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)

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)

Biomedical research today can be generally classified as human-based or nonhuman animal-based, each with separate and distinct review boards that must approve research protocols. Researchers wishing to work with humans or human tissues have become frustrated by the required burdensome approval panel, the Institutional Review Board. However, scientists have found it is much easier to work with the animal-based research review board, the Institutional Animal Care and Use Committee. Consequently, animals are used for investigations (...) even when scientists believe these studies should be performed with humans or human tissue. This situation deserves attention from society and more specifically the animal protection and patient advocate communities, as neither patients nor animals are well served by the present situation. (shrink)

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

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)

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)

In their target article, “The Rise of Citizen Science in Health and Biomedical Research,” Andrea Wiggins and John Wilbanks (2019) summarize some of the emerging ethical issues related to citizen sc...

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)

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)

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)

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)

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the waiver (...) of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood - the standard treatment for hemorrhagic shock - is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards. (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)

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)

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)

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)

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 Internet has been used as a place for and site of an array of research activities. From online ethnographies to public data sets and online surveys, researchers and research regulators have struggled with an array of ethical issues around the conduct of online research. This paper presents a discussion and findings from Buchanan and Ess's study on US-based institutional review boards and the state of internet research ethics.

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)

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the waiver (...) of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood—the standard treatment for hemorrhagic shock—is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards. (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 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)