Function Of Institutional Review Boards Research Articles

Perspectives of Singaporean biomedical researchers and research support staff on actual and ideal IRB review functions and characteristics: A quantitative analysis.

BackgroundBiomedical research is overseen by numerous Institutional Review Boards (IRBs) in Singapore but there has been no research that examines how the research review process is perceived by the local research community nor is there any systematic data on perceptions regarding the review process or other research ethics processes and IRB characteristics. The aim of this study was to ascertain general views regarding the overall perceived value of ethics review processes; to measure perceptions about local IRB functions and characteristics; to identify IRB functions and characteristics viewed as important; and to compare these views with those of other international studies.MethodsAn online survey was used with the main component being the IRB-Researcher Assessment Tool (IRB-RAT), a validated tool, to evaluate perceptions of ideal and actual IRB functions and characteristics held by Singaporean researchers and research support staff. Data were analysed descriptively first, with mean and SD of each item of IRB-RAT questionnaire reported, excluding the respondents whose answers were unknown or not applicable. The Wilcoxon Sign Rank test was used to compare the ideal and actual ratings of each IRB-RAT item, while the Mann-Whitney U test was used to compare the ratings of each IRB-RAT item between respondents with different characteristics. The Z-test was used to compare the mean ratings of our cohort with the mean ratings reported in the literature. The correlation between our mean ideal scores and those of two international studies also employing the IRB-RAT was examined.ResultsSeventy-one respondents completed the survey. This cohort generally held positive views of the impact of the ethics review process on: the quality of research; establishing and maintaining public trust in research; the protection of research participants; and on the scientific validity of research. The most important ideal IRB characteristics were timeliness, upholding participants’ rights while also facilitating research, working with investigators to find solutions when there are disagreements, and not allowing biases to affect reviews. For almost all 45 IRB-RAT statements, the rating of the importance of the characteristic was higher than the rating of how much that characteristic was descriptive of IRBs the respondents were familiar with. There was a significant strong correlation between our study’s scores on the ideal IRB characteristics and those of the first and largest published study that employed the IRB-RAT, the US National Validation (USNV) sample in Keith-Spiegel et al. [19].ConclusionsAn understanding of the perceptions held by Singaporean researchers and research support staff on the value that the ethics review process adds, their perceptions of actual IRB functions and characteristics as well as what they view as central to high functioning IRBs is the first step to considering the aspects of the review process that might benefit from improvements. This study provides insight into how our cohort compares to others internationally and highlights strengths and areas for improvement of Singapore IRBs as perceived by a small sample of the local research community. Such insights provide a springboard for additional research and may assist in further enhancing good relations so that both are working towards the same end.

Introducing a Research Management System to Speed Up and Streamline Clinical Research Activities.

Clinical Research is a complicated process within a research institution or a tertiary care hospital, almost all research project proposal needs to get an institutional review board (IRB) approval before any research activity takes place. IRB approval involves various processes, in form of sub-committees through which the proposal is reviewed. It is of utmost importance to understand the complete functioning of an IRB, in order to automate the various processes using a management system. The Research office entity forms the central body managing the IRB functions. It provides all sorts of administrative support as far as guidelines, documentation, communication and co-ordination is concerned; hence the research office forms the administrative wing of the IRB. Further the IRB has several sub-committees such as the Ethics Committee, Basic Research committee and the Animal Care and Use Committee. Each committee has a chairperson and several members from different specialty to cover all the aspects of research. Each committee may have its own process/workflow of approval, but usually the process of each committee is somewhat similar to each other. Apart from these workflows process the things that needs to be digitized would include researcher's profile, pre-award and post-award management, publication management, graduate student management and research analytics for the organization.

Nurse researchers' perspectives on research ethics in China.

In China, research ethics is a subject of increasingly formal regulation. However, little is known about how nursing researchers understand the concept of research ethics and the ways in which they can maintain ethical standards in their work. The aim of this study is to examine nursing researchers' perspectives on research ethics in China. We conducted a descriptive qualitative study. Qualitative research methods enabled us to gain an in-depth understanding of nursing researchers' views on research ethics. We carefully selected and extensively interviewed 28 nursing researchers, nursing faculty, and clinical nurses who had been involved in research or who may undertake research in the future. We collected data between October 2014 and March 2015. This study was approved by the institutional review boards of Yale University and Central South University. We grouped the data into five categories based on the interviewees' responses: (1) perceptions of ethics, bioethics, and research ethics; (2) perception of the ethics review process; (3) perception of the function of institutional review boards; (4) the need for comprehensive ethical guidelines for future studies; and (5) ethical challenges faced by the interviewees. This study contributes new insights into nursing researchers' views on research ethics in China and finds considerable shortcomings in researchers' understanding and implementation of ethical principles. Intensive educational efforts are needed to provide nursing researchers, institutional review board members, and even study subjects with accurate and up-to-date information and guidance on research ethics. In addition, while Western research ethics theoretically have guided Chinese clinical research for several years, the ways in which nursing researchers have implemented these ethical standards highlight the differences between the Eastern and Western ethical paradigms. This finding suggests the need for ethical standards that are more tailored to the Chinese context.

A case study of researchers’ knowledge and opinions about the ethical review process for research in Botswana

Most countries, including Botswana, have established Institutional Review Boards (IRBs) to provide oversight of research involving human beings. Although much has been published on the structure and function of IRBs around the world, there is less literature that empirically describes the perspectives of stakeholders in low- and middle-income country (LMIC) settings regarding IRB processes. In this study, we employed primarily quantitative methods to examine the perceptions of researchers at the University of Botswana (UB) about the review of research protocols by local IRBs. Data were collected using a web-based survey (SurveyMonkey1). This was a preliminary effort to document some of the emerging experiences of researchers with ethics review in a context where both research and research oversight are relatively new. Findings from 85 researchers indicate that researchers recognized the need for an IRB to review all human research protocols, expressed the need for research ethics training, experienced high rates of approval at government ministries and UB, and generally believed that ethics review processes can help researchers themselves better understand and appreciate research ethics in general. Though only about one-quarter of respondents reported a more positive view of research ethics after interacting with the UB IRB, 56.5 percent reported no change. In contexts where IRBs have recently been established, it can be particularly important to document the perspectives of researchers in order to align expectations with capabilities, and identify areas where IRBs can improve operations. Future efforts to advance research ethics and ethical review in Botswana should include establishing research ethics training requirements and courses for researchers, increasing investment in IRBs and their training, further developing institutional and national research ethics policies, and formalizing agreements between IRBs and others involved in research oversight in the country to support coordinated review.

Prioritizing initiatives for institutional review board (IRB) quality improvement

ABSTRACTBackground: Institutional review boards (IRBs) have been criticized for inconsistency, delay, and bias, suggesting an opportunity for quality improvement. To aid such quality improvement, this study aimed at determining IRB members’ and investigators’ priorities regarding IRB review at 10 Veterans Affairs (VA) IRBs. Methods: Six hundred and eighty anonymous Internet surveys were sent to 252 IRB members and staff, and to 428 principal investigators and project coordinators at 9 VA Medical Centers and the VA Central IRB. Surveys included 27 statements adapted from Koocher and Kieth-Spiegel's IRB-RAT describing IRB activities or functions (e.g., “An IRB that is open to reversing its earlier decisions”). Respondents indicated how each statement described both their “ideal” and “actual” IRBs. The difference between the ratings of the actual and ideal IRBs was calculated for each item, along with estimated 95% confidence intervals. Ratings outside those intervals indicated activities or functions with relatively good or poor performance compared to the ideal IRB. Results: Three hundred and ninety (57.4%) responses from 165 IRB members and staff (65.5%) and 225 investigators and project coordinators (52.6%) demonstrated that these IRBs were closest to the ideal when protecting human subjects, treating investigators with respect, and taking appropriate action for alleged scientific misconduct. The IRBs were furthest from the ideal regarding duplicative forms, timeliness of review, and provision of complete rationales for decisions. Although IRB members reported near-ideal willingness to reverse earlier decisions, investigators rated this capacity far from ideal. Investigators rated IRB members’ knowledge about procedures and policy as nearly ideal, but IRB members themselves rated this aspect far from ideal. Noteworthy site-level differences in the ratings of IRB functions and activities were also identified. Conclusions: Although these VA IRBs perform well in some areas, these data support the need for ongoing quality improvement. The described method of administering and analyzing the IRB-RAT may help identify and monitor site- and activity-specific initiatives for quality improvement.

Using the IRB Researcher Assessment Tool to Guide Quality Improvement.

Institutional Review Boards (IRBs) are intended to protect those who participate in research. However, because there is no established measure of IRB quality, it is unclear whether these committees achieve their goal. The IRB Researcher Assessment Tool is a previously validated, internally normed, proxy measure of IRB quality that assesses 45 distinct IRB activities and functions. We administered this instrument to a sample of investigators and IRB members at a large urban VA Medical Center. We describe a systematic approach to analyze and interpret survey responses that can identify the IRB activities and functions most in need of quality improvement. The proposed approach to empirical data analysis and presentation could inform local initiatives to improve the quality of IRB review.

Is your ethics committee efficient? Using "IRB Metrics" as a self-assessment tool for continuous improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand.

Tensions between researchers and ethics committees have been reported in several institutions. Some reports suggest researchers lack confidence in the quality of institutional review board (IRB) reviews, and that emphasis on strict procedural compliance and ethical issues raised by the IRB might unintentionally lead to delays in correspondence between researchers and ethics committees, and/or even encourage prevarication/equivocation, if researchers perceive committee concerns and criticisms unjust. This study systematically analyzed the efficiency of different IRB functions, and the relationship between efficiency and perceived quality of the decision-making process. The major purposes of this study were thus (1) to use the IRB Metrics developed by the Faculty of Tropical Medicine, Mahidol University, Thailand (FTM-EC) to assess the operational efficiency and perceived effectiveness of its ethics committees, and (2) to determine ethical issues that may cause the duration of approval process to be above the target limit of 60 days. Based on a literature review of definitions and methods used and proposed for use, in assessing aspects of IRB quality, an “IRB Metrics” was developed to assess IRB processes using a structure-process-outcome measurement model. To observe trends in the indicators evaluated, data related to all protocols submitted to the two panels of the FTM-EC (clinical and non-clinical), between January 2010–September 2013, were extracted and analyzed. Quantitative information based on IRB Metrics structure-process-outcome illuminates different areas for internal-process improvement. Ethical issues raised with researchers by the IRB, which were associated with the duration of the approval process in protocol review, could be considered root causes of tensions between the parties. The assessment of IRB structure-process-outcome thus provides a valuable opportunity to strengthen relationships and reduce conflicts between IRBs and researchers, with positive outcomes for all parties involved in the conduct of human-subject research.

A Systematic Review of the Empirical Literature Evaluating IRBs: What We Know and What We Still Need to Learn

Institutional review boards (IRBs) are integral to the U.S. system of protection of human research participants. Evaluation of IRBs, although difficult, is essential. To date, no systematic review of IRB studies has been published. We conducted a systematic review of empirical studies of U.S. IRBs to determine what is known about the function of IRBs and to identify gaps in knowledge. A structured search in PubMed identified forty-three empirical studies evaluating U.S. IRBs. Studies were included if they reported an empirical investigation of the structure, process, outcomes, effectiveness, or variation of U.S. IRBs. The authors reviewed each study to extract information about study objectives, sample and methods, study results, and conclusions. Empirical evidence collected in forty-three published studies shows that for review of a wide range of types of research, U.S. IRBs differ in their application of the federal regulations, in the time they take to review studies, and in the decisions made. Existing studies show evidence of variation in multicenter review, inconsistent or ambiguous interpretation of the federal regulations, and inefficiencies in review. Despite recognition of a need to evaluate effectiveness of IRB review, no identified published study included an evaluation of IRB effectiveness. Multiple studies evaluating the structure, process, and outcome of IRB review in the United States have documented inconsistencies and inefficiencies. Efforts should be made to address these concerns. Additional research is needed to understand how IRBs accomplish their objectives, what issues they find important, what quality IRB review is, and how effective IRBs are at protecting human research participants.

Ethics for the Pediatrician

Ethics for the Pediatrician

Medical research ethics in China

Medical research ethics has been a growing issue in China over the past two decades. In the 1990s, many relevant documents were translated into Chinese, and many ethics workshops were held in major Chinese research centres. Initially, momentum was generated by the need for ethical review in collaborations funded by international scientific agencies and the drug industry. The Ministry of Health issued requirements for good clinical practice in 1999 (revised in 2003) that also included ethical review. Another factor has been the recent trend toward documentation by ethics committees before publication in international journals. The protection of human participants in international medical research collaborations in China, and in other developing countries, has been a focus of attention in the mass media in developed countries and in the scientific literature. These moves have provided models for ethical implementation1 and brought attention to the controversies around the protection of participants in clinical trials and observational studies.2,3 Recently, as research funding from Chinese governmental sources has increased, so also has the requirement for ethical review of domestic research protocols. Currently, most of the ethical codes for medical research, including the regulations issued by the Ministry of Health in 2007,4 are based on the principles of autonomy, beneficence, and justice. Autonomy includes situations when consent might be compromised by low literacy or mistaking research for routine health-care services.5 Justice considerations can arise when large drug-company trials are done in less developed regions (the findings might not be reported back to participants and their communities, or the standard of care in such trials might be measured by domestic rather than global standards). There are two major criticisms of the principle-based framework in China. The first concerns whether, and how, a framework that focuses on individual autonomy can coexist with a traditional ethic that emphasises social harmony over individual interests. This debate is part of the worldwide critique of ethical imperialism,6 to which some have responded that principle-based ethics are universal and compatible with other ethical systems7 whereas others have argued that many medical moralities coexist in all societies.8 As with virtue-based ethics in developed countries,9 traditional Chinese ethics focus on relationships and the responsibility of a person to work for the good of others, rather than adherence to general principles of common morality. Some contend that this ethic undermines the protection of individual participants in medical research.10 However, leading Chinese bioethicists argue that virtues and ethical principles are compatible, and that respect for people, non-maleficence or beneficence, and justice are principles and virtues for a good person.11 For medical research, major ethical responsibility is placed on the researcher. Thus a signed consent form might be seen less as protection for participants’ rights than as a legal mechanism that will relieve researchers from their important virtue-based responsibilities. To further the goals of the ethical conduct of medical research, it is essential to continue to clarify how principles and virtues can be used together to enhance the protection of participants. The second critique takes a broader view of the purpose of medical research ethics, beyond both the function of institutional review boards and their principle-based reasoning, and assessment of actions based on good intentions or achieving good outcomes. Reflecting recent discussions of professional ethics in the context of market reforms,12 this critique encourages consideration of ethical aspects of the entire research domain, from funding to dissemination of findings,13 thus capturing the influences underlying economic and social changes within China today and locating potential participants within a broader domain of power and influence. In recent years, economic incentives in medical practice and research exacerbate the potential for conflicts of interest, which can undermine ethical relations between medical professionals and researchers, drug companies, or other research funders, patients who become research participants, and even the regulatory agencies whose mandate is to protect participants’ safety. Although forces at play in China might aid advocacy for research participants through the rise of civil society and non-governmental organisations, others might act to undermine essential human rights. The most crucial threat to the protection of human participants in research lies in failing to be aware of and to counteract these dangers. Essential here is maintenance of the independence of ethics committees, and fostering their ability to develop community-engagement mechanisms. The future looks promising. As China’s role in research continues to expand, principle-based ethical review of protocols will become increasingly widespread and standardised. The key issue is not whether, or to what extent, foreign versus traditional ethical theories are relevant in the Chinese context. Rather, it is more vigilant regulation of the business of medical research that is needed to ensure protection of research participants.

Research Ethics Boards: The Protection of Human Subjects

Compelling arguments, documentation, and published data have always been the basis of scholarly examination, discussion, and reasoning. Rhetorical catch phrases, biased ideologies, and anecdotal reports, when used to prove erroneous and often unrelated points, are creating condemnation and polarization instead of awareness on the important issues of research ethics boards. The statement that “they are in a client–provider business relationship” as expressed in the article by Lemmens and Elliott [1] implies a direct financial relationship between sponsors and those reviewing their research protocols. This is incorrect. Since we cannot speak on behalf of other for-profit Institutional Review Boards (IRBs), we will describe how our Canadian for-profit IRB functions. The owners of the company and those involved in the running of the business are not IRB members and have no voting privileges. IRB members are external consultants who are paid by the company providing the review services for the time spent in reviewing a protocol and providing an expert ruling regarding the ethics and science of a particular study. IRB members have no business interests in the company (e.g., partnership or profit-sharing) and no vested interest in the approval or non-approval of a specific study. It is worth noting that members of academic or governmental not-for-profit IRBs are often paid for the ethical review services they provide, in recognition of the time and skill required to carry out their duties. Respected, well-organized, and accredited IRBs (for-profit and not-for-profit) are not an enterprise of “five people”. This is merely the minimal regulatory requirement, which we consistently exceed in our meetings. IRBs are complex bodies of highly qualified professional experts from various disciplines, such as physicians, pharmacists, scientists, lawyers, philosophers, ethicists, and lay persons. They are multicultural, balanced in gender, diverse in social background, and dedicated to the protection of research subjects (which remains the main mandate for all IRBs). Often, for-profit IRB members are serving or have served as IRB members on academic or governmental not-for-profit IRBs. Is it expected that the work of these individuals is ethical when they are volunteers, and unethical when they are remunerated for their expertise? Rather than fixate on the concept that members of IRBs are paid, we should concentrate on the real challenges regarding IRBs (for-profit and not-for-profit) and try to propose some meaningful insight. Ethics in biomedical research is a serious and complex affair with huge societal implications. Expert advisors that are paid or not paid are not the problem that IRBs face today. It is rather the rapidly growing complexity of biomedical research that confronts IRBs, together with the lack of a timely transfer of knowledge, often due to insufficient resources, the lack of continuing education, and the lack of sufficient and appropriate member expertise. IRBs are expected to function as multifaceted oversight bodies and assume many duties, including ethics consultation, education, peer reviewing, adverse events reporting, publication policies, and the review of financial conflicts of interest. The attention should be focused on whether IRBs are performing to the highest ethical standards and conforming to existing regulations rather than if their members are remunerated or not. Singling out the issue of payment distracts from sincere discussion on how to improve and ensure high-quality reviews of biomedical research and maintain the protection of the human subjects involved.

Case studies in biomedical research ethics

This textbook for instruction in biomedical research ethics can also serve as a valuable reference for professionals in the field of bioethics. The 149 cases included in the book are grouped in nine chapters, each of which covers a key area of debate in the field. Some of the case studies are classics, including the famous cases of the Tuskegee Syphilis Study (in which subjects with syphilis were not given treatment) and the Willowbrook hepatitis studies (in which institutionalized subjects were intentionally exposed to hepatitis). Others focus on such current issues as human embryonic stem cell research, cloning by somatic nuclear transfer, and the design and function of institutional review boards. Each chapter begins with a brief introduction that places the issues raised in context; this is followed by a number of cases (each of which is no more than a few pages). Study questions meant to encourage further discussion follow each case.After an introductory discussion of the history and tenets of ethics in medical research, the book's chapters cover the topics of oversight and study design; informed consent; the selection of subjects; conflicts of interest; the social effects of research; embryos, fetuses, and children; genetic research; the use of animals; and authorship and publication. Following these chapters are appendixes with the texts of the Nuremburg Code and the World Declaration of Geneva, two key documents in the establishment of bioethical standards for research. Also included are a glossary, a table of cases by general category, and an alphabetical listing of cases.

Oversight of human participants research: identifying problems to evaluate reform proposals.

The oversight of research involving human participants is widely believed to be inadequate. The U.S. Congress, national commissions, the Department of Health and Human Services, the Institute of Medicine, numerous professional societies, and others are proposing remedies based on the assumption that the main problems are researchers' conflict of interest, lack of institutional review board (IRB) resources, and the volume and complexity of clinical research. Developing appropriate reform proposals requires carefully delineating the problems of the current system to know what reforms are needed. To stimulate a more informed and meaningful debate, we delineate 15 current problems into 3 broad categories. First, structural problems encompass 8 specific problems related to the way the research oversight system is organized. Second, procedural problems constitute 5 specific problems related to the operations of IRB review. Finally, performance assessment problems include 2 problems related to absence of systematic assessment of the outcomes of the oversight system. We critically assess proposed reforms, such as accreditation and central IRBs, according to how well they address these 15 problems. None of the reforms addresses all 15 problems. Indeed, most focus on the procedural problems, failing to address either the structure or the performance assessment problems. Finally, on the basis of the delineation of problems, we outline components of a more effective reform proposal, including bringing all research under federal oversight, a permanent advisory committee to address recurrent ethical issues in clinical research, mandatory single-time review for multicenter research protocols, additional financial support for IRB functions, and a standardized system for collecting and disseminating data on both adverse events and the performance assessment of IRBs.

Breaking the camel's back: multicenter clinical trials and local institutional review boards.

Clinical research has undergone remarkable and beneficial expansion in the past 25 years, but with this growth has come an unprecedented increase in workload for the human subjects protection system. Recently, a major change in federal oversight of local institutional review boards (IRBs) became evident. Although it was not announced publicly, in 1998 and 1999 federal regulatory actions against local IRBs increased threefold. Particularly notable was the marked increase in regulatory actions taken against the IRBs of academic medical centers (1 in 1997 compared with 14 in 1999). Ironically, this apparent federal crackdown began at the same time that two federal review panels called for major changes in the regulations governing local IRBs. A key factor in the current crisis in the function of local IRBs is the ascendance of multicenter clinical trials as the dominant form of clinical research. Local IRBs were not designed to handle the initial evaluation and ongoing review required by the rapidly increasing number of multicenter clinical trials. Furthermore, local IRB review of the thousands of safety reports from multicenter clinical trials monopolizes resources without promoting patient safety. Instead of rigid enforcement of outmoded regulations that do not contribute to patient safety, the responsibilities of the local IRB in the oversight of multicenter clinical trials must be systematically evaluated.

Taking names: the ethics of indirect recruitment in research on sexual networks.

Evaluating the risks and anticipated benefits of medical, behavioral and, social research is a central function of institutional review boards (IRBs). The calculation that IRBs undertake ultimately determines whether a particular research project involving human participants is permitted to proceed. In medical research the physical harms and even the anticipated benefits of a new procedure or drug are often apparent and quantifiable. In contrast, for social/behavioral research that may involve probing the most intimate feelings, thoughts, and actions of participants, the weighing of risks and anticipated benefits, the calculation of possible harms and the acceptability of that harm require a more intense level of scrutiny.Even the early step of identifying and recruiting participants for a research endeavor may potentially cause harm, making participant selection a focus of IRB analysis.

Research ethics committees: a regional approach.

Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs attain different levels of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures.

The Office for Protection from Research Risks.

Protecting Human Research SubjectsThe Office for Protection from Research Risks Joan Paine Porter (bio) The office for Protection from Research Risks (OPRR), located within the National Institutes of Health, has two divisions: Human Subject Protections and Animal Welfare. This article will address the overall responsibilities and current projects relating to human subject protections. OPRR implements the Department of Health and Human Services' (HHS) regulations for the protection of human subjects (45 CFR 46 (1991)). These regulations fulfill the responsibilities set forth in the Public Health Service (PHS) Act with regard to institutional review boards (IRB) and other protections for human subjects involved in biomedical and behavioral research conducted or supported by HHS. The PHS Act also mandates a program to clarify ethical issues in biomedical research involving human subjects and to address violations of the rights of human subjects of research (P.L. 99-158 (1985)). OPRR staff negotiate assurances of compliance with institutions conducting Federally-supported research involving human subjects. The assurances describe the policies and procedures each institution will follow to fulfill the requirements of the regulations, including specific IRB composition and functions. In addition, OPRR cosponsors with the Food and Drug Administration and awardee institutions a series of regional workshops that address human subject protections issues. These are attended by IRB members, institutional officials, research investigators, and others involved with human subject protections. Current Activities Numerous activities are underway in OPRR. The following describes only a few of the initiatives and studies aimed at helping develop policies and procedures to protect human subjects of research. "Points to Consider" Documents OPRR is currently working with the National Center for Human Genome Research (NCHGR) to develop a "points to consider" document for IRBs and others involved in large genetic pedigree studies. Many questions have emerged [End Page 279] on topics such as how subjects should be recruited, with whom information should be shared about others in the family, social risks of disclosure in employment and insurance, the circumstances and timing of informing subjects about study results, and involvement of children. OPRR and NCHGR hope to assemble a group this fall to review and refine the points that are now being developed jointly. A conference in South Carolina organized by the American Association for Advancement in the Sciences entitled "Project on the Ethical and Legal Implications of Genetic Testing," helped generate advice, and identified some of the more controversial issues in design and conduct of genetic research that involves large groups of family members. Another "points to consider" effort concerns enrollment of women and minorities in research. The PHS has established a policy that members of these groups must be included in research projects unless there are valid scientific justifications for their exclusion which can be made on a project by project basis (ADAMHA/NIH Policy 1990; NIH/ADAMHA Policy 1990). OPRR has commissioned several scholarly papers to help in developing "points to consider" for IRBs as they balance issues of equitable selection of subjects and protection of these selected individuals. Concerns about enrolling women of childbearing age in research that may be harmful to a fetus, and liability issues frequently dominate discussion in this area. The papers will address ethical, legal, and statistical aspects of enrollment of minorities and women as well as provide a description of various practices and roles of IRBs in addressing goals of fair selection of participants and appropriate protections. OPRR is also working with the PHS Panel on Women, Adolescents and Children to produce a document, also in the form of "points to consider" guidance, concerning enrollment of children who are wards of the state in HIV-related research. Subpart D of the regulations for the protection of human subjects (45 CFR 46) specifically addresses research involving children who are wards of the state, including the special protections that must be provided. State and local officials who have authority to enroll foster care children in research have indicated a desire to obtain advice in this area. The IRB Guidebook A major project that is now being completed under contract to the Poynter Center at Indiana University is the IRB Guidebook. It will revise and expand the current IRB Guidebook produced in the 1980s...

Federal Commissions and Local IRBs

Yesley reviews the studies done on institutional review boards (IRBs) by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and, later, by the President's Commission for the study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Basing his conclusions on the commissions' findings, he recommends that refining IRB functions may be the best way to improve their performance, and suggests that a review of IRB responsibilities as defined by Department of Health and Human Services regulations could be one task of a re-established Ethics Advisory Board.

The IRB's Monitoring Function: Four Concepts of Monitoring

Since Institutional Review Boards (IRBs) were introduced, concerns about institutional accountability, consumer rights, and conflicts of interests among institutional committees, the institutions, and the public have all increased. These concerns are reflected today in increased pressures on IRBs to diversify their membership, to submit to external audit of their activity, and to assume more functions. While monitoring is a term that is increasingly used to describe new IRB functions, it is used imprecisely and to refer to a range of possible activities. is acknowledged to have some meaning in the area of continuing review. It is also often discussed in terms of police-like duties and surveillance. Some proposed regulations refer to of solicitation of assent. The 1974 DHEW proposed regulation described the duties of the consent committees that were to be set up by using words such as oversee, monitor, and intervene. More recently the proposed FDA regulations on IRBs combine continuing review with assurances of compliance. IRBs are quickly developing a highly specialized jargon. Monitoring is a word that is being used in that new jargon without careful consideration given to its meaning. The word monitoring should be eliminated from the regulations and replaced with four more concrete and precise concepts. Each of these concepts can then be debated on its own merits without being confused with the other three. Some may be accepted and others rejected without tossing out all of altogether. The four concepts are (1) continuing review; (2) review of the consent process: (3) review for adherence to an approved protocol; and (4) review to identify unapproved activities.