Biobanking Research and Privacy Laws in the United States

2016 ◽  
Vol 44 (1) ◽  
pp. 106-127 ◽  
Author(s):  
Heather L. Harrell ◽  
Mark A. Rothstein
Keyword(s):  
Human Subjects ◽  
The United States ◽  
Common Rule ◽  
State Laws ◽  
Privacy Rule ◽  
Biobank Research ◽  
Privacy Laws ◽  
The Us ◽  
Protection Of Human Subjects ◽  
Hipaa Privacy Rule

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU–US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations.

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 End of the HIPAA Privacy Rule?

2016 ◽  
Vol 44 (2) ◽  
pp. 352-358 ◽  
Author(s):  
Mark A. Rothstein
Keyword(s):  
21St Century ◽  
Regulatory Action ◽  
Common Rule ◽  
Privacy Rule ◽  
Federal Research ◽  
Incomplete Coverage ◽  
Research Regulations ◽  
Hipaa Privacy Rule ◽  
21St Century Cures Act

The HIPAA Privacy Rule is notoriously weak because of its incomplete coverage, numerous exclusions and exemptions, and limited rights for individuals. The three areas in which it provides the most protection are fundraising, marketing, and research. Provisions of the 21st Century Cures Act, pending in Congress, and the Notice of Proposed Rulemaking to amend the federal research regulations (Common Rule), awaiting final regulatory action, would weaken the privacy protections for research. If these measures are adopted, the HIPAA Privacy Rule would have so little value that it might not be worth the aggravation and burden.

Research Ethics as Social Policy. Some Lessons from Experiences in Canada and in the United States

2003 ◽  
Vol 24 (2) ◽  
pp. 61-85
Author(s):  
Michael McDonald ◽  
Eric Meslin
Keyword(s):  
United States ◽  
Human Subjects ◽  
Ethics Committees ◽  
The United States ◽  
Prior Review ◽  
Emerging Trends ◽  
Policies And Procedures ◽  
Behavioural Research ◽  
Individual Informed Consent ◽  
Protection Of Human Subjects

For more than tlrree decades, Canada and the United States have used similar mechanisms for ensuring the protection of human subjects involved in biomedical and behavioural research: written guidelines that specify the substantive and procedural requirements of investigators and institutions; individual informed consent, and prior review and approval by interdisciplinary committees. Given the proximity of the countries to one another and the massive amount of trade and commerce that transpires between them, it is not surprising that these countries share a number of values in research. During the past fifteen years, however, both countries have experienced new challenges to their systems. Sorne of the challenges relate to new trends in research, such as genetics studies and massively increased private sector funding for pharmacological research. Other challenges relate to emerging trends in oversight policies and procedures, such as accreditation of ethics committees. Research reflects a country's particular social policies. The responses to emerging trends illustrate how such policies are evolving in sometimes quite different ways in both countries. This reflects the related but distinct political cultures and structures in the two countries. This paper will explore these trends and emerging responses, drawing lessons from each.

Analysis of the US Privacy Model

2021 ◽  
pp. 1818-1825
Author(s):  
Francisco García Martínez
Keyword(s):  
Data Privacy ◽  
Personal Information ◽  
National Level ◽  
The United States ◽  
The European Union ◽  
General Data Protection Regulation ◽  
Privacy Laws ◽  
The Us ◽  
General Data ◽  
State Of Art

The creation of the General Data Protection Regulation (GDPR) constituted an enormous advance in data privacy, empowering the online consumers, who were doomed to the complete loss of control of their personal information. Although it may first seem that it only affects companies within the European Union, the regulation clearly states that every company who has businesses in the EU must be compliant with the GDPR. Other non-EU countries, like the United States, have seen the benefits of the GDPR and are already developing their own privacy laws. In this article, the most important updates introduced by the GDPR concerning US corporations will be discussed, as well as how American companies can become compliant with the regulation. Besides, a comparison between the GDPR and the state of art of privacy in the US will be presented, highlighting similarities and disparities at the national level and in states of particular interest.

Analysis of the US Privacy Model

2019 ◽  
Vol 3 (1) ◽  
pp. 43-52
Author(s):  
Francisco García Martínez
Keyword(s):  
Data Privacy ◽  
Personal Information ◽  
National Level ◽  
The United States ◽  
The European Union ◽  
General Data Protection Regulation ◽  
Privacy Laws ◽  
The Us ◽  
General Data ◽  
The Eu

The creation of the General Data Protection Regulation (GDPR) constituted an enormous advance in data privacy, empowering the online consumers, who were doomed to the complete loss of control of their personal information. Although it may first seem that it only affects companies within the European Union, the regulation clearly states that every company who has businesses in the EU must be compliant with the GDPR. Other non-EU countries, like the United States, have seen the benefits of the GDPR and are already developing their own privacy laws. In this article, the most important updates introduced by the GDPR concerning US corporations will be discussed, as well as how American companies can become compliant with the regulation. Besides, a comparison between the GDPR and the state of art of privacy in the US will be presented, highlighting similarities and disparities at the national level and in states of particular interest.

Smoke-free and tobacco-free colleges and universities in the United States

2019 ◽  
pp. tobaccocontrol-2018-054829 ◽  
Author(s):  
Kelly D Blake ◽  
Amanda L Klein ◽  
Laura Walpert ◽  
Len Casey ◽  
Cynthia Hallett ◽  
...  
Keyword(s):  
United States ◽  
Postsecondary Education ◽  
The United States ◽  
Colleges And Universities ◽  
Department Of Education ◽  
State Laws ◽  
Education Data ◽  
The Us ◽  
The Usa ◽  
Education Statistics

ObjectiveTo describe the number and proportion of accredited, degree-granting institutions with 100% smoke-free and 100% tobacco-free protections across the USA and by state.MethodsData on postsecondary education institutions from the US Department of Education National Center for Education Statistics Integrated Postsecondary Education Data System 2015, and smoke-free and tobacco-free campus protections from the American Nonsmokers’ Rights Foundation’s Smokefree and Tobacco-Free Colleges and Universities List 2017, were integrated to calculate the number and proportion of: (1) smoke-free and tobacco-free accredited, degree-granting institutions and (2) students and staff protected by campus policies and state laws. Campus protections are given a 100% smoke-free designation if smoking is not allowed on campus anywhere, at any time; 100% tobacco-free designations extend smoke-free protections to include non-combustible products such as smokeless tobacco.Results823 accredited, degree-granting institutions (16.7%) representing 1816 individual campuses, sites and schools have either 100% smoke-free or 100% tobacco-free protections. An estimated 14.9 million college students (26.9%) and 8.9 million faculty and staff (25.4%) are protected by campus policies and state laws. Only three states and two territories have 100% smoke-free or 100% tobacco-free protections in over half of their institutions; four states and six territories have no known 100% smoke-free or 100% tobacco-free campus protections.ConclusionsIn 2017, just 16.7% of accredited, degree-granting institutions in the USA had 100% smoke-free or 100% tobacco-free protections. Despite progress, more efforts can ensure that students and staff benefit from comprehensive 100% smoke-free and 100% tobacco-free protections at US colleges and universities.

Vexed Again: Social Scientists and the Revision of the Common Rule, 2011-2018

2019 ◽  
Vol 47 (2) ◽  
pp. 254-263 ◽  
Author(s):  
Zachary M. Schrag
Keyword(s):  
Human Subjects ◽  
Social Scientists ◽  
Revision Process ◽  
Common Rule ◽  
Social Sciences And Humanities ◽  
The Social ◽  
Final Rule ◽  
Advance Notice ◽  
The Common ◽  
Protection Of Human Subjects

In revising the Federal Policy for the Protection of Human Subjects (Common Rule) between 2009 and 2018, regulators devoted the vast bulk of their attention to debates over biomedical research. They lacked both expertise in and concern about the social sciences and humanities, yet they imposed their will on experts in those fields. The revision process was secretive, spasmodic, and unrepresentative, especially compared to rulemaking in Canada, where social scientists participate in the process, and revisions take place every few years. The result was a final rule that offers some wins for social science and the humanities, but that fails to solve the problems identified by Ezekiel Emanuel and in the 2011 advance notice of proposed rulemaking.

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