Office for Protection from Research Risks (OPRR)

1994 ◽  
Vol 13 (2) ◽  
pp. 271-273 ◽  
Author(s):  
Gary B. Ellis
Keyword(s):  
Human Services ◽  
Public Health Service ◽  
Human Subjects ◽  
Laboratory Animals ◽  
Department Of Health ◽  
Research Risks ◽  
Policies And Procedures ◽  
Primary Responsibility ◽  
Protection Of Human Subjects ◽  
The U.S

The Office for Protection from Research Risks (OPRR) has primary responsibility within the U.S. Department of Health and Human Services (DHHS) for developing and implementing policies, procedures, and regulations for the protection of human subjects involved in research. It also has primary responsibility within the U.S. Public Health Service for developing and implementing policies and procedures for the care and use of laboratory animals. And, it has responsibility for coordinating the development and implementation of policies, procedures, and regulations for the protection of human subjects involved in research for all U.S. federal departments and agencies that conduct or support such research.

CTSA Institution Responses to Proposed Common Rule Changes: Did They Get What They Wanted?

2017 ◽  
Vol 12 (2) ◽  
pp. 79-86 ◽  
Author(s):  
Suzanne M. Rivera ◽  
Lisa Nichols ◽  
Lois Brako ◽  
Genevieve Croft ◽  
Toni Russo ◽  
...  
Keyword(s):  
Human Services ◽  
Human Subjects ◽  
National Institutes Of Health ◽  
Academic Medical Centers ◽  
Department Of Health ◽  
Medical Centers ◽  
Academic Medical ◽  
Rule Changes ◽  
Final Rule ◽  
Protection Of Human Subjects

In 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies proposed revisions to the Federal Policy for the Protection of Human Subjects. In this Notice of Proposed Rulemaking (NPRM), the departments sought to strengthen, modernize, and make more effective human subjects regulations while reducing administrative burden, delay, and ambiguity. We reviewed public comments from National Institutes of Health (NIH)-funded Clinical and Translational Science Awards (CTSA) institutions on key provisions of the NPRM to understand how the proposed changed were received at research-intensive institutions. CTSA institutions responding to the proposed rule were predominantly opposed to the major proposals, including proposed changes to the treatment of de-identified biospecimens, demonstrating a lack of support from academic medical centers. In January 2017, a Final Rule was issued. We compare the Final Rule to what was proposed.

scholarly journals Post-SARS-CoV-2 monoclonal antibody treatment hospitalizations as a sentinel for emergence of viral variants in New York City

2021 ◽  
Author(s):  
Kelsie Cowman ◽  
Yi Guo ◽  
Liise-anne Pirofski ◽  
David Wong ◽  
Hongkai Bao ◽  
...  
Keyword(s):  
New York ◽  
Monoclonal Antibody ◽  
New York City ◽  
York City ◽  
Human Services ◽  
Antibody Treatment ◽  
Health And Human Services ◽  
Department Of Health ◽  
Monoclonal Antibody Treatment ◽  
The U.S

Abstract We partnered with the U.S. Department of Health and Human Services to treat high-risk, non-admitted COVID-19 patients with bamlanivimab in the Bronx, NY per Emergency Use Authorization criteria. Increasing post-treatment hospitalizations were observed monthly between December 2020-March 2021 in parallel to the emergence of SARS-CoV-2 variants in New York City.

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.

ObamaCare’s 2014 Report Card? Preaching Patience — to Supporters and Opponents

HPHR Journal ◽  
2014 ◽  
Vol 2014 (1) ◽  
Author(s):  
Benjamin D. Sommers ◽  
Keyword(s):  
Access To Care ◽  
Affordable Care Act ◽  
Human Services ◽  
Insurance Coverage ◽  
Open Enrollment ◽  
Report Card ◽  
Health And Human Services ◽  
Department Of Health ◽  
The Affordable Care Act ◽  
The U.S

The first open enrollment period under the Affordable Care Act has come and gone. One might be tempted to ask, “How has the law done so far?” — if only that question hadn’t already been asked ad nauseum since the first week of open enrollment in October 2013. As a researcher whose primary interests are insurance coverage and access to care (and as an advisor in the U.S. Department of Health and Human Services), I have frequently been asked this question – by students, by friends and family, and by reporters. Consider this my response.

New Beginnings

2017 ◽  
pp. 39-78
Author(s):  
J. Benjamin Hurlbut
Keyword(s):  
Human Subjects ◽  
National Commission ◽  
Vitro Fertilization ◽  
Department Of Health ◽  
Human In Vitro Fertilization ◽  
First Child ◽  
New Beginnings ◽  
Protection Of Human Subjects

Chapter 1 examines the period from the mid-1960s to 1980. During this period, scientific advances made in human in vitro fertilization and embryo culture led to the birth of Louise Brown, the first child conceived through IVF, in 1978. The chapter examines the deliberations of two federal bioethics bodies: the National Commission for the protection of Human Subjects of Behavioral and Biomedical research, and the Ethics Advisory Board of the Department of Health, Education and Welfare.

The Need for Standards in Foodservice Sanitation Education

1978 ◽  
Vol 41 (4) ◽  
pp. 295-301
Author(s):  
OSCAR P. SNYDER
Keyword(s):  
Educational Outcomes ◽  
Educational Program ◽  
Public Health Service ◽  
Food Service ◽  
Point Of View ◽  
Educational Outcome ◽  
Department Of Health ◽  
Food Borne ◽  
Food Borne Illness ◽  
The U.S

At present there is only one guideline for determining what information should be taught in foodservice sanitation courses. This basic document is the Food Service Sanitation Manual, including a model foodservice sanitation ordinance, 1976 revision, by the U.S. Department of Health, Education and Welfare, Public Health Service, and Food and Drug Administration. However, this manual is not written in terms of educational outcome and is not truly based on sound educational principles. This paper approaches the problem of prevention of food borne illness from the educator's point of view. It discusses the instructional problem in sanitation, why people must learn, who the students are, the values and benefits of this educational program, and what should be taught if the educational outcomes are to be attained.

Sign in / Sign up

Export Citation Format

Share Document