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.

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.

Is it Really All about the Money? Reconsidering Non-Financial Interests in Medical Research

2012 ◽  
Vol 40 (3) ◽  
pp. 467-481 ◽  
Author(s):  
Richard S. Saver
Keyword(s):  
Medical Research ◽  
Conflicts Of Interest ◽  
Major Change ◽  
Academic Medical Centers ◽  
Department Of Health ◽  
Medical Centers ◽  
Institutional Review ◽  
Academic Medical ◽  
Financial Interests ◽  
Do So

Conflicts of interest have been reduced to financial conflicts. The National Institutes of Health’s (NIH) new rules for managing conflicts of interest in medical research, the first major change to the regulations in over 15 years, address only financial ties. Although several commentators urged that the regulations also cover non-financial interests, the Department of Health and Human Services declined to do so. Similarly, the Institute of Medicine’s (IOM) influential 2009 Conflict of Interest Report focuses almost exclusively on financial conflicts. Institutional policies at academic medical centers and guidance from professional bodies and medical journals also primarily emphasize financial ties. Even broadly worded rules are applied more readily to financial ties than non-financial interests, such as the regulations that restrict institutional review board (IRB) members with conflicting interests from participating in protocol reviews.

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.

scholarly journals Why Age and Aging Research Matters: A Chat With NIA Senior Leadership

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 825-825
Author(s):  
Marie Bernard
Keyword(s):  
Human Services ◽  
Research Priorities ◽  
Health Department ◽  
National Institutes Of Health ◽  
Senior Leadership ◽  
Aging Research ◽  
Research Directions ◽  
Lead Agency ◽  
Department Of Health ◽  
Significant Research

Abstract The National Institute on Aging (NIA) at the National Institutes of Health, Department of Health and Human Services, is the federally designated lead agency on aging research, and has supported significant research on aging as a life-long process. In the last five years, NIA experienced a tripling of its budget. Although much of this funding is targeted to Alzheimer’s disease (AD) and AD related dementias (ADRD) research, there was an increase in funds allocated to non-AD research in keeping with the overall growth of NIH. This symposium will provide a forum for exploration of the implications of the budget increases for the general research community. It will involve NIA’s senior staff discussing research priorities and programs supported by the Institute. A question-and-answer session will follow brief introductory remarks on current funding and future priorities and research directions of NIA.

Unplanned Reoperation and Implant Revision After Total Wrist Arthroplasty

Hand ◽  
2020 ◽  
pp. 155894471989881 ◽  
Author(s):  
Taylor M. Pong ◽  
Wouter F. van Leeuwen ◽  
Kamil Oflazoglu ◽  
Philip E. Blazar ◽  
Neal Chen
Keyword(s):  
Risk Factors ◽  
Implant Removal ◽  
Academic Medical Centers ◽  
Implant Design ◽  
Factors Associated ◽  
Medical Centers ◽  
Total Wrist Arthroplasty ◽  
Academic Medical ◽  
Related Risk ◽  
Wrist Arthroplasty

Background: Total wrist arthroplasty (TWA) is a treatment option for many debilitating wrist conditions. With recent improvements in implant design, indications for TWA have broadened. However, despite these improvements, there are still complications associated with TWA, such as unplanned reoperation and eventual implant removal. The goal of this study was to identify risk factors for an unplanned reoperation or implant revision after a TWA at 2 academic medical centers between 2002 and 2015. Methods: In this retrospective study, 24 consecutive TWAs were identified using CPT codes. Medical records were manually reviewed to identify demographic, patient- or disease-related, and surgery-related risk factors for reoperation and implant removal after a primary TWA. Results: Forty-six percent of wrists (11 of 24 TWAs performed) had a reoperation after a median of 3.4 years, while 29% (7 of 24) underwent implant revision after a median of 5 years. Two patients had wrist surgery prior to their TWA, both eventually had their implant removed ( P = .08). There were no risk factors associated with reoperation or implant removal. Conclusion: Unplanned reoperation and implant removal after a primary TWA are common. Approximately 1 in 3 wrists are likely to undergo revision surgery. We found no factors associated with reoperation or implant removal; however, prior wrist surgery showed a trend toward risk of implant removal after TWA.

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