Human Subjects

CDC Memo on Gender Ideology - read more...

CDC Memo on DEI Restrictions - read more...

UPDATED: Summary of Recent Significant Updates to the NIH Genomic Data Sharing Policy - read more...

COGR Responds to the Request for Information: Clinical Research Infrastructure and Emergency Clinical Trials - read more...

COGR Submits Comments to OHRP in Response to HHS-OASH-2022-0011 "Use of a Single IRB for Cooperative Research" Draft Guidance - read more...

NSF's Efforts to Support Institutional Diversity: June 2022 Meeting - read more...

COGR Submits Comment Letter to NIH on NOT-OD-22-064 - read more...

Strengthening Diversity, Equity, Inclusion and Accessibility at NIH: June 2022 Meeting - read more...

COGR Submits Letter to NIH on Genomic Data Sharing Policy RFI - read more...

COGR Submits Letter to NIH on Genomic Data Sharing Policy RFI (NOT-OD-22-029) - read more...

COGR Joins Coalition Statement in Support of Research Using Human Fetal Tissue - read more...

COGR Submits Comments to NIH on Diversity & Inclusion RFI (NOT-OD-21-066) - read more...

Posted April 14, 2021

Diversity in Clinical Trials: February 2021 Meeting - read more...

COGR Joins Coalition Letter to HHS on Proposed Fetal Tissue Rule (RIN 0991-AC15) - read more...

COGR Joins Multi Coalition Letter to President-elect Biden on Human Fetal Tissue Research - read more...

Posted January 7, 2021

COGR Joins Coalition Letter to DHHS on the NIH Human Fetal Tissue Ethics Advisory Board - read more...

Posted August 31, 2020

COGR Joins Coalition Letter to NIH Human Fetal Tissue Ethics Advisory Board - read more...

Posted July 28, 2020

ARCHIVED: 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 - read more...

Posted June 11, 2020 (Version 1.0)

ARCHIVED: Research Ethics and Compliance Human Subjects FAQs (Version 1.0) - read more...

Posted May 4, 2020

Joint Association & Institutional Letter to President Trump on Fetal Tissue Research Restrictions and COVID-19 - read more...

COGR Submits Joint Letter to NLM on RFI for Clinical Trials.gov Modernization - read more...

COGR Submits Joint Letter with AAU to NIH on Clinicaltrials.gov Modernization - read more...

Joint Letter to HHS on Fetal Tissue Research - read more...

Posted July 12, 2019

Final Joint Association Letter to OHRP on Cooperative Research - read more...

Posted May 1, 2019

COGR Letter to FDA Regarding Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations - read more...

Posted January 14, 2019

Joint Response to NIH Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Subjects (NOT-OD-18-217) - read more...

Posted November 13, 2018

NIH Basic Science Studies and Clinical Trials: Next Step - read more...

Meeting with Scientific Societies Regarding Basic Research with Human Subjects and NIH Clinical Trials Policies - read more...

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 - read more...

Posted May 16, 2018

COGR Comments on the Common Rule Interim Final Rule - read more...

Posted March 16, 2018

Higher Education Association Meeting with OIRA and Federal Agency Staff on Proposed Delayed Implementation of the Common Rule - read more...

Posted December 20, 2017

Joint Comment Letter on USDA Reform - read more...

COGR Submits Joint Letter with AAU & APLU on Access to Genomic Data - read more...

Posted October 20, 2017

Joint Association Letter on NIH Clinical Trial Case Studies - read more...

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. 

Read Joint Association Letter

*Sent to COGR Listserv 9/19/17

Joint Association Letter on NIH Clinical Trial Case Studies - read more...

What Do Revised U.S. Rules Mean for Human Research? (Science, Aug. 2017) - read more...

Posted August 30, 2017

Recommendations for HHS and NIH Research Regulatory Reform - read more...

June 2017 Presentation: State Universities' Sovereign Immunity in PTAB Trials - read more...

COGR Submits Joint Association Letter to Request Delay in Common Rule Compliance Date - read more...

Posted June 21, 2017

June 2017 Presentation: Continuing Challenges - read more...

June 2017 Presentation: Key ClinicalTrials.gov Reporting Requirements - read more...

COGR Submits Comments/Questions to NIH on "Single IRB Policy FAQs for Extramural Community" - read more...

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.

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Final Common Rule OHRP - read more...

Implementation of Single IRB - read more...

NIH SINGLE IRB POLICY: COSTING PERSPECTIVE - read more...

ARCHIVED: 2017 01058 Final Common Rule - read more...

Overview of the Final Revised Common Rule - read more...

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 Common Rule Summary Table

Final Revised Common Rule

ARCHIVED: Summary of Changes to the Common Rule - read more...

ARCHIVED: COGR Common Rule Summary Table - read more...

COGR Meets with OIRA Staff to Discuss Final Common Rule Under Review - read more...

Click here to review document.

ARCHIVED: NPRM Public Comments Overview - read more...

NIH Response to COGR Concerns Regarding GCP Training Requirements - read more...

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COGR Submits Joint Letter with AAU, APLU, and AAMC Requesting Extension to NIH sIRB Policy Implementation - read more...

August 22, 2016 OIRA Meeting Handout: Key Concerns with the Proposed Rule for Clinical Trials Registration and Results Submission - read more...

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ARCHIVED: COGR Releases Findings From a Review of the Common Rule NPRM Comments - read more...

ARCHIVED: NSF Approved Notice of Preliminary IRB Approval for a Project Lacking Immediate Plans for Involvement of Human Subjects - read more...

COGR has recently engaged in conversations with Jean Feldman, Head, Policy Office, and Jeff Mantz, Human Subjects Research Protection Officer, National Science Foundation, regarding applications and proposals lacking definite plans for involvement of human subjects. Per 45 CFR 690.118, applications lacking definite plans, such as “projects in which human subjects’ involvement will depend upon completion of instruments, prior animal studies, or purification of compounds,” need not be reviewed by an IRB before an award is made. NSF has indicated that for studies that meet these criteria, IRBs may use a “Preliminary Approval” notice for NSF projects (see "Read More" below) and that this approval is consistent with the Proposal and Award Policies and Procedures Guide.

The letter was drafted by Cindy Shindledecker and Lois Brako of the University of Michigan who have been working with Jeff and others on this for some time and we appreciate all of the work that they have done. The draft letter provides a limited approval period and indicates that the investigator must submit an amendment or new IRB application for full IRB approval of the project prior to the expiration date. It also emphasizes that no work with human subjects, including recruitment, may be conducted under the determination. Establishing a time limit, whether it is 3 or 6 months, requires investigators to return to the IRB and establishes accountability. Please contact Lisa Nichols if you have questions or concerns about the use of this draft letter.

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 2- Results

Table 3- Advocacy Groups by Subcategory

Common Rule NPRM Comment Summaries by Respondent Category:

Patients and Patient Representatives

General Public

Academic Researchers

Universities/Medical Centers/IRBs

Industry/Pharma/Trade Groups

Tribal Nations

Advisory and Related Groups

Independent IRBs

Departments of Health, Health Officials, Municipal Governments and Epidemiologists

Biorepositories, Affiliated Organizations and Consultants

Disease Registries

Professional Societies and Associations

Advocacy Groups

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

​Comments Overview PDF

Common Rule Notices of Proposed Rulemaking

2011 Common Rule ANPRM 

➣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”.

2015 Common Rule NPRM 

➣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

ARCHIVED: COGR Submits Comments on Common Rule NPRM and Provides Summary Brief

COGR Detailed and Summary Comments on Common Rule

Click here to read the full NPRM Comment Letter.

Click here to read a summary of the full NPRM Comment Letter.

NIH Definition of Clinical Trial Case Studies - read more...

ARCHIVED: January 22, 2015 - COGR Letter to OHRP on Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care - read more...

COGR sent a letter to the Office for Human Research Protections on draft guidance concerning disclosure of reasonably foreseeable risks in research evaluating standards of care.

NIH Definition of Clinical Trial Case Studies - read more...

Army Human Subjects Medical Insurance and Reimbursement

Click here to view clause
Click here to view policy

Modifications on HIPAA Privacy Rules

Click here to view

COGR Letter to Prime Reps on Proposed Common Rule to Replace OMB Circular A 110 - read more...

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.