Issuance of the Final Rule - Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors

Notice Number: NOT-OD-11-109

Update: The following update relating to this announcement has been issued:

Key Dates
Release Date: August 22, 2011

Issued by
National Institutes of Health (NIH), Office of Extramural Research

Purpose

The U.S. Department of Health and Human Services (HHS) is issuing a final rule in the Federal Register (http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf) that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).  The final rule specifies compliance dates in the "Dates" section, as discussed further below. 

Background    
           
Since the promulgation of these regulations in 1995, the growing complexity of biomedical and behavioral research; the increased interaction among Government, research Institutions, and the private sector in attaining common public health goals while meeting public expectations for research integrity; as well as increased public scrutiny, all have raised questions as to whether a more rigorous approach to Investigator disclosure, institutional management of financial conflicts, and federal oversight is required.   The HHS decided to explore the need for revisions to the 1995 regulations by publishing an Advance Notice of Proposed Rulemaking on May 8, 2009 (74 FR 21610). 
           
After analyzing public comments, HHS published a Notice of Proposed Rulemaking (75 FR 28688, hereafter referred to as "NPRM") on May 21, 2010, proposing changes to the 1995 regulations to strengthen accountability and transparency.  The proposed changes focused on Investigators’ disclosure requirements of significant financial interests (SFIs), Institutions’ reporting and management of identified financial conflicts of interest (FCOI), and public disclosure of information regarding Investigator FCOI.           

On July 21, 2010, HHS published a Notice (75 FR 42362) extending the 60 day comment period for the NPRM by another 30 days and seeking comment on whether HHS should clarify its authority to enforce compliance with the regulations by Institutions and Investigators, and whether HHS should clarify how the regulations apply in circumstances in which an Investigator or a PHS-funded research project transfers from one Institution to another.

After considering all public comments, and consistent with the proposals articulated in the NPRM, HHS developed the final rule, which includes the following major changes to the 1995 regulations: 

Topic

1995 Regulations

 2011 Final Rule

Significant Financial Interests (SFI) threshold

De minimis threshold of $10,000 for disclosure generally applies to payments or equity interests

De minimis threshold of $5,000 for disclosure generally applies to payments for services and/or equity interests.  Includes any equity interest in non-publicly traded entities.

Which SFIs need to be disclosed (once the threshold is met)

Only those SFI the Investigator deems related to the PHS-funded research.

All SFI related to the Investigator’s institutional responsibilities.

Excluded from disclosure requirement

Income from seminars, lectures, or teaching, and service on advisory committees or review panels, for public or nonprofit entities

Income from seminars, lectures, or teaching engagements sponsored by and service on advisory or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

Types of SFI excluded

All forms of remuneration are included – specific questions such as mutual funds and blind trusts are addressed in FAQ on the NIH website.

Excludes income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.

Travel reimbursements and sponsored travel

Travel reimbursement is not mentioned explicitly in the regulations but is not excluded from the SFI definition.

Disclose the occurrence of any reimbursed travel or sponsored travel related to Institutional responsibilities (including purpose of trip, sponsor/organizer, destination, and duration).  NOT required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.  The Institution will determine if any travel requires further investigation, including determination or disclosure of the monetary value.

Information on an identified Financial Conflict of Interest (FCOI) reported by the Institution to the PHS Awarding Component

Grant/Contract number
Project Director/Principal Investigator (PD/PI) or Contact PD/PI
Name of Investigator with FCOI
Whether FCOI was managed, reduced, or eliminated

INITIAL REPORT
Requirements in 1995 regulations, plus:
Name of the entity with which the Investigator has a FCOI
Nature of FCOI, e.g., equity, consulting fees, travel reimbursement, honoraria
Value of the financial interest $0-4,999; $5K-9,999; $10K-19,999; amts between $20K-$100K by increments of $20K; amts above $100K by increments of $50K or statement that a value cannot be readily determined.
A description how the financial interest relates to PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research
Key elements of the Institution’s management plan 
ANNUAL REPORT
status of the FCOI
changes to the management plan

Subrecipient Institutions/Investigators and Reporting of identified FCOIs

Institutions must take reasonable steps to ensure that Investigators working for subs comply with the regulations by requiring those Investigators to comply with the Institution's policy or by requiring the entities to provide assurances to the Institution that will enable the Institution to comply with the regulations.

Incorporate as part of a written agreement terms that establish whether the FCOI policy of the awardee Institution or that of the subrecipient will apply to subrecipient Investigators and include time periods to meet disclosure and/or FCOI reporting requirements
Subrecipient Institutions who rely on their FCOI policy must report identified FCOIs to the  awardee Institution in sufficient time to allow the  awardee Institution to report the FCOI to the PHS Awarding Component (e.g., NIH through the eRA Commons FCOI Module) to meet reporting obligations.

Public Accessibility

No requirement 

Make information available concerning identified FCOIs held by senior/key personnel via a publicly accessible Web site or by a written response to any requestor within five business days of a request, and update such information as specified in the rule.  This information will include at a minimum the Investigator’s name; the Investigator’s title and role with respect to the research project; the name of the entity in which the SFI is held; the nature of the SFI; and the approximate dollar value of the SFI, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

FCOI training

No requirement

Each Investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years, and immediately under the designated circumstances:
institutional FCOI policies change in a manner that affects Investigator requirements
an Investigator is new to an Institution
an Institution finds an Investigator noncompliant with Institution’s FCOI policy or management plan.

Retrospective Review (“Mitigation plan,” discussed in NPRM)

Not mentioned

Institution is required to conduct a retrospective review in those cases of non-compliance with the regulations. The Institution will be required to notify the PHS Awarding Component promptly and submit a report to the PHS Awarding Component in cases where bias is found.  The report will address the impact of the bias on the research project and the actions the Institution has taken, or will take, to eliminate or mitigate the effect of the bias. 


Compliance Dates:

An Institution applying for or receiving PHS funding from a grant, cooperative agreement, or contract that is covered by the final rule must be in full compliance with all of the revised regulatory requirements:

In the interim, Institutions should continue to comply with the 1995 regulations and report Investigator FCOIs to the Public Health Service (PHS) Awarding Component as required in the 1995 regulations.

NIH grant and cooperative agreement award recipients should continue to submit FCOI reports using the electronic Research Administration (eRA) Commons FCOI Module.  Once the institution is required to be in full compliance with the regulatory requirements, the additional reporting requirements must be met.  Therefore, if the eRA Commons FCOI Module is not updated by the time this occurs, the FCOI report should include an attachment that addresses the minimum elements of the FCOI report as provided in 42 CFR 50.605(b)(3).

Inquiries

Please direct all inquiries to:

Office of Policy for Extramural Research Administration
Division of Grants Compliance and Oversight
6701 Rockledge Drive MSC 7974
Bethesda, MD 20892-7974
Voice: (301) 435-0938
Fax: (301) 435-3059

or

FCOICompliance@mail.nih.gov


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