To IRB or Not to IRB?

Abstract

Improving medical practice begins with the improvement of medical education. In this process, most academic medical faculty assume the dual roles of both teacher and researcher, often without intending to or realizing that they are. With the increased tightening of regulation and supervision of biomedical research in the United States, academic medical institutions and their individual faculty face the daunting regulatory compliance problems that are traditionally associated with clinical and bench research projects. In 2000, as part of a new geriatrics curriculum initiative, one medical school (not the authors' present institution) developed a mentor program that was designed to positively influence students' attitudes about aging. Despite the attempts of faculty to design the curriculum and evaluation process to conform to human subjects regulations, formal allegations of research misconduct were brought against the faculty who were in charge of the curriculum. Even though research that shows that 70% of alleged research misconduct charges result in exoneration, an accusation of misconduct can have serious consequences for faculty including suspension of their project, undergoing an intensive investigation, and potentially making it impossible for the faculty member or institution to apply for future federally supported research funds. The authors wrote this article to serve as a wake-up call for medical educators to become intimately familiar with their own institution's institutional review board process and be proactive in educating themselves and their peers regarding research in medical education.

Clinician Educators??? Experiences with Institutional Review Boards: Results of a National Survey

“…Recent publications suggest that some clinician educators have experienced unnecessary frustration during the IRB review process. [7][8][9] These publications highlight difficulties with the process of IRB review (tediousness of required paperwork, multiple paper copies, prolonged delays, etc.) for medical education research.…”

Institutional review boards: A flawed system of risk management

“…They mention another ethical hazard: 'the unbalanced power relationship between the student and faculty member, and the relative feelings of powerlessness that might inhibit a student's ability to decline participation' (Tomkowiak and Gunderson, 2004).…”

Education Research and Human Subject Protection: Crossing the IRB Quagmire

“…Despite refutation of the allegations, research data were destroyed and valuable study results lost. 3 Course evaluations, if used for a publication, require IRB review and often informed consent. One strategy includes use of a cover sheet, attached to the evaluation, containing a recruitment script.…”

“…4 Education researchers report frustration with the required paperwork, multiple copies, prolonged delays, and other ''hurdles'' of the IRB oversight process. 3,12,13 Also, education researchers may have less assistance than biomedical researchers for creating ''The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. '' and tracking IRB submission paperwork.…”

“…This leads to a pervasive perception of IRB overregulation yet underprotection of human subjects. 2 Although the Office for Human Research Protections (OHRP) reports that 70% of allegations of research misconduct are ultimately not substantiated, 3 the risk of suspension or disruption of research during an investigation, in addition to the possibility of damaging reputations and future funding, creates a national climate of anxiety among researchers and ensures continuation of excessive scrutiny of research processes. In fact, deficiencies detected by OHRP are primarily failures of documentation or failure to follow required procedures, not claims of harm to persons or unethical conduct.…”