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.

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.

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.

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 Multicenter point prevalence evaluation of the utilization and safety of drug therapies for COVID-19 at the onset of the pandemic timeline in the United States

2021 ◽  
Author(s):  
Nathaniel J Rhodes ◽  
Atheer Dairem ◽  
William J Moore ◽  
Anooj Shah ◽  
Michael J Postelnick ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Therapy ◽  
Supportive Care ◽  
The United States ◽  
Primary Objective ◽  
Point Prevalence ◽  
Medical Centers ◽  
Academic Medical ◽  
History Of ◽  
Secondary Objective

Abstract Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose There are currently no FDA-approved medications for the treatment of coronavirus disease 2019 (COVID-19). At the onset of the pandemic, off-label medication use was supported by limited or no clinical data. We sought to characterize experimental COVID-19 therapies and identify safety signals during this period. Methods We conducted a non-interventional, multicenter, point prevalence study of patients hospitalized with suspected/confirmed COVID-19. Clinical and treatment characteristics within a 24-hour window were evaluated in a random sample of up to 30 patients per site. The primary objective was to describe COVID-19–targeted therapies. The secondary objective was to describe adverse drug reactions (ADRs). Results A total of 352 patients treated for COVID-19 at 15 US hospitals From April 18 to May 8, 2020, were included in the study. Most patients were treated at academic medical centers (53.4%) or community hospitals (42.6%). Sixty-seven patients (19%) were receiving drug therapy in addition to supportive care. Drug therapies used included hydroxychloroquine (69%), remdesivir (10%), and interleukin-6 antagonists (9%). Five patients (7.5%) were receiving combination therapy. The rate of use of COVID-19–directed drug therapy was higher in patients with vs patients without a history of asthma (14.9% vs 7%, P = 0.037) and in patients enrolled in clinical trials (26.9% vs 3.2%, P < 0.001). Among those receiving drug therapy, 8 patients (12%) experienced an ADR, and ADRs were recognized at a higher rate in patients enrolled in clinical trials (62.5% vs 22%; odds ratio, 5.9; P = 0.028). Conclusion While we observed high rates of supportive care for patients with COVID-19, we also found that ADRs were common among patients receiving drug therapy, including those enrolled in clinical trials. Comprehensive systems are needed to identify and mitigate ADRs associated with experimental COVID-19 treatments.

Abstract 30: Sex Differences in Faculty Rank Among Academic Vascular Neurologists in the United States

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Lindsay A Bliss ◽  
Carol A Vitellas ◽  
Nayanika Challa ◽  
Vivien H Lee
Keyword(s):  
United States ◽  
Assistant Professor ◽  
The United States ◽  
Associate Professor ◽  
Academic Medical Centers ◽  
Full Professor ◽  
Academic Rank ◽  
Faculty Rank ◽  
Medical Centers ◽  
Academic Medical

Introduction: The lower proportion of women at the rank of full professor compared to men has been documented in nearly all specialties. Women are under-represented in academic stroke neurology, but there is limited data. Methods: We reviewed all 160 U.S. medical schools and the associated medical centers for vascular neurologists. An internet search of stroke team websites and neurology department websites was performed from August 1, 2020 to August 25, 2020. We included 117 academic medical centers that had at least 1 vascular neurologist on faculty. We included vascular neurology ABPN certified or board eligible (fellowship-trained) neurologists. Data was collected on sex, academic rank, and American Board of Psychiatry and Neurology (ABPN) certification status. ABPN board certification status was verified on the ABPN verify CERT website. Social medical women’s neurology groups were also queried for names of women full professor to cross check. Results: Among 540 academic ABPN vascular neurologists, 182 (33.8%) were women and 358 (66.3%) were men. Among academic ranks, women made up 108/269 (40.1%) of Assistant professors, 49/137 (35.8%) of Associate professors, and 25/134 (18.8%) of full professors. Twenty two academic centers had vascular neurology female professors on faculty, compared to 70 academic centers with male full professors on faculty. Twenty nine academic centers had multiple male professors on faculty compared to only 3 centers with multiple female full professors. Among women, 108 (59.3%) were assistant professor, 49 (26.7%) were associate professor, 25 (13.7%) were full professor. Among men, 161 (45.0%) were assistant professor, 88 (24.6%) were associate professor, and 109 (30.5%) were professor. There was a significant difference between academic rank based upon sex (p <0.0001). Conclusion: Among academic medical centers in the United States, significant sex differences were observed in academic faculty rank for ABPN vascular neurologists, with women less likely than men to be full professors. Further study is warranted to address the gender gap in the field of stroke.

scholarly journals Pediatric Integrative Medicine in Academia: Stanford Children’s Experience

Children ◽  
2018 ◽  
Vol 5 (12) ◽  
pp. 168 ◽  
Author(s):  
Gautam Ramesh ◽  
Dana Gerstbacher ◽  
Jenna Arruda ◽  
Brenda Golianu ◽  
John Mark ◽  
...  
Keyword(s):  
Integrative Medicine ◽  
Well Being ◽  
The United States ◽  
Potential Barriers ◽  
Medical Centers ◽  
Academic Medical ◽  
Patient Complexity ◽  
Irritable Bowel ◽  
Pediatric Illnesses ◽  
Integrative Medicine Program

Pediatric integrative medicine is an emerging field which, to date, has not been described in detail in academic medical centers in the United States. Early research of pediatric integrative medicine modalities shows promise for the treatment of common pediatric conditions such as irritable bowel syndrome, acute and chronic pain, headache, and allergy, among others. In light of the growing prevalence of pediatric illnesses and patient complexity, it is crucial to emphasize the patient’s overall well-being. As academic centers around the world start to develop pediatric integrative medicine programs, the aim of this manuscript is to briefly highlight evidence of effective integrative treatments in pediatric subspecialties, to describe the establishment of our integrative medicine program, to summarize its early efforts, and to discuss potential barriers and keys to success.

A Survey of Intravenous Remifentanil Use for Labor Analgesia at Academic Medical Centers in the United States

2017 ◽  
Vol 124 (4) ◽  
pp. 1208-1210 ◽  
Author(s):  
Jaime Aaronson ◽  
Sharon Abramovitz ◽  
Richard Smiley ◽  
Virginia Tangel ◽  
Ruth Landau
Keyword(s):  
United States ◽  
The United States ◽  
Labor Analgesia ◽  
Academic Medical Centers ◽  
Medical Centers ◽  
Academic Medical

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.

Sign in / Sign up

Export Citation Format

Share Document