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Background The review of human participant research by Research Ethics Committees or Institutional Review Boards is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Shared Ethical Debate” where multiple committees review the same project. Committee reviews (...) |
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The review of human participant research by Research Ethics Committees or Institutional Review Boards is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Shared Ethical Debate” where multiple committees review the same project. Committee reviews are (...) |
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In biobanks, a broader model of consent is often used and justified by a range of different strategies that make reference to the potential benefits brought by the research it will facilitate combined with the low level of risk involved (provided adequate measures are in place to protect privacy and confidentiality) or a questioning of the centrality of the notion of informed consent. Against this, it has been suggested that the lack of specific information about particular uses of the samples (...) |
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Proper procedures for informed consent are widely recognized as an ethical requirement for biomedical research involving human beings, in particular as a means to respect the autonomy and personal integrity of potential and actual research participants. |
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As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented. |
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Research Ethics Committees (RECs) are frequently a focus of complaints from researchers, but evidence about the operation and decisions of RECs tends to be anecdotal. We conducted a systematic study to identify and compare the ethical issues raised in 54 letters to researchers about the same 18 applications submitted to three RECs over one year. The most common type of ethical trouble identified in REC letters related to informed consent, followed by scientific design and conduct, care and protection of research (...) |
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