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.     

The Importance of Ethical Appraisal in Social Science Research: Reviewing a Faculty of Humanities’ Research Ethics Committee

Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) are rapidly becoming indispensable mechanisms in the overall workings of university institutions. In fact, the ethical dimension is an important aspect of research governance processes present in institutions of higher learning. However, it is often deemed that research in the social sciences do not require ethical appraisal or clearance, because of the alleged absence of harm in conducting such research. This is an erroneous and dangerous assumption given that research in social sciences poses various and complex dilemmas related to ethics. The article aims to gauge the importance of ethical appraisal at a particular institution of higher learning’s Faculty of Humanities. This is done by scrutinising its defunct REC, and the views that Heads of Departments of the Faculty have of ethics in research and the need for ethical appraisal by this REC. Finally, some suggestions are made to proceed to review and restructure the current REC with the ultimate objective to make it functional again. It was found that the development and discussion around ethics in research and ethical appraisal are part of a much needed thrust to sensitise the entire Faculty and the institution on the widespread beneficial repercussions of ethical awareness in research and beyond.     

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.     

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.     

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.     

Students' Ethical Awareness and Conceptions of Research Ethics

The study focused on university students' understanding and conceptions of ethical issues in research. Domain-specific and domain-transcending measures were developed to gauge the students' awareness of ethical issues. Responses were obtained from 269 undergraduate and graduate students at a U.S. regional university. Participant withdrawal, the debriefing of research participants, the dissemination of findings, and giving credit to co-contributors were the most challenging ethical issues for the students. Ethical awareness was predicted by professional and organizational socialization, and perspective taking. Contextualization greatly improved the students' ability to recognize ethical issues. Simulations and role-taking are suggested as the means with which to teach students about the ethical issues perceived as challenging.     

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.     

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.     

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.     

IRB and Research Regulatory Delays Within the Military Health System: Do They Really Matter? And If So,Why and for Whom?

Institutional review board (IRB) delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improve the IRB system and, ultimately, research within military, veteran, and civilian populations.     

Shaping Medical Students' Attitudes Toward Ethically Important Aspects of Clinical Research: Results of a Randomized,Controlled Educational Intervention

The effects of research ethics training on medical students' attitudes about clinical research are examined. A preliminary randomized controlled trial evaluated 2 didactic approaches to ethics training compared to a no-intervention control. The participant-oriented intervention emphasized subjective experiences of research participants (empathy focused). The criteria-oriented intervention emphasized specific ethical criteria for analyzing protocols (analytic focused). Compared to controls, those in the participant-oriented intervention group exhibited greater attunement to research participants' attitudes related to altruism, trust, quality of relationships with researchers, desire for information, hopes about participation and possible therapeutic misconception, importance of consent forms, and deciding quickly about participation. The participant-oriented group also agreed more strongly that seriously ill people are capable of making their own research participation decisions. The criteria-oriented intervention did not affect learners' attitudes about clinical research, ethical duties of investigators, or research participants' decision making. An empathy-focused approach affected medical students' attunement to research volunteer perspectives, preferences, and attributes, but an analytically oriented approach had no influence. These findings underscore the need to further examine the differential effects of empathy-versus analytic-focused approaches to the teaching of ethics.     

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.     

A Troubled Dance: Doing the Work of Research Ethics Review

The fast growing interest in the work of university ethics review boards is evident in the proliferation of research and literature in the area. This article focuses on a Research Ethics Board (REB) in the Canadian context. In-depth, open-ended interviews with REB members and findings from a qualitative study designed to examine the ethics review of school-based research are used to illustrate points raised in the paper. The author’s experiences as academic researcher, advisor to student researchers and a 3-year term as an REB member inform the discussion. Macro issues related to the general workings of the board (e.g., maintaining appropriate membership) and micro issues connected to individual REB members’ experiences of reviewing research applications are examined. The author’s goal is to contribute to a fastgrowing conversation related to the issues that influence university ethics review while drawing attention to the contribution that faculty members’ understandings of their work as REB members can make to that conversation.     

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.     

Ethical and Regulatory Considerations for Using Social Media Platforms to Locate and Track Research Participants

As social media becomes increasingly popular, human subjects researchers are able to use these platforms to locate, track, and communicate with study participants, thereby increasing participant retention and the generalizability and validity of research. The use of social media; however, raises novel ethical and regulatory issues that have received limited attention in the literature and federal regulations. We review research ethics and regulations and outline the implications for maintaining participant privacy, respecting participant autonomy, and promoting researcher transparency when using social media to locate and track participants. We offer a rubric that can be used in future studies to determine ethical and regulation-consistent use of social media platforms and illustrate the rubric using our study team’s experience with Facebook. We also offer recommendations for both researchers and institutional review boards that emphasize the importance of well-described procedures for social media use as part of informed consent.     

RELIGIOUS ETHICS AND EMPIRICAL ETHICS

In recent decades, cognitive and behavioral scientists have learned a great deal about how people think and behave. On the most general level, there is a basic consensus that many judgments, including ethical judgments, are made by intuitive, even unconscious, impulses. This basic insight has opened the door to a wide variety of more particular studies that investigate how judgments are influenced by group identity, self‐conception, emotions, perceptions of risk, and many other factors. When these forms of research engage ethical issues, they are sometimes called empirical ethics. This essay argues that the field of religious ethics would benefit from a more robust engagement with empirical ethics than it has thus far undertaken. In doing so, it offers a brief account of how issues of moral psychology and moral anthropology have been treated in religious ethics, and it highlights ways that the scientific findings challenge some prevailing norms in religious ethics. It ends by suggesting avenues by which religious ethics research could productively engage empirical ethics.     

National Human Research Ethics: A Preliminary Comparative Case Study of Germany,Great Britain,Romania, and Sweden

Although international research is increasing in volume and importance, there remains a dearth of knowledge on similarities and differences in “national human research ethics” (NHREs), that is, national ethical guidelines (NEGs), Institutional Review Boards (IRBs), and research stakeholder’ ethical attitudes and behaviors (EABs). We begin to address this situation by reporting upon our experiences in conducting a multinational study into the mental health of children who had a parent/carer in prison. The study was conducted in 4 countries: Germany, Great Britain, Romania, and Sweden. Data on NHREs were gathered via a questionnaire survey, two ethics-related seminars, and ongoing contact between members of the research consortium. There was correspondence but even more so divergence between countries in the availability of NEGs and IRBs and in researcher’ EABs. Differences in NHREs have implications particularly in terms of harmonization but also for ethical philosophy and practice and for research integrity.     

Human participants challenges in youth-focused research: perspectives and practices of IRB administrators

The purpose of this research was to understand institutional review board (IRB) challenges regarding youth-focused research submissions and to present advice from administrators. Semistructured self-report questionnaires were sent via e-mail to administrators identified using published lists of universities and hospitals an Internet searches. Of 183 eligible institutions, 49 responded. One half indicated they never granted parental waivers. Among those considering waivers, decision factors included research risks, survey content, and feasibility. Smoking and substance abuse research among children was generally considered more than minimal risk. These findings are consistent with those from a study conducted by Mammel and Kaplan (1995), which investigated IRB practices concerning protocols involving adolescent participants. IRBs and investigators need to become aware of regulations' flexibility to ensure adequate participant protection. Investigators need to limit jargon and assumptions about participants' understanding of research objectives.     

心理学研究中的伦理

本文介绍了美国心理学会关于科学研究的伦理原则和相关的规定,以及结合心理学科研实践讨论怎样实施这些原则与规定。本文对我国心理学的伦理建设有一定参考价值。主要内容如下:1.人类参与的研究; a.知情同意及欺骗; b.自由退出; c.保护免受伤害和事后情况说明; d.清除有害后果; e.保密。2.动物研究的伦理:a.反对研究动物的论点; b.赞成研究动物的论点。c.研究动物的指南。3.科学欺诈。4.监督伦理实践。