“The challenge of moving its research programs closer to the clinic and California’s large biotechnology sector is certainly on CIRM’s agenda, but substantial achievements in this arena remain to be made.”
“Far too many board members represent organizations that receive CIRM funding or benefit from that funding. These competing personal and professional interests compromise the perceived independence of the ICOC(the CIRM governing board), introduce potential bias into the board’s decision making, and threaten to undermine confidence in the board.”
“Recent controversy surrounding the Cancer Prevention and Research Institute of Texas grants process illustrates the importance of rigorous scientific review free from inherent or perceived conflict and the consequences when these boundaries appear to be breached.”
“Because the committee was not charged with reviewing CIRM's past funding decisions, it did not identify any specific cases of conflict.”The IOM surveyed members of the board (ICOC) about conflicts of interest. The report said,
"While a majority of respondents stated that personal interests did not play a role in their work on the ICOC, some responses were more equivocal. One respondent replied that it was 'hard to tell' given that 'so many decisions take place off camera in secret meetings,' while another acknowledged that ICOC members are human, and of course their decisions are influenced by personal beliefs and interests."
“California law focuses primarily on financial conflicts of interest, but the committee believes that personal conflicts of interest arising from one’s own or a family member’s affliction with a particular disease or advocacy on behalf of a particular disease also can create bias for board members. Studies in psychology and behavioral economics show that conflict of interest leads to unconscious and unintentional 'self-serving bias' and to a 'bias blind spot' that prevents recognition of one’s own bias. Bias distorts evaluation of evidence and assessment of what is fair.”
“The board should transfer management responsibilities to management so it can provide truly independent oversight and evaluation of management, strategic planning, and broad direction for resource allocation.”
- Greater engagement with industry to commercialize stem cell research. Noting that industry has received only 6 percent of the agency grants, the report said business representation on CIRM working groups and other committees “should be enhanced to leverage industry’s expertise and resources in product development, manufacturing, and regulatory approval in support of the ultimate goal of bringing therapies to patients.”
- Elimination of the current process in which applicants rejected by reviewers appeal publicly to the governing board. Noting that 32 percent of “extraordinary petitions” have been successful, the report said they “undermine the credibility and independent work” of grant reviewers. Instead appeals would heard only by staff behind closed doors.
- Creation of a new scientific advisory board, appointed by the CIRM president with a majority from outside of California, instead of multiple advisory groups. The report said,“Such an external board would be invaluable in vetting ideas for new RFAs, suggesting RFAs that otherwise would not have been considered, and helping CIRM maintain an appropriate balance in its research portfolio. Input from this board would help CIRM make fundamental decisions about dealing with challenges that cut across particular diseases, decide which discoveries should progress toward the clinic, and determine how best to engage industry partners in developing new therapies.”
- Funding of programs on bioethics and regulatory problems. The report said,“It is difficult for researchers to find appropriate funding for stem cell-specific ethics and policy work, and filling this funding gap is well within CIRM’s budget.”
“The critical tasks performed by the vice chairs should be reassigned to management. In particular, the important tasks of government relations and corporate relations both should be carried out by staff reporting to the president rather than by the vice chairs of the board.”