Volume 19, Issue 9, September 2019, Page 58-60.

A number of unique problems plague human research protection efforts at United States (U.S.) State and Territorial Departments of Health (DOHs) problems which might be ameliorated through a consolidated national or regional, independent, not-for-profit Institutional Review Board (IRB).

A number of unique problems plague human research protection efforts at United States State and Territorial Departments of Health. The first problem is related to the number of Institutional Review Boards operated by and Federalwide Assurances held by DOHs. The lack of these two essential regulatory human research protection program mechanisms points to a possible inadequacy of infrastructure at DOHs for protecting human subjects. The second and third problems are related to the use and interpretation of research protection (...) laws and regulations at DOHs. Parsing public health activities into research or practice can be vexing and likely produces variability in how individual DOHs make the determination between research and practice and the outcomes of such decisions for the same or similar projects. A related problem is that DOH or Institutional Review Board officials might misclassify public health practice activities as research, which can have costly, adverse consequences. (shrink)

The National Institutes of Health (NIH) invests over $37 billion per year in support of research to improve human health. All research funded by NIH that involves human subjects is subject to regulatory oversight, requiring institutions to staff and manage Institutional Review Boards (IRBs). IRB members, chairs, and the many associated human subjects protections oversight professionals who support the work of the IRB must navigate complex federal regulations issued by multiple agencies. This book is the industry standard reference (...) work for the research oversight community, providing comprehensive, understandable interpretations of the regulations, clear descriptions of the ethical principles on which the regulations are based, and practical best-practices guidelines for effectively implementing regulatory oversight. (shrink)

Objectives: There are indications that institutional review board members do not find it easy to assess the risks and benefits in medical experiments, although this is their principal duty. This study examined how IRB members assessed the risk/benefit ratio of a specific phase II breast cancer clinical trial.Participants and methods: The trial was evaluated by means of a questionnaire administered to 43 members of IRBs at six academic hospitals and specialised cancer centres in the Netherlands. The questionnaire (...) addressed: identification and estimation of inconvenience, toxicity, psychosocial distress, and benefits of trial participation to patients; identification and estimation of benefits to future patients and medical science; assessment of the trial’s RBR; and assessment of its ethical acceptability.Results: Most IRB members expected trial participation to involve fairly or very serious inconvenience, fairly severe to sometimes life-threatening toxicity, and serious psychological and social consequences. Conversely, the perceived likelihood of benefits to patients was modest. Most regarded the study as important, and the balance between risks and benefits to be favourable, and believed that the protocol should be approved. The IRB members’ final judgement on the trial’s ethical acceptability was significantly correlated with their RBR assessment of the protocol.Conclusions: Because most patients who participate in clinical trials hope this will prolong their lives, it is suggested that patient information should better describe the anticipated benefits—for example, the likelihood of prolonging life. This would allow patients to make decisions regarding participation based on realistic expectations. (shrink)

This book is a small handbook designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient. The chapters of this book are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and (...) during full-committee meetings. (shrink)

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. (shrink)

Institutional Review Boards and their federal overseers protect human subjects, but this vital work is often dysfunctional despite their conscientious efforts. A cardinal, but unrecognized, explanation is that IRBs are performing a specific function – the management of risk – using a flawed theoretical and practical approach. At the time of the IRB system’s creation, risk management theory emphasized the suppression of risk. Since then, scholars of governance, studying the experience of business and government, have learned that we (...) must distinguish pure from opportunity risks. Pure risks should be suppressed. Some opportunity risks, in contrast, must be accepted if the institution is to meet its goals. Contemporary theory shows how institutions may make these decisions wisely. It also shows how a sound organizational understanding of risk, a proper locus of responsibility, and appropriate institutional oversight all contribute to effective risk management. We can apply this general theory, developed in other contexts, to the problems of the IRB system. Doing so provides a unifying explanation for IRBs’ disparate dysfunctions by spotlighting five related deficiencies in IRB theory and structure. These deficiencies are inability to focus on greater risks, loss of balanced theory, inaccessibility to guidance from senior leadership, unbalanced federal oversight, and inflexibility. These flaws are deeply rooted in the system, and superficial reform cannot resolve them. Congress should overhaul the system to meet contemporary standards of risk management; this would benefit subjects, scientists, and the public that needs the fruits of research. (shrink)

The quality of a research study application sends a distinct signal to the institutional review board (IRB) about the skills, capacities, preparation, communication, experience, and resources of its authors. However, efforts to research and define IRB application quality have been insufficient. Inattention to the quality of an IRB application is consequential because the application precedes IRB review, and perceptions of quality between the two may be interrelated and interdependent. Without a clear understanding of quality, IRBs do (...) not know how to define quality and researchers do not know how to achieve quality. This position has not been systematically studied to date, and future research could provide much-needed empirical validation. This paper lays the conceptual groundwork for future investigation into what constitutes quality in an IRB application. It includes a landscape review of multidisciplinary research on quality, as well as a discussion of quality frameworks analogous to research with human participants that exist in the published literature. It also examines the background and significance of federal research regulations, regulatory burdens, researchers’ regulatory literacy, and the roles and responsibilities of IRB professionals within this ecosystem. (shrink)

Institutional Review Boards are confronted with new challenges in the face of expanding technologies while fulfll-ing their existing regulatory mandate to ensure that plans are in place to protect subjects and to inform them of risks and benefts of research participation. Existing regulations and guidance do not address the issue of incidental fndings , thus leaving awareness of the issue and the application of ethical principles to IRB judgment alone. In order to assure that researchers are aware of (...) the potential for IFs, IRBs must identify which studies are likely to identify IFs and establish what plans should be put into place prior to study initiation to assure the subjects are appropriately informed of the likelihood of IFs, how IFs will be communicated to subjects, and whether the burden of follow-up falls on the researchers or is the subject's responsibility. (shrink)

Ethics committees like Institutional Review Boards and Research Ethics Committees are typically empowered to approve or reject proposed studies, typically conditional on certain conditions or revisions being met. While some have argued this power should be primarily a function of applying clear, codified requirements, most institutions and legal regimes allow discretion for IRBs to ethically evaluate studies, such as to ensure a favourable risk-benefit ratio, fair subject selection, adequate informed consent, and so forth. As a result, ethics committees (...) typically make moral demands on researchers: require them to act in a way the committee considers ethically right or appropriate. This paper argues that moral demands are legitimate only if publicly justifiable; and as a result, committee decisions are subject to a public justification requirement. Ethics committees can permissibly request for more information, changes to the research protocol or that the research is delayed or even stopped only if these demands are publicly justifiable. This latter claim is in turn justified on the basis that moral demands to φ are permissible only if we are in a position to know that the addressee ought to φ and that we are in a position to know a proposition only if it is publicly justifiable. This argument suggests that ethics committees must consciously and explicitly appeal to public reasons in their decision-making. In cases where public reasons cannot be offered, committees would not be permitted to reject a given study or make approval conditional on an amendment. (shrink)

BackgroundInstitutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia.MethodThis was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey (...) was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions.ResultsTwenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review.ConclusionSaudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies. (shrink)

With rapidly expanding technological capacity, research has outpaced the existing infrastructure of ethical and regulatory guidance. In the area of incidental findings, this is particularly true.The regulations under which most Institutional Review Boards operate were established over 25 years ago and have not been substantially altered in the intervening years. The technology available today that creates the opportunity for IFs was not conceived of, or considered, in the crafting of those regulations. Therefore, little guidance can be derived directly (...) from these regulations. Rather, aspects of existing ethical guidance and regulations can be adapted to assist IRBs and researchers in dealing with issues surrounding IFs. (shrink)

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not (...) following checklists; limited expertise in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general. (shrink)

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not (...) following checklists; limited expertise in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general. (shrink)

Objectives: This study was designed to explore the prevalence and types of stipulations required of investigators by the institutional review board of one institution over a five year period.Design: Stipulations to research proposals were documented from the minutes of the IRB meetings.Setting: Community hospital.Participants: IRB submissions.Main measurements: Number and type of IRB stipulations.Results: Nineteen research submissions were approved without any stipulations. For the remainder, the majority of stipulations related to consent forms .Conclusions: Consent forms appear to be (...) at highest risk for IRB stipulations. Being aware of high risk areas before submission of research proposals may reduce the frequency of stipulations required of investigators. (shrink)

To show how the case of Mary Shelley’s Victor Frankenstein brings light to the ethical and moral issues raised in Institutional Review Board protocols, we nest an imaginary IRB proposal dated August 1790 by Victor Frankenstein within a discussion of the importance and function of the IRB. Considering the world of science as would have appeared in 1790 when Victor was a student at Ingolstadt, we offer a schematic overview of a fecund moment when advances in comparative (...) anatomy, medical experimentation and theories of life involving animalcules and animal electricity sparked intensive debates about the basic principles of life and the relationship between body and soul. Constructing an IRB application based upon myriad speculations circulating up to 1790, we imagine how Victor would have drawn upon his contemporaries’ scientific work to justify the feasibility of his project, as well as how he might have outlined the ethical implications of his plan to animate life from “dead” tissues. In Mary Shelley’s Frankenstein, Victor failed to consider his creature’s autonomy, vulnerability, and welfare. In this IRB proposal, we show Victor facing those issues of justice and emphasize how the novel can be an important component in courses or workshops on research ethics. Had Victor Frankenstein had to submit an IRB proposal tragedy may have been averted, for he would have been compelled to consider the consequences of his experiment and acknowledge, if not fulfill, his concomitant responsibilities to the creature that he abandoned and left to fend for itself. (shrink)

This paper addresses a certain lacuna in moral theological reflec­tion. An institutional review board (IRB) reviews research on human subjects and so represents the institution’s ethical review mechanism for research. The author argues that if an IRB approves a research project that is immoral, it thereby implicates the institution in formal cooperation. The author also argues that numerous ethical concerns are created by current research enterprises—concerns that extend beyond the “usual suspects” of embryonic stem cell research (...) and research using cell lines of illicit origin. The author describes these more subtle issues and shows how IRBs at Catholic hospitals can navigate them. National Catholic Bioethics Quarterly 11.2 (Summer 2011): 257–266. (shrink)

Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards and research ethics committees’ about the need for researchers to translate consent forms and other study materials. Sixty US IRBs were contacted, and leaders from 34 and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals—what, (...) when and how to translate , why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy and justice against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions. (shrink)

Background: Emergency exception to informed consent regulation was introduced to provide a venue to perform research on subjects in emergency situations before obtaining informed consent. For a study to proceed, institutional review boards need to determine if the regulations have been met.Aim: To determine IRB members’ experience reviewing research protocols using emergency exception to informed consent.Methods: This qualitative research used semistructured telephone interviews of 10 selected IRB members from around the US in the fall of 2003. IRB members (...) were chosen as little is known about their views of exception to consent, and part of their mandate is the protection of human subjects in research. Interview questions focused on the length of review process, ethical and legal considerations, training provided to IRB members on the regulations, and experience using community consultation and notification. Content analysis was performed on the transcripts of interviews. To ensure validity, data analysis was performed by individuals with varying backgrounds: three emergency physicians, an IRB member and a layperson.Results: Respondents noted that: emergency exception to informed consent studies require lengthy review; community consultation and notification regulations are vague and hard to implement; current regulations, if applied correctly, protect human subjects; legal counsel is an important aspect of reviewing exception to informed-consent protocols; and IRB members have had little or no formal training in these regulations, but are able to access materials needed to review such protocols.Conclusions: This preliminary study suggests that IRB members find emergency exception to informed consent studies take longer to review than other protocols, and that community consultation and community notification are the most difficult aspect of the regulations with which to comply but that they adequately protect human subjects. (shrink)

The concepts of informed consent and surveillance of human research designed to protect human subjects is commendable. The regulations of the Institutional Review Board are having a major impact on clinical cancer research. There is greater administrative time needed of the investigator, the mechanisms of patient care have become cumbersome and some patients reject optional medical management that could be life saving. IRB regulations must be flexible to meet the needs of human subjects as well as those (...) of the clinical investigator. (shrink)

Because many institutions struggle to determine how best to support their institutional review board programs, we conducted an exploratory study to identify the individual, group, and institutional factors that may influence commitment to the role responsibilities of being on an IRB. We defined this commitment as consisting of time spent preparing for IRB meetings, views of the importance of serving on an IRB, time dedicated to IRB activities relative to other academic committee service, and willingness to (...) attend IRB meetings. Our study suggests that member commitment to IRB role responsibilities may be related to adequate compensation for time spent on IRB activities, serving on an IRB whose chair fosters a supportive group dynamic, IRB size, length of tenure, efficiency of protocol review, receiving training on the ethical and regulatory requirements for research with humans, and attendance of principal investigators at convened meetings. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:594 Feminist Studies 41, no. 3. © 2015 by Feminist Studies, Inc. Liberty Walther Barnes and Christin L. Munsch The Paradoxical Privilege of Men and Masculinity in Institutional Review Boards In the 1939 Hollywood classic The Wizard of Oz, the great wizard admonishes Dorothy and her friends to “pay no attention to that man behind the curtain.” Dorothy and company turn to see a man standing before (...) a large control panel operating the smoke, holographic image, and voice of the great wizard. Realizing he has been discovered, the man gives up manipulating the switches and the nebulous wizard vanishes.1 Hegemonic masculinity is analogous to the “all-powerful” wizard.2 In order to maintain its grandeur, power, and mystique, the mechanics of masculine ideology—as well as the social actors who participate in its reproduction —must be kept hidden.3 A crucial aim of feminist research is to 1. The Wizard of Oz, directed by Victor Fleming (Culver City, CA: Metro-Goldwyn -Mayer, 1939). 2. See R. W. Connell, Masculinities: Knowledge, Power and Social Change (Berkeley : University of California Press, 1995); R. W. Connell and James W. Messerschmidt, “Hegemonic Masculinity: Rethinking the Concept,” Gender & Society 19 (2005): 829–61; Michael Kaufman, “Me, Feminism, and Men’s Contradictory Experiences of Power,” in Theorizing Masculinities, ed. Harry Brod and Michael Kaufman (Thousand Oaks, CA: Sage Publications, 1994), 142– 63; and Michael S. Kimmel, “Masculinity as Homophobia: Fear, Shame, and Silence in the Construction of Gender Identity” in Brod and Kaufman, Theorizing Masculinities, 119–42. 3. Michael Flood and Bob Pease, “Undoing Men’s Privilege and Advancing Gender Equality in Public Sector Institutions,” Policy and Society 24, no. 4 (2005): 119–38; Allan G. Johnson, The Gender Knot: Unraveling Liberty Walther Barnes and Christin L. Munsch 595 pull back the curtain on men’s lives and masculine institutions in order to demystify socially constructed masculinities, particularly in their most powerful forms. As early feminist scholars note, male privilege renders women’s lives invisible.4 But male privilege renders aspects of men’s lives invisible, too. In this article we highlight how institutional review boards (IRBs) in universities and hospitals erect barriers to research that render particular aspects of men’s lives invisible. We draw on our experiences of submitting ten applications for a series of methodologically diverse studies of masculinity to eight IRBs. First, we argue that, despite their original function of protecting subordinated groups, IRBs are gendered institutions in which members base their decisions on culturally dominant, normative images of women and men. We show how this results in the stringent protection of male research participants, the safeguarding of participants’ personal masculinity, and the shielding of men’s lives from social inquiry. Second, we argue that IRBs are gendering institutions. Our experiences reveal how the privileging and protection of masculinity results in mandatory protocol modifications that idealize hegemonic masculinity. These modifications require researcher-participant interactions that socialize men to engage in gender “appropriate” behavior and reify gendered expectations. Third, our experiences reveal the ways in which IRBs protect the institution itself and privilege the universities, hospitals, and (predominantly male) medical doctors they represent. Consequently, the ways they reproduce social inequality remain impervious to academic inquiry. IRBS AS GENDERED AND GENDERING INSTITUTIONS Every university and hospital in the United States where human research is conducted houses a human research protections program, or IRB, to oversee academic research. Universities with hospitals typically our Patriarchal Legacy (Philadelphia, PA: Temple University Press, 1997); Michael Kimmel, Guyland: The Perilous World Where Boys Become Men (New York: Harper Collins, 2008). 4. Simone de Beauvoir, The Second Sex, trans. Howard M. Parshley (New York: Knopf, 1951); Sandra Harding, The Science Question in Feminism (Ithaca, NY: Cornell University Press, 1986); Dorothy E. Smith, “Women’s Perspective as a Radical Critique of Sociology,” in Feminist Perspectives on Social Research, ed. Sharlene N. Hesse-Biber and Michelle L. Yaiser (New York: Oxford University Press, 2004), 84–96. 596 Liberty Walther Barnes and Christin L. Munsch maintain two types of IRB committees: a social-behavioral committee that oversees studies in the social sciences, and a biomedical committee to supervise clinical drug trials, experimental medical treatments, and tissue and blood research. The duty of the... (shrink)

The community representative plays a very important role in an institutional review board but there is sparse data about their understanding of their role in an IRB. This study was conducted to assess perceptions of community members serving on IRBs of one region in India. A validated questionnaire was administered to community members of IRBs in a prospective cross-sectional study. The questions related to demography, perceptions of their role in the IRB, experiences while serving on the IRBs, (...) difficulties faced by them, and suggestions to improve their contributions. Of the 56 IRBs contacted, all 15 of the public institutions shared details of their community members, while only 26 of the 41 IRBs of private institutions responded. When questioned about why they joined the IRB, one third of the respondents said either that there was “no specific reason” for joining or that they accepted the invitation to serve on the insistence of other members of the IRBs or the head of their institution. All except one felt that community members were needed for optimal functioning. Six participants said that they did not review informed consent documents, and 10 were unaware that their presence was vital for quorum to be met. Twenty-eight said they participated actively in meetings and did not feel intimidated by the presence of clinicians. Twelve reported difficulties in understanding medical terminologies in ICDs. Although the majority of participants were aware about their role in an IRB, some did not review important documents such as ICDs. Restricted participation by private hospital IRBs was a striking observation in our study. There is a need to define eligibility criteria and develop targeted training modules for community members to ensure their effective contribution to effective oversight of clinical research. (shrink)

Background The European Union aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury, aiming to inform and stimulate initiatives to improve efficiency. Methods We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury. (...) Documents included detailed information on IRB procedures and the duration from IRB submission until approval. They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally or locally and primary IRB approval was obtained after one, two or three review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days and appeared to be shorter after submission to local IRBs compared to central IRBs. Conclusion We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries. (shrink)

The welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards were thus set up to be impartial reviewers of research protocols in clinical research. Their main role is to stand between the investigator and her human subjects in order to ensure that the welfare of human subjects are protected. While there is much literature on the conflicts of interest faced by investigators and researchers in clinical investigations, an area (...) that is less explored is CIs that may affect members of IRBs during the institutional ethics review of clinical investigations. This article examines the notion of CIs in clinical research and attempts to develop a framework for a clearer and more balanced approach to identifying CIs that may influence members of IRBs and impede their independence. It will also apply the proposed framework to demonstrate how IRBs possess, or at least may appear to possess, forms of financial CIs and non-financial CIs. The proper identification and management of these CIs is critical to preserving the integrity of clinical investigations and achieving the primary aim of human subjects protection. (shrink)

OBJECTIVES: To compare 2005 and 1995 ethics guidelines from journal editors to authors regarding requirements for institutional review board (IRB) approval and conflict-of-interest (COI) disclosure. DESIGN: A descriptive study of the ethics guidelines published in 103 English-language biomedical journals listed in the Abridged Index Medicus in 1995 and 2005. Each journal was reviewed by the principal author and one of four independent reviewers. RESULTS: During the period, the proportion of journals requiring IRB approval increased from 42% (95% (...) CI 32.2% to 51.2%, p<0.001) to 76% (95% CI 66.4% to 83.1%, p<0.001). In 2005, an additional 9% referred to the Declaration of Helsinki or the International Committee of Medical Journal Editors' Uniform requirements for ethical guidelines; 15% (95% CI 8.5% to 22.5%, p<0.01) provided ambiguous or no requirements. The proportion of journals requiring COI disclosure increased from 75% (95% CI 66.6% to 83.3%, p<0.05) to 94% (95% CI 89.4% to 98.6%, p<0.05); 41% had comprehensive requirements, while some addressed only funding source (6%), were vague (10%) or both (14%). Criteria for authorship rose from 40% (95% CI 30.5% to 49.5%, p<0.05) to 72% (95% CI 63.3% to 80.7%, p<0.05). Journals with higher impact factors were more likely to require IRB approval (p<0.01). Journals in anaesthesia and radiology all required IRB approval; requirements in other disciplines varied. CONCLUSIONS: Instructions to authors regarding ethical standards have improved. Some remain incomplete, especially regarding the scope of disclosure of COI. The ethical guidelines presented to authors need further clarification and standardisation. (shrink)

Genome-wide association studies raise important ethical and regulatory issues. This is particularly true of the current move toward broad sharing of genomic and phenotypic data. Our survey study examined the opinions of professionals involved in human subjects protection regarding genetic research review. The majority indicated that it is important for their institutional review board to offer guidance about developing and using a data repository or biobank that includes genetic data, and also about sharing this data with (...) other investigators. Only one-third of respondents reported that the National Institutes of Health policy regarding data sharing among researchers in genome-wide association studies is clear. Another third answered that they did not know whether this policy is clear. Findings from this study suggest a need for increased education for IRB professionals regarding the existing data sharing policy, collaboration among IRB professionals and researchers to define best practices, and further empirical research into prospective research participants’ information needs and preferences in the context of wide data sharing. (shrink)

uBiome offers a gut bacteria sequencing service to consumers to entice data donation. It aims to establish a genomic repository for microbiomics. In 2013, some bloggers worried that uBiome operations had not received any Institutional Review Board ethics approval. uBiome co-founders Richman and Apte replied by effectively arguing that crony research agencies hamper innovation by requiring cumbersome for-fee IRBs to so-called “citizen science” projects. The debate soon ascended from ethics to appropriate institutional design for research and (...) innovation. I reconstruct the ethical issues underpinning the uBiome-IRB debate and situate them in the emerging context of entrepreneurial science relying on crowdsourcing. This paper contributes to the dialogue between social scientists and bioethicists promoted in this volume by offering an analysis of a case study that requires attention to the organizational and economic context and lends itself to collaboration across disciplines. (shrink)

ABSTRACTGiven the ethical controversies concerning HIV vaccine trials , we aimed to understand through an exploratory study how members of institutional review boards in the United States and research ethics committees in South Africa view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires . In both countries, members tended to (...) be white males with advanced academic degrees. Compared to the US, SA members called for ‘major changes’ in HVT protocols more frequently , and were less likely to think that HVT participants understood risks and benefits or informed consent forms . In both countries, members were divided on several critical issues , but agreed that they needed more training. Of the SA respondents, 40% reported that they were ‘self‐taught’ in ethics. This study, the first we know of to offer quantitative data comparing US vs. non‐US IRBs/RECs, thus suggests key similarities and differences , along with needs for education. These initial exploratory data in this area have important implications for IRBs, RECs, policy‐makers and scholars concerning future practice, training, policy, and investigations in research ethics, and prevention and treatment of HIV and other diseases in the developing world and elsewhere. (shrink)

BackgroundInstitutional Review Boards (IRBs) play a vital role in safeguarding the rights and interests of both research participants and researchers. However, China initiated the establishment of its own IRB system relatively late in comparison to international standards. Despite commendable progress, there is a pressing need to strengthen the organizational capacity building of Chinese IRBs. Hence, this study aims to analyze the key factors driving the enhancement of organizational capacity within these committees.MethodThe cross-sectional survey for this research was conducted from (...) July 2020 to January 2022. Following the statistical grouping based on the "2020 China Health Statistical Yearbook", a systematic investigation of IRBs in various provinces of China was carried out. In-depth interviews and questionnaire surveys were conducted with the chairpersons and administrative executives (or secretaries) of highly cooperative IRBs. Subsequently, data were collected from 107 IRBs. Qualitative Comparative Analysis (QCA) was employed as the method to analyze the factors influencing the organizational capacity of medical ethics committees and explore the diverse combinations of these factors.ResultsThrough a singular necessary condition analysis, the variable "protection of rights and interests" emerges as a critical factor contributing to the robust construction of Institutional Review Boards Institutional Review Boards (IRBs). Conversely, the variables of "lack of member ability, absence of review process, and deficiency in the supervision mechanism" collectively constitute a sufficient condition leading to weaker IRB construction. The state analysis uncovers three interpretation modes: member ability-oriented (M1), system process-oriented mode (M2), and resource system-oriented mode (M3).ConclusionsThe results of this study are effectively explicable using the "Triangular Force" model proposed for the hypothesis of IRBs' organizational capacity, which provides a solid foundation for the development of organizational capabilities in IRBs. To enhance the organizational capacity of IRBs in China, it is imperative to elevate the competence of committee members and strengthen team development. This can be achieved by establishing a comprehensive regulatory framework and refining procedural protocols. Moreover, clarifying the organizational structure and optimizing resource allocation are essential steps in bolstering the overall organizational capabilities of these committees. (shrink)

The Institutional Review Board is a committee of the institution responsible for carrying out the institution's responsibilities for the protection of human research subjects. Since it is a local committee, most of the complaints about the IRB can be resolved locally provided it is borne in mind that the IRB is the champion not only of the human research subject but also of the investigator. National or regional cooperative research protocols present problems that are not insurmountable.

BackgroundTo investigate the factors related to approval after review by an Institutional Review Board, the structure equation model was used to analyze the latent variables ‘investigators’, ‘vulnerability’ and ‘review process’ for 221 proposals submitted to our IRB.MethodsThe vulnerability factor included vulnerable cases, and studies that involved drug tests and genetic analyses. The principal investigator factor included the license level of the PI and whether they belonged to our institution. The review factor included administration time, (...) total review time, and revision frequency. The revision frequency and total review time influenced the efficiency of review.ResultsThe latent variable of reviewing was the most important factor mediating the PIs and vulnerability to IRB review approval. The local PIs moderated with genetic study and revision frequency had an impact on the review process and mediated non-approval.ConclusionsBetter guidance of the investigators and reviewers might improve the efficiency with which IRBs function. (shrink)

Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We (...) look at what we know about IRB decision-making in relation to protecting and including “vulnerable” groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight. (shrink)

This book traces the historic transformation of institutional review boards (IRBs) from academic committees to compliance bureaucracies. Sarah Babb opens the black box of contemporary IRB decision-making, which is increasingly outsourced to specialized private firms.

Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants (...) inhaled hexamethonium, a chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s. (shrink)

Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems (...) to accommodate the sIRB process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials. (shrink)