New NIH Rules on Conflict of Interest

The NIH has issued new policies related to Financial Conflict of Interest. As part of these policies, Palmer College now requires that all faculty conducting research must complete an initial financial conflict of interest screening form annually. This should be submitted with each new research/IRB application. I am taking the following information directly from the NIH website (http://grants.nih.gov/grants/policy/coi/coi_faqs.htm), wherein the new requirements are described more fully.

A. General Questions

1.      What is the purpose of this regulation? (Institution and Investigator)

The 2011 revised regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. This regulation is commonly referred to as the Financial Conflict of Interest (FCOI) regulation. (http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf).

2.      When are Institutions required to comply with the 2011 revised regulation? (Institution)

An Institution applying for or receiving NIH funding from a grant or cooperative agreement must be in compliance with all of the revised regulatory requirements no later than 365 days after publication of the regulation in the Federal Register, i.e., August 24, 2012, and immediately upon making the Institution’s Financial Conflict of Interest policy publicly accessible as described in 42 CFR part 50.604(a).

3.      How does an Institution signify compliance with the 2011 revised regulation? (Institution)

When the Institution posts its Financial Conflict of Interest policy (or, if the institution does not have a current presence on a publicly accessible Web site, makes the policy publicly accessible by written request), it signifies that the Institution applying for or receiving PHS funding from a grant or cooperative agreement that is covered by the 2011 revised regulation is in full compliance with all the regulatory requirements. The Institution must be in compliance with the 2011 revised regulation no later than August 24, 2012.

4.      Is the 2011 revised regulation retroactive? (Institution)

No. The revised regulation will apply to each grant or cooperative agreement with an issue date of the Notice of Award that is subsequent to the compliance dates of the Final Rule (including noncompeting continuations) no later than August 24, 2012 and immediately upon making its Financial Conflict of Interest policy publicly accessible. Through their policies, however, Institutions may choose to apply the revised regulations to all active PHS awards. For example, Institutions may choose, in their Financial Conflict of Interest policy, to implement the regulation on a single date for all PHS-funded awards rather than implementing the regulation sequentially on the specific award date of each individual project.

5.      What is the most significant difference between the 1995 regulation and the 2011 revised regulation? (Institution and Investigator)

The 2011 revised regulation includes comprehensive changes, focusing on these areas in particular:

§  Definition of Significant Financial Interest

§  Extent of Investigators’ disclosure of information to Institutions regarding their Significant Financial Interests;

§  Institutions’ management of identified Financial Conflicts of Interest

§  Information reported to the PHS funding component (e.g., NIH);

§  Information made accessible to the public (i.e., Institutional FCOI policy and FCOIs of senior/key personnel); and

§  Investigator training.

6.      Where can I find additional information? (Institution and Investigator)

More information specific to grants and cooperative agreements is available on the Financial Conflict of Interest Web Page of the Grants Policy and Guidance section of the NIH Office of Extramural Research home page (http://grants.nih.gov/grants/policy/coi/index.htm.)

7.      May an Institution have conflict of interest policies that go beyond the regulation (e.g., impose more stringent requirements than those in the regulation)? (Institution and Investigator)

Yes, as long as the Institution’s policies meet the minimum requirements of the PHS regulation. The regulation states the Institution’s policy must inform each Investigator of the Institution’s policy on Financial Conflict of Interest; of the Investigator's Significant Financial Interest disclosure responsibilities; and of the PHS regulation. If an Institution adopts a policy that includes more restrictive disclosure thresholds than those in the 2011 revised regulation, the Institution must adhere to the requirements of the policy’s more restrictive standards. Institutions must report all identified FCOIs to the NIH, including any financial conflicts of interest identified in accordance with the Institution’s own more restrictive standards, in the time and manner specified in the regulation (see “Reporting” section for additional information).

8.      I have heard there is a special requirement for clinical research. Is this true? (Institution and Investigator)

Yes. In any case in which the HHS determines that an NIH-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a conflicting interest that was not managed or reported by the Institution as required by the regulation, the Institution must require the Investigator(s) involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations. Institution’s Financial Conflict of Interest policy may have additional requirements.

9.      For how long must Institutions keep records of financial disclosures and any resulting actions under the Institution’s policy or following a retrospective review, if applicable? (Institution)

Institutional policies must be followed regarding maintenance of records as long as they are in compliance with the PHS regulation. Under the regulation, the Institution is required to keep all records of all Investigator disclosures of financial interests and the Institution’s review of, or response to, such disclosure (whether or not a disclosure resulted in the Institution’s determination of a Financial Conflict of Interest), and all actions under the Institution’s policy or retrospective review, if applicable, as follows:

§  Records of financial disclosures and any resulting action must be maintained by the Institution for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 74.53(b) and 92.42 (b) for different situations.

NIH expects Institutions to retain records for each competitive segment as provided in the regulation.

10.  What is the purpose of this regulation? (Institution and Investigator)

The 2011 revised regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. This regulation is commonly referred to as the Financial Conflict of Interest (FCOI) regulation. (http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf).