Institutional Review Board Chairs Research Articles

Challenges in Arranging to Waive Parental Consent in HIV Prevention Studies of Adolescent Men Who have Sex with Men: The Case of HPTN 078

ABSTRACT Including adolescent men who have sex with men (AMSM) in HIV prevention and treatment studies without parental permission is vital, but has often faced barriers. We examine the case of recent Institutional Review Boards (IRB) reviews of an HIV treatment and prevention study that requested waiving parental permission at four United States sites, but received different responses from each institution. IRBs varied in whether and how they weighed parental rights against AMSMs’ rights and individual and social benefits, and potential harms (e.g., if a parent disapproves of the adolescents’ sexual behavior). One IRB “tabled” the decision to receive advice from the university Office of General Counsel (OGC), despite state laws allowing minors to consent to HIV testing and treatment without parental permission. Another IRB consulted the university’s Chief Compliance Officer (CCO), which thought the waiver was inconsistent with state law, which discusses “venereal disease,” but not HIV. University attorneys may have competing priorities, however, and thus interpret relevant laws differently. This case raises critical concerns, highlighting needs for advocates for AMSM, researchers, IRBs and others at institutional, governmental, and community levels to educate policymakers, public health departments, IRB chairs, members, and staff, OGCs and CCOs about these issues.

Reflections on Becoming a Qualitative IRB Chair

Research Article| July 01 2021 Reflections on Becoming a Qualitative IRB Chair: Recommendations for IRBs and Autoethnographic/Qualitative Researchers Austin Pickup Austin Pickup Austin Pickup is an assistant professor in the Doctor of Education program at Aurora University. He holds a PhD in Educational Research and an MA in Secondary Education from the University of Alabama. His research interests focus broadly on qualitative inquiry, critical research methodologies, philosophy of education, and social studies education. email: apickup@aurora.edu Search for other works by this author on: This Site PubMed Google Scholar Journal of Autoethnography (2021) 2 (3): 347–350. https://doi.org/10.1525/joae.2021.2.3.347 Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Facebook Twitter LinkedIn MailTo Tools Icon Tools Get Permissions Cite Icon Cite Search Site Citation Austin Pickup; Reflections on Becoming a Qualitative IRB Chair: Recommendations for IRBs and Autoethnographic/Qualitative Researchers. Journal of Autoethnography 1 July 2021; 2 (3): 347–350. doi: https://doi.org/10.1525/joae.2021.2.3.347 Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search Search Dropdown Menu toolbar search search input Search input auto suggest filter your search All ContentJournal of Autoethnography Search This essay reflects upon my experiences as a qualitative research faculty member becoming chair of the Institutional Review Board (IRB) at my university. Many scholars have discussed the particular tensions and challenges that exist between qualitative research and IRBs.1 Other scholars have focused specifically on the challenges, disruptions, and successes of submitting autoethnographic studies to IRBs.2 These difficulties are often the result of the underlying incongruent paradigms between much qualitative inquiry and the understanding of research within IRBs. However, I argue that these challenges can be exacerbated by a lack of representation of qualitative inquirers on IRBs and the lack of specific knowledge of IRB processes and regulations that qualitative researchers, generally, and autoethnographers, specifically, could use to their advantage. After reviewing my experiences navigating the dual roles of qualitative/autoethnography dissertation advisor and IRB chair, I offer several suggestions for IRBs and researchers/teachers who desire to protect research... You do not currently have access to this content.

EHR phenotyping for research recruitment: Researcher, IRB, and physician perspectives on approaches to contacting patients.

Failure to achieve accrual goals is a common problem in health-related research. Electronic health records represent a promising resource, offering the ability to identify a precisely defined cohort of patients who meet inclusion/exclusion criteria. However, challenges associated with the recruitment process remain and institutional policies vary. We interviewed researchers, institutional review board chairs, and primary care physicians in North Carolina and Tennessee. Questions focused on strategies for initiating contact with potentially eligible patients, as well as recruitment letters asking recipients to opt in versus opt out of further communication. When we asked about initiating contact with prospective participants, qualitative themes included trust, credibility, and established relationships; research efficiency and validity; privacy and autonomy; the intersection between research and clinical care; and disruption to physician-researcher and physician-patient relationships. All interviewees said it was acceptable for researchers to contact patients through their physicians; most said it was acceptable for researchers to contact patients directly. Over half chose contact through physicians as more appropriate. Regarding recruitment letters, qualitative themes included the quality of the participant pool; privacy and control; research efficiency and representativeness; and patients' opportunity to make their own decisions. All interviewees said asking recipients to opt in to further communication was acceptable; nearly all said opt out was acceptable. Similar proportions chose each approach as more appropriate. Comparing these results to our previous research with patients reveals potential differences in stakeholder perspectives. We offer suggestions for developing balanced approaches that respect patients and facilitate the advancement of science.

Safeguarding Participants in Psychiatric Genetic Research: Perspectives of Key Stakeholder Groups.

Public trust in research depends on implementation of research protections. Genetic and psychiatric research may elicit "exceptionalism," the belief that these types of research deserve special protections. Genetic information has been viewed as different from other health information. Psychiatric research has been scrutinized based on concerns about the impact of psychiatric illness on individuals' abilities to make decisions. This study compared four stakeholder groups' attitudes toward research safeguards. Psychiatric genetic researchers and institutional review board chairs received structured surveys. Individuals with mental illness and family members participated in semistructured interviews. Paired sample t-tests were used to compare mean ratings of importance of safeguard procedures for genetic versus nongenetic research on physical versus mental illnesses. All groups provided higher ratings for the importance of safeguards for genetic research and for mental illness. Individuals with mental illness and family members rated the importance of safeguards more highly than researchers and chairs did. Results of generalized linear models showed significant effects of gender and ethnicity.

Abstract WP108: What is Equipoise? Stroke Researchers and IRB Chairs Respond

Background: The concept of “equipoise” is often cited as a prerequisite to the conduct of ethical randomized clinical trials (RCTs). However, significant difficulties persist in determining when it exists around a specific clinical question. This issue has arisen around recent stroke RCTs such as ESCAPE and SWIFT DIRECT. We sought to capture how stroke research principal investigators (PIs) and institutional review board (IRB) chairs understand the concept of equipoise. Methods: We invited stroke PIs and IRB chairs to complete a telephone interview consisting of 9 semi-structured questions surrounding equipoise and the ethics of RCTs. Interviewees provided written informed consent and results remained anonymous. The study was approved by our local IRB. Interviews were recorded and transcribed. Each interview was then analyzed for relevance to the concept of equipoise, with relevant sections coded and organized into themes. Results: We invited 59 PIs and 84 IRB chairs, with 13 PIs and 15 IRB chairs completing the standardized interview. Respondents defined equipoise in 5 different ways, with the most common definition being uncertainty based on any of individual opinion, group opinion, evidence, lack of evidence, regional variation, or trial design. PIs sought to determine equipoise through appeals to the literature, preliminary clinical data, surveys of expert opinion, and known disagreement. IRB chairs were more dependent upon expert opinion, including that of trial PIs themselves, and were more concerned with patient protections and specifics of study design. All (100%) PIs and 77% of IRB chairs felt that the concept was helpful, though 80% of both groups also found it to be problematic. Conclusion: Stroke PIs and IRB chairs differ in their understanding of how equipoise is defined and operationalized, which may directly impact the design and approval of current and future stroke trials.

Perspectives of psychiatric investigators and IRB chairs regarding benefits of psychiatric genetics research

There is hope that psychiatric genetics inquiry will provide important insights into the origins and treatment of mental illness given the burden of these conditions. We sought to examine perspectives of psychiatric genetic investigators regarding the potential benefits of genetic research in general and the potential benefits of genetic research for the diagnosis and treatment of mental illnesses specifically. We compared investigator attitudes with those of chairs of Institutional Review Boards (IRBs) entrusted with evaluating the benefits and risks of human research studies. Two groups directly engaged with the conduct and oversight of psychiatric genetic research were examined (psychiatric investigators, n = 203; IRB Chairs, n = 183). Participants rated 15 survey items regarding current and future benefits of general genetic research, possible benefits of psychiatric genetic research, and the importance to society of genetic vs. non-genetic research examining causes and treatments of illnesses. Investigators and IRB Chairs strongly endorsed the future benefits of general genetic research for society and for the health of individuals; compared to IRB Chairs, investigators were more positive about these benefits. Even after adjusting for demographic variables, psychiatric genetic investigators were significantly more optimistic about genetic research compared with IRB Chairs. Both groups were moderately optimistic about the possible benefits of genetic research related to mental illness. Greater optimism was seen regarding new or personalized medications for mental illnesses, as well as genetic predictive testing of mental illnesses. Greater precision and circumspection about the potential benefits of psychiatric genetic research are needed.

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.”

Applications for Research Concerning Fetal or Placental Tissue and Expected Institutional Review Board Responses.

Proposals for research concerning fetal and/or placental tissue may be refused institutional review board (IRB) review, effectively preventing the research from occurring. We conducted an anonymous electronic survey of IRB chairs to determine their assessment of the likely response to research projects using fetal/placental tissue obtained from various procedures. We found that proposals concerning tissue obtained from diagnostic procedures or miscarriage were anticipated to be considered at most institutions. Tissue obtained after abortion was likely to be refused consideration by more than 25% of respondents. Additional consultation during review was anticipated for up to 30% of scenarios. Responses for fetal and placental tissue were similar. The most frequently anticipated reason for refusal was institutional policy.

Perspectives of IRB chairs on the informed consent process

ABSTRACTBackground: Questions have been raised by researchers and ethics committees about whether human research subjects comprehend study participation when signing a research consent form. Methods: To determine existing beliefs about the informed consent review process, impediments to shorter consent, and augmented/alternative consent methods, a survey of institutional review board (IRB) chairpersons was conducted. Results: IRB chairs expressed concern with (but do not often assess) the length, complexity, and reading level of the consent form or participant comprehension. IRB chairs reported varied (but generally low) familiarity, acceptance, and use of possible solutions and alternatives. Conclusions: Best practice standards should be developed for (1) assessing consent form reading level; (2) measuring and monitoring participant comprehension; (3) alternative consent methods and enhancements; and (4) electronic signatures.

Academic and Institutional Review Board Collaboration to Ensure Ethical Conduct of Doctor of Nursing Practice Projects.

Navigating the regulations to protect human subjects and private health information for Doctor of Nursing Practice (DNP) projects can be a formidable task for students, faculty, and the institutional review board (IRB). Key stakeholders from the University of Iowa College of Nursing and the Human Subjects Office developed a standardized process for DNP students to follow, using a decision algorithm, a student orientation to the human subjects review process conducted by faculty and IRB chairs and staff, and a brief Human Subjects Research Determination form. Over 2 years, 109 students completed the process, and 96.3% of their projects were deemed not to be human subjects research. Every student submitted documentation of adherence to the standardized process. Less time was spent by students, faculty, and the IRB in preparing and processing review requests. The interprofessional collaboration resulted in a streamlined process for the timely review of DNP projects.

How good does the science have to be in proposals submitted to Institutional Review Boards? An interview study of Institutional Review Board personnel.

Institutional Review Boards (IRBs) have been increasingly criticized for how they review protocols, but how IRBs perceive, and make decisions about, the quality of the science of protocols has not been examined. To explore how and when IRBs view and make decisions about the quality of the science of studies they review. I contacted the leadership of 60 IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding) and interviewed IRB chairs, co-chairs, administrators, and a director from 34 IRBs (response rate = 55%), and an additional 7 members. Interviewees faced several ambiguities and questions concerning the quality of the science of protocols. IRBs are often not sure how and to what extent to evaluate the science of protocols, whether the science should be 'good enough' (and if so, what that means) versus as good as possible. Federal regulations state that IRBs should ensure that risks are minimized, and commensurate with benefits. Thus, at times IRBs feel that changing the science is ethically necessary. But IRBs also then struggle with whether to adopt a higher threshold (1) that social and thus scientific benefits be maximized and (2) that scientific efforts and resources should not be wasted. Committees face dilemmas - for example, if a 'perfect' study is not feasible. For protocols already approved elsewhere (e.g., by the NIH), IRBs vary in how much they feel they can request alterations, and sometimes make changes nonetheless. Larger institutional contexts and biases can shape these issues, and IRBs differ in how much they are 'pro-research', and have sufficient expertise. IRBs at times also approve studies despite reservations about the science. This study includes interviews with IRBs, but not observations of IRB meetings. IRBs often face ambiguities and conflicting goals in assessing scientific quality. Many IRBs try to improve the science beyond what the regulations mandate. These data have important implications for improving practice, education, research, and policy.

The disclosure of incidental genomic findings: an “ethically important moment” in pediatric research and practice

Although there are numerous position papers on the issues and challenges surrounding disclosure of incidental genomic findings involving children, there is very little research. To fill this gap, the purpose of this study was to explore the perspectives of multiple professional (N = 103) and public (N = 63) stakeholders using both interviews and focus groups. Using qualitative analysis, we identified one overarching theme, "It's hard for us; it's hard for them," and three subthemes/questions: "What to disclose?," "Who gets the information?," and "What happens later?" Perspectives differed between professional (Institutional Review Board chairs, clinicians, and researchers) and public stakeholders. While professionals focused on the complexities of what to disclose, the lay public stated that parents should have all information laid out for them. Professionals pondered multiple parent and child situations, while the public identified parents as informational gatekeepers who know their children best. Professionals described the potential requirement for follow-up over time as a logistical "nightmare," while the public believed that parents have the responsibility for managing their children's health information over time. However, the parent role as gatekeeper was seen as time limited and in need of professional support and backup. Our findings present a case for needed dialogue around what we propose as an "ethically important moment," with the goal of protecting and respecting the viewpoints of all stakeholders when policies regarding children are developed.

A Closer Look at the Recommended Criteria for Disclosing Genetic Results: Perspectives of Medical Genetic Specialists, Genomic Researchers, and Institutional Review Board Chairs

Next generation sequencing offers benefit of improved health through knowledge, but comes with challenges, such as inevitable incidental findings (IFs). The applicability of recommended criteria for disclosure of individual results when applied to disclosure of IFs is not well known. The purpose of this study was to examine how medical genetic specialists, genomic researchers, and Institutional Review Board (IRB) chairs perceive the importance of recommended criteria when applied to genetic/genomic IFs. We conducted telephone interviews with medical genetic specialists (genetic counselors, genetic nurses, medical geneticists, laboratory professionals), genomic researchers, and IRB chairs (N = 103). Respondents rated and discussed the importance of nine recommended criteria regarding disclosure of genetic/genomic IFs. Stakeholders agreed the most important criteria for disclosure were: (1) the IF points to a life-threatening condition; (2) there is a treatment; (3) individuals indicate in writing they wanted to be informed of IFs. Criteria rated less important were: analytic validity, high penetrance, association with a young age of onset and relative risk more than 2.0. Respondents indicated that some technical criteria were confusing, and in need of context. Our findings suggest that development of guidelines regarding management of IF include multiple stakeholders' perspectives and be based on a common language.

Assessing the Need for a Research Ethics Remediation Program

With supplement funding to the Washington University CTSA, the Restoring Professionalism and Integrity in Research (RePAIR) program was developed at Saint Louis University to meet the remediation needs of institutions nationwide regarding investigators who violate research regulations. With the aim of determining the frequency and kinds of wrongdoing at leading research institutions in the United States, as well as institutional responses and levels of interest in a formal remediation program, an online questionnaire was distributed by email to a research integrity officer (RIO) and institutional review board (IRB) chair at all medical schools and comprehensive doctoral institutions in the United States (N = 194). One hundred sixty‐one individuals responded (44%) representing 66% of institutions. For those institutions that had both RIOs and IRB chairs responding, 96% had investigated at least one case over the past 2 years; the modal individual response was 3–5 cases, with a range from 0 to more than 16 cases. The most common forms of wrongdoing were violations of procedure, informed consent, research integrity (fabrication, falsification, plagiarism), privacy, and conflict of interest policies. Most RIOs and IRB chairs expressed interest in the RePAIR program, despite concerns about costs and faculty resistance.

Institutional review boards' use and understanding of certificates of confidentiality.

Certificates of Confidentiality, issued by agencies of the U.S. government, are regarded as an important tool for meeting ethical and legal obligations to safeguard research participants’ privacy and confidentiality. By shielding against forced disclosure of identifying data, Certificates are intended to facilitate research on sensitive topics critical to the public’s health. Although Certificates are potentially applicable to an extensive array of research, their full legal effect is unclear, and little is known about stakeholders’ views of the protections they provide. To begin addressing this challenge, we conducted a national survey of institutional review board (IRB) chairs, followed by telephone interviews with selected chairs, to learn more about their familiarity with and opinions about Certificates; their institutions’ use of Certificates; policies and practices concerning when Certificates are required or recommended; and the role Certificates play in assessments of research risk. Overall, our results suggest uncertainty about Certificates among IRB chairs. On most objective knowledge questions, most respondents chose the incorrect answer or ‘unsure’. Among chairs who reported more familiarity with Certificates, composite opinion scores calculated based on five survey questions were evenly distributed among positive, neutral/middle, and negative views. Further, respondents expressed a variety of ideas about the appropriate use of Certificates, what they are intended to protect, and their effect on research risk. Nevertheless, chairs who participated in our study commonly viewed Certificates as a potentially valuable tool, frequently describing them as an ‘extra layer’ of protection. These findings lead to several practical observations concerning the need for more stakeholder education about Certificates, consideration of Certificates for a broader range of studies, the importance of remaining vigilant and using all tools available to protect participants’ confidentiality, and the need for further empirical investigation of Certificates’ effect on researchers and research participants.

The presumption of benefit in clinical research with children and adolescents

The concept of benefit is integral to the conduct of child and adolescent clinical research. When evaluating the ethical acceptability of research protocols, Institutional Review Boards (IRBs) must determine if benefits of the proposed study outweigh the risks and whether the research offers the prospect for direct benefit. This latter consideration is a particularly crucial determinant in situations where the child or adolescent wishes to dissent to research participation, since parents may legally overrule a dissenting child and compel their participation in research only when the IRB has concluded that the study offers the prospect for direct benefit [1]. Direct benefit refers to research where the purpose is to establish efficacy for an actual treatment for a disease, disorder or problem behavior [2]. King distinguishes other types of benefits that are ancillary to the primary purpose of the research, such as medical procedures or diagnostic tests, medical care, relationships with healthcare providers, positive feelings associated with altruistic behavior and financial compensation as ‘collateral benefits’ [2]. Future benefits to society are further classified as ‘aspirational’. However, a survey of IRB chairs responsible for reviewing research involving children revealed that direct and collateral benefits are often conflated. For example, the availability of psychological counseling unrelated to the research purpose was considered a direct benefit by 60% of the IRB Chair respondents and medical evaluations unrelated to the research purpose were thought to offer the prospect of direct benefit by 51% of the IRB Chairpersons sampled [3]. IRB Chair responses raise the concern that research involving children may be inappropriately perceived as offering direct benefit that, in turn, can curtail the autonomy of children and adolescents to dissent. Researchers and IRBs need a clear definition and conceptual understanding of research benefits, and how prospective research participants may be inclined to perceive them and be influenced by them.

Commentary

Much of the academic medicine community's confusion over institutional review board (IRB) composition and representation stems from the federal regulations themselves. The intent of these regulations is twofold-to ensure that IRBs are properly composed to review research proposals and to garner respect from the community for the decisions that they make.Klitzman's research, presented in this issue of Academic Medicine, looks at the roles of nonaffiliated and nonscientific IRB members. He found that those whom he interviewed, primarily IRB chairs, directors, and administrators, were confused about the role of these nonaffiliated and nonscientific members, how to train them, and how to engage them when reviewing protocols.The authors recommend moving away from a system of labeling IRB members (as scientific, nonaffiliated, etc.) and returning to the intent of the federal regulations-ensuring that the composition of the IRB results in an ethical review of the research. Every IRB appointment and every member's qualifications should be evaluated in light of the intentions of the federal regulations and the requirement that the IRB meet them. For example, if an individual's primary concerns are in scientific areas, the IRB should identify the individual as such, doing the same for those whose primary concerns are nonscientific. If the IRB needs individuals whose primary concerns are in nonscientific areas to represent the perspectives of human subjects, then it should recruit current or former research subjects for these positions. These changes would strengthen both the review process and the quality of the research.

Institutional Review Board Community Members

The roles of nonaffiliated and nonscientific institutional review board (IRB) members at academic medical centers have received some attention, but questions remain-Who are they, what do they do, and whom, if anyone, do they represent? The author interviewed 46 IRB chairs, directors, administrators, and members in 2007-2009. He contacted the leadership of 60 IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), interviewed IRB leaders from 34 of these institutions, then recruited 7 additional members from these IRBs to interview. Regular IRB members often called these individuals community members and were confused as to who these members were, or should be, and whether they did, or should, represent anyone and, if so, whom. IRBs encountered challenges in finding, training, and retaining these community members. Tensions emerged because nonscientific members, by definition, have no scientific training, so they have difficulty understanding key aspects of protocols, making them feel unempowered to contribute to reviews. IRBs varied in how much they encouraged these members to participate, in what ways, and with what success. At academic medical centers, IRBs struggled with how to view, choose, employ, and retain nonaffiliated and nonscientific members, and they varied widely in these regards. Some IRBs had these members review entire protocols, others only limited parts (particularly reading consent forms for comprehension), pro forma. Yet, at times, these members' input proved very important. These findings have critical implications for policy, practice, and research.

US IRBS CONFRONTING RESEARCH IN THE DEVELOPING WORLD

Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear. I conducted in-depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%). US IRBs face ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long-standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and 'negotiate' for maximum benefits for participants and fearing 'worst-case scenarios'. US and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice.

Researcher and Institutional Review Board Chair Perspectives on Incidental Findings in Genomic Research

Genomic research can produce findings unrelated to a study's aims. The purpose of this study was to examine researcher and Institutional Review Board (IRB) chair perspectives on genomic incidental findings (GIFs). Nineteen genomic researchers and 34 IRB chairs from 42 institutions participated in semi-structured telephone interviews. Researchers and chairs described GIFs within their respective roles. Few had direct experience with disclosure of GIFs. Researchers favored policies where a case by case determination regarding whether GIF disclosure would be offered after discovery, whereas IRB chairs preferred policies where procedures for disclosure would be determined prior to approval of the research. Researcher and IRB chair perspectives on management of GIFs overlap, but each group provides a unique perspective on decisions regarding disclosure of GIFs in research. Engagement of both groups is essential in efforts to provide guidance for researchers and IRBs regarding disclosure of GIFs in research.