Administrative Burden

COGR Responds to RFI on Potential Changes to the Policies for Oversight of Dual Use Research of Concern (DURC) and the Potential Pandemic Pathogen Care and Oversight (P3CO) Policy Framework - read more...

COGR Responds to RFI on Flexibilities for Streamlining IACUC Review of Protocols and Significant Changes (NOT-OD-23-152) - read more...

Preparing for a Government Shutdown: A List of Institutional Considerations - read more...

COGR Submits Comment Letter in Response to Notice to Announce NIH Updated Policy Guidance for Subaward/Consortium Written Agreements (88 FR 36603) - read more...

Aggregated Regulatory Requirements Impacting Federally Funded Research Since 1991 - read more...

Results from the COGR Survey on the Cost of Complying with the New NIH DMS Policy - read more...

COGR's Response to Request for Information (RFI): Re-envisioning U.S. Postdoctoral Research Training and Career Progression within the Biomedical Research Enterprise [NOT-OD-23-084] - read more...

COGR's 2 CFR 200 "Uniform Guidance" Resource Page - read more...

COGR Requests a 30-Day Extension to Respond to OMB's RFI - read more...

COGR requested a 30-day extension to respond to OMB’s RFI regarding updates to 2 CFR Part 200, Uniform Guidance.

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

Digging Into DPIs (Digital Persistent Identifiers) 9/23 Webinar Materials - read more...

Multi-Association Follow Up Letter to DoEd on Section 117 - read more...

This letter provides comments from the American Council on Education, Association of American Universities, Association of Public and Land-grant Universities, and COGR expressing concerns regarding Dept. of Education requirements under Sec. 117 of the Higher Education Act of 1965. 

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. 

COGR Submits Letter to OSTP on Reducing Administrative Burden - read more...

This letter provides specific suggestions to OSTP for achieving its objective of reducing administrative burden associated with federally funded research, including suggestions regarding research security requirements.  

Posted December 21, 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

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

Posted July 26, 2021

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

Posted January 7, 2021

Joint Association Comment Letter Regarding Foundational Technologies ANPRM - read more...

Posted November 2020

This letter contains joint association comments regarding concerns associated with potential expansion of controls on foundational technologies. 

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

Posted 9/22/20

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

COGR, AAU, APLU and AAMC Submit Letter to EPA on Strengthening Transparency in Regulatory Science - read more...

Posted May 18, 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]

COGR Submits Joint Association Comment Letter to NIST on iEdison RFI - read more...

Posted January 24, 2020

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

Posted 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. 

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

Posted May 1, 2019

HERD Survey Questions from COGR - read more...

Posted 3/21/19

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

COGR Research Regulatory Reform Matrix - read more...

Posted December 19, 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

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

Posted October 10, 2018

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

Posted  7/27/18

Engage Research Institutions on Research Regulatory Reform - read more...

Science, July 20, 2018

Summary

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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

COGR Releases Matrix of Recent Legislative Actions Taken to Reduce Research Regulatory Burden - read more...

Posted January 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 Association Comments on USDA Regulatory Reform - read more...

Posted November 14, 2017

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

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

Posted August 30, 2017

Recommendations for Non-HHS Research Regulatory Reform - read more...

Discussion Points on Facilities and Administrative Costs and Regulatory Reform - read more...

COGR Recommendations on Research Regulatory Reform

Posted August 24, 2017

Recommendations for HHS and NIH Research Regulatory Reform (Updated 2/28/18)

Recommendations for Non-HHS Research Regulatory Reform

Discussion Points on Facilities and Administrative Costs and Regulatory Reform

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

COGR Submits Joint Association Letter on DOE Regulatory Reform - read more...

Posted July 14, 2017

This letter provides joint association comments on Department of Energy regulations, paperwork requirements and other regulatory obligations as part of the agency’s implementation of Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs.” 

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

Posted June 21, 2017

Joint Association Request to OMB on the Research Policy Board - read more...

Posted April 27, 2017

COGR Submits Letter to DOD Regarding Pre/Post Award Administrative Matters on Financial Assistance Awards - read more...

Posted April 5, 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.

Actions for Reducing Administrative Work for Federally Sponsored Research

Reports from the National Academies, National Science Board, Federal Demonstration Partnership and others have highlighted increasing regulatory burden for federally funded research. Many of the recommendations for reducing burden target federal regulations and policies. Part 1 of the National Academies report, Optimizing the Nation’s Investment in Academic Research, also recommended that research institutions review policies developed to comply with federal regulations to determine whether the institution has created additional and unnecessary administrative burden.

The checklist COGR has created highlights actions that more closely adhere to regulation and policy or otherwise offer the potential to reduce administrative work in a number of areas including those researchers have identified as being particularly burdensome. Many of the approximately 100 actions put forward have previously been initiated at some of our member institutions with positive effect. However, we note that they may not be relevant, or applicable, to all institutions and that institutions may have reasons for establishing criteria that exceed the minimum regulatory requirements (e.g., state law). The list is intended to represent action taken, and ideas to consider, rather than a recommended action plan. We will continue to modify and expand the checklist in response to member feedback.
 

Administrative Burden Checklist

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

Click here to review document.

Joint Comment Letter with AAU, AAMC, APLU & AUTM to NIST Regarding Bayh-Dole NPRM - read more...

Click here for letter

COGR Supports Cures Legislation in Letter to Senate HELP Staff - read more...

Click here for letter

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

Click here to view

GAO Report on Federal Research Grants

COGR Preliminary Analysis of GAO Report on Federal Research Grants 

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

Posted October 6, 2016

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

Posted July 8, 2016

National Academies Report Optimizing the Nation's Investment in Academic Research

The National Academies Committee on Federal Research Regulations and Reporting Requirements released Part 2 of its report, Optimizing the Nation’s Investment in Academic Research; A New Regulatory Framework for the 21st Century on June 29. The full report is now available online. Appendix B of the report includes a table of recommendations.

COGR's Response to Part 1 of the National Academies Report

COGR's Response to Part 2 of the National Academies Report

National Academies Panel on Reforming Regulation and Reporting Requirements - Lisa Nichol's Remarks on Behalf of the Council on Governmental Relations

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

Posted April 8, 2016

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

Posted February 11, 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

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

Posted November 9, 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 - COGR Letter to EPA on Interim Conflict of Interest Policy - read more...

Posted February 20, 2015

Resources

NIH Initiative to Reduce Regulatory Burden (1999)

Federal Demonstration Partnership Faculty Workload Survey Reports (2012)

National Academies report Research Universities and the Future of America (2012)

National Science Board report Reducing Investigators’ Administrative Workload for Federally Funded Research (2014)

National Academies report Optimizing the Nation’s Investment in Academic Research (2016)

Government Accountability Office report Federal Research Grants: Opportunities Remain for Agencies to Streamline Administrative Requirements (2016)

21st Century Cures Act, section 2034, Reducing Administrative Burden for Researchers (2016)

Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden (2017)

COGR Response to NIH RFI

 Input on Reduction of Cost and Burden Associated with Federal Cost Principles for Educational Institutions (OMB Circular A-21), July 2011.  Click here to view the Letter and here to view the Attachment.

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

Click here to view the Recommendations.

Cost and Facility Issues in Conducting Stem Cell Research

Summary of June 2005 COGR Meeting Discussion

Cost of Doing Business Study

Click here to view Study.
Click here to view Table of Contents.
Click here to view Inventory.

New Business Models for Research

Click here to view letter 
Click here to view appendix with references
Click here to view background paper

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.