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

Posted January 7, 2021

COGR Joins Coalition Letter to DHHS on the NIH Human Fetal Tissue Ethics Advisory Board

Posted August 31, 2020

COGR Joins Coalition Letter to NIH Human Fetal Tissue Ethics Advisory Board

Posted July 28, 2020

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

Posted June 11, 2020 (Version 1.0)

Research Ethics and Compliance Human Subjects FAQs (Version 1.0)

Posted May 4, 2020

Final Joint Association Letter to OHRP on Cooperative Research

Posted May 1, 2019

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

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)

Posted November 13, 2018

Final Joint Association Comments on Proposed Changes to the NIH Guidelines on Recombinant or Synthetic Nucleic Acid Research

Posted October 10, 2018

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

Posted May 16, 2018

COGR Comments on the Common Rule Interim Final Rule

Posted March 16, 2018

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

Posted December 20, 2017

COGR Submits Joint Letter with AAU & APLU on Access to Genomic Data

Posted October 20, 2017

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. 

Read Joint Association Letter

*Sent to COGR Listserv 9/19/17

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

Posted August 30, 2017

COGR Submits Joint Association Letter to Request Delay in Common Rule Compliance Date

Posted June 21, 2017

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.

 

Click here.

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 Common Rule Summary Table

Final Revised Common Rule

COGR Meets with OIRA Staff to Discuss Final Common Rule Under Review

Click here to review document.

COGR's Letter on NIH GCP Training Requirement

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

Click here

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

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.