Institutional Review Board Review Research Articles

When IRBs Say No to Participating in Research about Single IRBs.

In response to a policy of the National Institutes of Health and requirements in the revised Common Rule, a protocol for a multisite study must be reviewed by a single institutional review board (IRB), rather than by the IRB at each study site. The goal of the single IRB approach is to increase the efficiency of IRB review of multisite research without jeopardizing protections for research subjects. Yet the extent to which these joint goals are being achieved is unclear. To better understand how single IRBs function, we recruited academic, government, and commercial single IRBs (N = 49) to participate in a study involving observation of protocol review meetings and/or interviews with their members, chairs, and administrators. Twenty (40.8%) agreed to participate, of which 50% agreed to both interviews and observation. While 81.8% (9/11) of academic and 50% (4/8) of government single IRBs participated in some way, only 23.3% (7/30) of commercial single IRBs did so. The four largest commercial single IRBs declined to participate. Because evaluation of single IRBs is important to inform development, implementation, monitoring, and refinement of federal policies, single IRBs should be encouraged to participate in research that examines how they function.

A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months

Background: The aim of this study is to evaluate whether a dedicated Institutional Review Board (IRB) Liaison Service situated at our Institute's central location could provide additional useful staff support to the investigator community for interactions with the IRB at various levels of protocol submission and review. Materials and Methods: Over a period of 2½ years, from January 2015 to June 2017, a total of 501 in-person consultations were performed during office hours, usually 25–30 per month. Most requests concerned new protocol development, IRB policy questions, and strategies for compliance or assistance in addressing IRB comments on returned protocols. We analyzed the results of a user evaluation survey for in-person consults and performed a focused in-depth analysis of the impact of the IRB Liaison Service. Results: Survey response rate was 43%. Results of 215 completed satisfaction surveys were 100% positive. Users were primarily study coordinators and investigators. Of a randomly selected sample of consultations analyzed in-depth for 67 unique protocols, 73% were subsequently approved within 14 days. Conclusion: National concerns about IRB-related research delays have led to the re-assessment of IRB review processes at institutional levels. Overall, we have found the Liaison Service to be a popular, useful addition to research support for a meaningful number of researchers, enhancing our already research-friendly environment. We plan to continue the service and the evaluation going forward. We will focus in the next phase on exploring whether the Liaison Service can reduce IRB approval times for protocols using its services and on providing support for the use of single IRBs for multi-site studies. The following core competencies are addressed in this article: Practice-based learning and improvement.

Implementation of Common Rule Changes to the Informed Consent Form: A Research Staff and Institutional Review Board Collaboration.

Background: The Common Rule, which governs federally funded clinical research involving human subjects, formally defines the requirements for institutional review board (IRB) membership, functions and operations, and review of research, as well as the requirements for obtaining informed consent from research participants. The revisions to the Common Rule effective in January 2019 changed some content requirements for informed consent forms.Methods: This article summarizes the history of informed consent requirements, the changes made to the requirements by the revision to the Common Rule, and the ways in which IRBs and research staff work together to develop informed consent forms that comply with the regulations and provide all the information potential research subjects need to decide whether to participate in a study.Results: Clinical research coordinators, under their investigators’ supervision, are responsible for ensuring that research consent forms comply with the requirements of the federal regulations and the institution. Many IRBs have provided education regarding these new requirements, as well as consent templates that contain all the required elements. To ensure that the Common Rule's requirements are met, the IRB reviews each study submission, including the consent form. The IRB panel makes revisions to the consent forms as needed and returns the approved consent form to the investigator and clinical research coordinator.Conclusion: Research coordinators play an essential role in developing consent forms and providing the required review information to the IRB. In turn, through optimizing and standardizing consent forms and ensuring that all requirements of the Common Rule are followed, IRBs ensure that the rights of participants are protected and upheld.

Understanding Broad Consent.

Background: The 2018 revisions to the Common Rule that were effective in January 2019 introduced a new category of informed consent: broad consent.Methods: Investigators and institutional review board (IRB) members need to understand (1) what broad consent is, (2) the role of broad consent under the revised Common Rule, (3) how and when broad consent can be used, (4) exempt research categories that relate to broad consent, and (5) the scope of limited IRB review as it relates to broad consent.Results: Under the prior regulations, researchers had two consent options: obtain study-specific informed consent or request the IRB to waive the requirement to obtain informed consent. The revision to the Common Rule introduced the third option of broad consent, but its applicability is limited. Broad consent can only be used to obtain an individual's consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. The regulatory authority for broad consent is at 45 CFR §46.116(d). None of the required elements of broad consent can be omitted or altered because each element is considered essential. Broad consent shares many of the requirements for study-specific informed consent, but several elements are unique: a description of the types of secondary research that may be conducted; statements describing the private information or biospecimens that might be used in research, whether sharing of the information or biospecimens might occur, and the types of institutions or researchers that might conduct research with the information or biospecimens; information on how long the information or biospecimens may be stored, maintained, and used; a statement that subjects will or will not be informed of the details of any subsequent research; a statement that research results will or will not be disclosed to subjects; and contact information for obtaining answers to questions about the subjects’ rights regarding storage and use of information or biospecimens and whom to contact regarding research-related harm.Conclusion: Broad consent provides flexibility that did not exist prior to the revision, giving researchers the option to obtain broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. With an understanding of the regulations, an investigator can plan how best to organize his or her research plan and decide whether to obtain study-specific informed consent, to apply for a waiver of consent, or to obtain broad consent.

Why institutional review boards should have a role in the open science movement

Open science involves the use of practices across the research life cycle that facilitate the transparency, reproducibility, and availability of scientific products and output. Prominent open science practices include registration of study protocols and preanalysis plans; materials, data, and code sharing; and publication of summary findings in open access outlets (1). To achieve openness as the default approach, initiatives are trying to use a systems approach to engage stakeholders—namely, scientific journals, funding agencies, and professional societies (2, 3). Proponents hope to realign the research enterprise with the values of transparency and reproducibility (4). Institutional review boards are overlooked, yet critical, stakeholders for the promotion of open science initiatives that enhance access to research products. Image credit: David Cutler (artist). Institutional review boards (IRBs) are overlooked, yet critical, stakeholders for proponents to engage in open science initiatives (5). For instance, IRBs can require modifications to and even disapprove data sharing plans based on information in the application, protocol, and informed consent forms investigators submit for IRB review (6). Conversely, IRB workflows can increase if a greater number of submissions require higher levels of IRB review because of data sharing plans that risk disclosure of identifiable private information about living individuals. Practical tutorials on ethical open science primarily focus on educating study investigators about their responsibilities to protect human research subjects. IRBs, in turn, need to be informed about open science practices and the impact of their growth on IRB responsibilities to protect human research subjects. In other words, IRB members and professionals themselves should be part of the movement toward open science. Although IRBs are ethics bodies concerned with moral obligations (7 … [↵][1]1To whom correspondence may be addressed. Email: spgrant{at}iu.edu. [1]: #xref-corresp-1-1

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.

2931 Lumen-Apposing Metal Stent for Treating Pancreatic Fluid Collections in Patients at Sarasota Memorial Hospital: A Quality Improvement Initiative to Compare Outcomes With Meta-Analysis Benchmarks

INTRODUCTION: Acute pancreatitis can result in four different subtypes of fluid collections including acute peri-pancreatic fluid collection, pseudocyst, acute necrotic collection, and walled-off necrosis (WON). Complications including symptoms due to large size and infection may occur and warrant intervention. Endoscopic ultrasound (EUS)-guided drainage with a lumen-apposing metal stent (LAMS) is now commonly performed for cases where certain parameters are met. Evidence from academic centers reveals comparable or even superior technical and clinical outcomes over traditional drainage. The primary aim of our study is to evaluate technical and clinical outcomes of EUS-guided LAMS at a community-based hospital. METHODS: The Sarasota Memorial Hospital (SMH) Institutional Review Board (IRB) deemed this a quality improvement initiative, exempt from IRB review. Data was retrospectively collected from the SMH electronic medical records of 31 patients who underwent EUS-guided LAMS between April 2016 to October 2018. Contrast benchmarks were derived from a meta-analysis of eleven studies that evaluated efficacy of LAMS in the management in 688 patients. RESULTS: EUS-guided LAMS was performed by two endoscopists in 24 males and 7 females with median age of 55 years. Technical success was defined as correct placement of the stent with immediate drainage and occurred in 29 cases. Technical failure occurred in 2 cases, one due to solid debris preventing deployment of stent, and the other due to numerous varices surrounding the PFC resulting in limited access. Clinical success was defined as decrease of symptoms as well as decrease in size of the PFC and occurred in 25 cases. Four cases were considered a clinical failure: 3 patients required surgery, and one patient died due to complications from pancreatitis. Overall complications of LAMS placement included one pneumothorax, one infected WON in previously sterile WON, and one stent migration; Tables 1 and 2. CONCLUSION: EUS-guided LAMS for the treatment of pseudocyst or WON performed in a community hospital setting has equivalent technical and clinical outcomes and rate of complications compared to benchmarks established in an academic medical center.

The SMART IRB platform: A national resource for IRB review for multisite studies.

Single institutional review board (IRB) review of multisite research increased in frequency over a decade ago with a proliferation of master IRB reliance agreements supporting statewide and regional consortia and disease- and population-specific networks. Although successful, the increasing number of agreements presented significant challenges and illuminated potential benefits of a single, nationwide agreement. Anticipated changes in federal regulations highlighted the need to systematize and simplify IRB reliance. To address these challenges, the NIH National Center for Advancing Translational Sciences funded a project to establish a national IRB reliance network that would support national adoption of single IRB (sIRB) review. The Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Platform launched in July 2016 to facilitate dissemination, adoption, and implementation of a collaboratively developed master IRB reliance agreement and supportive tools and resources. More than 580 institutions have joined SMART IRB's Master Common Reciprocal Institutional Review Board Authorization Agreement and begun using the SMART IRB platform to support sIRB arrangements. Here, we describe the tenets of the agreement and operational benefits and challenges of its use. SMART IRB's early success affirms the utility of collaborative, flexible, and centralized approaches to supporting sIRB review while highlighting the need for further national harmonization.

From Moving Beyond Compliance to Quality to Moving Beyond Quality to Effectiveness: Realities and Challenges.

In 2007, Taylor proposed to move beyond compliance to develop measures for assessing the ethical quality of institutional review board (IRB) reviews. To date, no such tool has been developed. In 2018, Lynch et al. proposed to move beyond quality to advance effective research ethics oversight. Instead of providing a set of measures, they proposed to define and specify ways to measure the effectiveness of IRBs in protecting human subjects. They further claimed that any attempts to measure the quality and performance of IRBs without using such measures, to be developed by them in the unforeseeable future, were not helpful. The realities are that nearly 50 years after its establishment, there has been no systematic assessment of the quality and performance of IRBs, and that nearly two decades after the deaths of Jesse Gelsinger and Ellen Roche and the implementation of reform processes to improve our system of protecting human subjects, there is still plenty of room for improvement. The challenges today are for Taylor to come up with a tool to measure the ethical quality of IRB reviews, for Lynch et al. to develop measures for assessing the effectiveness of IRBs in protecting human subjects, and for the IRB community to decide whether to continue to wait for Taylor and Lynch et al. to develop their promised tools or to start taking advantage of performance measurements to improve the quality and performance of IRBs by using existing IRB performance metrics or to improve those existing performance metrics.

Implementing a Central IRB Model in a Multicenter Research Network.

Implementing the National Institutes of Health's (NIH's) new single institutional review board (IRB) policy has caused a paradigm shift in IRB review across the country. IRBs and human research protection programs are looking more closely at their processes for ceding review and developing procedures to handle local review when relying on a single IRB. This article describes an NIH-funded network that proactively instituted a central IRB (CIRB) in 2012, anticipating the NIH future mandate. Lessons learned are described. There was a steep learning curve for IRBs and participating sites. IRB submission workload burden shifted from study teams to the data coordinating center, which created new workflow challenges, especially preparing hundreds of consent documents centrally. Despite difficulties encountered with CIRB review, this network is now fully functioning under a CIRB model. Further review and experience are needed to determine whether this shift in IRB review has eliminated duplicative review or regulatory burden from study teams.

Single-Patient Expanded Access Requests: IRB Professionals’ Experiences and Perspectives

Background: U.S. physicians may treat a patient with an investigational drug outside of a clinical trial by using the expanded access (EA) pathway or the recently created federal right to try (RTT) pathway. The EA pathway requires physicians to get prior permission from the U.S. Food and Drug Administration (FDA) and, except in emergency cases, institutional review board (IRB) approval. The perspectives of IRB professionals on the review of single-patient EA requests have not been empirically studied. Methods: We used a cross-sectional online survey to ascertain IRB professionals’ perspectives on IRB experiences with and preparedness for review of single-patient EA requests, as well as their attitudes about the importance of IRB review of such requests. Email invitations were sent to 234 IRB professionals connected to the SMART IRB platform. Approximately half of the survey questions used a Likert scale to assess respondents’ agreement with specific statements. Results: Eighty-three respondents completed the survey (36.4% response rate, with 228 deliverable e-mail invitations). Of the respondents, 73.5% were affiliated with an academic medical institution; 78.3% of respondents agreed that it is important for a designated member of an IRB to review single-patient EA requests before investigational drugs are used by patients. The majority indicated that local review of the EA request was important and that a single designated reviewer was sufficient (rather than full board). Further, 86.6% felt that their IRBs were prepared to review these requests, and 9.2% indicated that not all the single-patient EA requests reviewed by their IRBs in 2017 were approved. Conclusions: A large majority of IRB professionals affiliated with the SMART IRB platform who responded to this survey felt IRB review of single-patient EA requests is important and that their IRBs were prepared to handle such requests.

Variability in Institutional Board Review for a Multisite Assessment of Resident Professionalism.

Residents serve as both trainees and employees and can be considered potentially vulnerable research participants. This can lead to variation in the institutional review board (IRB) review. We studied sites participating in the Assessment of Professional Behaviors Study sponsored by the National Board of Medical Examiners (2009-2011). Of the 19 sites, all but one were university affiliated. IRB review varied; 2/19 did not submit to a local IRB, 4/17 (23%) were exempt, 11/17 (65%) were expedited, and 2/17 (12%) required full Board review; 12/17 (71%) required written informed consent. The interval from submission to approval was 1 to 2 months (8/17); the range was 1 to 7 months. Although most stated there were no major barriers to approval, the most common concern was resident coercion and loss of confidentiality. Local IRB review of this educational research study varied.

Medical Scribe Impact on Patient and Provider Experience

The electronic health record (EHR) has created additional administrative burdens on providers to perform data entry while trying to engage with the patient during the health care visit. Providers have become frustrated and distracted with the documentation requirements which further hindered connectivity, and communication with the patient. The utilization of medical scribes in the outpatient clinical setting was a strategy shown to enhance patient and provider interaction, decrease clinician's administrative tasks, and promote satisfaction among providers and patients. This was an innovative quality improvement pilot project to improve the patient and provider experience using scribes in an outpatient setting. Two providers, to include one Family Medicine doctor and one Internal Medicine physician, and four hospital corpsmen participated in this pilot project. The four hospital corpsmen received a 2-week training of the fundamentals of the EHR and their role as scribes prior to the start of the project. Two corpsmen were designated for each provider and worked with their provider throughout the 12-week project period. The two primary aspects evaluated during the implementation of the scribes were the patient experience, and provider experience. Navy Medicine and the University of South Carolina Institutional Review Boards (IRB) considered this project exempt from full IRB review. The experience questionnaire results indicated a slight mean decrease, but did not negatively impact patient satisfaction or overall patient experience. The local Medical Treatment Facility patient satisfaction, obtained through the Interactive Customer Evaluation, and the Joint Outpatient Experience Survey, indicated that there was no decrease in patient satisfaction or overall experience during the project period. The providers' experience improved with an average 50% decrease in time spent after hours documenting in the EHR, enhanced engagement with patient, staff, and ancillary team members, and improved work life balance. Additional findings of improved clinic efficiencies, completion of notes for both providers and positive qualitative comments from the scribes were identified. In multiple settings, documentation requirements burden providers. The consideration of scribes could foster work life balance, retention, and wellness. The patient and provider experience was strengthened through the utilization of medical scribes, so future research centered on the provider and patient experience could be beneficial to organizations. Further study of the scribe's experience, especially considering the positive comments from the hospital corpsmen that participated as scribes during the project, could provide beneficial outcomes. Navy Medicine is advancing every opportunity to strengthen clinical and operational readiness, health and partnerships to provide the highest quality care and promote wellness for our patients. This type of quality improvement initiative could positively support readiness, quality and wellness for our organization, providers, and patients.

Updated Rules for Human Research Become Effective in January

Back to table of contents Previous article Next article Professional NewsFull AccessUpdated Rules for Human Research Become Effective in JanuaryNick ZagorskiNick ZagorskiSearch for more papers by this authorPublished Online:26 Oct 2018https://doi.org/10.1176/appi.pn.2018.11a15AbstractForthcoming changes to the Federal Policy for the Protection of Human Subjects are hoped to reduce the administrative burdens facing clinical trial designers while also simplifying the consent forms given to participants.After more than six years of extensive deliberation and review, the Department of Health and Human Services (HHS) will finally implement a host of changes to the rules governing the use of human subjects in clinical research. The updated Federal Policy for the Protection of Human Subjects, popularly known as the Common Rule, will go into effect on January 21, 2019.Robert K. Chin/Alamy These are the first revisions made to the Common Rule since it was officially codified by HHS in 1991. Many of the regulations involving human research subjects, however, had been in place since the mid-1970s.“The intent of these changes is to streamline the administrative requirements involved in the oversight of clinical trials, while also providing more clarity to participants and researchers about how information and biological specimens can be used,” said Philip Wang, M.D., Ph.D., director of APA’s Division of Research.The updates were a needed response to the increase in size and complexity of clinical trials over the past three decades. Today, multisite clinical trials and the use of digital tools to create and store large amounts of data are the norm in clinical research. Many researchers believed that the Common Rule requirements have not kept up with these changes, making the administrative portion of clinical trials costly and cumbersome.The most significant change overall is that multisite clinical studies will no longer require an Institutional Review Board (IRB) at every trial site. IRBs are independent entities that oversee every clinical trial, with the power to stop a trial if deemed necessary. Researchers conducting large, multisite studies will now be able to use a single IRB, which will make coordination much easier. However, since it may take a while for some researchers to select a central IRB and determine how to coordinate information, HHS has pushed back this requirement until January 2020.For mental health researchers, perhaps the most significant change involves reducing the IRB requirements for studies with minimal risk. Currently, all clinical trials must undergo an annual review. However, starting next year, studies considered “minimal risk” will no longer have this requirement.One class of studies that falls under this low-risk category is “benign behavioral interventions,” which includes any cognitive or behavioral trial that is not overly long or potentially causing emotional distress in participants.Research studies that conduct secondary analyses of existing clinical trial data are also exempt from IRB reviews, so long as patient information remains protected.Another important change is that researchers conducting clinical trials that collect identifiable biospecimens—samples such as DNA that could be traced back to an individual—can ask participants to give “broad consent” on how the biospecimen is used. That way, future trials can use that specimen rather than having to reacquire patient consent or seek a waiver through the IRB.“This is a sensible change that will greatly benefit research,” Wang told Psychiatric News. “We don’t know what the important research questions in mental health will be five or 10 years from now. Broad consent provides the flexibility to address unexpected changes, while still ensuring that individuals who give samples are protected.”While researchers will benefit from many of these changes, so will participants. One example concerns today’s overly complex consent forms that can perplex even seasoned lawyers. The updated rule requires consent forms to contain a simple and concise explanation at the beginning of the document about the key elements of the clinical trial. These elements include the purpose of the research, its risks and benefits, and alternative treatments that might be beneficial to the prospective subject. Consent forms must also clearly state the circumstances when clinically relevant research findings (for example, a genetic analysis reveals a strong risk of some disease) will be shared with the subject. ■ More information on the Common Rule, including the new updates, can be accessed here. ISSUES NewArchived

Practice-Based Research Networks Ceding to a Single Institutional Review Board: A Report From the INSTTEPP Trial and Meta-LARC Consortium.

Historically, a single research project involving numerous practice-based research networks (PBRNs) required multiple institutional review boards (IRBs) to be involved in approval of the project. However, to avoid redundancies, federal IRB regulations now allow cooperative research projects that involve more than one institution to use reasonable methods of cooperative IRB review and to cede authority for review and oversight of the project to a single lead IRB. Through ceding, a lead IRB has the authority for review and oversight of the project delegated by all participating sites' IRBs and becomes the IRB of record for the ceded sites. In the conduct of cooperative research projects, each institution or primary care office site is still responsible for safeguarding the rights and welfare of human subjects and for complying with applicable regulations. The purpose of this report is to delineate the process, including cooperation and effort of personnel, for accomplishing IRB approval for the Implementing Networks' Self-management Tools Through Engaging Patients and Practices (INSTTEPP) clinical trial. This process involved 4 PBRNs, 16 family physician offices, 4 academic institution's IRBs, and 4 family practice office external IRBs ceding to the lead IRB. Once ceding was accomplished, subsequent IRB modifications and continuing reviews were the responsibility of the lead IRB, ultimately saving time for all participants and keeping the project on schedule.

When Nowhere Is Safe: Interpersonal Trauma and Attachment Adversity as Antecedents of Posttraumatic Stress Disorder and Developmental Trauma Disorder.

Developmental trauma disorder (DTD) has been proposed as clinical framework for the sequelae of complex trauma exposure in children. In this study, we investigated whether DTD is associated with different traumatic antecedents than posttraumatic stress disorder (PTSD). In a multisite sample of 236 children referred from pediatric or mental health treatment, DTD was assessed using the DTD Structured Interview. Trauma history was assessed using the Traumatic Events Screening Instrument (TESI). On an unadjusted basis, both DTD, odds ratios (ORs) = 2.0–3.8, 95% CI [1.17, 7.19]; and PTSD, ORs = 1.8–3.0, 95% CI [1.04, 6.27], were associated with past physical assault and/or abuse, family violence, emotional abuse, neglect, and impaired caregivers; and DTD was associated community violence, OR = 2.7, 95% CI [1.35, 5.43]. On a multivariate basis after controlling for the effects of PTSD, DTD was associated with family and community violence and impaired caregivers, ORs = 2.0–2.5, 95% CI [1.09, 5.97], whereas PTSD was only associated with physical assault and/or abuse after controlling for the effects of DTD, OR = 2.4, 95% CI [1.07, 4.99]. Exposure to both interpersonal trauma and attachment adversity was associated with the highest DTD symptom count, controlling for the PTSD symptom count. Although childhood PTSD and DTD share several traumatic antecedents, DTD may be uniquely associated with pervasive exposure to violent environments and impaired caregiving. Therefore, DTD warrants further investigation as a framework for the assessment and treatment of children with histories of interpersonal victimization and attachment adversity.

Experiences of Health Professions Educators Utilizing Multiple Institutional Review Boards for Collaborative Research

This study describes the experiences and perspectives of health professions educators around institutional review board (IRB) review of multi-institutional education research. This survey study gathered quantitative and qualitative data from members of three of the four geographic regions of the AAMC Group on Educational Affairs (GEA) as well as a snowball sample from the fourth region, where access to the listserv was not possible. Quantitative data is described and qualitative comments were coded and themed. Ninety-six percent of the 151 respondents considered multi-institutional incredibly or somewhat valuable to their educational research goals. Sixty-two percent had submitted at least one project to multiple institutions for review. Of 57 respondents, 21 identified disagreements in the type of IRB review required (exempt, expedited, or full-board review). Disagreements between IRBs are also reported, including changes in wording or informed consent procedures. Of the 36 participants who noted disagreement between IRBs for any changes, only three participants believed that the process significantly improved the research subject protections. Most health professions education researchers across the USA and Canada appreciated the value and role of IRB review and expressed frustration in the face of review that seemingly did not result in meaningful improvements. Final changes to the federal Common Rule call for a single-IRB review in multi-institutional research, particularly for low-risk studies. This change on the horizon could not only mitigate current concerns but also bolster the proliferation of multi-institutional research studies in health professions education.

Overcoming a primary barrier to practice-based research: Access to an institutional review board (IRB) for independent ethics review.

Practice-based research is an important means of bridging the gap between the science and practice of psychotherapy. Unfortunately, numerous barriers exist for clinicians who want to conduct research in practice settings. One specific barrier that has received minimal attention in the literature-lack of access to institutional review board (IRB) oversight for independent ethics review-can impede the ability to carry out and disseminate research projects. This article identifies reasons that practice-based researchers may want to seek IRB review even when not required, reviews the pros and cons of a range of strategies that some practice-based researchers have used to try and address lack of access to an IRB, and describes a novel solution for this problem: the creation of the Behavioral Health Research Collective IRB, a nonprofit IRB whose mission is to provide ethical oversight to practice-based researchers. The authors describe their experiences of developing and running the Behavioral Health Research Collective IRB, with the intent of providing a model for other professionals to create similar mechanisms for supporting practice-based research. (PsycINFO Database Record

Institutional Review Board Basics for Pedagogy Research

The institutional review board (IRB) process is often protracted and can be a source of frustration, especially when you want your research and publications to move apace. However, because of historical events, the IRB is an important requirement for conducting research with human participants and is regulated by federal oversite. When conducting research as part of a pedagogical study, it is important to identify which level of IRB review (exempt, expedited, or full board) is required. The purpose of this article is to highlight IRB basics within the United States for pedagogy research. Although there are guidelines internationally, this article specifically focuses on U.S. IRBs, including a brief history of the IRB, pedagogical and community-based participatory research, IRB review, tips for IRB submissions, and example case studies.

Why Public Comments Matter: The Case of the National Institutes of Health Policy on Single Institutional Review Board Review of Multicenter Studies.

In 2014, the National Institutes of Health (NIH) requested public comments on a draft policy requiring NIH-funded, U.S.-based investigators to use a single institutional review board (sIRB) for ethical review of multicenter studies. The authors conducted a directed content analysis and qualitative summary of the comments and discuss how they shaped the final policy. Two reviewers independently assessed support for the policy from a review of comments on the draft policy in 2016. A reviewer conducted an open text review to identify prespecified and additional comment themes. A second researcher reviewed 20% of comments; discrepancies were resolved through discussion. The NIH received 167 comments: 65% (108/167) supportive of the policy, 23% (38/167) not supportive, and 12% (21/167) not indicating support. Clarifications or changes to the policy were suggested in 102/167 comments (61%). Criteria for selecting sIRBs were addressed in 32/102 comments (31%). Also addressed were institutional review board (IRB) responsibilities (39/102; 38%), cost (27/102; 26%), the role of local IRBs (14/102; 14%), and allowable policy exceptions (19/102; 19%). The NIH further clarified or provided guidance for selection criteria, IRB responsibilities, and cost in the final policy (June 2016). Local IRB reviews and exemptions guidance were unchanged. In this case study, public comments were effective in shaping policy as the NIH modified provisions or planned supplemental guidance in response to comments. Yet critical knowledge gaps remain, and empirical data are necessary. The NIH is considering mechanisms to support the establishment of best practices for sIRB implementation.