The Role and Importance of Institutional Review Boards in a University Setting

Frederick G More, DDS, MSProfessor

New York UniversityNew York, NY, USA

July 2009 University of Haiti

Definition:External ethics review:

This is a general term that describes a review of a proposed research project by a group that does not include anyone from the project.

Institutional Review Board: This is a specific term that relates to external

ethics review in the U.S.


What is “research ethics”?1. Compliance with regulations?2. Review by Institutional Review Boards?3. Design of research?4. Use of data, publication, fabricating data?5. Process of gaining consent?6. Competence of researcher?7. Fairness of equity to access?8. Respect for subjects who volunteer?9. Sensitivity to vulnerable groups?10. Plagiarism, data integrity



History of efforts to protect subjectsExploitation of subjects

Patients on charity wards in hospitals



Classic experiments by William Beaumont on digestion



Nazi medical researchers Japanese experiments with POWs and

bioweaponsU.S. research with radioactive elements



Tuskegee Syphilis Study – landmark for changes


Belmont ReportProduct of the National Commission for the

Protection of Human Subjects of Biomedical and Behavioral Research

Emphasized three basic ethical principlesRespect for persons

Individual autonomy Individual with reduced autonomy

BeneficenceJustice


Research in U.S. TodayFounded on the National Research Act

Regulations by the National Institutes of Health

Assurance given by institutions that they comply with guidelines

A system of Institutional Review Boards for external review of all proposed research that uses humans


Important MilestonesNuremberg Code (1947)

Voluntary consentBenefits outweigh the risksAbility of the subject to terminate participation

Declaration of Helsinki (1964 updated)World Medical Association (2008 is the most

recent)National Research Act (1974)*

National Commission for the Protection of Human Subjects

Belmont Report (1979)July 2009 University of Haiti

Moral Principles

Guidelines on Research Ethics

Regulations and Oversight Agencies

Ethical Review Committees


Moral Principles

Guidelines on Research Ethics

Regulations and Oversight Agencies

Ethical Review Committees

Goal-basedDuty-basedRights based

Nuremberg CodeDeclaration of HelsinkiBelmont Report**

Common Rule (45 CFR 46)Non-discrimination policiesDHHS-OHSP

IRBs



Purpose of research?Provide new knowledge, propose new

therapies, validate present therapies, determine effectiveness, promote human welfare and well-being.

A systemic investigation, included research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.


Research versus TherapyPractice or therapy refers to interventions

that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success.

Research designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge.


Institutional Review BoardsExist to protect human subjects used in

researchMulti-center clinical trialsDocuments that govern the IRB:

Belmont Report (U.S.)Declaration of Helsinki (world-wide)Guideline for Good Clinical Practice


Reviewing researchProtection of human subjects – primary goal

Design of the researchGoals and AimsConsent/AssentVoluntarinessRight to withdrawInjury


Example of a projectA U.S. researcher comes to Haiti, works with

faculty members at the University of HaitiGoal: to discover how Haitians use tobacco,

alcohol, and other substancesDescription: Haitian interviewers will be

recruited and trained in how to interviewInterviewers will go to Haitian villages and

conduct interviews with persons who are locals in the villages

Data will be analyzed to define which substances are used, how often, and so on


The Review ProcessThe researcher wants to use human subjects

to find out something he does not knowA survey is developedInterviewers are trained in HaitiInterviewers will conduct and oral surveyParticipation is completely voluntaryConfidential and anonymous

The benefit will be the discovery of information about alcohol and tobacco use in Haiti


Anatomy of a project: IRBExternal review body – researchers, members who

know the guidelines but are not scientists; and, a public member. An administrator should be appointed to keep records, minutes, and monitor studies.

Review: Design of the project Study activities Equity and access (selection of subjects) Consent (informed, voluntary, competent) Assessment of risks and benefits Use of data

Yearly continuation reportsMonitor the research until it is finished


The review processA primary and secondary reviewer are selectedReview the application and the proposed research

The study designHow subjects are recruited and selectedWhat are the risks to the subjectsAre there benefits to the subjects or the communityHow is privacy maintainedHow will the data be analyzed and by whomWhat is the mechanism for review adverse events


Board actionsApproval – the study meets all criteria and is

okay to commenceConditional approval – the study meets the

criteria but need a few minor changes. Once the changes are made, the study may commence

Deferral – the study needs major changes and will be reviewed after the changes are made

Disapproval – the study is not acceptable and may not commence in its present form



Researcher’s responsibilityConsider the design of the studyAre human subjects necessary to the

outcome?What measures

Protect subjects from risksInform subjects of potential risksProvide privacyPermit subjects to withdraw w/o penalty


External Ethics Review ExperiencesAn external ethics review board should be

considered to review all research that uses human subjectsChairman – scientific member who conducts

meetings and helps group to arrive at a consensusScientific members – members with specific

expertise who will review applicationsNon-scientific members – university faculty

members who look at other aspects of the application

Community member – a respected person from the community who represents a community focus

A staff person who maintains recordsJuly 2009 University of Haiti

After the study commencesAnnual review (or sooner if the board

chooses): the board reviews the progress of the study to see if it is meeting its goals

Amendments: the investigator requests changes in the protocol

Adverse events: required reporting of adverse events that are expected or unexpected


Next steps?1. Make a decision to review all research using

human subjects a) Locally (research conducted by University of

Haiti faculty alone or in collaboration with others

b) Regionally (universities doing research collaborating as a single committee)

2. Get an expert consult to help with applications and processes


Next steps3. Review the standards that exist (Declaration

of Helsinki)4. Develop an application process and appoint

a committee 5. Research should be reviewed in a timely

manner6. Develop a process to keep track of all the

research that has been reviewed


Final Thoughts:No research should ever be conducted using

human subjects without a review by an external board

The University should be a model for responsible action and oversee all research done by the faculty

The main benefit is to increase the safety for subjects and to avoid abuse

