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An Association of Research Institutions
Human Subjects
COGR Submits Comment Letter to NIH on NOT-OD-22-064
COGR Joins Multi Coalition Letter to President-elect Biden on Human Fetal Tissue Research
COGR Joins Coalition Letter to DHHS on the NIH Human Fetal Tissue Ethics Advisory Board
COGR Joins Coalition Letter to NIH Human Fetal Tissue Ethics Advisory Board
COGR Releases Research Ramp Up Road Map: A Guide to Considerations and Resources for Ramping Up On-Campus Laboratory, Animal and Human Subjects Research as COVID-19 Restrictions are Lifted
Research Ethics and Compliance Human Subjects FAQs (Version 1.0)
Final Joint Association Letter to OHRP on Cooperative Research
COGR Letter to FDA Regarding Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
Joint Response to NIH Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Subjects (NOT-OD-18-217)
Final Joint Association Comments on Proposed Changes to the NIH Guidelines on Recombinant or Synthetic Nucleic Acid Research
NIH Clinical Trial Case Studies
NIH Definition of Clinical Trial Case Studies 2015 (UPDATED) - Posted August 31, 2018
NIH Definition of Clinical Trial Case Studies 2014 - Posted August 31, 2018
NIH’s June 17 Proposed Plans to Address the Treatment of Basic Science Research - Posted June 20, 2018
Notes from a May 2 Meeting with Dr. Larry Tabak, NIH Principal Deputy Director - Posted June 20, 2018
Joint Association Comments on the Common Rule NPRM
COGR Comments on the Common Rule Interim Final Rule
Higher Education Association Meeting with OIRA and Federal Agency Staff on Proposed Delayed Implementation of the Common Rule
COGR Submits Joint Letter with AAU & APLU on Access to Genomic Data
Joint Association Letter on NIH Clinical Trial Case Studies
A number of institutions have contacted COGR over the last several weeks to express concern about clinical trial case studies that NIH has posted to their website to provide guidance on determining whether proposed research meets NIH criteria for a clinical trial. Many in the research community have been surprised to find that several of the case studies suggest that some basic health-related research meets the clinical trial definition. COGR, AAMC, AAU and APLU have communicated these concerns to NIH officials. The associations also sent a letter to Mike Lauer, NIH Deputy Director for Extramural Research, yesterday afternoon detailing our concerns and requesting continued dialogue. NIH made revisions to the case studies on September 8 and has indicated that the case studies and related guidance may continue to evolve. We will keep the membership informed of any further developments.
*Sent to COGR Listserv 9/19/17
What Do Revised U.S. Rules Mean for Human Research? (Science, Aug. 2017)
COGR Submits Joint Association Letter to Request Delay in Common Rule Compliance Date
COGR Submits Comments/Questions to NIH on "Single IRB Policy FAQs for Extramural Community"
COGR submits comments and questions to NIH on the document 'NIH Single IRB Policy FAQs for Extramural Community." Comments are indicated in red italic text.
Overview of the Final Revised Common Rule
February 1, 2017: An overview of the changes to the revised Common Rule published in the Federal Register on January 19, 2017, a one page summary table of the changes made, and a link to the final revised Common Rule.
Summary of Changes Made to the Common Rule
COGR Meets with OIRA Staff to Discuss Final Common Rule Under Review
COGR's Letter on NIH GCP Training Requirement
August 22, 2016 OIRA Meeting Handout: Key Concerns with the Proposed Rule for Clinical Trials Registration and Results Submission
Analysis of Common Rule Comments
In January 2016, COGR staff and university and association volunteers began an analysis of the 2,186 comments submitted to regulations.gov in response to the Notice of Proposed Rulemaking (NPRM) on the Federal Policy for the Protection of Human Subjects (Common Rule). Respondents were grouped by category (e.g., patient, public, university, researcher, etc.) and comments on major provisions coded. A summary and table of the findings, as well as summaries for each respondent category, can be found below. For more information on this analysis, please contact Lisa Nichols, Director for Research & Regulatory Reform.
Analysis of Public Comments on the Common Rule NPRM
Data Tables:
Table 1- Responses by Respondent Category
Table 3- Advocacy Groups by Subcategory
Common Rule NPRM Comment Summaries by Respondent Category:
Patients and Patient Representatives
Universities/Medical Centers/IRBs
Departments of Health, Health Officials, Municipal Governments and Epidemiologists
Biorepositories, Affiliated Organizations and Consultants
Professional Societies and Associations
Press Release
May 9, 2016- COGR/APLU/AAU Issue Joint Press Release
HHS Office for Human Research Protections Review of Public Comments on the Common Rule NPRM
Common Rule Notices of Proposed Rulemaking
➣COGR's 2011 response to the Department of Health and Human Services (HHS) and White House Office of Science and Technology Policy (OSTP) advanced notice of proposed rulemaking (ANPRM) on Human Subjects Protections also known as the “Common Rule”.
➣COGR’s December 8, 2015 response to the HHS Common Rule notice of proposed rulemaking (NPRM) and response summary
➣Summary of Proposed Changes provided by HHS, Office of Human Research Protections
Notification Letter for 45 CFR 46.118 Determinations for NSF Awards
COGR has been working with NSF staff to develop a letter that universities can submit for proposals lacking definite plans for involvement of human subjects. The letter indicates that the grant or protocol meets the requirements of 45 CFR 46.118 and stipulates that “one year from the date identified above, the Authorized Organizational Representative is required to either verify that the project continues to lack immediate plans for the involvement of human subjects, their data, or their specimens; or provide documentation to the cognizant NSF Program Officer to demonstrate that IRB approval has been obtained.” Universities that utilize this notification letter will therefore track the expiration through their financial or IRB systems (or other mechanisms). These changes will be reflected in the next version of the NSF Proposal and Award Policies and Procedures Guide that is scheduled for release in October 2016 and a link provided to the letter which will be available on the NSF website.
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Phone: (202) 289-6655
Email: memberservices@cogr.edu
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Contact Us
COGR
601 13th Street, N.W.
12th Floor
Washington, D.C. 20005
Phone: (202) 289-6655
Email: memberservices@cogr.edu