IOM Recommends Sweeping Changes at California Stem Cell Agency

 “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.”