18th HMORN Annual ConferenceMay 1, 2012

Seattle, Washington

Jeffrey P. Braff, DrPHDirector—Human Research Protections

Kaiser Foundation Research Institute

The new regulations◦ Why◦ What are the major differences between the

current regulations and the new ones What this means for you as an institution What this means for you as a researcher

◦ What these differences represent What does an institution need to do to

comply with the new rules◦ Implementation issues that you’re likely facing

Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought-42 CFR Part 50 Subpart F

Advance Notice – May 8, 2009 Proposed Rule – May 21, 2010 Final Rule Published August 25, 2011 in the

Federal Register◦ http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011

-21633.pdf◦ Compliance Date: August 24, 2012 or when the new

COI policy is put on your institution’s publicly-accessible website, if earlier.

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Egregious violations of current regulations and institutional policies at large academic medical centers (Harvard, Emory, Penn)

Heightened visibility and action from Congressional investigations (Sen. Grassley)

Desire for transparency (NIH: Collins, Rockey) “The National Institutes of Health must ensure that the research it funds on the behalf of US taxpayers is scientifically rigorous and free of bias. ... [M]ore must be done to retain, and in some instances regain, public trust in the biomedical and behavioral research enterprise.” Managing financial conflict of interest in biomedical research. JAMA 2010;303(23).

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1995 Regulations 2011 RegulationsSFI Disclosure Requirements

$10,000 de minimisEquity >5%ProspectiveResearch-related

$5,000 de minimisAny non-publicly traded equityRetrospectiveRelated to institutional duties

Travel Reimbursements No explicit mention Any reimbursed travel except government or funded by an institution of higher learning must be disclosed

Public Accessibility None Institutional policyFCOIs for PHS-sponsored research held by senior/key personnel

Training None Required

Institutional Review None Retrospective review-mitigation plan

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The new regulations remove investigator personal discretion about what possibly conflicting financial interests related to their research they must report.  

The new regulations essentially require that institutions collect from investigators an annual disclosure of all financial interests held by that investigator that are related to any of the investigator’s “institutional responsibilities,” including clinical work, research, committee service, etc.  

The institution then makes the determination whether any of these reported financial interests may represent a conflict of interest in the investigator’s specific proposed research, and must take appropriate action to manage any perceived conflicts.

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Does it meet the disclosure threshold?

Is it related to research?

Does it affect the design, conduct, or reporting of the research?

Remuneration or Equity

Is it a Significant Financial Interest?

This is a potential Financial Conflict of Interest

This is a Financial Conflict of Interest

Develop a Management Plan

Report the FCOI and Details to the NIH

Make the information publicly available

Thanks to Heather Pierce, JD

American Association of Medical Colleges

Informing, involving, and educating stakeholders Seeking approval of and promulgating the new

regulations in a policy document Revising and developing procedures dealing with:

◦ Operations◦ Training◦ Infrastructure

Learning from both the feds and other research institutions

The landscape is still forming. NIH recently issued (March 21) new FAQs in response to requests from extramural awardees.

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Application of the same disclosure procedures (not reporting procedures) for federally-funded and non-federally-funded research.

Identification of all investigators. Are they the same as “key personnel?”

How do we assess the “relatedness” of reported financial interests to the nature of the research?

What, if any, new infrastructure needs to be in place?

The policy will be both outward- and inward-facing. This is new for some institutions.

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