Next week the Patient Centered Outcomes Research Institute (PCORI) will be meeting to plan out how to conduct comparative effectiveness research and one of their discussion items is conflict of interest. PCORI is proposing a similar conflict of interest policy as NIH’s.
Within the Patient Protection and Affordable Care Act [Section 6301 and Section 10602, Public Law 111-148], According to the legislation, the PCORI will act as a non-profit organization to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by carrying out research projects that provide quality, relevant evidence on how diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed.
Under this provision, the Comptroller General of the United States was required to appoint 19 members to the Board of Governors of PCORI. The Act also provides that the Directors of the Agency for Healthcare Research and Quality (AHRQ) and the National Institutes of Health (NIH), or their designees, be members of the Board.
Consequently, during a recent presentation, PCORI discussed their proposed conflict of interest policy. The proposed policy applies to Board, Methodology Committee, Advisory Committees, and staff. It does not apply to consultants, peer reviewers, vendors, and other third parties.
The policy aims to resolve concerns related to federal employees and follows the clear requirements of the statute. The policy also prohibits gifts to members. Specifically, the policy:
- Defines “conflict of interest” and “real conflict of interest”
- Requires PCORI members to make regular conflict disclosures
- When an issue arises for PCORI discussion/action, members must disclose and…
- Recuse oneself voluntarily, or
- Let the Board decide
The legislation defines “conflict of interest as “an association, including a financial or personal association, that have the potential to bias or have the appearance of biasing an individual’s decisions in matters related to the Institute or the conduct of activities under this section.
Additionally, the bill defines a “real conflict of interest” as “any instance where a member of the Board, the methodology committee, or an advisory panel, or a close relative of such member, has received or could receive either of the following:
- A direct financial benefit of any amount deriving from the result or findings of a study conducted by PCORI.
- A financial benefit from individuals or companies that own or manufacture medical treatments, services, or items to be studied by PCORI that in the aggregate exceeds $10,000 per year.
For purposes of the preceding sentence, a financial benefit includes honoraria, fees, stock, or other financial benefit and the current value of the member or close relative’s already existing stock holdings, in addition to any direct financial benefit deriving from the results or findings of a study conducted by PCORI
With respect to third parties, the PCORI conflict of interest policy will apply to vendors, consultants, peer reviewers, grantees, etc. There are some statutory requirements, but there is more flexibility for third parties. In particular, there are three approaches:
A high-level policy based only on the disclosure standards in the statute
- Mirror NIH policies
- Currently undergoing a rewrite
- Do not include PCORI statutory public disclosure requirements
- Relates to peer review of grant applications, not of research.
- A hybrid
- Based largely on NIH standards
- Add PCORI statutory requirements
- Add peer review standards for research
- Review standards from other research institutions
- PCORI noted that in deciding what policy to adopt for third parties, it is possible to publish a proposed policy for public comment.
Other Details of PCORI
With respect to the 2011 budget, there have been no changes to a previous draft reviewed by the Boar. It is a 12-month budget that looks back and forward. Spending is based on previously approved workplans, Methodology Committee numbers are still rough estimates, and the Senate Finance Committee will track spending throughout the year, with a report on significant issues or variances. The carryover from 2010 is $9.6 million, with total 2011 revenue at $50 million. There is a transfer of $10 million from HHS/AHRQ, an estimated spend of $19.3 million in 2011 and $30.3 million in carryover to 2012.
Other activities of PCORI include working with the executive director on staffing structure, employment policies, benefits, office location, and reviewing the compensation policy.
Conclusion
Ultimately, there is a growing concern about the PCORI conflict of interest policy. If the policy becomes something akin to that at NIH, it may be fine for academics in basic research, but has zero applicability to private research organizations such as Contract Research Organizations (CROs) who conduct large scale clinical trials. The legislation specifically calls for the use of private researchers, and any proposed COI policy under PCORI will make it extremely difficult to find researchers who do not work with industry, especially highly qualified researchers.
Accordingly, PCORI must create a COI policy that ensures high quality experts and professionals to carry out the legislatively required research. Otherwise, PCORI will be composed of unqualified experts whose advice and research could have a detrimental impact on patient care.
PCORI Meeting Information
July 18-19, 2011
Westin Georgetown
2350 M Street NW
Washington, DC
DRAFT Agenda (PDF)
Participant Dial-in Numbers:
U.S. Toll Free: 888-299-4099
Canadian Toll Free: 866-682-1172
International Toll: 302-709-8337
Verbal Passcode (to be given to the operator): VB23117
Webcast:
Individuals do not need to RSVP in order to attend. Individuals interested in speaking during a Public Comment Period can sign up to speak on-site the day of the event or can provide PCORI advance notice of their intent to speak by emailing info@pcori.org.