The contributions in part 1 of the book highlight both promoting research and protecting subjects Rosamond Rhodes recommends a new category of de minimusresearch risk that would need little oversight, while Ana Iltis argues for retaining continuing reviews even for low-risk research as an important protection for participants. The ANPRM’s stated goals-seeking to better protect research participants while facilitating valuable research and reducing burden, delay, and ambiguity for researchers-might even be seen as contradictory. Previous attempts at regulatory reform may have been stymied by disagreement between those who see the current system as providing inadequate protection and those who fear that it stifles research. Historically, a strong focus on protecting research participants because research was thought to be risky has been tempered by perceptions of research as beneficial to society and sometimes to participants. The product is the timely and wide-ranging volume Human Subjects Research Regulation: Perspectives on the Future, edited by Cohen and Lynch.Ĭohen and Lynch divide the book into five parts: 1) “Regulation of Risk,” 2) “Protection of Vulnerable Populations,” 3) “Redefining the Researcher-Participant Relationship and the Role of IRBs,” 4) “Specimens, Data, and Privacy,” and 5) “Paradigm Shifts in Research Ethics.” One important thread throughout the book is the perceived struggle between promoting ethical research on the one hand and protecting research participants on the other, and the tension between inadequate protection and burdensome overregulation. Seeing the proposed regulatory changes as an opportunity to reexamine how research participants oughtto be protected, Glenn Cohen, then the codirector, and Holly Lynch, the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, brought a diverse group of scholars in research ethics together at a 2010 conference to engender creative and innovative ideas. Department of Health and Human Services published an Advanced Notice of Proposed Rulemaking (ANPRM) that presaged the most comprehensive change to the regulations for protecting human subjects since their inception. In 2011, the Office for Human Research Protections (OHRP) of the U.S. The same regulations and procedures apply to research whether it involves previously collected blood samples, surveys of behavior, or first-in-human evaluation of drugs or biologics. In the ensuing years, research has significantly grown and diversified, and although the system of oversight and protection in the United States has also grown, many believe the oversight system has not kept pace with changes in research. These regulations were put into place several decades ago and have since undergone only modest changes. government follows a system of federal rules and regulations that were designed to protect human participants and ensure that clinical research is conducted in an ethical manner. Research of this type that is supported by the U.S.
Unregulated (Facebook) and regulated (Cornell University) activities were combined in the PNAS publication ( 1), the former by experimenting with large numbers of unwitting participants, the latter by approving the use of preexisting experimental data as exempt from the university’s ethical review.Clinical research with human subjects is key to progress in understanding and improving human health. One might well wonder why academic research is more subject to ethical review than that of business enterprises.
#Protecting human research participants code#
In contrast, academic research is almost always governed by the provisions of the “Common Rule,” the US Department of Health and Human Services’ Code of Federal Regulations Title 45 Part 46 (45CFR46), “common” because it has been adopted by numerous federal agencies and applied to many research institutions. In commerce and on the Internet, experimentation is ubiquitous and invisible, and there are no protections for human participants beyond typically unread use agreements. Those events were recognized in an Expression of Concern in PNAS ( 2). Facebook’s experimental manipulation of newsfeed content and the subsequent PNAS publication of significant findings from it ( 1) have drawn attention to the regulation of human participation in academic research and to the differences between commercial and academic research.
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