Patient Protection Oversight Committee Progress Report Questions and Answers

Q1. What is the Committee for Patient Protection in Research Trials (CPPRT)?

A1. This committee was established by the Board of Trustees last year to review the current policies and procedures of the Fred Hutchinson Cancer Research Center in clinical research trials. This group found that the Center's current policies were fully in compliance with federal guidelines. Nevertheless, they made recommendations for enhancing current policies. One recommendation was the establishment of the Patient Protection Oversight Committee (PPOC). The CPPRT completed its duties in September 2001 and was dissolved.

Q2. What is the Patient Protection Oversight Committee (PPOC)?

A2. This is a board oversight committee formed last fall to assist the Fred Hutchinson Cancer Research Center in evaluating and implementing the recommendations made by the CPPRT.

Q3. Why was the Patient Protection Oversight Committee (PPOC) created?

A3. The PPOC was created by the Board of Trustees and recommended by the Committee for Patient Protection in Research Trials (CPPRT) to assure oversight of the Center's activities in conducting clinical trials. This is a standing committee of the board.

Q4. How does the PPOC differ from the CPPRT?

A4. The Center's Board of Trustees created the PPOC as a news standing committee to provide trustee oversight of the Center's policies and practices pertaining to research involving human subjects. As part of its duties the PPOC was charged with reviewing and implementing the findings of the CPPRT. Late last year, the CPPRT community-based committee made recommendations to enhance the Center's practices and policies related to the conduct of clinical trials.

Q5. Did the PPOC recommend implementation of all of the recommendations of the CPPRT?

A5. The PPOC supported all of the recommendations made by the CPPRT, with some modifications to the financial conflict of interest policy.

Q6. What did the CPPRT recommend regarding conflict of interest?

A6. The community based CPPRT recommended "an outright prohibition on the part of individuals participating in human subjects trials of any financial interest in for-profit corporations which may benefit from such trials."

Q7. What did the PPOC propose?

A7. The PPOC proposed revisions to the Center's existing financial conflict of interest policy that expressly prohibit a Center scientist from being involved in a human subject trial if he/ she has certain financial interests in a for-profit sponsor that could be impacted by the outcome of the trial.

The PPOC recommended that the Center retain the standard of permitting members of the Center's scientific staff to receive honoraria for speeches, compensation for service on scientific advisory boards, fees for general consultation services and reimbursement for travel and other expenses, subject to an aggregate limitation of $10,000 per year from any single entity.

Q8. What is covered under the revised conflict of interest policy?

A8. The Center's financial conflict of interest policy expressly prohibits Center scientists from participating in human subject trials if they have what is defined as prohibited financial interests in the for-profit sponsors of those trials. Prohibited Financial interests include shares of stock and royalty rights in any amount, on patents or other intellectual property, and payments, which exceed $10,000 per year from a single entity. Payments of any sort based on or related to the outcome of the trials continue to be prohibited.

Q9. Why does the revised policy allow up to $10,000 of payments for such things as speeches and scientific advisory boards?

A9. The PPOC as well as other institutions have concluded that limited payments in these areas is acceptable. For example, meeting to discuss the progress of studies and giving seminars to disseminate the knowledge of research efforts are part of the normal course of conducting research trials. This policy permits reimbursement for expenses incurred in the course of carrying out effective research and education, costs that are normally borne by companies supporting a research study.

The US Public Health Service in the "Objectivity in Research regulations," the AAMC guidelines issued in December 2001, and a number of research institutions across the United States also consider these practices to be acceptable.

Q10. Why did the PPOC decide these are acceptable for the Center?

A10. Strong collaborations among for-profit life sciences companies, the non-profit and public sector, and individual scientists developing new technology is vital to the Center's goal of advancing scientific knowledge to save lives. Current federal policies encourage institutions to seek private investment to translate the ideas of biomedical research into medically useful products.

Q11. Doesn't this automatically create a conflict of interest?

A11. No. In fact, the report of the Association of Academic Medical Colleges (AAMC) noted that scientific staff receiving financial rewards from research endeavors is not intrinsically unacceptable, as long as it does not adversely influence scientific or clinical decision-making.

Q12. How does this new policy compare with the policies of other research centers?

A12. The new prohibition imposes a more restrictive standard than those recommended in the most recent AAMC guidelines and in the policies of many research centers in two key respects:

1. The Center's revised policy prohibits researchers from participating in human subject trials if they have a financial interest in the for-profit sponsors of the trials. The AAMC guidelines and the policies of several research centers do not have an absolute prohibition, but allow approved exceptions to this rule. Under these exceptions at other institutions, a person with a financial interest in a for-profit company may still be allowed to conduct research subject to restrictions specified by a conflict of interest committee if that person is able to demonstrate compelling circumstances.
2. The Center's policy prohibits any ownership interest in a for-profit entity, except for publicly-traded diversified mutual funds. A number of other research centers do not have such a prohibition, but allow equity interests of up to $10,000.

Q13. Will these payments be disclosed to clinical trial participants?

A13. Yes. The PPOC acknowledges the importance of disclosing to study participants compensation received by Center staff participating in the study.

Q14. What are you doing about adding ethics expertise?

A14. The Center is creating a new research ethics committee under the Research Trials Office. The ethics committee will provide consultative services to researchers and staff designing or reviewing research studies and offer advice to Institutional Review Boards.

Q15. Will you be reviewing these actions with the original independent reviewers?

A15. The Center plans a follow up review of its policies and procedures on the conduct of clinical trials in 2002. While some of the same reviewers will be invited back, there may be additional reviewers if it is felt that the Center could benefit from a different perspective.

Q16. How often did the PPOC meet?

A16. At least once a month.

Q17. Did the committee meet with any patients or family members?

A17. The committee's meetings included a session with former patients and a family member who shared their personal experiences of the informed consent process.

Q18. How will the Center support these activities?

A18. The Center has already allocated additional resources of $1 million to help support these activities but will provide additional funds as needed.

Q19. Are there other actions that the PPOC has recommended that have been adopted?

A19. Many of the recommendations have been implemented. An FDA consultant has been retained. An associate general counsel has joined the staff of the Office of the General Counsel to provide increased support for regulatory compliance. A physician assistant has been hired in the protocol development office to help with standardization and simplification of language for informed consent documents. A complete list of actions recommended by the PPOC, which have been adopted is available on the Center's Web site.

Q20. When will the recommendations of the PPOC be adopted?

A20. Many of the action plans for improvement are now being implemented. Some activities were initiate during the reviews of the community based CPPRT.

Q21. How do these activities relate to some of the concerns from the recent FDA audits?

A21. The PPOC was aware of the FDA issues and knew that their recommendations would address concerns raised by the FDA. For example, the Center has recently updated its ongoing system for protocol data and safety monitoring. This new system has been approved by the National Cancer Institute. For some studies that benefit from specialized review, monitoring continues to be under the oversight of data safety monitoring boards, bodies consisting of internal or outside experts who are independent of the study.

	Committee Report