October 6, 2000

Mr. Ronald Collins
Director, Integrity in Science Project
Center for Science in the Public Interest
1875 Connecticut Avenue, N.W.
Suite 300
Washington, DC 20009-5728

Dear Mr. Collins:

     I would like to thank you and your colleagues for your thoughtful letters of May 22, July 7, and September 8 regarding the committee composition and disclosure policies of the National Academies. We have carefully considered the suggestions from your letters and from our joint meeting on July 5, and we found your input to be helpful and constructive.

     For the past several months we have been reevaluating our policies associated with conflict of interest and disclosure. While this reevaluation process is not yet complete, I am writing now to explain our general views on these issues and to convey some of the changes that we will be making in our procedures. For clarity, I have attempted first to summarize our general approach in forming a study committee, and then to focus on the issues that you have raised.

Composition of Academy study committees

     In selecting members for a study committee, we examine three aspects of the backgrounds of potential candidates: relevant expertise, possible conflicts of interest, and potential sources of bias. All three aspects are assessed in terms of the specific task for the study. "Conflict of interest" means any current financial or other interest that conflicts with the service of an individual because it could impair the individual’s objectivity. "Potential sources of bias" relates to points of view or positions that are largely intellectually motivated or that arise from the close identification or association of an individual with a point of view of a particular group.

     In assessing potential "conflicts of interest" and different points of view of provisionally-appointed committee members, we collect three types of information. We ask these individuals to complete a confidential form of self-disclosure. We post their names and brief biographies on our web site and seek comments from the public for a period of twenty days. We also ask each provisional member to discuss potential conflicts and points of view orally in front of the other provisional members of the committee and our staff in a closed session at the first meeting. Based on these three sources of information, we make a determination if any provisional member has a conflict of interest. If so, that person is usually removed from the committee and replaced with someone else with comparable expertise. In rare situations, however, we find that, after reasonable effort, we are unable to identify individuals with the required level and quality of specific expertise and direct experience necessary for the study who do not have some level of conflict of interest. If the Academy decides to appoint such a person to the committee, we publicly disclose the conflict and explain why it is unavoidable.

     After dealing with potential conflicts of interest, we evaluate the overall composition of the committee in terms of different points of view. Each person has views that depend upon his or her intellectual background, experiences, and other factors. Our goal is to ensure that relevant points of view on a highly expert committee are, in the Academy’s view, reasonably balanced, so that the committee can carry out its task objectively. As another check on quality and objectivity of the study, the Academy appoints additional experts with a range of views and perspectives to review the draft report prepared by the committee under the Academy’s report review process. The Academy takes very seriously its responsibility in assuring both the integrity and quality of the reports prepared by its study committees.

Issues raised by the Center for Science in the Public Interest

     In your letter of May 22, you imply that the "apparent conflicts of interest of members of the recent Committee on Genetically Modified Pest Protected Plants (GMPPP) exemplifies the need for (greater) balance" and that the "NAS should have been far more sensitive to the balance question from the outset." I disagree with your assessment. For this particular study examining the adequacy of the regulatory approach for GMPPP, we made the decision to appoint three individuals whom we determined to have conflicts of interest, and we publicly disclosed these conflicts and the rationale for including these experts on the committee. None of the other committee members were determined to have conflicts of interest. As you noted, the brief biographies of GMPPP committee members posted on our web site were informative, containing information about relevant relationships of these individuals, such as receiving research support from private industry. Even though these relationships were determined not to be conflicts of interest (other than the three cases noted above), we felt that the information provided the public with useful knowledge about committee members’ backgrounds. Overall, we believe that the GMPPP committee was appropriately balanced and the study was objective, thorough, and of high quality.

     Regarding the Committee on Biotechnology, Food and Fiber Production, and the Environment (BFFPE), this committee was appointed to make recommendations to the Academy on what relevant studies and activities might be carried out in the future. The BFFPE committee was not charged with carrying out studies. Study committees are being appointed separately, as in the case of the Committee on Environmental Impacts Associated with Commercialization of Transgenic Crops (EIACTC), which is referenced in your letter of September 8.

     Regarding the EIACTC committee, we agree with you that the brief biographies posted on our web site should have included more information about relevant relationships, as was done with the GMPPP committee. For that reason, we are going to repost the committee members biographies and solicit public comment for another twenty day period as well as request additional information from committee members. We will review the composition of the committee based on any new information that we receive.

     We also agree with you that we should aim for more uniformity in presenting relevant information in our brief biographies of committee members. We have sent new direction to our staff as follows:

RSOs should ensure that each biographical posting provides an appropriate statement of the member’s qualifications to serve on the committee, highlighting the member’s expertise and technical credentials related to the committee’s charge and his or her relevant current and past affiliations, e.g., consulting for the sponsor, research support from public and private sources, service on related committees within the National Academies and outside, etc.

     Regarding the above policy direction for our staff, I should point out that it is a matter of judgment concerning what is relevant to be included in the biographies for relationships that do not represent conflicts of interest. These factors are considered in determining committee composition. For relationships that do represent conflicts of interest for members who are retained on committees, we will continue to disclose these conflicts and explain why they are unavoidable.

     In summary, we appreciate your careful and thoughtful suggestions, which have influenced our decisions to date. As stated earlier, we are continuing to review our policies and procedures regarding conflict of interest and disclosure. As soon as we complete this review, we will inform you of any additional changes.

     Because I do not have addresses of the co-signers of your letters, I would appreciate your forwarding a copy of my letter to them or sending me a list of their addresses. Also, I would be happy to meet with you to discuss my letter, and I look forward to appearing with you on a panel at the AAAS meeting in February to discuss this topic.

Sincerely,
 

E. William Colglazier, Ph.D.
Executive Officer