An open letter to institutional review boards considering Northfield Laboratories' PolyHeme trial

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.     

Trauma and sex surveys meet minimal risk standards: implications for institutional review boards

Institutional review boards assume that questionnaires asking about "sensitive" topics (e.g., trauma and sex) pose more risk to respondents than seemingly innocuous measures (e.g., cognitive tests). We tested this assumption by asking 504 undergraduates to answer either surveys on trauma and sex or measures of cognitive ability, such as tests of vocabulary and abstract reasoning. Participants rated their positive and negative emotional reactions and the perceived benefits and mental costs of participating; they also compared their study-related distress with the distress arising from normal life stressors. Participants who completed trauma and sex surveys, relative to participants who completed cognitive measures, rated the study as resulting in higher positive affect and as having greater perceived benefits and fewer mental costs. Although participants who completed trauma and sex surveys reported slightly higher levels of negative emotion than did participants who completed cognitive measures, averages were very low for both groups, and outliers were rare. All participants rated each normal life stressor as more distressing than participating in the study. These results suggest that trauma and sex surveys pose minimal risk.     

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.     

Moral reasoning and the review of research involving human subjects

The model of moral reasoning used in Institutional Review Board review fails to uphold ethical ideals for research participants for it does not adequately acknowledge the particular context of research or of subjects, including their gender, their socioeconomic status, and the communities in which they lead their lives. The ethical review of research needs to take seriously the particularities of the research context as well as the situations of potential participants. A variety of conclusions are drawn for changes to the system for ethical review. Most significant is a call for effective consultation with the various communities affected by research and greater reliance on subject representatives. Also proposed is national review for selected research.     

The institutional review board is an impediment to human research: the result is more animal-based research

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.     

Individual and institutional conflict of interest: policy review by research universities in the United States

This paper is a discussion of efforts to manage real and potential conflicts of interest in university research in the United States. The focus is on the report by an Association of American Universities (AAU) task force that addresses both individual and institutional conflict of interest issues. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Issues in the study of indigenous psychologies: historical perspectives, cultural interdependence and institutional regulations

This paper aims to present a critical analysis of the development of indigenous psychologies within the western and non–western contexts. The rhetoric of indigenous psychologies is cross–examined to include historical perspectives, cultural interdependence and institutional regulations. The paper also examines the processes of psychologizing indigenous views that are largely regulated by the powerful social agencies. The paper endeavors to draw a link between historical perspectives and post–historical cultural interdependence in order to explicate the contentious issues of 'micro and macro indigenous psychologies', both within and beyond western indigenous psychologies. The importance of the cross–fertilization of knowledge from diverse indigenous psychologies for the development of a global indigenous psychology is reaffirmed.