Institutional Review Board Review Process Research Articles

Impact of institutional review board stipulations on turnaround time for approvals of surgical studies.

We have examined the number and types of stipulations received following the submission of surgical study protocols to the Institutional Review Boards (IRBs) for review, and their effect on turnaround time for approval. This analysis will enable our organization to improve the quality of applications and design of study protocols, which can streamline the approval process and increase efficiency of the startup phase for clinical research. IRB stipulations for 48 surgical studies were analyzed. Various factors were assessed: surgical specialty, type of study by design, clinical trial phase, type of investigational product, type of IRB utilized (local or centralized), study complexity score, type of review (e.g., exempt, expedited, or full board), turnaround time, and number of stipulations received. Statistical analyses were performed to examine associations between the number/type of stipulations received during the IRB review process and any of the aforementioned study-related factors. For analyzed surgical studies, the number of stipulations allotted to a study and time taken for approval had moderate association with the complexity of the study. The turnaround time for approval was the highest for randomized, controlled trials and studies undergoing full board review. This study elucidates characteristics that are associated with increased time for IRB approval. Analysis of IRB stipulations can help improve the turnaround time for the approval process, increase efficiency of startup phase, and transition to execution phase faster, which will allow more time for enrollment of research subjects, and increase return on investment made into research and development programs.

Challenges and recommendations to improve institutional review boards' review of community-engaged research proposals: A scoping review.

Academic and community investigators conducting community-engaged research (CEnR) are often met with challenges when seeking Institutional Review Board (IRB) approval. This scoping review aims to identify challenges and recommendations for CEnR investigators and community partners working with IRBs. Peer-reviewed articles that reported on CEnR, specified study-related challenges, and lessons learned for working with IRBs and conducted in the United States were included for review. Fifteen studies met the criteria and were extracted for this review. Four challenges identified (1) Community partners not being recognized as research partners (2) Cultural competence, language of consent forms, and literacy level of partners; (3) IRBs apply formulaic approaches to CEnR; & (4) Extensive delays in IRB preparation and approval potentially stifle the relationships with community partners. Recommendations included (1) Training IRBs to understand CEnR principles to streamline and increase the flexibility of the IRB review process; (2) Identifying influential community stakeholders who can provide support for the study; and (3) Disseminating human subjects research training that is accessible to all community investigator to satisfy IRB concerns. Findings from our study suggest that IRBs can benefit from more training in CEnR requirements and methodologies.

Institutional Review Board Use of Outside Experts: A National Survey

Background Institutional review board (IRB) expertise is necessarily limited by maintaining a manageable board size. IRBs are therefore permitted by regulation to rely on outside experts for review. However, little is known about whether, when, why, and how IRBs use outside experts. Methods We conducted a national survey of U.S. IRBs to characterize utilization of outside experts. Our study uses a descriptive, cross-sectional design to understand how IRBs engage with such experts and to identify areas where outside expertise is most frequently requested. Results The survey response rate was 18.4%, with 55.4% of respondents reporting their institution’s IRB uses outside experts. Nearly all respondents who reported using outside experts indicated they do so less than once a month, but occasionally each year (95%). The most common method of identifying an outside expert was securing a previously known subject matter expert (83.3%). Most frequently, respondents sought consultation for scientific expertise not held by current members (69.6%). Almost all respondents whose IRBs had used outside experts reported an overall positive impact on the IRB review process (91.5%). Conclusions Just over half of the IRBs in our sample report use of outside experts; among them, outside experts were described as helpful, but their use was infrequent overall. Many IRBs report not relying on outside experts at all. This raises important questions about what type of engagement with outside experts should be viewed as optimal to promote the highest quality review. For example, few respondents sought assistance from a Community Advisory Board, which could address expertise gaps in community perspectives. Further exploration is needed to understand how to optimize IRB use of outside experts, including how to recognize when expertise is lacking, what barriers IRBs face in using outside experts, and perspectives on how outside expert review impacts IRB decision-making and review quality.

Nothing about Us without Us: Inclusion and IRB Review of Mental Health Research Protocols.

Research on mental health and illness presents a variety of unique ethical challenges. This article argues that institutional review boards (IRBs) can improve their reviews of such research by including the perspectives of individuals with the condition under study either as members of the IRB or as consultants thereto. Several reasons for including the perspectives of these individuals are advanced, with the discussion organized around a hypothetical case study involving the assessment of a novel talk-therapy modality. Having made this case, the article goes on to explain how to implement the idea by building on a recent proposal by Rebecca Dresser, who argues in a number of publications for the inclusion of former research participants in the IRB review process. Finally, concerns about protecting reviewer and consultant confidentiality are addressed.

Modernization Updates to the Common Rule: Recommendations for Researchers Working With Human Participants

Introduction: This tutorial article explicates some of the 2017 updates to the 1991 Common Rule. Implemented in January 2019, these changes impact the evolving landscape of research with human participants in the US. The introduction provides context for the article as well as framing research questions. Key concepts: These include a brief definition of research for the purposes of the article; a discussion of the foundational ethical principles of autonomy (respect for persons), beneficence, and justice; and a brief overview of the recent policy revision process and its impact on scholarship in the field. After establishing this context, readers are provided five key lessons from the policy revisions. Key lessons: The lessons for researchers working with human participants include discussion of the impact of policy changes in the Common Rule associated with broad consent, single Institutional Review Board (IRB) mandate/cooperative review, updated exemptions, modified definitions of vulnerability, and international research. These are all contextualized within a specific example for professional communication researchers. Implications for practice: Although educative efforts are underway at both the federal and institutional levels, it is important for disciplines and researchers to understand how policy changes will impact the IRB review process. Attendance to the infrastructures that guide our research design and development warrants attention.

Evaluation of a University's Institutional Review Board Based on Campus Feedback: A Cross-Sectional Study.

IntroductionMaintaining research ethics within a university and monitoring the campus Institutional Review Board (IRB) are essential responsibilities not to be taken lightly. IRBs occasionally need to be reviewed to see that they, as well as researchers, are adhering to rules and regulations on ethics through their submission and review procedures. Since there are no established measures for assessing IRB quality, it is unclear how to determine whether IRBs are achieving their intended aims. This study used the feedback and input of campus members at a newly-established, private, non-profit university within the Kingdom of Saudi Arabia (KSA) to evaluate their campus IRB.MethodsFollowing the university’s IRB approval, and in close collaboration with the Saudi National Committee of Bioethics (NCBE), this cross-sectional study was conducted from February through May of 2019. Self-administered surveys were sent out via university emails to faculty and students at Alfaisal University in Riyadh of Saudi Arabia. The questions in the surveys included inquiries on participants’ demographics, their familiarity with campus IRB research ethics, their satisfaction with IRB procedures, the challenges encountered during the IRB submission and review process, the effectiveness of a recent IRB-coordinated research ethics campaign, and any suggestions for IRB improvement. Surveys were sent to faculty members and students at five colleges on campus.ResultsOf the campus members who were sent surveys, 8% responded (175). Of those who responded, 29.7% had submitted at least one research proposal for IRB review during the past three years (2016-2019), and more than half of this group were satisfied with the IRB submission and review procedures. For those who had submitted at least one research proposal, respondents reported the more usual challenges that researchers tend to encounter, such as time-consuming and tedious IRB review processes and ambiguous IRB guidelines and regulations. The less typical IRB challenges that were reported, and that are unique to academia, include the IRB tendency to deny undergraduate student requests to serve as principal investigators of their research projects. Concerning IRB efforts to educate and train campus members on research ethics, only 26.3% of the participants were aware of the recently performed research ethics campaign, and 7.6% of the participants attended the end-of-campaign workshop. Of those who attended the workshop, 76.9% reported that the campaign and workshop effectively met their expectations.Conclusions This study revealed several issues encountered by university faculty and students seeking campus IRB approval for their research projects. The main academia-specific challenge was over whether undergraduate students could serve as PIs for research projects, and a universal one was that they find the IRB process to be very time-consuming and tedious, which is a situation that has already been relayed in several other articles on IRB issues. About two-thirds of respondents reported a lack of familiarity with the topic of research ethics. This challenge makes it clear that information on research ethics is not effectively reaching enough campus members in the busy environment of academia.

Inquiring to Benefit Society While Protecting Subjects: The Debates, Complexities and Moral Obligations of the IRB Review Process

Whitney’s text Balanced Ethics Review: A Guide for Institutional Review Board Members highlights and problematizes pertinent issues in the Institutional Review Board (IRB) review process with a focus on the USA. The book, which is meant for “IRB member or chair” engages readers in exploring in-depth and from multiple perspectives the debates on the roles and responsibilities of IRBs. Within this context, the author demonstrates the need for the IRB process that balances the protection of human subjects with the benefits of research to the society. Furthermore, the book engages readers in exploring and reflecting on the intersections between power relations, and the moral obligations of IRBs. Moreover, insights are provided into the work of federal agencies that “control the IRB system.”

IRB Process Improvements: A Machine Learning Analysis.

Clinical research involving humans is critically important, but it is a lengthy and expensive process. Most studies require institutional review board (IRB) approval. Our objective is to identify predictors of delays or accelerations in the IRB review process and apply this knowledge to inform process change in an effort to improve IRB efficiency, transparency, consistency and communication. We analyzed timelines of protocol submissions to determine protocol or IRB characteristics associated with different processing times. Our evaluation included single variable analysis to identify significant predictors of IRB processing time and machine learning methods to predict processing times through the IRB review system. Based on initial identified predictors, changes to IRB workflow and staffing procedures were instituted and we repeated our analysis. Our analysis identified several predictors of delays in the IRB review process including type of IRB review to be conducted, whether a protocol falls under Veteran's Administration purview and specific staff in charge of a protocol's review. We have identified several predictors of delays in IRB protocol review processing times using statistical and machine learning methods. Application of this knowledge to process improvement efforts in two IRBs has led to increased efficiency in protocol review. The workflow and system enhancements that are being made support our four-part goal of improving IRB efficiency, consistency, transparency, and communication.

한국의 한 대학병원의 연구윤리심의위원회 심의에서 나타난 임상연구계획의 과학적, 윤리적 문제*

With the increased number of clinical trials being conducted in South Korea, Institutional Review Boards (IRBs) have acquired greater significance. In human clinical trials, unscientific studies may be unethical in light of their potential for causing harm to participants. Therefore, IRBs should review both the scientific and the ethical issues of any research protocol. However, research into the IRB review process is lacking in Korea. This study examined the protocols for clinical trials under the review of the IRB at Seoul National University Hospital. In total 1,244 protocols (752 between 2004 and 2006; 492 in 2013) were analyzed. Of these 22.7% were approved, 64.2% underwent minor revision, and 12.6% underwent major revision. In total, 62.2% of these protocols raised scientific issues, and 47.0% raised ethical issues. Among the scientific issues, “unclear sample size calculation” occurred most frequently. “Subjects’ recruitment/inclusion criteria” was the most frequently cited ethical issue. A total of 67.0% had consent issues and 41.3% raised questions about the case report form. Compared to the period from 2004 to 2006, the prevalence of protocols with “unclear study design” and those that raised questions about “privacy/personal data” increased in 2013. While scientific issues were the most frequent among investigator-initiated trials, consent issues were the most frequent in sponsor-initiated trials. Although all issues were significantly associated with the approval decision, the approval rate of studies with ethical issues was lowest. These results provide a basis for the development of guidelines for researchers by identifying common issues in clinical protocols.

Time required to review research protocols at 10 Veterans Affairs Institutional Review Boards

BackgroundDespite perceptions that institutional review boards (IRBs) delay research, little is known about how long it takes to secure IRB approval. We retrospectively quantified IRB review times at 10 large Veterans Affairs (VA) IRBs. MethodsWe collected IRB records pertaining to a stratified random sample of research protocols drawn from 10 of the 26 largest VA IRBs. Two independent analysts abstracted dates from the IRB records, from which we calculated overall and incremental review times. We used multivariable linear regression to assess variation in total and incremental review times by IRB and review level (i.e., exempt, expedited, or full board) and to identify potential targets for efforts to improve the efficiency and uniformity of the IRB review process. ResultsIn a sample of 277 protocols, the mean review time was 112 d (95% confidence interval [CI]: 105-120). Compared with full-board reviews at IRB 1, average review times at IRBs 3, 8, 9, and 10 were 27 (95% CI: 6-48), 37 (95% CI: 11-63), 45 (95% CI: 20-69), and 24 (95% CI: 2-45) d shorter, and at IRB 6, times were 56 (95% CI: 28-84) d longer. Across all IRBs, expedited reviews were 44 (95% CI: 30-58) d shorter on average than were full-board reviews, with no significant difference between exempt and full-board reviews. However, after subtracting the time required for Research and Development Committee review, exempt reviews were 21 (95% CI: 1-41) d shorter on average than were full-board reviews. ConclusionsIRB review times differ significantly by IRB and review level. Few VA IRBs approach a consensus panel goal of 60 d for IRB review. The unexpectedly longer review times for exempt protocols in the VA can be attributed to time required for Research and Development Committee review. Prospective, routine collection of key time points in the IRB review process could inform IRB-specific initiatives for reducing VA IRB review times.

The Impact of Institutional Review Boards (IRBs) on Clinical Innovation: A Survey of Investigators and IRB Members.

We conducted a survey to assess the perspectives of principal investigators and Institutional Review Board (IRB) members on the impact of the IRB structure on the conduct of research and innovative therapy, defined as a nonstandard treatment intended to enhance the well-being of an individual patient. Although investigators and IRB members agreed that the IRB provides adequate protection to study subjects (97% vs. 100%) and an ethically insightful review (88% vs. 100%), a third of clinical investigators felt that the IRB review process limits clinical innovation, in comparison with only 4% of IRB representatives. Limitations of the current IRB review process were explored. We propose several measures to improve the IRB review process while maintaining the protection of human research subjects, including the use of centralized IRBs, the opening of IRB meetings to investigators, the development of metrics and outcome measures for the IRB, and the promotion of guidelines that distinguish research and innovative therapy.

Time required for institutional review board review at one Veterans Affairs medical center.

Despite growing concern that institutional review boards (IRBs) impose burdensome delays on research, little is known about the time required for IRB review across different types of research. To measure the overall and incremental process times for IRB review as a process of quality improvement. After developing a detailed process flowchart of the IRB review process, 2 analysts abstracted temporal data from the records pertaining to all 103 protocols newly submitted to the IRB at a large urban Veterans Affairs medical center from June 1, 2009, through May 31, 2011. Disagreements were reviewed with the principal investigator to reach consensus. We then compared the review times across review types using analysis of variance and post hoc Scheffé tests after achieving normally distributed data through logarithmic transformation. Calendar days from initial submission to final approval of research protocols. Initial IRB review took 2 to 4 months, with expedited and exempt reviews requiring less time (median [range], 85 [23-631] and 82 [16-437] days, respectively) than full board reviews (median [range], 131 [64-296] days; P = .008). The median time required for credentialing of investigators was 1 day (range, 0-74 days), and review by the research and development committee took a median of 15 days (range, 0-184 days). There were no significant differences in credentialing or research and development times across review types (exempt, expedited, or full board). Of the extreme delays in IRB review, 80.0% were due to investigators' slow responses to requested changes. There were no systematic delays attributable to the information security officer, privacy officer, or IRB chair. Measuring and analyzing review times is a critical first step in establishing a culture and process of continuous quality improvement among IRBs that govern research programs. The review times observed at this IRB are substantially longer than the 60-day target recommended by expert panels. The method described here could be applied to other IRBs to begin identifying and improving inefficiencies.

Approaches to Facilitate Institutional Review Board Approval of Multicenter Research Studies

Gaining Institutional Review Board (IRB) approval for a multicenter research study can be a lengthy and time-consuming process. It can increase the complexity of consent forms, decreasing patient understanding and lowering recruitment numbers. It also leads to increased costs through the duplication of effort. This paper examines some of the strategies used to streamline the IRB review process for multicenter studies and provides examples used by 2 existing multicenter comparative effectiveness research networks. A literature search was conducted to identify sources that described the challenges and potential strategies to facilitate multicenter IRB approval. The most promising avenues were identified and included in this review. Phone interviews were conducted with the Principal Investigators and Project Managers of 2 successful multicenter research networks to learn their "keys to success" and their lessons learned. Three strategies were identified that held the most promise: working with IRBs before submission, the use of central and/or federated IRBs, and the establishment of an umbrella protocol. Each of these strategies was used to some degree by the case study projects. Although the approaches documented here can help streamline the IRB approval process, they are not a "silver bullet." Because some of these approaches are still relatively new, empirical data are sparse. However, it is believed that they will significantly reduce the administrative burden of the project as a whole and lead to a decrease in the overall time to protocol approval.

Institutional Review Board Variability in Minimal-Risk Multicenter Urogynecology Studies

To investigate variability among local institutional review boards (IRBs) in the review process of standardized multicenter urogynecologic studies with common protocols. Descriptive study of the IRB review and approval process for common urogynecologic protocols of 4 minimal-risk multicenter studies conducted within the Fellow's Pelvic Research Network (FPRN), including prospective cohort, retrospective review, and case-control studies. Most of the 22 network sites (73%) were in academic institutions. The level of IRB review varied by site and study design. Institutional review boards had local requirements regarding standard format and language that resulted in 86% of consent documents and 33% of protocols being changed before submission. Institutional review boards queried most (55%) submissions, with significantly more queries for prospective studies compared to retrospective studies (78.6% vs 35.3%; P = 0.03). After submission, IRB requirements necessitated changes for 71% of consents and 28% of protocols. There were no substantive changes made to any consent document or protocol. There was considerable variability in time between IRB submission and approval (10 ± 3 days; range, 7-12 days for exempt; 22 ± 17 days; range, 1-57 days for expedited; and 34 ± 32 days; range, 13-81 days for full board reviews). We detected considerable variability in IRB review of standardized multicenter protocols across minimal-risk study designs. Reduction in variability may improve expediency of multicenter studies while maintaining the highest level of protections for research participants.

Attitudes toward Genetic Research Review: Results from a Survey of Human Genetics Researchers

Background: Researchers often relate personal experiences of difficulties and challenges with Institutional Review Board (IRB) review of their human genetic research protocols. However, there have been no studies that document the range and frequency of these concerns among researchers conducting human genetic/genomic studies. Methods: An online anonymous survey was used to collect information from human genetic researchers regarding views about IRB review of genetic protocols. Logistic regression was used to test specific hypotheses. Results from the national online survey of 351 human genomic researchers are summarized in this report. Results: Issues involving considerable discussion with IRBs included reconsent of subjects (51%), protection of participants’ personal information (39%) and return of results to participants (34%). Over half of the participants had experienced one or more negative consequences of the IRB review process and approximately 25% had experienced one or more positive consequences. Respondents who had served on an IRB were about 80% more likely to report positive consequences of IRB review than their colleagues who had never served on an IRB (p = 0.03). Survey responses were mixed on the need for reconsent before data sharing and risks related to participant reidentification from genomic data. Conclusion: The results from this study provide important perspectives of researchers regarding genetic research review and show lack of consensus on key research ethics issues in genomic research.

Oral Presentation 19

OBJECTIVES: To investigate qualitative and quantitative variability among local Institutional Review Boards (IRBs) in the approval of research protocols and informed consent documents for a standardized a multicenter study with a common protocol MATERIALS AND METHODS: Descriptive study of the variability of local IRB review and approval process for four multicenter studies with common protocols conducted within the Fellow's Pelvic Research Network (FPRN). The local IRBs follow all applicable federal guidance including the DHHS at 45 CFR Part 46 and the FDA at 21 CFR Part 50 and 56 pertaining to human subjects research and the applicable regulations pertaining to privacy in research under the Health Information Portability and Accountability Act (HIPAA) at 45 CFR Part 160 and 164. RESULTS: Most of the 22 unique network sites (68%) were in academic institutions and (63%) had ABOG-ABU accredited fellowships. The four multicenter network studies included two prospective cohorts, one retrospective review and one retrospective case-control study. Sites participated in 1 (55%), 2 (18%) or 3 (27%) studies. Local IRBs varied in their requirements for identical research study protocols. Many IRBs had varied local requirements regarding standard format and language of consent forms that resulted in most sites (86%) changing consent document prior to IRB submission. Nonetheless, the IRB required changes to 71% of consent documents for the prospective studies. Required changes to consent documents primarily comprised alterations in wording with the intent of improving subject understanding of study risk and privacy safeguards. Thirty-three percent of sites were required to make minor format changes to the common protocol to meet local institution requirements. Despite federal guidelines for review of research, the level of review varied across sites (Table 1). Local IRB's had queries for most (55%) submissions with a significantly more queries for the prospective cohorts compared to retrospective studies [78.6% vs. 35.3% (P = 0.03)]. IRBs required changes to 29% of protocols, but there were no substantive changes made to any protocol. There was considerable variability in time between IRB submission and approval [10 ± 3 days, range 7–12 days for exempt; 22 ± 17 days, range 1–57 days for expedited and 34 ± 32 days, range 13–81 days for full board reviews]. Length of time to approval was longer for prospective than retrospective studies 30 ± 22 vs. 16 ± 15 days but failed to reach significance (P = 0.08). CONCLUSION: We detected considerable variability in local IRB review of standardized multicenter network protocols across a range of minimal-risk study designs. The reasons for this variability may include varied local interpretation in federal guidelines. Reduction in this variability may improve the expediency of multicenter studies while maintaining the highest level of protections for research participants.

Institutional Review, Protecting Human Subjects, and Running User Studies: What Law Librarians Need to Know About IRBs

Institutional Review Boards (IRBs) are the arbiters of human subjects research, yet many law librarians lack experience and familiarity with the IRB application and review process. This article presents IRBs in their historical and legal context, describes what IRBs expect to find in an approvable application, and concludes with a description of the authors’ experience with their IRB.

Working with the institutional review board

Working with an institutional review board (IRB) to ensure compliance and ethical conduct of research involving human subjects is discussed. The Department of Health and Human Services (DHHS) and Food and Drug Administration regulations for the conduct of human research are grounded in the principles of the Belmont Report. By establishing the requirements for the function and operation of the IRB, the criteria needed for the review and approval of research, and the requirements for obtaining and documenting informed consent, the federal regulations help ensure the safety, rights and welfare of subjects. In developing research protocols and submissions to the IRB, the investigator should include clear, detailed information that addresses the regulatory requirements for the review and approval of research. Before starting a research study, review and approval by the IRB is required unless the study is determined to be minimal risk and fits one of the defined categories. Some research projects involving observation of public behavior, collection of anonymous surveys of nonvulnerable individuals in which the information is not considered sensitive, and evaluation of standard education practices may be exempt from DHHS regulations. Informed consent is central to the protection of human subjects and is required unless the IRB allows a waiver or alteration of informed consent. Once the study is approved, the investigator must conduct the study as approved by the IRB and continue to meet the regulatory requirements related to modifications, reporting unanticipated events, and continuing review. IRB review is integral to ensuring regulatory compliance and ethical conduct of research involving human subjects. Working closely with the IRB or colleagues who have had experience with the IRB will help junior investigators better understand the IRB submission and review process.

The Expanding Purview: Institutional Review Boards and the Review of Human Subjects Research

The implications of the institutional review board (IRB) system's growing purview are examined. Among the issues discussed are whether IRBs are censoring research and whether the IRB review process fundamentally alters the research that is being conducted. The intersection between IRB review and free speech is also explored. In general, it is argued that the review system for human subjects research (HSR) should be modified in order to limit the scope of IRB review.

Clinical research: Protection of the “vulnerable”?

In this age of evidence-based medicine, clinical research is critical for developing new therapeutics and determining the best way to use these therapies. To perform appropriate clinical research, researchers must adhere to ethical standards. These standards have developed in large part as a response to egregious violations of ethically appropriate behavior. In this respect certain populations have been identified as at risk of being treated inappropriately in medical research. Current ethical guidelines prohibit or severely limit what types of research can be performed involving these "vulnerable" populations. Although this might protect these populations, the lack of research on them might actually do harm in limiting their access to life-saving therapies. We explore the historical underpinnings of protecting the vulnerable populations and whether a newer ethical paradigm that would allow for protected research on these populations should be adopted by society.