Is compliance a professional virtue of researchers? Reflections on promoting the responsible conduct of research

Evidence exists that behavioral and social science researchers have been frustrated with regulations and institutional review boards (IRBs) from the 1970s through today. Making matters worse, many human participants protection instruction programs--now mandated by IRBs--offer inadequate reasons why researchers should comply with regulations and IRBs. Promoting compliance either for its own sake or to avoid penalties is contrary to the developmental aims of moral education and may be ineffective in fostering the responsible conduct of research. This article explores the concept of professional virtue and argues that compliance is capable of becoming a professional virtue like scientific honesty. This requires, however, that regulatory and IRB demands contribute to human well-being and to the aims of research as a profession and that researchers, therefore, internalize the norms that underlie regulatory and IRB demands. This, in turn, requires a series of changes in the way society develops, promulgates, and enforces regulatory and IRB rules. The challenge is, simply put, to embed compliance into the world of living morality.     

Using our best judgment in conducting human research

The federal regulations of human research were written to permit the use of discretion so that research can fit the circumstances under which it is conducted. For example, the researcher and institutional review board (IRB) could waive or alter some informed consent elements if they deem this the morally and scientifically best way to conduct the research. To do so, however, researchers and IRBs would first have to use mature moral and scientific judgment. They might also have to rely on empirical research to discover the most effective way to act on their moral sense (e.g., to discover how best to approach potential research participants and explain the nature and purpose of the research participation for which they are being recruited, to ensure comprehension and competent decision making). On discovering the most ethical way to proceed, they would then need to look to the federal regulations of human research to discover how to document their decision and justify it within that somewhat flexible regulatory structure. Unfortunately, many IRBs and researchers fail to take these sensible steps to solve ethical problems and proceed immediately to a default requirement of the regulations that places science at odds with the regulations and, ostensibly, with ethics. The following articles in this special issue are about the process of learning to engage in ethical problem solving and using the flexibility permitted by the federal regulations. These articles extricate researchers from the mindset that has gotten them into trouble, and, ideally, provoke them to use mature common sense and moral judgment.     

Responsible Conduct of Research Training and Trust Between Research Postgraduate Students and Supervisors

The federal regulations of human research were written to permit the use of discretion so that research can fit the circumstances under which it is conducted. For example, the researcher and institutional review board (IRB) could waive or alter some informed consent elements if they deem this the morally and scientifically best way to conduct the research. To do so, however, researchers and IRBs would first have to use mature moral and scientific judgment. They might also have to rely on empirical research to discover the most effective way to act on their moral sense (e.g., to discover how best to approach potential research participants and explain the nature and purpose of the research participation for which they are being recruited, to ensure comprehension and competent decision making). On discovering the most ethical way to proceed, they would then need to look to the federal regulations of human research to discover how to document their decision and justify it within that somewhat flexible regulatory structure. Unfortunately, many IRBs and researchers fail to take these sensible steps to solve ethical problems and proceed immediately to a default requirement of the regulations that places science at odds with the regulations and, ostensibly, with ethics. The following articles in this special issue are about the process of learning to engage in ethical problem solving and using the flexibility permitted by the federal regulations. These articles extricate researchers from the mindset that has gotten them into trouble, and, ideally, provoke them to use mature common sense and moral judgment.     

The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative

The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards (IRBs), to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation (REC) services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research.     

Dealing with the long-term social implications of research

Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards (IRBs) responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from considering them in their decisions. Yet IRBs often do consider the social implications of research protocols and sometimes create significant delays in initiating or even prevent such research. The social implications of research are important topics for public scrutiny and professional discussion. This article examines the reasons that the federal regulations preclude IRBs from assessing the social risks of research, and examines alternative approaches that have been used with varying success by national advisory groups to provide such guidance. The article concludes with recommendations for characteristics of a national advisory group that could successfully fulfill this need, including sustainability, independence, diverse and relevant expertise, and public transparency.     

Conflict and Convergence: The Ethics Review of Action Research

The article is based on the author’s experience as an administrator of three primarily social science institutional review boards (IRBs) to which researchers presented research protocols that purported to be minimal risk studies of teacher practice where the “teacher–researcher” was the “research subject.” Recently, educational, social, and behavioral science researchers encounter many problems with regard to their methodologies and the oversight mandate of the IRBs. There is a divergence between the IRB’s role and assumed bio-clinical predisposition and the ability of behavioral and social science researchers to have their research methodologies and research understood and appreciated by IRB members. The article explores some of the dilemmas confronting IRB members and administrators in the review and administration of the action research protocols, particularly those that involve vulnerable populations and which, from the practitioner–researcher’s perspective, focus on the practitioner–researcher as the object of the research.     

Introduction to Special Section: Student Paper Competition

It is not unusual for researchers to complain about institutional review board (IRB) oversight, but social scientists have a unique set of objections to the work of ethics committees. In an effort to better understand the problems associated with ethics review of social, behavioral, and economic sciences (SBES) research, this article examines 3 different aspects of research ethics committees: (a) the composition of review boards; (b) the guidelines used by these boards to review SBES—and in particular, behavioral health—research; and (c) the actual deliberations of IRBs. The article concludes with recommendations for changes in the review process and with suggestions for filling the gaps in knowledge about the way IRBs work.     

Human participants challenges in youth tobacco cessation research: researchers' perspectives

Recruiting adolescents into smoking cessation studies is challenging, particularly given institutional review board (IRB) requirements for research conducted with adolescents. This article provides a brief review of the federal regulations that apply to research conducted with adolescents, and describes researchers' experiences of seeking IRB approval for youth cessation research. Twenty-one researchers provided information. The most frequently reported difficulty involved obtaining parental consent. Solutions to commonly reported problems with obtaining IRB approval are also identified. Waivers of parental consent can facilitate recruitment of youths into studies; however, researchers must ensure that their protocols comply with federal regulations when requesting a waiver.     

SAMHSA Philosophy and statement of Ethical Principles

The efforts of some institutional review boards (IRBs) to exercise what is viewed as appropriate oversight may contribute to deceit on the part of investigators who feel unjustly treated. An organizational justice paradigm provides a useful context for exploring why certain IRB behaviors may lead investigators to believe that they have not received fair treatment. These feelings may, in turn, lead to intentional deception by investigators that IRBs will rarely detect. Paradoxically, excessive protective zeal by IRBs may actually encourage misconduct by some investigators. The authors contend that, by fostering a climate in which investigators perceive that they receive fair and unbiased treatment, IRBs optimize the likelihood of collegial compliance with appropriate participant protections.     

The IRB paradox: could the protectors also encourage deceit?

The efforts of some institutional review boards (IRBs) to exercise what is viewed as appropriate oversight may contribute to deceit on the part of investigators who feel unjustly treated. An organizational justice paradigm provides a useful context for exploring why certain IRB behaviors may lead investigators to believe that they have not received fair treatment. These feelings may, in turn, lead to intentional deception by investigators that IRBs will rarely detect. Paradoxically, excessive protective zeal by IRBs may actually encourage misconduct by some investigators. The authors contend that, by fostering a climate in which investigators perceive that they receive fair and unbiased treatment, IRBs optimize the likelihood of collegial compliance with appropriate participant protections.     

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. This revised version was published online in August 2006 with corrections to the Cover Date.     

Ethics review of social, behavioral, and economic research: where should we go from here?

It is not unusual for researchers to complain about institutional review board (IRB) oversight, but social scientists have a unique set of objections to the work of ethics committees. In an effort to better understand the problems associated with ethics review of social, behavioral, and economic sciences (SBES) research, this article examinees 3 different aspects of research ethics committees: (a) the composition of review boards; (b) the guidelines used by these boards to review SBES--and in particular, behavioral health--research; and (c) the actual deliberations of IRBs. The article concludes with recommendations for changes in the review process and with suggestions for filling the gaps in knowledge about the way IRBs work.     

Determining risk in pediatric research with no prospect of direct benefit: time for a national consensus on the interpretation of federal regulations

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" ( section sign 45CFR46.404); or 2) no more than a "minor increase over minimal risk" if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition ( section sign 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have helped IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations section sign section sign 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria.     

Institutional Review Boards and Professional Counseling Research

Institutional review boards (IRBs) are responsible for regulating and safeguarding research with human participants in academic institutions in the United States. The authors explore (a) the historical impetus for IRBs, (b) the ethical values and principles as core components of the review process, and (c) the American Counseling Association's (2005) standards for ethical research. In many ways, IRB review and counseling research are complementary, yet some challenges and obstacles unique to counseling research also exist and are elaborated in the article. Implications for counselors initiating research projects and suggestions for implementation are provided.     

Conducting Industrial and Organizational Psychological Research: Institutional Review of Research in Work Organizations

Although informed consent is a primary mechanism for ensuring the ethical treatment of human participants in research, both federal guidelines and American Psychological Association ethical standards recognize that exceptions to it are reasonable under certain conditions. However, agreement about what constitutes a reasonable exception to informed consent is sometimes lacking. We presented the same protocols to samples of respondents drawn from 4 populations: Institutional review board (IRB) members, managers, employees, and university faculty who were not members of IRBs. Differences in perceptions of IRB members from the other samples with respect to the risks of the protocols without informed consent and on the feasibility of conducting the research in employment organizations are discussed in terms of implications for industrial and organizational psychology research.     

Conducting industrial and organizational psychological research: institutional review of research in work organizations

Although informed consent is a primary mechanism for ensuring the ethical treatment of human participants in research, both federal guidelines and American Psychological Association ethical standards recognize that exceptions to it are reasonable under certain conditions. However, agreement about what constitutes a reasonable exception to informed consent is sometimes lacking. We presented the same protocols to samples of respondents drawn from 4 populations: Institutional review board (IRB) members, managers, employees, and university faculty who were not members of IRBs. Differences in perceptions of IRB members from the other samples with respect to the risks of the protocols without informed consent and on the feasibility of conducting the research in employment organizations are discussed in terms of implications for industrial and organizational psychology research.     

A plea for pragmatism in clinical research ethics

Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research.     

Impact of Institutional Review Boards on cancer research

The concepts of informed consent and surveillance of human research designed to protect human subjects is commendable. The regulations of the Institutional Review Board (IRB) 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.     

Institutional Review Boards: From Bane to Benefit

ABSTRACT— Institutional review boards (IRBs) are primarily prevention-focused, avoiding damage to human subjects and averting ethical infractions, thereby protecting participants, researchers, and universities. Yet, the cost of prevention focus is simply avoiding negative outcomes and is enacted through control, risk-aversion, security, detail-orientation, reactivity, anxiety, avoidance, punishment, negative possibilities, and seizing on a single dominant solution. These endanger the research enterprise. An alternative promotion focus is more advantageous as it seeks positive outcomes and thus facilitating research, which is the IRB's second duty. This alternative guides recruiting and training of staff, panel, and researchers; orienting to and reinforcing promotion norms; creating well-known, transparent, responsive, and efficient processes; and understanding the IRB's boundaries. Promotion balances prevention to make IRBs support research and protect subjects.     

The Duty to Rescue and the Limits of Confidentiality

Surveys and routine clinical procedures applied in research protocols are typically considered only minimally risky to participants. The apparent benign nature of "minimal risk" tasks increases the chance that investigators and Institutional Review Boards (IRBs) will overlook the probability that clinical tools will identify signs, symptoms, or definitive test results that are clinically-relevant to subjects' welfare. "Minimal risk" procedures may also pose a particular hazard to participants in clinical research by increasing the therapeutic misconception because the tasks mimic clinical care and are often conducted in clinical settings. Investigators should anticipate which measures could yield clinically-important findings and should describe explicit plans for data monitoring, disclosure, and follow-up. Protocols that include reliable and valid clinical measures should prompt a more detailed risk assessment by the IRB, even when the tasks meet the regulatory criteria for minimal physical, psychological, or emotional risk.