Ethical Issues in Human Experimentation The 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.

Jurisdiction n 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 IRB n At least five members, not all of the same gender n 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 n No IRB may consist entirely of members of one profession

UM Structure n Medical School (IRB-MED)IRB-MED n Health Sciences (IRB-HEALTH)IRB-HEALTH – Dentistry, Nursing, Public Health, Social Work n Behavioral Sciences (IRB-BehavSci)IRB-BehavSci – LSA, Architecture, Education, ISR n UM Dearborn UM Dearborn n UM Flint

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 Principles Derived from the Belmont Report – Respect for persons (autonomy) – Beneficence – Justice Full text of Belmont Report available via

Autonomy Respect for persons: Individuals who are autonomous should be treated as such, and persons who are not autonomous should be protected – Application: informed consent

Beneficence Beneficence: Individuals should avoid harming others, and should attempt in their actions to maximize possible benefits and minimize harms – Application: risk/benefit assessment

Justice Justice: Fairness in distribution of the burdens and benefits of research – Application: selection of subjects

Choose the appropriate IRB Download forms – initial application – modifications – renewals – adverse event reports Links to other research/ethics sites

Stay Tuned n Regulations change often; even regulatory agencies n Requirement that all “key personnel” will have some training in research ethics / human subjects protection (Oct 1, 2000) – may lead to testing/certification n IRB-MED x 4?

Research using Animals n Links from IRBMED site – Unit for Laboratory Animal Medicine (ULAM) Unit for Laboratory Animal Medicine – UCUCA forms (University Committee for the Use and Care of Animals); applications and regulations UCUCA forms