of harm reasonably anticipated are Research in which the risks of harm reasonably anticipated are

not greater than those ordinarily encountered in daily life or not greater than those ordinarily encountered in daily life or during the performance of routine procedures in education and/or during the performance of routine procedures in education and/or in the practice of psychology and medicine in the practice of psychology and medicine

Research on the effectiveness of educational, classroom, and/or Research on the effectiveness of educational, classroom, and/or instructional strategies, provided that these strategies are instructional strategies, provided that these strategies are familiar, and nonintrusive in their implementation familiar, and nonintrusive in their implementation

Research using educational tests (cognitive, diagnostic, aptitude, Research using educational tests (cognitive, diagnostic, aptitude, achievement) if participants' identities are thoroughly protected achievement) if participants' identities are thoroughly protected

Research using survey procedures or interview procedures where Research using survey procedures or interview procedures where participants' identities are thoroughly protected and their participants' identities are thoroughly protected and their answers do not participant them to criminal and civil liability answers do not participant them to criminal and civil liability

Research involving the collection or study of existing data, Research involving the collection or study of existing data, documents, records, specimens, or other products, if these documents, records, specimens, or other products, if these sources are publicly available or the information is recorded by sources are publicly available or the information is recorded by the investigator in such a manner that the participants cannot be the investigator in such a manner that the participants cannot be identified directly or indirectly. identified directly or indirectly.

Remember – The IRB, not the investigator, decides upon Remember – The IRB, not the investigator, decides upon the exemption status of a protocolthe exemption status of a protocol

Some research can not Some research can not be exempted!!!!be exempted!!!!

Socio-behavioral Socio-behavioral research?research? Regarding Laud Humphreys Tea Room Sex Research….Regarding Laud Humphreys Tea Room Sex Research…. There was considerable public outrage as well. There was considerable public outrage as well.

Journalist Nicholas von Hoffman, who was given some Journalist Nicholas von Hoffman, who was given some details of the case by one of the angered members of details of the case by one of the angered members of the Sociology Department, wrote an article about the Sociology Department, wrote an article about Humphreys' research and offered the following Humphreys' research and offered the following condemnation of social scientists: "We're so condemnation of social scientists: "We're so preoccupied with defending our privacy against preoccupied with defending our privacy against insurance investigators, dope sleuths, insurance investigators, dope sleuths, counterespionage men, divorce detectives and credit counterespionage men, divorce detectives and credit checkers, that we overlook the social scientists behind checkers, that we overlook the social scientists behind the hunting blinds who're also peeping into what we the hunting blinds who're also peeping into what we thought were our most private and secret lives. But thought were our most private and secret lives. But there they are, studying us, taking notes, getting to there they are, studying us, taking notes, getting to know us, as indifferent as everybody else to the feeling know us, as indifferent as everybody else to the feeling that to be a complete human involves having an aspect that to be a complete human involves having an aspect of ourselves that's unknown."of ourselves that's unknown."

ConsiderationsConsiderations

Confidentiality of Information - The confidentiality of the human Confidentiality of Information - The confidentiality of the human participants is typically the most important factor in determining participants is typically the most important factor in determining whether a research proposal is exempt from further review.  whether a research proposal is exempt from further review. 

One University states that “…an investigator must not maintain One University states that “…an investigator must not maintain any form of linkage in order to go back and review the record at a any form of linkage in order to go back and review the record at a later time. If linkage between the data and the participant must be later time. If linkage between the data and the participant must be maintained, the protocol should be submitted for review.”maintained, the protocol should be submitted for review.”

Due to the nature of much social science research, the possibility Due to the nature of much social science research, the possibility of physical harm to human participants is typically minimal or non-of physical harm to human participants is typically minimal or non-existent.  However, human participants could suffer financial or existent.  However, human participants could suffer financial or emotional harm in some circumstances if their individual emotional harm in some circumstances if their individual responses to sensitive questions became public knowledge.  responses to sensitive questions became public knowledge. 

As an example, if a participant describes various faults in the As an example, if a participant describes various faults in the management practices of their organization as part of a research management practices of their organization as part of a research survey and if their identifying information is later associated with survey and if their identifying information is later associated with their responses then they may face retribution by their managers.  their responses then they may face retribution by their managers.  To avoid any possibility of this type of problem the confidentiality To avoid any possibility of this type of problem the confidentiality of the participant’s responses must be maintained and the of the participant’s responses must be maintained and the measures taken by the researcher to protect this confidentiality measures taken by the researcher to protect this confidentiality must be fully delineated in the IRB Research Protocol.must be fully delineated in the IRB Research Protocol.    

Examples of Examples of confidentiality confidentiality statements…statements… ““Strict confidentiality will be maintained at all Strict confidentiality will be maintained at all

times.  New employees and their project times.  New employees and their project managers will be given numbers for tracking managers will be given numbers for tracking purposes.  Contact records used for linking the purposes.  Contact records used for linking the names of the new employees and their project names of the new employees and their project managers to their tracking numbers will be managers to their tracking numbers will be deleted at the conclusion of the study.  During deleted at the conclusion of the study.  During the study, the contact records will be the study, the contact records will be maintained in one computer location protected maintained in one computer location protected by password and one disk backup stored in a by password and one disk backup stored in a government-classified safe.  All reporting will be government-classified safe.  All reporting will be in the aggregate; names or colleges will not be in the aggregate; names or colleges will not be used to identify individuals.” used to identify individuals.”

Example…Example…

““Information obtained in this study will be strictly Information obtained in this study will be strictly confidential unless disclosure is required by law.  confidential unless disclosure is required by law.  Participants will be assigned a study number, and this Participants will be assigned a study number, and this number, rather than the participants’ names, will be number, rather than the participants’ names, will be recorded at the time of interviews.  Only the study recorded at the time of interviews.  Only the study investigator will have a record of which person has investigator will have a record of which person has been assigned what number and this information will been assigned what number and this information will be secured in a locked filing cabinet.  Participant be secured in a locked filing cabinet.  Participant names will not be used in the reporting of information names will not be used in the reporting of information in publications or conference presentations.  The in publications or conference presentations.  The results of the study will be reported in terms of the results of the study will be reported in terms of the various treatment groups, not in terms of individuals.  various treatment groups, not in terms of individuals.  Thus anonymity and confidentiality will be protected.” Thus anonymity and confidentiality will be protected.”

Informed ConsentInformed Consent

Use of Informed Consent FormsUse of Informed Consent Forms   The participation by human participants in any The participation by human participants in any

research project must be consensual.   research project must be consensual.    “…“…no investigator may involve a human being as no investigator may involve a human being as

a participant in research, as defined in this policy a participant in research, as defined in this policy and procedure manual, unless the investigator and procedure manual, unless the investigator has obtained the participant's informed consent. has obtained the participant's informed consent. The process of The process of informed consentinformed consent is constituted by is constituted by two essential elements: (1) the participant has two essential elements: (1) the participant has the information he or she requires to make an the information he or she requires to make an effective decision, and (2) the participant's effective decision, and (2) the participant's participation is not coerced, i.e. his or her consent participation is not coerced, i.e. his or her consent is voluntary.”is voluntary.”

Informed Consent Informed Consent ProcessProcess While this requirement usually results in the use of an While this requirement usually results in the use of an

Informed Consent Form in the proposed research, the Informed Consent Form in the proposed research, the requirement for human participants to provide their requirement for human participants to provide their informed consent does not necessarily require the informed consent does not necessarily require the participant to execute a document as proof of their participant to execute a document as proof of their consent.  The IRB may approve a consent procedure which consent.  The IRB may approve a consent procedure which does not include, or which alters, some or all or the does not include, or which alters, some or all or the elements of informed consent, or waive the requirement to elements of informed consent, or waive the requirement to obtain informed consent provided the IRB finds and obtain informed consent provided the IRB finds and documents:documents:– The research involves no more than minimal risksThe research involves no more than minimal risks– The rights and welfare of participants will not be The rights and welfare of participants will not be

adversely affectedadversely affected– The research could not practicably be carried out The research could not practicably be carried out

without the waiver or alterationwithout the waiver or alteration– Whenever appropriate, the participants will be provided Whenever appropriate, the participants will be provided

with additional pertinent information after participationwith additional pertinent information after participation

IRB ProcessIRB Process

Review the IRB website and submit a signed Review the IRB website and submit a signed application (including your faculty mentor) application (including your faculty mentor) http://www.huirb.howard.edu/apps.htmhttp://www.huirb.howard.edu/apps.htm

Dissertations and Theses require submission of Dissertations and Theses require submission of committee approvalcommittee approval

The IRB will review at the next scheduled meeting The IRB will review at the next scheduled meeting (every other week) and provide one of the following (every other week) and provide one of the following recommendations;recommendations;– ApproveApprove– AmendAmend– RejectReject– TableTable

Conduct your research project and meet the Conduct your research project and meet the requirements for responsible conduct of researchrequirements for responsible conduct of research

Submit required reports and documentationSubmit required reports and documentation

Summary…Take home Summary…Take home messagemessage The IRB is a key element in the The IRB is a key element in the

conduct of human participant research conduct of human participant research at the University.at the University.

But, it is the primary responsibility of But, it is the primary responsibility of the IRB to safeguard the rights and the IRB to safeguard the rights and safety of human participants. It is not safety of human participants. It is not necessarily the role of the IRB to necessarily the role of the IRB to expedite research at the University at expedite research at the University at the expense of safety and human the expense of safety and human rights.rights.

ReferencesReferences

http://muse.jhu.edu/journals/journal_ofhttp://muse.jhu.edu/journals/journal_of_health_politics_policy_and_law/v025/2_health_politics_policy_and_law/v025/25.5merz.html5.5merz.html

desu.edu/research/osp/forms/desu.edu/research/osp/forms/IRBIRBpresentation.ppt presentation.ppt

education.ua.edu/ncate/documents/education.ua.edu/ncate/documents/IRBIRB%20Fall%202005%20update.ppt %20Fall%202005%20update.ppt

http://web.missouri.edu/~bondesonw/http://web.missouri.edu/~bondesonw/Laud.htmlLaud.html

Isn’t the IRB Great?!?!?Isn’t the IRB Great?!?!?

I love the IRB