Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators

2011 ◽  
Vol 30 (6) ◽  
pp. 707-727 ◽  
Keyword(s):  
Human Subjects ◽  
Research Subjects ◽  
Human Subjects Research ◽  
Research Protections

scholarly journals Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?

2013 ◽  
Vol 41 (2) ◽  
pp. 440-453 ◽  
Author(s):  
Brett A. Williams ◽  
Leslie E. Wolf
Keyword(s):  
Human Services ◽  
Human Subjects ◽  
Regulatory System ◽  
Research Subjects ◽  
Human Subjects Research ◽  
Common Rule ◽  
Department Of Health ◽  
Initial Interaction ◽  
Research Protections ◽  
The Common

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.

Human Subjects Research Protections

2015 ◽  
pp. 1-20
Author(s):  
John R. Baumann ◽  
Heather Mullins-Owens ◽  
David Russell ◽  
Amy Waltz
Keyword(s):  
Human Subjects ◽  
Human Subjects Research ◽  
Research Protections

Symposium on Human Subjects Research: Redux

2002 ◽  
Vol 30 (3) ◽  
pp. 358-360
Author(s):  
Jesse A. Goldner
Keyword(s):  
Quality Improvement ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Human Subjects Research ◽  
Institutional Review ◽  
New Directions ◽  
Short Run ◽  
Research Protections ◽  
Review Boards

Two years ago, the Journal of Law, Medicine & Ethics published volume 28, number 4, devoted to a symposium entitled Human Subjects Research and the Role of Institutional Review Boards - Conflicts and Challenges. I had the good fortune to be asked to serve as editor of that issue. In her introduction to the symposium, the then editor-in-chief of the journal, Ellen Wright Clayton, observed that the country is currently undergoing a major reexamination of how biomedical research is conducted. While that reexamination has continued in the interim, some very recent events raise questions about the extent to which this will continue, at least in the short run, with equal vigor. The intervening years have witnessed a variety of new directions and events. The federal Office of Human Research Protections (OHRP), directed by Dr. Greg Koski, who wrote a brief commentary for the last symposium,L has taken a new direction, strongly stressing the need for institutions and their institutional review boards ORBS) to engage in extensive educational and quality improvement efforts with both researchers and their own member.

scholarly journals SoTL and the Institutional Review Board: Considerations before navigating the application process for classroom research in higher education

2014 ◽  
pp. 1-14 ◽  
Author(s):  
Kathryn E. Linder ◽  
E. Deborah Elek ◽  
Lucia Calderon
Keyword(s):  
Teaching And Learning ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Human Subjects Research ◽  
Application Process ◽  
Institutional Review ◽  
History Of ◽  
Research Protections ◽  
Faculty Developer ◽  
Research Compliance

One of the more challenging areas of Scholarship of Teaching and Learning (SoTL) research can be navigating the components of human subjects research protections implemented by the Institutional Review Board (IRB). The authors of this article, a faculty developer and a current and former research compliance coordinator, discuss the history of IRB in relation to SoTL research and explicate some of the foundational components of IRB protocols for SoTL projects. In particular, the authors explore what constitutes “research” for SoTL projects, explain the different IRB types of review, and offer some sample SoTL projects with respect to their IRB implications.

scholarly journals Analysis of Faculty Knowledge of Human Subjects Protections in Research

2016 ◽  
Vol 6 (4) ◽  
pp. 20
Author(s):  
Anissa Ybarra ◽  
Lori Kupczynski ◽  
Marie-Anne Mundy ◽  
Stephen D. Oller
Keyword(s):  
Higher Education ◽  
Human Subject ◽  
Human Subjects ◽  
Statistical Tests ◽  
Statistical Significance ◽  
Human Subject Research ◽  
Human Subjects Research ◽  
Faculty Knowledge ◽  
Research Protections ◽  
Faculty Experience

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. 

scholarly journals Avoiding Exploitation in Phase I Clinical Trials: More than (Un)Just Compensation

2018 ◽  
Vol 46 (1) ◽  
pp. 52-63 ◽  
Author(s):  
Matt Lamkin ◽  
Carl Elliott
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Human Subjects ◽  
Research Participation ◽  
Research Subjects ◽  
Phase I Clinical Trials ◽  
Human Subjects Research ◽  
Undue Influence ◽  
Just Compensation ◽  
Undue Inducement

Lowering compensation to research subjects to protect them from “undue inducement” is a misguided attempt to shoehorn a concern about exploitation into the framework of autonomy. We suggest that oversight bodies should be less concerned about undue influence than about exploitation of subjects. Avoiding exploitation in human subjects research requires not only increasing compensation, but enhancing the dignity of research participation.

The Ethical Analysis of Risk

2000 ◽  
Vol 28 (4) ◽  
pp. 344-361 ◽  
Author(s):  
Charles Weijer
Keyword(s):  
Informed Consent ◽  
Human Subjects ◽  
Research Subjects ◽  
Human Subjects Research ◽  
Selection Procedures ◽  
Subject Selection ◽  
Research Protocols ◽  
Institutional Review ◽  
The Social ◽  
Potential Benefits

The institutional review board (IRB) is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality (142 articles) and considerably fewer on the assessment of risks and potential harms (40), study design (20), and subject-selection procedures (5).

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