Research Compliance

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

COGR Response to NSF RFI on CHIPS and Science Act, Section 10343 - read more...

Survey of Research Integrity Officers on Final ORI Research Misconduct Rule (Please Complete by 11/30) - read more...

As sent to the COGR and ARIO listservs on 10/31:

Subject:  Survey of Research Integrity Officers on Final ORI Research Misconduct Rule:  Please Complete by 11/30

COGR Membership and ERI Pilot Participants,

COGR and the Association of Research Integrity Officers (ARIO) are conducting a survey of Research Integrity Officers on the Final ORI Research Misconduct Rule.  We invite the appropriate individual at each institution to submit a response to aid in COGR and ARIO’s advocacy efforts.  We ask that each institution submit one survey via the link below by November 30, 2024.  We estimate this survey to take approximately 15 minutes to complete for those that are already familiar with the Final Rule.  Read on for more information on this survey.

Survey of Research Integrity Officers on Final ORI Research Misconduct Rule

Who is conducting this survey?

This survey is being jointly conducted by COGR (Council on Governmental Relations) and ARIO (Association of Research Integrity Officers).  Representatives from both COGR and ARIO will have access to and analyze the survey responses.

Who should complete this survey?

This survey is being sent to COGR and ARIO members.  It is designed to be answered by the individual at the institution who is responsible for administering the institution’s policies and processes regarding the review of allegations of research misconduct (i.e., fabrication, falsification, and plagiarism).  At many institutions this individual may be the research integrity officer, but it will vary from institution to institution.   If you receive this survey link and you are not responsible for handling your institution's allegations of research misconduct, please forward the link to the appropriate individual for response.  Only one response per institution should be submitted.

What is the purpose of this survey? 

The federal Office of Research Integrity (ORI) recently issued its final research misconduct rule – Public Health Service (PHS) Policies on Research Misconduct  (“Final Rule”) – which updated the requirements for the policies and process that institutions must have in place to address allegations of research misconduct concerning PHS-supported research.  This survey is designed to identify areas of the Final Rule for which RIOs or other individuals responsible for handling allegations of research misconduct believe it would be beneficial to receive additional guidance or clarification from (a) ORI; (b) the RIO community working through COGR and ARIO; or (c) both ORI and the RIO community.  COGR and ARIO will use the information that is collected in developing advocacy plans, communications with ORI, and materials to assist member institutions in their implementation of the Final Rule.

How Long Does the Survey Take to Complete?

If you are familiar with the provisions of the Final Rule, it should take about 15 minutes to complete the survey.  If you are less familiar with the provisions of the Final Rule, you may want to look at the following summaries of its provisions before you start the survey:

• ORI/ARIO Presentation Slides from COGR October 2024 Meeting
• COGR's September 2024 Update to the Membership
• ARIO’s Final Rule Resources (ARIO member log in required)

Confidentiality of Information

COGR and ARIO will keep the information that they collect confidential and only report results in an aggregated and deidentified fashion.

Collection Tool and Due Date

COGR and ARIO will use the Alchemer online survey tool to collect survey responses.  Responses are due no later than November 30, 2024.  A Word copy of the survey is available here so that institutions can preview the questions before completing the online survey.

Points of Contact

For  questions regarding the survey, please contact Kris West, COGR’s Director of Research Ethics & Compliance at kwest@cogr.edu and Lauran Qualkenbush, ARIO’s President at lhaney@northwestern.edu.

Slides: Going AI: Cutting-Edge Strategies for Enhancing Research Administration Efficiency through Practical Application of Artificial Intelligence - read more...

COGR, AAU, and APLU Letter to DOE on Financial Assistance Regulations-Conflict of Interest and Conflict of Commitment Policy Requirements - read more...

Updated: Quick Reference Table of Current & Upcoming Federal Research Security Requirements - read more...

Overview of OSTP Guidelines for Research Security Programs at Covered Institutions - read more...

COGR and AAMC Submit Joint Letter to DEA on Rescheduling Marijuana - read more...

COGR Responds to APHIS Notice of Proposed Rulemaking on Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List - read more...

COGR Submits Response to CDC on Notice of Proposed Rulemaking on Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins - read more...

COGR Responds to EPA Scientific Integrity Policy Draft for Public Comment (EPA-HQ-ORD-2023-0240; FRL-10973-01-ORD) - read more...

Update Now Available: Quick Reference Table of Current & Upcoming Federal Research Security Requirements - read more...

Update Now Available (V.4): COGR Matrix of Science & Security Laws, Regulations, and Policies - read more...

COGR Letter to OEI HHS-OIG - read more...

COGR Comments & Extension Request to Office of Evaluation and Inspections, OIG, HHS on NIH Monetary Donations that Support Research Survey (OEI-03-22-00570) - read more...

COGR Responds to NIH Request for Information (RFI) on Proposed Guidance to Assured Institutions on Cephalopod Care and Use (NOT-OD-23-176) - read more...

COGR Responds to Request for Information (RFI) on an Update to the Current OLAW Guidance Disclaimer - read more...

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 Proposed Amendments to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) (88 FR 54332) - read more...

Session Materials Available: Workshop on Compliance with Research Security Requirements and the Associated Cost of Compliance Survey - read more...

On September 27, 2023, COGR is hosted a virtual, interactive workshop to provide an opportunity for members to share information on institutional efforts to comply with research security requirements and how to assess associated costs and institutional burden.  The workshop was led by COGR directors and members of COGR’s four committees.

NSTC is expected to finalize its model disclosure forms and research security program standards this autumn, and upon their issuance, COGR will initiate Phase II of its research security cost survey.  This workshop provided a forum for institutions to discuss their compliance strategies, learn about the methodology of the Phase II survey, and consider the resources they will need to implement research security programs and additional disclosure requirements.  The workshop begins with an overview of current requirements and the Phase II survey, and then participants joined break-out rooms to discuss how their institutions are addressing certification mandates, training requirements, security program structures and associated costs and administrative burden. 

Institutions that participated in the Workshop will be highly encouraged to complete the Phase II Survey.  Phase II will be initiated later this autumn, and COGR will follow-up with workshop participants at the time to determine if they will participate.  

Questions and topics of interest may be sent in advance of the session to Kristin West at kwest@cogr.edu.

Workshop materials include:

Session recording (log in required)
Slide Presentation
Institutional Resources on Research Security (log in required)

COGR Submits Response to Congressional RFI on Federal Regulation of CBD Products - read more...

COGR Joins Multi-Organization Statement on Addressing the Shortage of Long-Tailed Macaques for Research - read more...

COGR Responds to OLAW's Request for Information (RFI) on Clarification of Animal Activities Exempt from PHS Policy Requirements for IACUC Review (NOT-OD-23-119) - read more...

Overview of Department of Defense Statement on Countering Unwanted Foreign Influence in Department-Funded Research Institutions of Higher Education - read more...

COGR's Response to Request for Information (RFI) on Update to NOT-OD-05-034 Guidance on Prompt Reporting of Noncompliances to OLAW (NOT-OD-23-063) - read more...

COGR Publishes "Analyzing Personal Financial and Institutional Conflicts of Interest in Academic Research Contexts" - read more...

COGR has published a new report:  “Analyzing Personal Financial and Institutional Conflicts of Interest in Academic Research Contexts.”  Ensuring the objective conduct of research, free from bias, is one of a research institution’s most important duties, as well as a key focus for federal research funding agencies.  This report discusses both personal financial and institutional conflict of interest issues in the context of situations in which these conflicts most commonly occur, including consulting, licensing, and clinical studies.  The report also addresses federal research funding agencies’ recent focus on the intersection of conflicts and malign foreign influence, and includes key regulations and guidance documents, points institutions should consider in evaluating scenarios, and case studies that can be used to foster discussion and support educational efforts. 

“Analyzing Personal Financial and Institutional Conflicts of Interest in Academic Research Contexts” complements COGR’s 2021 publication:  "Principles for Conflict of Commitment Concerns in Academic Research." 

COGR's Joint Response to NASA’s “New Conflict of Interest and Conflict of Commitment Policy for Recipients of NASA Financial Assistance Awards” - read more...

COGR Submits Comments in Response to ANPRM Entitled Wild and Exotic Animal Handling, Training of Personnel Involved with Public Handling of Wild and Exotic Animals, and Environmental Enrichment for Species - read more...

COGR Signs on to Multi-Association Letter to DoEd Regarding Foreign Gift & Contract Disclosures (ED-2022-SCC-0159) - read more...

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

COGR Responds to HHS Notice of Proposed Rulemaking “Confidentiality of Substance Abuse Disorder Patient Records” - read more...

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.

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

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

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

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. 

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

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

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. 

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. 

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.  

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

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)

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

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.

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

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

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

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

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. 

NSPM Presentation Slides - read more...

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

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.

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. 

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.

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

Posted October 26, 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. 

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

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

Posted August 6, 2021

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

Posted July 27, 2021

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

Posted July 26, 2021

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

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

Posted April 14, 2021

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

Posted January 7, 2021

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. 

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

Posted November 13, 2020

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

Posted October 30, 2020

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

Posted 10/21/20

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

Posted October 20, 2020

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 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

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

Posted November 19, 2019

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

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 - read more...

Posted June 11, 2020 (Version 1.0)

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

Posted May 4, 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 Releases Commentary on Disclosing Other Support - read more...

Posted December 5, 2019

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

Posted November 13, 2019

Conflict of Commitment Policies for COGR Member Institutions

Posted November 5, 2019

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

Posted 8/29/19

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

Posted October 3, 2019

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

Posted 8/16/19

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

Posted 7/16/19

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

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

Posted February 20, 2019

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

Posted February 4, 2019

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

Posted January 15, 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

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

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

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

Posted November 5, 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

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

Posted September 20, 2018

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

Posted September 20, 2018

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

Posted  7/27/18

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

Posted June 21, 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 - read more...

Posted May 16, 2018

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

Posted May 15, 2018

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

Posted May 1, 2018

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

Posted April 19, 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

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

Read COGR's Comments

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

Posted November 14, 2017

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

Posted November 6, 2017

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

Posted 10/24/17

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

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

Posted June 21, 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.

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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

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

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

Click here to review document.

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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Association Responses to Petitions to the USDA

August 3, 2015 - COGR Submits Joint Letter with AAU to APHIS on the Request for Comments to the  Petition to Develop Specific 
Ethologically Appropriate Standards for Nonhuman Primates in Research

August 3, 2015 - COGR Submits Joint Letter with AAU and APLU to USDA on Identifying and Regulatory Burdens, 81 FR 4213
 

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

Posted July 8, 2016

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

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

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

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

Click here to view the Recommendations.

Institute of Medicine Research Integrity Report Analysis

Click here to view

COGR Develops an Animal Research Statement

Click here to view

DHHS/PHS Policies on Research Misconduct Summary

Click here to view

Cost of Doing Business Study

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

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

Click here to view

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

Food and Drug Administration Clinical Misconduct Guidance

Click here to view

Sponsored Programs Offices: A Continuing Evolution Responding to Federal Requirements

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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. 

USDA Retrospective Review

August 3, 2015 - COGR Submits Joint Letter with AAU & APLU  to USDA on Reducing Regulatory Burden