Research Compliance

November 14, 2022

Research Security and the Cost of Compliance – Phase I Report, Disclosure Requirements Now Available - read more...

COGR conducted Phase I of the survey described in this report to quantify the considerable time and resources (financial and otherwise) that research institutions have invested (or will invest) to achieve compliance with the Disclosure Requirements.  COGR is providing this Phase I report to research institutions and federal research funding agencies in the hope that it will both encourage and facilitate discussions of equitable cost allocation, as well as how “return on investment” (ROI) should be considered and measured.

 

November 8, 2022

Chapter 3 Part II of COGR's NIH DMS Readiness Guide: Roles and Responsibilities (Excel Download) Now Available - read more...

 

November 4, 2022

Joint Comments from AAU, AAMC, APLU, ACE and COGR to NSF on Standard Disclosures - read more...

 

October 31, 2022

COGR Letter for Request for Comment for Common Disclosure Forms - read more...

 

October 21, 2022

NSPM-33 Implementation Guidance Disclosure Requirements Standardization Talking Points for Institutions - read more...

The proposed Standardized Disclosure Forms were released for public comment on August 31, 2022. This document includes critical themes for institutions to consider. These themes were included in the COGR response

 

October 15, 2022

COGR and AAMC Submit Joint Comment Letter to NIH on Cannabis RFI (NOT-AT-22-026) - read more...

 

September 29, 2022

COGR & the Association of Research Libraries Present: Gearing Up for January 2023: Institutional Strategies for Implementing the NIH Data Management & Sharing Policy - read more...

 

September 23, 2022

Overview of the NSPM-33 Standardization Disclosure Forms for the Common Biographical Sketch and Current and Pending (Other) Support 9/23 Webinar Materials - read more...

The highly anticipated Standardize Disclosure Forms were released on August 31, 2022 for public comment. Section 4(b)(vi) of NSPM-33 directs that “agencies should standardize forms for initial disclosures as well as annual updates…and should provide clear instructions to accompany these forms and to minimize any associated administrative burden”. This webinar provides an overview of the standardized disclosure forms and associated attributes highlighting key considerations for institutions.

Speakers for this webinar are Pamela Webb, Associate Vice President for Research, University of Minnesota; Jeffrey Friedland, Associate Vice President, Research Administration; University of Delaware; Craig Reynolds Assistant Vice President for Research - Sponsored Projects University of Michigan; and Krystal Toups, Director, Contracts & Grants Administration. This webinar provides information on how institutions can engage and provide comments by October 31, 2022. 

 

September 7, 2022

COGR Matrix of Laws, Regulations, and Policies Regarding Science & Security - read more...

COGR has developed a comprehensive chart that summarizes and compares federal laws, regulations, and policies in the area of science and security.  The chart is divided into three separate tabs that cover (a) major federal-wide legislation or policy (e.g., National Presidential Security Memorandum 33, CHIPS and Science Act of 2022); (b) agency disclosure requirements for researchers and research institutions; and (c) agency conflict of interest policies.  The chart will be updated as new laws, policy and guidance are published. 

 

September 7, 2022

COGR Comparison of the Department of Energy Interim Financial Conflict of Interest Policy and Public Health Service Regulations for Promoting Objectivity in Research - read more...

COGR has developed a comprehensive chart that summarizes and compares federal laws, regulations, and policies in the area of science and security.  The chart is divided into three separate tabs that cover (a) major federal-wide legislation or policy (e.g., National Presidential Security Memorandum 33, CHIPS and Science Act of 2022); (b) agency disclosure requirements for researchers and research institutions; and (c) agency conflict of interest policies.  

 

August 30, 2022

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

 

August 11, 2022

Looking at the CHIPS on the Table Webinar Materials - read more...

The CHIPS and Science Act of 2022 is expected to have a major impact on numerous facets of the U.S. science and technology landscape, including manufacturing, support of innovation, STEM education, promotion of more inclusive and diverse research and research settings, along with additional efforts aimed at increasing research security. This COGR webinar provides members which an early look at the new Act, with a particular focus on the new research security provisions, agency authorizations and potential new STEM training and research opportunities.    

Presentation Slides

Recording (Log in required)

 

July 8, 2022

COGR Letter of Support for SACHRP’s Efforts to Redefine “Engaged in Research” - read more...

 

June 8, 2022

Comparison Chart: NIH Pre-Award and Post-Award Disclosures Relating to the Biographical Sketch and Other Support - read more...

This document compares the June 2022 version of the NIH Pre-award and Post-award Disclosures Relating to the Biographical Sketch and Other Support with the prior version of the chart related by NIH.

 

May 3, 2022

NIH Data Management and Sharing Resource Page - read more...

 

April 22, 2022

COGR Submits Comments to USDA on Proposal Rule on Standards for Birds Not Bred for Use in Research Under AWA - read more...

 

March 28, 2022

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

 

February 28, 2022

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

 

February 15, 2022

COGR Submits Comment Letter to OSTP Concerning January 2022 Guidance for Implementing NSPM-33 - read more...

This letter contains COGR’s comments regarding the Implementation Guidance for National Security Presidential Memorandum 33, and stresses the need for transparency, a risk-based approach, and cross-agency consistency. 

 

January 13, 2022

NSPM Presentation Slides - read more...

These are slides from COGR's webinar providing an overview of OSTP's NSPM-33 Implementation Guidance. 

 

January 10, 2022

Summary of NSTC Guidance for Implementing National Security Presidential Memorandum 33: Provisions Regarding DPIs, Consequences, Information Sharing and Research Security Programs - read more...

This summary highlights key points of the NSPM-33 Guidance that address the other topics covered by the document: DPIs, consequences, information sharing, and research security programs.

 

January 7, 2022

COGR Releases a Summary of NSTC Guidance for Implementing NSPM-33's Disclosure Requirements & Other Provisions - read more...

This summary highlights key points of the NSPM-33 Guidance’s disclosure requirements, including comparison of those provisions with current NIH and NSF requirements in this area. 

 

December 31, 2021

Framework for Review of Individual Global Engagements in Academic Research - read more...

This paper provides research institutions with an underlying structure to support the analysis of international engagements by their researchers, assess potential risks, and develop strategies for mitigation.

Click Here

 

December 8, 2021

COGR Submits Comment Letter to NSF in Response to "Notice of a New System of Records: (SORN) - read more...

This letter provides comments regarding to NSF concerning its Privacy Act notice of a new system of records that describes the use of a data analytics tool to analyze information collected from researcher disclosures. 

Posted December 8, 2021

 

October 26, 2021

COGR Submits Joint Association Letter to OLAW on NOT-OD-21-161 RFI - read more...

Posted October 26, 2021

 

September 22, 2021

Principles for Evaluating Conflict of Commitment Concerns in Academic Research (Update) - read more...

Updated September 22, 2021

This paper examines the issue of conflict of commitment in the context of concerns regarding inappropriate foreign influence, promoting transparency, and avoiding conflicts. 

 

August 18, 2021

Federal Focus on Inappropriate Foreign Influence on Research: Practical Considerations in Developing an Institutional Response - read more...

This paper provides an overview of points that institutions should consider on issues related to research security as they perform risk assessments and develop/implement processes to appropriately address areas of higher research security risk

 

August 6, 2021

COGR Submits Comments to USDA in Response to Notice of Proposed Rulemaking - Handling of Animals; Contingency Plans - read more...

Posted August 6, 2021

 

July 27, 2021

COGR Submits Joint Association Comments with AAU, AAMC, AAAS, and APLU to OSTP on Scientific Integrity RFI - read more...

Posted July 27, 2021

 

July 26, 2021

COGR Submits Letter to NIH on NOT-OD-21-118 RFI Regarding Zebrafish - read more...

Posted July 26, 2021

 

June 7, 2021

Materials Transfer in Academia: 20 Questions and Answers - read more...

 

April 14, 2021

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

Posted April 14, 2021

 

January 7, 2021

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

Posted January 7, 2021

 

December 18, 2020

COGR’s Survey on Institutional Disclosure Practices: Responding to Inappropriate Foreign Influence Amid Evolving Requirements

COGR’s Survey on Institutional Disclosure Practices: Responding to Inappropriate Foreign Influence Amid Evolving Requirements (Log in required)

Released December 2020

This paper provides analysis of the data collected via COGR's survey on institutional disclosure requirements regarding research support and researcher affiiliations.  It is availble only to COGR members. 

 

November 13, 2020

COGR Submits Letter to USDA APHIS on Proposed Rule Regarding AWA Research Facility Registration, Updates, Reviews, and Reports - read more...

Posted November 13, 2020

 

October 30, 2020

COGR Submits Comments to NIH on NOT-OD-20-153 RFI Regarding Grant and Congruency Reviews - read more...

Posted October 30, 2020

 

October 21, 2020

COGR Submits Letter to DEA on RIN 1117-AB53 Implementation of the Agriculture Improvement Act of 2018 - read more...

Posted 10/21/20

 

October 20, 2020

COGR Submits Comments to NIH on NOT-OD-20-145 RFI Regarding Semiannual Inspections - read more...

Posted October 20, 2020

 

September 22, 2020

COGR Releases Current and Pending Support Table (NSF) - read more...

Posted 9/22/20

 

August 31, 2020

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

Posted August 31, 2020

 

August 19, 2020

COGR Submits Comments to NIH in Response to NOT-OD-20-130 RFI on Enhancing Rigor, Transparency, and Translatability to Improve Biomedical Research Involving Animal Models - read more...

Posted August 19, 2020

 

August 4, 2020

Conflict of Commitment Policies for COGR Member Institutions - read more...

Posted November 19, 2019

 

July 28, 2020

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

Posted July 28, 2020

 

June 11, 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 - read more...

Posted June 11, 2020 (Version 1.0)

 

May 4, 2020

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

Posted May 4, 2020

 

January 27, 2020

COGR's Response to JCORE RFI - read more...

Posted January 27, 2020

This letter contains COGR's comments in response to the request for information on aspects of the American Research Environment [FR Doc. 2019-25604]

 

December 5, 2019

COGR Releases Commentary on Disclosing Other Support - read more...

Posted December 5, 2019

 

November 13, 2019

COGR Submits Joint Letter to EPA Expressing Concern on Proposed Rule "Strengthening Transparency in Regulatory Science" - read more...

Posted November 13, 2019

 

November 5, 2019

Conflict of Commitment Policies for COGR Member Institutions

Posted November 5, 2019

 

August 29, 2019

COGR and ARIO Release "Confidentiality Issues Related to Responding to Allegations of Research Misconduct" - read more...

Posted 8/29/19

 

August 23, 2019

ARCHIVED: Foreign Influence Resources Provided by COGR Members (ARCHIVED) - read more...

Posted October 3, 2019

 

August 16, 2019

Joint Association Letter to NASA on Sexual Harassment Federal Register Notice - read more...

Posted 8/16/19

 

July 16, 2019

COGR Submits Letter to FDA on Cannabis Research - read more...

Posted 7/16/19

 

July 12, 2019

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

Posted July 12, 2019

 

July 12, 2019

Association Response to DoEd on Section 117 Reporting - read more...

Posted 7/12/19

This letter expresses joint association concerns regarding the continuing need for clarification regarding reporting requirements under Sec. 117 of the Higher Education Act of 1965. 

 

May 1, 2019

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

Posted May 1, 2019

 

February 20, 2019

COGR Comments on the Draft Federal Report Reducing Administrative Burden for Researchers: Animal Care and Use in Research - read more...

Posted February 20, 2019

 

February 4, 2019

COGR Survey Report on Institutional Administrative Requirements for Animal Research - read more...

Posted February 4, 2019

 

January 15, 2019

COGR Sends Letter to OMB on Data Standards - read more...

Posted January 15, 2019

 

January 14, 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

 

November 16, 2018

COGR, AAMC, and ARIO Submit Joint Letter to NIH on Communicating Research Misconduct to NIH, NOT-OD-19-020 - read more...

Posted November 16, 2018

 

November 13, 2018

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

 

November 5, 2018

Joint Association Letter on Industrial Hemp - read more...

Posted November 5, 2018

 

October 10, 2018

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

Posted October 10, 2018

 

September 20, 2018

COGR Submission to DOT on NABR Complaint - read more...

Posted September 20, 2018

 

September 20, 2018

COGR Submits Letter to DEA Regarding Production Quotas for Schedule I & II Controlled Substances - read more...

Posted September 20, 2018

 

July 27, 2018

Higher Education Associations RFI Response: Federal Technology Transfer Authorities and Processes - read more...

Posted  7/27/18

 

June 21, 2018

Joint Association Letter on Revisions to the Animal Welfare Act - read more...

Posted June 21, 2018

 

May 16, 2018

Joint Association Comments on the Common Rule NPRM - read more...

Posted May 16, 2018

 

May 15, 2018

Joint Association Letter in Support of Amendment to Farm Bill - read more...

Posted May 15, 2018

 

May 1, 2018

COGR Working Group Develops FAQs on Cannabis Research - read more...

Posted May 1, 2018

 

April 19, 2018

COGR Submits Joint Association Letter in Support of HR 5485 - read more...

Posted April 19, 2018

 

March 16, 2018

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

Posted March 16, 2018

 

December 20, 2017

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

Posted December 20, 2017

 

December 18, 2017

COGR Comments on AAALAC's Proposed Revision to the definition of Lab Animal - read more...

Read COGR's Comments

 

November 14, 2017

Joint Association Comments on USDA Regulatory Reform - read more...

Posted November 14, 2017

 

November 6, 2017

COGR Submits Joint Association Letter to EPA Regarding Advisory Boards & Committees - read more...

Posted November 6, 2017

 

October 24, 2017

New Report Aims to Advance Regulatory Efficiency in Animal Research - read more...

Posted 10/24/17

 

October 20, 2017

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

Posted October 20, 2017

 

September 19, 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

 

August 30, 2017

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

Posted August 30, 2017

 

August 24, 2017

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

 

June 21, 2017

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

Posted June 21, 2017

 

March 16, 2017

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.

 

Click here.

 

February 2, 2017

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

 

January 17, 2017

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

Click here to review document.

 

November 21, 2016

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

Click here to view

 

October 6, 2016

 

October 4, 2016

COGR's Letter to CMS on COI Procedures - read more...

Posted October 6, 2016

 

August 22, 2016

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

Click here

 

July 8, 2016

COGR Submits Letter to OMB on COI Under Uniform Guidance - read more...

Posted July 8, 2016

 

April 8, 2016

COGR Comments on DOI Conflict of Interest Policy - read more...

Posted April 8, 2016

 

February 11, 2016

COGR Seeks Clarification from the U.S. Fish & Wildlife Service on COI Language - read more...

Posted February 11, 2016

 

January 1, 2016

How to Conduct Non-Federal Stem Cell Research Without Violating the Federal Stem Cell Funding Prohibition

How to Conduct Non-Federal Stem Cell Research Without Violating the Federal Stem Cell Funding Prohibition
By Robert J. Kenny, Jr. [Medical Research Law and Policy Review, 2005]

National Institutes of Health Stem Cell Resource Web Site

 

January 1, 2016

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

 

November 9, 2015

COGR Submits Letter to DOD on COI Requirements - read more...

Posted November 9, 2015

 

March 27, 2015

March 27, 2015 - COGR Letter to NIH on Proposed Extension of Reporting Requirements for FCOI - read more...

COGR sent at letter to OPERA on the request for a three-year extension of the reporting requirements set out in regulations on the Responsibility of Applicants for Promoting Objectivity in Research.

 

February 20, 2015

February 20, 2015 - COGR Letter to EPA on Interim Conflict of Interest Policy - read more...

Posted February 20, 2015

 

January 1, 2011

Regulatory and Financial Reform of Federal Research Policy - Recommendations to the NRC

Click here to view the Recommendations.

 

January 7, 2010

Institute of Medicine Research Integrity Report Analysis

Click here to view

 

December 18, 2007

COGR Develops an Animal Research Statement

Click here to view

 

July 6, 2005

DHHS/PHS Policies on Research Misconduct Summary

Click here to view

 

October 1, 2002

Recognizing and Managing Personal Financial Conflicts of Interest (2002) - read more...

Click here to view

 

July 28, 2002

Army Human Subjects Medical Insurance and Reimbursement

Click here to view clause
Click here to view policy

 

April 25, 2002

Modifications on HIPAA Privacy Rules

Click here to view

 

July 20, 2001

Food and Drug Administration Clinical Misconduct Guidance

Click here to view

 

January 1, 1998

Sponsored Programs Offices: A Continuing Evolution Responding to Federal Requirements

Click here to view

 

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.