Avoiding the Pitfalls of an IRB Submission Chris Ayres Chair, Institutional Review Board Social & Behavioral Science & Chair, Department of Kinesiology, Sport and Recreation Management

Members 18 ETSU Faculty Community Prisoner Advocate Child Advocate Non-ETSU Affiliated Faculty Senate

Purpose of the IRB The primary concern of the IRB is the protection of the rights and welfare of human subjects in research.

Association for the Accreditation of Human Research Protection Programs AAHRPP AAHRPP accreditation is a public affirmation of your commitment to protecting research participants. That commitment resonates not only with participants but also with researchers, sponsors, government agencies, and the general public.

Some Criteria for Approval identification of the risk evaluation of the risk & a determination of whether or not the risk/benefit ratio is acceptable/appropriate evaluation of procedures to minimize risk evaluation of the informed consent process which must adequately explain the risks privacy and confidentiality issues. compensation & costs for subjects

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Privacy

Privacy - Study Design and Scientific Quality

Minimal Risk? Risk/Benefit Ratio

Informed Consent - Voluntary - Compensation

Debriefing

First determination: Is it research.

Federal DHHS Definition (45 CFR 46) Research is defined as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Is it research?

Issue: Terms within the definition are not defined in the federal regulations. Systematic investigation: One example: “systematic investigation is an activity that involves a prospective research plan which incorporates data collection, either quantitative or qualitative, and data analysis to answer a research question.” source: Jeff Cohen, accessed 5/28/09

Issue: Terms within the definition are not defined in the federal regulations. Generalizable: One example: “Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings.” source: Jeff Cohen, accessed 5/28/09

Second determination: Does the research involve human subjects?

Federal DHHS Definition (45 CFR 46) Human Subjects are defined in the “Common Rule” as “living individuals about whom an investigator (whether professional or student) conducting research obtains either (1) data through intervention or interaction with the individual or (2) identifiable private information.”

Does the research involve obtaining data about living individuals? If yes, Chair proceeds to next consideration. If no, the activity is not human subject research.

Will the researcher obtain that data through intervention or interaction with those individuals? If yes, this is human subject research. If no, Chair proceeds to next determination.

Is the information both private and identifiable*? If yes, this is human subject research. If no to the last 2 determinations, the research is not human subject research. * See next slides for definitions

Federal DHHS Definition (45 CFR 46) Private, because the information is about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place OR the individual has provided the information for specific purposes and can reasonably expect that the information will not be made public (for example, a medical record)

Federal DHHS Definition (45 CFR 46) Individually Identifiable, because the identity of the participant is or may readily be ascertained by the investigator or associated with the information.

Who makes these determinations? Determinations of whether activities are constitute human subject research are made by the IRB. The IRB delegates this decision to the IRB Chair or Vice Chair.

IRB Policy 5: The IRB has the sole authority to make a final determination of whether a proposed activity is human research according to DHHS or FDA regulatory definitions. Unless you are familiar enough with these regulations to be certain that the activity does not represent human research, the activity should be brought forward to the IRB for a determination.

Not Human Subject Research Exempt Study Expedited Study Full Study

Important Documents Is it research Narrative Informed Consent Parental Consent Child Assent

“If we knew what it was we were doing, it would not be called research, would it?” Albert Einstein