New Challenges Facing Interinstitutional Social Science and Educational Program Evaluation Research at Academic Health Centers: A Case Study from the ELAM Program

Abstract

Since the mid-1990s, the protection of human subjects through institutional review boards (IRBs) has progressively broadened in scope. In this case study, the authors describe their challenges in effectively handling IRB processes to conduct educational and social sciences research within academic health centers, particularly (1) complications in conducting longitudinal interinstitutional research that involves multiple IRBs, each with different procedures that changed over ten years; and (2) factors affecting consent form and survey response rates when applying the biomedical IRB process to obtain the consent of human subjects for participation in social and educational research. The authors had a unique opportunity to follow the effect of changes in consent forms (from no form to a one-page form to a three-page form requiring signature of a witness), ways of administration (in person or by mail), and time of administration (at the time of the program or years later) on consent form and survey response rates among medical and dental school faculty members. The authors explore the extended timelines required for data collection and increased costs in dealing with these issues, as well as the effects on response rates of consent form language and administration procedures. The authors recommend strategies to lessen adverse effects of dealing with multiple IRBs at different institutions for social science and educational research, and discuss policy implications for funders, institutions and investigators.

Evaluating a Leadership Program: A Comparative, Longitudinal Study to Assess the Impact of the Executive Leadership in Academic Medicine (ELAM) Program for Women

“…There were four rounds of follow-ups, using methods we had learned from previous experience to increase response rate. 28 Because of the delay involved in obtaining IRB approval from the collaborating institutions, 28 we were unable to administer the Time One survey to members of ELAM Cohort Seven before their participation in the program. In an effort to maintain a longitudinal focus, we made the decision to base much of the data analysis on the 2006 survey (Time Two), with information recalled about 2001 status serving as a proxy for the Time One survey.…”

Human Subjects Protections in Community-Engaged Research: A Research Ethics Framework

“…Although the Belmont Report and the federal regulations derived from it were developed to provide guidance for both biomedical and behavioral research, they have been most useful in providing guidance for clinical trials that enrolled ideal patients under very controlled circumstances. Social science and behavioral researchers have long been critical that the requirements found in the federal regulations are cumbersome when applied to the type of research they perform and fail to consider the different types of risks that their research may pose (DeVries, DeBruin, & Goodgame, 2004; Eckenwiler, 2001; Morahan et al, 2006; Reynolds, 2000). Similar concerns are raised by researchers who attempt to ensure that research findings from phase 1 translational research (traditional bench to bedside research) are applicable in the community, where patients and their environments are less ideal.…”

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.…”

“…for medical education research. 8,9 Such difficulties, and the reported substantial variability in revisions requested by multiple IRBs to a single medical education research protocol, 8 present potential barriers to much-needed multiinstitutional medical education research.…”