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.

Learning Health Systems and the Revised Common Rule

2019 ◽  
Vol 47 (2) ◽  
pp. 238-246 ◽  
Author(s):  
Joshua A. Rolnick
Keyword(s):  
Public Policy ◽  
Quality Improvement ◽  
Health Systems ◽  
Human Subjects ◽  
Minimal Risk ◽  
Human Subjects Research ◽  
Common Rule ◽  
Quality Improvement Process ◽  
Improvement Process ◽  
The Common

Quality improvement (QI) is an important function of learning health systems, and public policy should promote QI activities. Use of systematic methodologies in QI has prompted substantial confusion regarding when QI is human subjects research under the Common Rule, and this confusion persists with the revised Rule. Difficulty distinguishing research from QI imposes costs on the quality improvement process. I offer guidance to IRBs to mitigate these costs and suggest a new regulatory exclusion for minimal risk quality improvement activities.

Justice, Fairness, and Membership in a Class: Conceptual Confusions and Moral Puzzles in the Regulation of Human Subjects Research

2011 ◽  
Vol 39 (3) ◽  
pp. 488-501 ◽  
Author(s):  
Ana S. Iltis
Keyword(s):  
United States ◽  
Human Subjects ◽  
United States Public Health ◽  
The United States ◽  
National Commission ◽  
Human Research ◽  
Common Rule ◽  
Department Of Health ◽  
The Common ◽  
Protection Of Human Subjects

Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services (whose regulations appear at 45CFR46), to require that investigators follow the same rules for conducting human research. (The Food and Drug Administration [FDA] has its own rules (at 21CFR50 and 21CFR56), though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter the National Commission). The National Commission was appointed in 1974 as part of the National Research Act (P.L. 93-348) in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study.

Currents in Contemporary Ethics

2005 ◽  
Vol 33 (1) ◽  
pp. 154-159 ◽  
Author(s):  
Mark A. Rothstein
Keyword(s):  
Privacy Protection ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Common Rule ◽  
Privacy Rule ◽  
Institutional Review ◽  
The Common ◽  
Protection Of Human Subjects ◽  
Privacy Issues

For nearly twenty-five years, federal regulation of privacy issues in research involving human subjects was the primary province of the federal rule for Protection of Human Subjects (Common Rule). As of April 14, 2003, the compliance date for the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA), however, the Common Rule and the Privacy Rule jointly regulate research privacy. Although, in theory, the Privacy Rule is intended to complement the Common Rule, there are several areas in which the rules diverge. In some instances the inconsistencies result in gaps in privacy protection; in other instances the inconsistencies result in added burdens on researchers without additional privacy protections. In all instances, the lack of harmonization of these rules has created confusion, frustration, and misunderstanding by researchers, research subjects, and institutional review boards (IRBs). In this article, I review the major provisions of the Privacy Rule for research, explain the areas in which the Privacy Rule and Common Rule differ, and conclude that the two rules should be revised to promote consistency and maximize privacy protections while minimizing the burdens on research.

The Invisible Vulnerable: The Economically and Educationally Disadvantaged Subjects of Clinical Research

2003 ◽  
Vol 31 (1) ◽  
pp. 149-153 ◽  
Author(s):  
T. Howard Stone
Keyword(s):  
Human Subjects ◽  
Disabled Persons ◽  
Federal Regulations ◽  
Research Subjects ◽  
Undue Influence ◽  
Common Rule ◽  
Educationally Disadvantaged ◽  
Mentally Disabled ◽  
The Common ◽  
Protection Of Human Subjects

U.S. Department of Health and Human Services (HHS) federal regulations pertaining to the protection of human subjects at Title 45 of the Code of Federal Regulations, Part 46, Subpart A (“the Common Rule”), refer to the need for special precautions when persons characterized as vulnerable are used as human research subjects. Under the Common Rule, persons considered “vulnerablae” are those who are likely to be susceptible to coercive or undue influence; the term “vulnerable” includes “children, prisoners, pregnant women, mentally disabled persons,” or those who are “economically or educationally disadvantaged.” The need for special precautions with some of these vulnerable persons in the context of research has long been addressed by both mandatory additional protections found in Subparts B through D of 45 C.F.R. pt. 46 (that are not, coincidentally, part of the Common Rule) and additional detailed guidance documents provided by HHS or its components to investigators and their respective institutions.

scholarly journals Responsible Conduct in Nanomedicine Research: Environmental Concerns beyond the Common Rule

2012 ◽  
Vol 40 (4) ◽  
pp. 848-855 ◽  
Author(s):  
David B. Resnik
Keyword(s):  
Human Services ◽  
Federal Agencies ◽  
Environmental Concerns ◽  
Common Rule ◽  
Department Of Health ◽  
Responsible Conduct ◽  
Institutional Review ◽  
The Common ◽  
Human Participants ◽  
And Function

The Common Rule (45 CFR 46, subpart A) is a set of regulations for protecting human participants in research funded by the Department of Health and Human Services (DHHS), which has been adopted in part by 17 federal agencies. It includes four different subparts: Subpart A (general protections for human research participants), Subpart B (additional protections for pregnant women, fetuses, and neonates), Subpart C (additional protections for prisoners), and Subpart D (additional protections for children). The Common Rule has not been significantly revised since 1981 although some significant changes may be forthcoming. The Food and Drug Administration (FDA) has adopted its own regulations for the protection of human participants, which are similar to the Common Rule in many key areas, such as the structure and function of the Institutional Review Board (IRB), and the criteria for approving research.

Comment on the Proposed Institutional Review Board Retrospective Review of Research

2020 ◽  
Vol 15 (3) ◽  
pp. 229-231 ◽  
Author(s):  
Min-Fu Tsan
Keyword(s):  
Retrospective Review ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Human Subjects Research ◽  
Common Rule ◽  
Institutional Review ◽  
The Common

Investigators of nonexempt human subjects research conducted without prior institutional review board (IRB) approval often have difficulties in publishing data obtained from such research. Retrospective review and approval of such research has been suggested as a potential pathway for an IRB to help these investigators to publish those data. However, under the Common Rule, an IRB has no authority to retrospectively review and approve human subjects research. Prevention remains the best strategy to ensure that no nonexempt human subjects research is initiated prior to IRB approval.

The Role of State Law in Protecting Human Subjects of Public Health Research and Practice

2003 ◽  
Vol 31 (4) ◽  
pp. 654-662 ◽  
Author(s):  
Scott Burris ◽  
Lance Gable ◽  
Lesley Stone ◽  
Zita Lazzarini
Keyword(s):  
Public Health ◽  
Human Subjects ◽  
Public Health Practice ◽  
Public Health Research ◽  
Health Practice ◽  
Research Subjects ◽  
Common Rule ◽  
Public Health Agencies ◽  
Specimen Collection ◽  
The Common

“Public health practice” consists of activities and Programs managed by public health agencies to promote health and prevent disease, injury, and disability. Some of these activities might be deemed to fit within the broad definition of “research” under federal regulations, known as the Common Rule, designed to protect human research subjects. The Common Rule defines research as “a systeniatic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Public health activities that might under some circumstances be considered research include disease reporting, review of medical records, surveys, interviews, focus groups, specimen collection (blood, urine, etc.), and laboratory testing (both identifiable and anonymous).There are questions about the extent to which the Common Rule applies or was intended to apply to public health practice: and it has been suggested in any case that Common Rule regulation of public health practice may not be socially optimal for both practical and principled reasons.

scholarly journals Are Changes to the Common Rule Necessary to Address Evolving Areas of Research?

2013 ◽  
Vol 41 (2) ◽  
pp. 454-469 ◽  
Author(s):  
Diane E. Hoffmann ◽  
J. Dennis Fortenberry ◽  
Jacques Ravel
Keyword(s):  
Human Subjects ◽  
Computer Software ◽  
The United States ◽  
Common Rule ◽  
Department Of Health ◽  
Medical Centers ◽  
Technological Advances ◽  
Academic Medical ◽  
The Common ◽  
New Research

The proposed changes to the Common Rule, described in the recent Advanced Notice of Proposed Rulemaking (ANPRM), come more than 20 years after the U.S. Department of Health and Human Services adopted the Rule in 1991. Since that time, human subjects research has changed in significant ways. Not only has the volume of clinical research grown dramatically, this research is now regularly conducted at multiple collaborative sites that are often outside of the United States. Research takes place not only in academic medical centers, but also at outpatient clinics, community hospitals, and other nontraditional venues. In addition, technological advances, such as sophisticated computer software programs, the Internet, social media, new research methods, and mobile applications have exponentially increased the volume of data available and the possibilities for accessing, analyzing, and sharing that data.

Applying the Common Rule to Public Health Agencies: Questions and Tentative Answers about a Separate Regulatory Regime

2003 ◽  
Vol 31 (4) ◽  
pp. 638-653 ◽  
Author(s):  
Scott Burris ◽  
James Buehler ◽  
Zita Lazzarini
Keyword(s):  
Public Health ◽  
Human Subjects ◽  
Regulatory System ◽  
Regulatory Regime ◽  
Common Rule ◽  
Public Health Agencies ◽  
The Past ◽  
Health Agencies ◽  
Control And Prevention ◽  
The Common

No one questions the importance of protecting human subjects of research, but over the past few years dissatisfaction has surfaced with the manner in which the protection is conferred by the federal regulatory system referred to as “The Common Rule. ” Some of the criticism surfaces in print. Some bubbles out anecdotally in conversations among researchers, with complaints about the review process being virtually inevitable whenever the topic arises. Like those in other disciplines that differ more or less dramatically from the world of clinical medical research around which the Common Rule was conceptualized, public health researchers, particularly those working in official public health agencies, have experienced some tension and difficulty in adapting to the rules. The Centers For Disease Control and Prevention (CDC) has adopted guidelines that require Common Rule review for “research” but not “practice” activities.

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