Notice Number: NOT-HS-15-016

Key Dates
Release Date: September 8, 2015

Issued by
Agency for Healthcare Research and Quality (http://www.ahrq.gov/)

Purpose

This Notice informs current and future Agency for Healthcare Research and Quality (AHRQ) recipients of grants, cooperative agreements and contracts that compliance with the 2011 Financial Conflict of Interest (FCOI) regulations, at 42 CFR Part 50, subpart F, and 45 CFR Part 94, is required. Further, AHRQ is implementing use of the eRA FCOI Commons module for submission of FCOI reports in accord with 42 CFR Part 50, Subpart F, effective immediately.

Background: To address the increasing complexities of the financial interests held by researchers and the resulting interactions among Government, research Institutions, and the private sector, the Department of Health and Human Services and the National Institutes of Health published revised regulations on the "Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought and Responsible Prospective Contractors" in 2011. Commonly known as the Financial Conflict of Interest (FCOI) regulations, the rules established new standards to be followed by Institutions that apply for or receive research funding from PHS awarding components for grants, cooperative agreements, and research contracts. The primary goal is to promote objectivity by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded by PHS will be free from bias resulting from Investigator financial conflicts of interest. Therefore the 2011 revised regulations increased accountability, added transparency, enhanced regulatory compliance and effective Institutional management of Investigators’ financial conflicts of interest, and strengthened compliance oversight by federal funding agencies. The 2011 FCOI regulations Promoting Objectivity in Research - are found at 42 CFR part 50, subpart F, and at 45 CFR Part 94, (the latter is applicable to responsible prospective contractors). Note that the regulations also include provisions addressing the conduct of PHS funded research through subrecipients (e.g., subcontractors or consortium members).

HHS implementation of 2 CFR Part 200 (known as the Uniform Regulations), at 45 CFR 75.112 states that “Agencies with Public Health Service (PHS) funded research will ensure that any conflict of interest policies are aligned with the requirements of 42 CFR part 50, subpart F.” Accordingly, AHRQ hereby notifies all AHRQ applicants, grantees and contractors that they are required to comply with the FCOI regulations and that compliance is a term and condition of award.

Reporting via eRA Commons: The eRA Commons FCOI Module accommodates the 2011 rule and associated reporting requirements. However, until now it has not been available to AHRQ grantees. With the August 27, 2015, eRA system release, the eRA FCOI Module will allow AHRQ grantees to electronically report (and later view) any FCOI and associated data it identifies concerning an AHRQ award in accord with the FCOI regulations, including:

- Initiating and submitting FCOI reports,
- Submitting annual FCOI reports,
- Submitting additional information when requested by AHRQ, and
- Searching and viewing FCOI reports and associated data previously submitted through the Commons.

In situations of noncompliance, the module will allow for the submission of a revised FCOI report following a Retrospective Review, if needed, to specify the actions that will be taken to manage the FCOI in the future. The module will also allow for the submission of a Mitigation Report when bias is found following a Retrospective Review.

The eRA Commons is not the system of record, but the FCOI information will be stored within another internal system of record (IMPAC II) database.

The eRA Financial Conflict of Interest User Guide provides instructions for specific users to manage the eRA Commons FCOI module for their particular institution.

Since AHRQ’s implementation of the use of the eRA Commons FCOI module does not differ from NIH’s use, AHRQ recipients are encouraged to utilize the NIH resources, FAQs, training webinars and tutorial posted on the NIH FCOI website. If implementation is new to the organization, the NIH Checklist for Policy Development Related to the 2011 Revised Financial Conflict of Interest (FCOI) Regulation, Promoting Objectivity in Research (42 CFR Part 50 Subpart F) is a comprehensive list of all of the required components of an institutional policy.

FCOI reports for AHRQ-funded contracts should be submitted to the AHRQ Contract Specialist identified on the contract.

Annual FCOI Report Due Dates: Annual FCOI reports, required for a previously reported FCOI, must be submitted each subsequent year during the project’s competitive segment and must address the status of the financial interest and any changes to the management plan, and state whether the FCOI is still being managed or explain why the FCOI no longer exists. Annual FCOI reports must be submitted using the eRA Commons FCOI module and are due at the same time as the institution’s annual progress report (usually the RPPR), i.e., 3 months before the anniversary of the award (see NOT-HS-15-001). An annual FCOI report is also required when a project enters a no-cost extension phase.

Inquiries

Inquiries regarding this notice should be directed to AHRQ Grants Management at [email protected].

General inquiries about the FCOI regulation for research contracts should be directed to AHRQ Contract Specialist.