Ethical Issues in Human Experimentation Ethical Issues in Human Experimentation The Role of the IRBThe Role of the IRB

The IRB is an administrative body established to protect the rights and welfare of human subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modifications in, or disapprove all research in its jurisdiction. Research that has been reviewed by an IRB may be subject to review and disapproval by the institution. However, the institution may not approve research if it has been disapproved by the IRB.

JurisdictionJurisdiction

Basically, all research involving human subjects– Research: “ a systematic investigation designed to

develop or contribute to generalizeable knowledge.”– Human subject: “living individual(s) about whom an

investigator obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

Composition of the IRBComposition of the IRB

At least five members, not all of the same gender Varying backgrounds, to promote complete and

adequate review of research activities commonly conducted by the institution– at least one “scientist”– at least one “non-scientist”– at least one not affiliated with the institution

No IRB may consist entirely of members of one profession

UM StructureUM Structure

Medical School (IRB-MED) Health Sciences (IRB-HEALTH)

– Dentistry, Nursing, Public Health, Social Work

Behavioral Sciences (IRB-BehavSci)– LSA, Architecture, Education, ISR

UM Dearborn UM Flint

Why are IRBs Necessary?Why are IRBs Necessary?

• Nuremberg Trials/Code• Tuskegee syphilis study• Willowbrook study• Jewish Chronic Disease Hospital study• Radiation tests on mentally impaired boys• More contemporary problems

IRB Guiding PrinciplesIRB Guiding Principles

• Derived from the Belmont Report– Respect for persons (autonomy)– Beneficence– Justice

• Full text of Belmont Report available via

www.irb.research.umich.edu

AutonomyAutonomy

• Respect for persons: Individuals who are autonomous should be treated as such, and persons who are not autonomous should be protected

– Application: informed consent

BeneficenceBeneficence

• Beneficence: Individuals should avoid harming others, and should attempt in their actions to maximize possible benefits and minimize harms

– Application: risk/benefit assessment

JusticeJustice

• Justice: Fairness in distribution of the burdens and benefits of research

– Application: selection of subjects

www.irb.research.umich.edu

• Choose the appropriate IRB• Download forms

– initial application– modifications– renewals– adverse event reports

• Links to other research/ethics sites

Stay TunedStay Tuned

Regulations change often; even regulatory agencies

Requirement that all “key personnel” will have some training in research ethics / human subjects protection (Oct 1, 2000)– may lead to testing/certification

IRB-MED x 4?

Research using AnimalsResearch using Animals

Links from IRBMED site– Unit for Laboratory Animal Medicine (ULAM)– UCUCA forms (University Committee for the Use

and Care of Animals); applications and regulations