No, says the California stem cell
agency, despite concerns by the state auditor and the state's Fair
Political Practices Commission (FPPC) that date back at least six
years. The agency says that its governing board makes the decisions
on the applications – not the grant reviewers – and that the
members of the board fully disclose their economic interests.
However, last month the agency produced
a document that sheds new light on the issue. The document confirms
that the board rubber-stamps virtually all the reviewers' decisions,
going along with their actions 98 percent of the time. The board
exercised independent judgment on 28 out of 1,355 applications.
Why is this important? Here is what the state auditor said in 2007,
“(T)he FPPC believes that, under state regulations, working group members (including grant reviewers) may act as decision makers if they make substantive recommendations that are, over an extended period, regularly approved without significant amendment or modification by the committee. Thus, as decision makers, working group members would need to be subject to the conflict-of-interest code. This would mean that working groups would be subject not only to the (public) financial disclosure requirements of the Political Reform Act but also to the prohibition against a member participating in a government decision in which that member has a disqualifying financial interest and may be subject to the penalties that may be imposed on individuals who violate that act.”
The auditor recommended that the stem
cell agency seek an attorney general's opinion on the matter, a
recommendation the agency agency summarily dismissed seven months later..
Then interim CIRM
President Richard Murphy, a former member of the agency's board and
former president of the Salk Institute, replied to the auditor:
"We have given careful consideration to your recommendation and have decided it is not appropriate to implement at this time. In almost three years of operation and approval of four rounds of grants, the recommendations of the CIRM working groups have never been routinely and/or regularly adopted by the ICOC. Until the time that such a pattern is detected, the question you suggest we raise with the attorney general is entirely hypothetical, and is therefore not appropriate for submission. We will, however, continue to monitor approvals for such a pattern and will reconsider our decision if one emerges."
In the four rounds mentioned in
Murphy's response, 100 percent of reviewer decisions were
rubber-stamped by the board. In the other two rounds, the percentage
was 95 and 96 percent.
Currently, scientific grant reviewers at the stem cell agency, all of whom are from out-of-state, disclose financial and professional conflicts
of interest in private to selected CIRM officials. (See policy here.)
From time to time, grant reviewers are excused from evaluating
specific applications.
The CIRM governing board has resisted
requiring public disclosure of the interests of reviewers. The subject
has come up several times, but board members have been concerned
about losing reviewers who would not be pleased about disclosing
their financial interests. Nonetheless, disclosure of interests among researchers is becoming routine in scientific research articles. Many universities, including
Stanford, also require public disclosure of financial interests of
their researchers. Stanford says,
“No matter what the circumstances -- if an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal financial gain, the relationship should be disclosed to the public during presentations, in publications, teaching or other public venues.”
The latest version of CIRM's conflict
of interest rules are under review by the FPPC. They do not include
any changes in public disclosure for grant reviewers. In view of the
new information that confirms that reviewers are making 98 percent of
the decisions on who gets the taxpayers' dollars, it would seem that it is long past due for public disclosure of both financial and professional
interests of reviewers. Indeed, given the nature of scientific
research and the tiny size of the stem cell community, disclosure of
professional interests may be more important than financial
disclosures.
As Francis S. Collins, head of the NIH,
said concerning his organization's own strengthening of disclosure requirements,
"The public trust in what we do is just essential, and we cannot afford to take any chances with the integrity of the research process."
Here is the CIRM document concerning
reviewers' decisions and governing board action. The table has not
been posted on the CIRM website, but it was prepared for last month's
meeting dealing with the Institute of Medicine's recommendations for
sweeping changes at the agency, especially related to conflicts of
interest.
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