ABSTRACT
This article proposes a means by which benefits provided in international research collaborations might be employed to strengthen health care, research, and other capacities in less-developed countries. The Declaration of Helsinki and CIOMS Guidelines define certain expectations of benefits, but these requirements are ambiguous, logistically problematic, and studies suggest they are inconsistently upheld. Drawing on the principle of respect for persons, a right to benefit from hosting externally-sponsored research is proposed. This right guarantees host communities benefits of a certain value, the nature and use of which is controlled by indigenous personnel. Suggestions are made as to how implementation of this right, using structured incentives, may systematically promote capacity building in host communities.
Subject(s)
Beneficence , Developing Countries , Ethics, Research , International Cooperation , Research/organization & administration , Guidelines as Topic , HumansSubject(s)
Decision Making/ethics , Genetic Counseling , Morals , Uncertainty , Humans , United StatesSubject(s)
Decision Making , Genetic Counseling , Genetic Testing , Pastoral Care , Religion and Medicine , Spirituality , Choice Behavior , HumansSubject(s)
Consciousness Disorders/diagnosis , Diagnostic Errors , Intuition , Persistent Vegetative State/diagnosis , Consciousness Disorders/history , Diagnosis, Differential , Diagnostic Errors/history , Diagnostic Errors/prevention & control , Federal Government , Florida , History, 20th Century , History, 21st Century , Humans , Legislation, Medical , Persistent Vegetative State/etiology , Persistent Vegetative State/history , State Government , United StatesABSTRACT
Numerous position papers have outlined informed consent recommendations for the collection, storage, and future use of biological samples; however, there currently is no consensus regarding what kinds of information should be included in consent forms. This study aimed to determine whether institutional review boards (IRBs) vary in their informed consent requirements for research on stored biological samples, and whether any variation observed could be correlated to factors such as volume of work, IRB members' familiarity with ethical issues in genetic research, and IRBs' use of either of two policy guidelines as resources. A brief survey was mailed to all IRB chairpersons on a mailing list obtained from the Office for Human Research Protections. Survey questions included whether consent forms for the collection of biological samples for future use address each of six provisions recommended in current guidelines and position statements, and whether IRBs used the Office for Protection from Research Risks' 1993 Protecting Human Research Subjects: Institutional Review Board Guidebook, chapter 5 (hereinafter IRB Guidebook) or the National Bioethics Advisory Commission's 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I (hereinafter Report) in their deliberations. Despite a low response rate (22%, 427 respondents), results indicate that IRB practices vary substantially. The degree to which the provisions were included in consent forms was found to correlate positively with IRBs that review a greater volume of protocols annually, those that use the National Bioethics Advisory Commission Report in their deliberations, and those that draw on both the Report and the IRB Guidebook.
