The Common Rule: Updating Human Subject Research Protections for a New Era of Research

2012 ◽  
Author(s):  
Kyle Thomson
2009 ◽  
Vol 37 (1) ◽  
pp. 12-18 ◽  
Author(s):  
Carl H. Coleman

The concept of vulnerability has long played a central role in discussions of research ethics. In addition to its rhetorical use, vulnerability has become a term of art in U.S. and international research regulations and guidelines, many of which contain specific provisions applicable to research with vulnerable subjects. Yet, despite the frequency with which the term vulnerability is used, little consensus exists on what it actually means in the context of human subject protection or, more importantly, on how a finding of vulnerability should affect the process of research ethics review.The Common Rule, the centerpiece of the U.S. human subject protection regulations, uses the word vulnerable three times. First, it provides that institutional review boards (IRBs) that regularly review research involving a vulnerable category of subjects should consider including one or more individuals who are knowledgeable about and experienced in working with these subjects.


2013 ◽  
Vol 41 (2) ◽  
pp. 440-453 ◽  
Author(s):  
Brett A. Williams ◽  
Leslie E. Wolf

The U.S. Department of Health and Human Services (HHS) has proposed substantial changes to the current regulatory system governing human subjects research in its Advanced Notice of Proposed Rulemaking (ANPRM), entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” Some of the most significant proposed changes concern the use of biospecimens in research. Because research involving biological materials begins with an initial interaction with an individual, such research falls squarely within the human subjects research regulatory framework known as the “Common Rule,” which applies to research conducted or funded by the HHS and the other signatory agencies and departments. However, as described in detail below, much biospecimen research may fall within exemptions and exceptions under the Common Rule and, thus, may be conducted without consent. The ANPRM proposes requiring written consent for research use of biospecimens, even if the biospecimens were initially collected for a purpose other than research or have been stripped of identifiers.


2017 ◽  
Vol 45 (3) ◽  
pp. 365-374 ◽  
Author(s):  
John D. Lantos

There is a debate at the highest levels of government about how to classify the risks of research studies that evaluate therapies that are in widespread use. Should the risks of those therapies be considered as risks of research that is designed to evaluate those therapies? Or not? The Common Rule states, “In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).” (CFR 46.111 (a)(2)). By contrast, the Office of Human Research Protections, in a proposed “guidance” states, “The reasonably foreseeable risks of research include already-identified risks of the standards of care being evaluated as a purpose of the research.” (emphasis added).In this paper, I argue that the Common Rule got it right and OHRP got it wrong. When treatments are in widespread use, the risks of those treatments are ever-present for all patients. By enrolling in formal studies that use rigorous methods to compare one treatment with another and that carefully monitor outcomes and adverse events, patients are protected from the risks of idiosyncratic practice variation. Their risks are decreased, rather than increased.If OHRP's approach becomes the law of the land, patients will be misinformed about the relative risks of treatment and research in ways that undermine autonomy rather than promoting it and that make truly informed consent impossible.


2016 ◽  
Vol 6 (4) ◽  
pp. 20
Author(s):  
Anissa Ybarra ◽  
Lori Kupczynski ◽  
Marie-Anne Mundy ◽  
Stephen D. Oller

Institutions of higher education are continually engaging in human subject research at the faculty and student level. It is extremely important that all research involving human subjects is in compliance with the UnitedInstitutions of higher education are continually engaging in human subject research at the faculty and student level. It is extremely important that all research involving human subjects is in compliance with the United States (U.S.) Federal Policy for the Protection of Human Research Subjects. If faculty and students are not following the guidelines for the ethical conduct of human subject research, their institution will be at risk of losing any federal funding acquired through these studies and risk the possibility of having all research shut down. The lack of faculty knowledge in the area of human subjects research protections has been considered non-compliance for human subjects research. The purpose of this study was to determine if a significant relationship exists between the areas of faculty research experience in higher education and knowledge of the Total Governing Principles of U.S. Codes and Regulations. The study sought to find if faculty experience in research could predict their knowledge of human subjects research protections. In order to test each hypothesis, two statistical tests were conducted. A Multiple Linear Regression (MLR) was utilized as well as a One-Way Multivariate Analysis of Variance (MANOVA). Findings indicated that there is no statistical significance between the amount of faculty experience in research and their knowledge of the U.S. Codes and Regulations for human subjects research protections. States (U.S.) Federal Policy for the Protection of Human Research Subjects. If faculty and students are not following the guidelines for the ethical conduct of human subject research, their institution will be at risk of losing any federal funding acquired through these studies and risk the possibility of having all research shut down. The lack of faculty knowledge in the area of human subjects research protections has been considered non-compliance for human subjects research. The purpose of this study was to determine if a significant relationship exists between the areas of faculty research experience in higher education and knowledge of the Total Governing Principles of human subjects research protections U.S. Codes and Regulations. The study sought to find if faculty’s experience in research could predict their knowledge of human subjects research protections. In order to test each hypothesis, two statistical tests were conducted. A Multiple Linear Regression (MLR) was utilized as well as a One-Way Multivariate Analysis of Variance (MANOVA). Findings indicated that there is no statistical significance between the amount of faculty experience in research and their knowledge of the U.S. Codes and Regulations for human subjects research protections. 


2001 ◽  
Vol 32 (5) ◽  
pp. 473-474 ◽  
Author(s):  
Paula L Knudson ◽  
Executive Coordinator

2018 ◽  
Vol 32 (2) ◽  
pp. 101-120 ◽  
Author(s):  
Zoltán Boldizsár Simon

Today’s technological-scientific prospect of posthumanity simultaneously evokes and defies historical understanding. On the one hand, it implies a historical claim of an epochal transformation concerning posthumanity as a new era. On the other, by postulating the birth of a novel, better-than-human subject for this new era, it eliminates the human subject of modern Western historical understanding. In this article, I attempt to understand posthumanity as measured against the story of humanity as the story of history itself. I examine the fate of humanity as the central subject of history in three consecutive steps: first, by exploring how classical philosophies of history achieved the integrity of the greatest historical narrative of history itself through the very invention of humanity as its subject; second, by recounting how this central subject came under heavy criticism by postcolonial and gender studies in the last half-century, targeting the universalism of the story of humanity as the greatest historical narrative of history; and third, by conceptualizing the challenge of posthumanity against both the story of humanity and its criticism. Whereas criticism fragmented history but retained the possibility of smaller-scale narratives, posthumanity does not doubt the feasibility of the story of humanity. Instead, it necessarily invokes humanity, if only in order to be able to claim its supersession by a better-than-human subject. In that, it represents a fundamental challenge to the modern Western historical condition and the very possibility of historical narratives – small-scale or large-scale, fragmented or universal.


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