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When the human research protection program (HRPP) at the University of Florida in Gainesville decided to undergo accreditation with the Association for the Accreditation of Human Research Protection Programs (AAHRPP), officials revised policies and procedures, making them consistent across IRBs and easy to follow.
Here are a few examples of information included in one of the newly created investigator guideline documents, which are in question format:
Q: What does the IRB look for when offering subject compensation?
Answer: Compensation cannot be coercive or unduly influence subjects. The IRB will review proposed subject compensation on a protocol-by-protocol basis, including the type of compensation and amount, schedule, and proration of payments to assure that the proposed compensation is not so significant that prospective subjects may consider participation in research that they may otherwise not participate in if it were not for the compensation.
Q: What should potential participants be told when they are excluded from participation?
Answer: Unless there is a specific reason for informing potential subjects about the basis of exclusion, the default recommendation is to merely tell them that based on their responses, they don’t qualify for inclusion in the study, and thank them for their time.
Q: What should be done if you need more study subjects than you are currently approved for?
Answer: Submit a revision and justify why additional subjects are needed. If your study is a greater-than-minimal-risk study, such a revision must be reviewed and approved by the full board since you are exposing additional subjects to the risks in your study.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group
Manager Terrey L. Hatcher, Physician Editor Lindsay McNair, MD, MPH, MSBioethics, and Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.