The roles and experiences of nonaffiliated and non-scientist members of institutional review boards.

PURPOSE: Little is known about the roles and experiences of non-scientist and nonaffiliated institutional review board (IRB) members (also known as lay members), and what contributions they are making to IRBs. This study investigated the experiences of IRB lay members from leading academic medical institutions in the United States and presents their recommendations for future education and training. METHOD: In 2000, the authors randomly selected and contacted 20 IRBs. From the 11 IRBs that agreed to participate, a total of 32 lay members participated in telephone interviews in which they were asked open-ended questions about the types of initial and ongoing education they had received, their interactions with scientific members, their contributions, the problems they experienced on the IRB, and recommendations for future education and training. RESULTS: Participants believed their role was to represent the community of human subjects, and 94% reported that their main contribution was simplifying the consent forms. Although 94% of participants had positive experiences working with scientist IRB members, 88% occasionally had been intimidated and felt disrespected by them. Forty-seven percent of participants identified lack of education and training as a problem, and 78% wanted more intensive education and training for future non-scientist/nonaffiliated members. CONCLUSION: IRB reform should include better training for non-scientist and nonaffiliated members so that they can take on more active roles. In addition, measures are needed to strengthen the relationships between scientist and non-scientist and nonaffiliated members.     

New challenges facing interinstitutional social science and educational program evaluation research at academic health centers: a case study from the ELAM program.

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.     

Current status of the institutional review boards in Korea: constitution,operation, and policy for protection of human research participants

The institutional review board is crucial to ensure the scientific and ethical quality of human participant research. This paper analyzes a survey on the current constitution and operation of institutional review boards (IRBs) in Korea, conducted by the Korean Association of Institutional Review Boards in April 2002. Out of 74 IRBs, 63 responded to the survey (85.1% response rate). IRB membership has a male-to-female ratio of approximately 80:20, a predominance of male clinicians (60%) and an underrepresentation of community people unaffiliated to the institutions (less than 10%). Most IRBs (around 80%) confine the scope of their reviews to the clinical evaluation of drugs or devices, leaving the remaining areas of research involving human participants untouched. As their role is limited, the majority of IRBs do not operate actively: 72% of responding IRBs reviewed less than one protocol per month in 2001. Sixty two percent of institutions have never discussed the need for insuring research participants' risks or making indemnity arrangements. This survey reveals many shortcomings and points for improvement by the institutional support bodies, including the need to establish regular education programs for IRB members and investigators.     

Medical schools' attitudes and perceptions regarding the use of central institutional review boards.

PURPOSE: To investigate the current practices, attitudes, perceptions, and future plans of U.S. medical schools regarding the use of central institutional review boards (IRBs) to review research involving human participants. METHOD: In 2003, a survey instrument was distributed via fax and e-mail to the deans of research at the 125 accredited U.S. medical schools. Each dean was asked to have the instrument completed by the official at that school who decided on the use of a central versus local IRB. The survey instrument consisted primarily of a variety of closed-ended questions. RESULTS: Eighty-eight medical schools (69.8%) completed the instrument; 76% of these indicated that they had never used a central IRB and 24% had used a central IRB. Most of the respondents expressed no interest in using a central IRB in the future because they believed that their local IRB was working efficiently, and they were concerned about issues of institutional liability and the loss of local representation in the review process. Of the medical schools that had used a central IRB, most were pleased with the performance of the central IRB and would continue to use a central IRB in the future. Of interest, most of these respondents did not agree that a central IRB had helped them to attract industry-sponsored research. CONCLUSIONS: In spite of much discussion about the advantages of central IRBs in expediting overview of human subjects research, especially in multicenter trials, the majority of medical schools surveyed had never used a central IRB and expressed no interest in doing so.     

Medical education research and IRB review: an analysis and comparison of the IRB review process at six institutions.

PURPOSE: To compare how different institutional review boards (IRBs) process and evaluate the same multiinstitutional educational research proposal of medical students' quality of life. METHOD: Prospective collection in 2005 of key variables regarding the IRB submission and review process of the same educational research proposal involving medical students, which was submitted to six IRBs, each associated with a different medical school. RESULTS: Four IRBs determined the protocol was appropriate for expedited review, and the remaining two required full review. Substantial variation existed in the time to review the protocol by an IRB administrator/IRB member (range 1-101 days) and by the IRB committee (range 6-115 days). One IRB committee approved the study as written. The remaining five IRB committees had a median of 13 requests for additional information/changes to the protocol. Sixty-eight percent of requests (36 of 53) pertained to the informed consent letter; one third (12 of 36) of these requests were unique modifications requested by one IRB but not the others. Although five IRB committees approved the survey after a median of 47 days (range 6-73), one committee had not responded six months after submission (164 days), preventing that school from participating. CONCLUSIONS: The findings suggest variability in the timeliness and consistency of IRB review of medical education research across institutions that may hinder multi-institutional research and slow evidence-based medical education reform. The findings demonstrate the difficulties of having medical education research reviewed by IRBs, which are typically designed to review clinical trials, and suggest that the review process for medical education research needs reform.     

The role of institutional support in protecting human research subjects.

Institutional review boards (IRBs) and the federal "assurance" procedures play critical roles in the current research and regulatory environments for clinical research in academic medical centers and other institutions. The author focuses on what institutions can and ought to do to create an infrastructure that assures the protection of human subjects. Specifically, an institution should (1) create an ethics infrastructure in which both IRBs and the function of protecting human subjects are respected; (2) assure that adequate resources (space, staff, equipment) are available; (3) support IRB members with appropriate recognition and time, since their IRB workloads can be heavy; and (4) provide adequate and appropriate education for IRB administrators, members, and staff, and for investigators and research staff. Academic medical centers should also use their expertise in analyzing the current system and developing means of improving it. Nevertheless, providing adequate resources for proper research conduct will be challenging, given the current financial limitations within academic medical centers.     

When do medical students become human subjects of research? The case of program evaluation.

Intense national dialogue exists around federal requirements protecting the rights of human subjects in clinical research. There is much less discussion surrounding protections for human subjects in such areas as evaluation research when the subjects are also students. Differential interpretation of 45 CFR 46 (the standing regulation on research involving human subjects) by institutional review boards (IRBs) leaves many confused about whether research using student data requires IRB review. At the heart of the uncertainty are "dual purpose activities," for example, when student data from program evaluation or routine assessments subsequently become the basis for faculty scholarship that is disseminated as "generalizable knowledge" to the community of medical educators. The authors identify two factors that should be considered as institutions develop applications and interpretations of 45 CFR 46. First, medical educators should enter into dialogues with their IRBs to become more familiar with these regulations and their application in evaluation or assessment studies. Second, for reasons of professionalism, faculty should seek opportunities to model in their role as researchers those ethical behaviors that are central to an honest relationship between physician and patient. In the educational context this means faculty disclosure of how student data may be used by faculty in their own scholarship and determination of when student consent is needed. The authors also describe how one medical school addressed this thorny challenge with assistance from the university IRB and offer suggestions to improve institutional procedures.     

How local IRBs view central IRBs in the US

Background

Centralization of IRB reviews have been increasing in the US and elsewhere, but many questions about it remain. In the US, a few centralized IRBs (CIRBs) have been established, but how they do and could operate remain unclear.

Methods

I contacted 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate = 55%) and an additional 12 members and administrators.

Results

These interviewees had often interacted with CIRBs, but supported local reviews, and offered advantages and disadvantages of each. Interviewees argued that local IRBs can provide "local knowledge" of subjects and PIs, and "curbside consults" with PIs, facilitating mutual trust. PIs may interact more fully and informally, and hence effectively with local IRBs. IRBs also felt additional responsibility to protect "their own" subjects. Respondents mentioned a few advantages of CIRBs (e.g., CIRBs may streamline reviews), though far more rarely and cursorily. Overall, interviewees were wary of CIRBs, which they saw as varying widely in quality, depending on who happened to be members. Both local and centralized IRBs appear to have unintended consequences. For instance, discrepancies arose between IRBs that appeared to reflect differences in institutional culture and history, and personalities of chairs and/or vocal members, more than in local community values per se, and thus do not seem to be the intent of the regulations. While some critics see CIRBs as solutions to many IRB problems, critical tradeoffs and uncertainties emerge.

Conclusions

These data have critical implications for future policy and research. Debates need to evolve beyond simply a binary discussion of whether CIRBs should replace local IRBs, to examine how and to what degree different models might operate, and what the relative advantages and disadvantages of each are. While some critics see CIRBs as panaceas, certain problems appear likely to continue. Careful consideration needs to be given to whether the advantages of local IRBs outweigh the problems that result, and whether a system can be developed that provides these benefits, while avoiding the disadvantages of local IRBs.     

Rejuvenating a foundering institutional review board: one institution's story.

This report recounts one institution's experience in the fundamental reorganization of its institutional review board (IRB). With an appropriate approach, organizational structure, and ethos, the goals of research participant safety, regulatory compliance, and efficiency are not in conflict but, rather, mutually reinforcing. These important goals were realized because all aspects of the IRB reorganization were guided by and measured against five related principles: (1) expertise, (2) service, (3) credibility, (4) efficiency, and (5) accountability. This medium-sized academic IRB was successfully reorganized to increase the scrutiny of protection of human subjects and to promote efficiency and investigator services. On average, the office returned expedited submissions to investigators with approvals or queries within two working days of submission. On submissions requiring full committee review, letters and faxes were issued to investigators within 48 hours of committee meetings. This turnaround time (combined with a nine-day premeeting submission requirement) meant that investigators who had submitted new studies for full committee review received an approval, request for modifications, queries for more information, or disapproval within 11 days from the reorganized IRB. In contrast, an Office of the Inspector General study noted that IRBs in academic medical centers typically report decisions within an average of 37 days. The reforms included mechanical and operational changes within office procedure, a robust educational program for committee members, and a revamped IRB office staff that decreased the total number of office employees from five to four but that increased educational levels and skills of the staff members.     

IRB reliance: An informatics approach

Multi-site Institutional Review Board (IRB) review of clinical research projects is an important but complex and time-consuming activity that is hampered by disparate non-interoperable computer systems for management of IRB applications. This paper describes our work toward harmonizing the workflow and data model of IRB applications through the development of a software-as-a-service shared-IRB platform for five institutions in South Carolina. Several commonalities and differences were recognized across institutions and a core data model that included the data elements necessary for IRB applications across all institutions was identified. We extended and modified the system to support collaborative reviews of IRB proposals within routine workflows of participating IRBs. Overall about 80% of IRB application content was harmonized across all institutions, establishing the foundation for a streamlined cooperative review and reliance. Since going live in 2011, 49 applications that underwent cooperative reviews over a three year period were approved, with the majority involving 2 out of 5 institutions. We believe this effort will inform future work on a common IRB data model that will allow interoperability through a federated approach for sharing IRB reviews and decisions with the goal of promoting reliance across institutions in the translational research community at large.     

Integrating stakeholder feedback in translational genomics research: an ethnographic analysis of a study protocol’s evolution

PurposeThis study describes challenges faced while incorporating sometimes conflicting stakeholder feedback into study design and development of patient-facing materials for a translational genomics study aiming to reduce health disparities among diverse populations.MethodsWe conducted an ethnographic analysis of study documents including summaries of patient advisory committee meetings and interviews, reflective field notes written by study team members, and correspondence with our institutional review board (IRB). Through this analysis, we identified cross-cutting challenges for incorporating stakeholder feedback into development of our recruitment, risk assessment, and informed consent processes and materials.ResultsOur analysis revealed three key challenges: (1) balancing precision and simplicity in the design of study materials, (2) providing clinical care within the research context, and (3) emphasizing potential study benefits versus risks and limitations.ConclusionsWhile involving patient stakeholders in study design and materials development can increase inclusivity and responsiveness to patient needs, patient feedback may conflict with that of content area experts on the research team and IRBs who are tasked with overseeing the research. Our analysis highlights the need for further empirical research about ethical challenges when incorporating patient feedback into study design, and for dialogue with genomic researchers and IRB representatives about these issues.     

The cost of operating institutional review boards (IRBs).

PURPOSE: Recent reports have claimed that institutional review boards (IRBs) are underfunded, yet little is known about the costs of operating IRBs. This study estimated the costs for operating high-volume and low-volume IRBs. METHOD: IRB costs were calculated from published summary data. Costs were standardized to reflect 2001 dollars. RESULTS: Total estimated costs for operating high-volume and low-volume IRBs were $770,674 and $76,626, respectively. The average cost per action, a measure of economic efficiency, was lower for high-volume IRBs ($277 per action) than it was for low-volume IRBs ($799 per action). CONCLUSIONS: Although high-volume IRBs are more expensive than are low-volume IRBs in absolute terms, they are more economically efficient. Policy debates should consider the potential savings from large IRBs, perhaps by encouraging small IRBs to merge, although this may result in less local review, control, and oversight.     

Examining the Gap Between Medical School Matriculation and Graduation Rates Amongst Self-Identified Minorities

PurposeDespite increasing diversity, data indicates that there is a gap between the matriculation or admission of and graduation rates amongst medical students who identify with racial or ethnic minority groups. The purpose of this study was to identify barriers experienced by minority medical students that may account for this gap.MethodsAn IRB approved online survey was created, and distributed electronically to minority medical students, residents, and practicing physicians. Information on demographics, family dynamics, academic struggles, health issues, financial difficulties and faculty diversity was collected via self-report.ResultsParticipants (n = 167) who completed the survey identified as Black/African/African American (60%), Hispanic/Latinx (26%), Asian (8%), and as Other racial or ethnic minority (6%). The majority of survey participants graduated within the traditional 4 years of medical school (83%) and 17% did not. The most frequently reported reason was to pursue academic advancement (42%) which included completing a research year, dual degree, or PhD. The second reason was due to academic deficiencies (38%), either course failure or failure of a board exam. The majority of respondents (59%) also reported not having enough faculty members who were members of racial or ethnic minority groups at their medical school.ConclusionsOur data suggests the majority of racial and ethnic minority medical students graduate within the traditional 4 years of medical school. However, if they do not, it is either due to academic advancement to become a more successful residency applicant, or due to academic issues. The majority of respondents reported that they perceive a lack of racial and ethnic minority faculty members in academics.     

The impact of a program for systematically recognizing and rewarding academic performance.

PURPOSE: To describe an academic performance incentive system (APIS) and faculty perception of it; explore the impacts of incentive level, faculty rank, clinical practice volume, and administrative responsibility on academic productivity; and describe the APIS's use in maintaining congruence between department mission and activities. METHOD: A list of teaching, research, and academic service activities was developed, which full-time faculty (n = 33) used to report activities. Clinical faculty members received incentive income based on credits earned. APIS initially distributed 1% of practice plan receipts (subsequently increased to 3% and then 5%). Productivity was measured by differences in APIS points achieved. Satisfaction of all faculty participants was measured by survey. RESULTS: Faculty members (n = 20) who participated throughout averaged 22 credits per month (nine to 42 credits), and quarterly incentive bonuses ranged from 145 US dollars to 6,128 US dollars. Average credits earned per month were 24 for the 1% incentive, 23 for the 3% incentive, and 20 for the 5% incentive. Faculty members with administrative responsibilities were as productive academically as were their non-administrative counterparts. Senior faculty members were as productive as junior faculty. Faculty members who were more productive clinically were more productive academically. Seventy percent of respondents reported they were either very satisfied or somewhat satisfied with the APIS. Seventy-eight percent felt that the APIS accurately reflected their academic productivity. Most respondents (81%) felt that the amount of money allocated to the incentive system was appropriate (15% felt it should be increased and one respondent recommended reduction). CONCLUSIONS: The APIS system has been well accepted by faculty and allows for data-driven discussion of the department's mission and activities.     

Market competition and patient-oriented research: the results of a national survey of medical school faculty.

PURPOSE: To understand the effect of market competition on patient-oriented research at U.S. medical schools and teaching hospitals. METHOD: From a multi-stage stratified, random sample, the authors surveyed 3,804 research faculty at 117 U.S. medical schools. The questionnaire assessed five variables, the type of research conducted by the respondent, changes in patient-oriented and non-clinical research in the preceding three years, amount of time spent on patient care, market stage of the respondent's institution, and research productivity. RESULTS: Of the 2,336 faculty who responded (62%), 84% of those conducting patient-oriented research and 80% of those engaged in non-clinical research reported conducting the same amount of research or more in 1996-1997 than in the preceding three years. However, both patient-oriented and non-clinical researchers in the most competitive health care markets and those with high levels of patient care duties were most likely to report decreases in the amounts of such research conducted in the previous three years. Further, researchers reporting such decreases had been as productive in recent years and over their careers as had those who did not report a decrease. CONCLUSIONS: This study provides additional evidence of the negative relationships that exist between high levels of market competition and patient care services on the patient-oriented and non-clinical research missions of teaching hospitals.     

Increasing the pool of educational leaders for UCLA.

The dual goals of the faculty Fellowship in Medical Education (MEF) program at the David Geffen School of Medicine at UCLA, established in 1992, are to prepare excellent teachers to serve as clerkship chairs, course chairs, or residency program directors while strengthening their dossiers for promotion based on a scholarly approach to curriculum development, implementation, and evaluation. Fellows are nominated from their departments and must demonstrate a strong interest in assuming educational leadership in their respective specialties. A total of eight fellows are accommodated each year based on interviews with the MEF faculty. The two-year program consists of two seminars and two projects focused on four objectives: to critique teaching and testing practices in medical education in light of current theories of learning; to develop and implement curricula that reflect these theories; to improve personal teaching skills through reflection and feedback; and to design and conduct an educational research or program evaluation study. An analysis of the curricula vitae of faculty members who have completed the fellowship suggest that this program continues to provide educational leaders for the school as originally intended. Of the 71 medical school faculty members who completed the MEF between 1993 and 2004 and have remained at the university, 43 (61%) have assumed new leadership roles in medical education. The evaluation data strongly suggest that the MEF has had a major role since its inception in creating a pool of faculty members with the confidence to manage the tasks of educational planning and implementation.     

Understanding and retention of the informed consent process among parents in rural northern Ghana

Background

In Nigeria, as in other developing countries, access to training in research ethics is limited, due to weak social, economic, and health infrastructure. The project described in this article was designed to develop the capacity of academic staff of the College of Medicine, University of Ibadan, Nigeria to conduct ethically acceptable research involving human participants.

Methods

Three in-depth interviews and one focus group discussion were conducted to assess the training needs of participants. A research ethics training workshop was then conducted with College of Medicine faculty. A 23-item questionnaire that assessed knowledge of research ethics, application of principles of ethics, operations of the Institutional Review Board (IRB) and ethics reasoning was developed to be a pre-post test evaluation of the training workshop. Ninety-seven workshop participants completed the questionnaire before and after the workshop; 59 of them completed a second post-test questionnaire one month after the workshop.

Results

The trainees came from a multi-disciplinary background including medicine, nursing, pharmacy, social science and laboratory science. The mean scores for knowledge of the principles of research ethics rose from 0.67 out of 3 points at pre-test to 2.25 at post-test (p < 0.05). Also, 42% correctly mentioned one international guideline or regulation at pretest, with most of those knowing of the Declaration of Helsinki. Trainees' knowledge of the operations of an IRB increased from 6.05 at pre-test to 6.29 at post test out of 7 points. Overall, participants retained much of the knowledge acquired from the workshop one month after its completion.

Conclusion

The training improved participants' knowledge of principles of research ethics, international guidelines and regulations and operations of IRBs. It thus provided an opportunity for research ethics capacity development among academic staff in a developing country institution.     

Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants.

PURPOSE: To document the current state of institutional review board (IRB) and conflict of interest committee policies regarding disclosures of financial conflicts of interest to potential research participants, and to use this information to identify and share models for effectively achieving disclosure. METHOD: The authors identified the 123 U.S. academic medical centers that have IRBs and sought their IRB and institutional policies regarding financial conflicts of interest. In February and March 2004, using manual and key word searches, each institution's Web site was searched to identify documents containing information regarding the disclosure of financial conflicts of interest. Letters were sent to 24 institutions that had either no information or incomplete information posted on their Web sites. To assess institutions' guidelines for disclosure, the authors extracted and content coded each institution's information on disclosure. RESULTS: Relevant information was obtained from 120 (98%) academic medical centers (AMCs), of which 57 (48%) mentioned disclosing financial conflicts to potential research participants. Of these 57, 33 (58%) included verbatim language that could be used in informed consent documents. AMCs' recommendations and requirements for disclosure included details of the financial arrangement, administrative management of conflicts of interest, and encouragement of dialogue between the investigator and the potential research participant. CONCLUSIONS: Considerable variability exists concerning the specific information that should be disclosed. Most of the AMCs' policies were consistent with the goal of protection from legal liability. Significant questions remain, however, concerning the goals of disclosure and the most effective methods for achieving those goals.     

The impact of centers and institutes on faculty life: findings from a study of basic science and internal medicine faculty at research-intensive medical schools.

PURPOSE: To examine the impact of organized research centers on faculty productivity and work life for basic science and internal medicine faculty at research-intensive medical schools. METHOD: In 2005, the authors administered a questionnaire to a random stratified sample of full-time faculty in basic science and internal medicine departments at the top 40 research-intensive U.S. medical schools. The survey instrument asked faculty about the extent of their involvement in centers and institutes, the direction and extent of their activities, and their satisfaction with various dimensions of work. RESULTS: A total of 778 faculty members completed the questionnaire (72.0%). Basic science faculty with center affiliations produced more research publications and grants while devoting comparable effort to teaching as their non-center-affiliated peers. These faculty reported greater dissatisfaction in workload and in the mix of their activities. Internal medicine MD center-affiliated faculty were more productive in research activities and spent less effort in patient care and more effort in research than their non-center-affiliated peers. These faculty were more satisfied with promotion, opportunities for research, and the pace of their professional advancement. CONCLUSIONS: Findings indicate that faculty from different departments and with different ranks and backgrounds interact with centers and institutes in multiple ways. For basic science faculty, center involvement appears to be an addition to, not a substitute for, their usual departmental obligations. For internal medicine MD faculty, center involvement appears to serve as an opportunity for protected effort in research away from the demands of clinical practice.     

Comparing research activities of women and men faculty in departments of internal medicine

The findings from a questionnaire prepared by the Association of Professors of Medicine and the Association of American Medical Colleges were published in two reports in 1986 and 1987. These reports assessed the research activities of full-time members of departments of internal medicine in 1982 and 1983. The purpose of the present study was to analyze the data of the earlier reports in order to compare the research activities of women and men who were full-time faculty in departments of medicine during the time period originally surveyed. More than half of the faculty women who responded (52%) were less than 40 years old, compared with 23% of the faculty men. Sixty-seven percent of the women held the rank of instructor or assistant professor, in contrast to 40% of the men holding these ranks. Although the faculty of both genders reported generally the same proportions of time devoted to research, the women researchers with M.D. degrees had significantly less National Institutes of Health (NIH) grant support than did their counterparts who were men. Since this difference may have been a function of age, the authors compared NIH grant support of the faculty men and women with M.D. degrees who were 40-59 years old. Even in this older group, significantly fewer of the faculty women had NIH grant support than did the men (16% versus 30%). Furthermore, the percentage of designated laboratory space was significantly lower among the faculty women, regardless of degree (M.D., M.D./Ph.D., or Ph.D.). Further investigation is warranted to monitor the progress of women attempting to develop their research careers and to assess their overall clinical teaching and administrative roles in departments of medicine.