From Patient Advocates to Presidents: Decision-making Roles on Billions in Research

Directors of the California stem cell agency are moving to spell out the roles of the players who make the de facto decisions on its $3 billion in research funding.

This Wednesday evening in Burlingame, Ca., the directors' Science Subcommittee is scheduled to consider delineating the functions of members of the grant review group, also known as the Grants Working Group, along with CIRM staff in connection with grant reviews. Although the full CIRM board has legal authority to approve or reject grants, it almost never overturns a positive decision by the Grants Working Group on an application.

The agenda for Wednesay's meeting contains the full text of the addition to the working group's bylaws, but it does not say why changes are needed in the reviewers' closed-door procedures. However, from time to time, CIRM directors have commented during their public meetings that it is not always clear to the scientific reviewers what the full process entails.

Among other things, the bylaws addition spells out the role of the CIRM president, Alan Trounson, and other CIRM staff. It says the president can participate in discussions but cannot assign scores or vote. The president, however, has the top decision authority on grant pre-applications, which are a separate process. 

The new language makes it clear that the high-powered scientific reviewers can be expected, from time to time, to be asked by staff to explain themselves, or as the new bylaw phrases it, to “clarify their views or address specific issues in order to present a complete and useful” public review summary report to the CIRM governing board.

Also added to thebylaws would be this language,

“Prior to governing board consideration of GWG recommendations, the president and scientific staff should consider whether there are applications which they believe warrant particularly close review by the board, or whether specific modifications may be needed to successfully execute a particular proposal.”

The bylaw change also deals the roles of the eight patient advocates on the grant review group -- all of whom are also members of the CIRM governing board. They play a key role during “programmatic review,” an extremely broad-ranging process.

The bylaws addition states:

“Programmatic review is led by one of the GWG (Grants Working Group) vice chairs, who is a patient advocate, or a patient advocate member designated by the vice chairs. During programmatic review, patient advocate members of the GWG join the scientist members to make and vote on programmatic motions and funding recommendations to the gtoverning board. Programmatic review is intended to allow consideration of issues beyond scientific merit, such as disease representation and societal impact. In making funding recommendations to the governing board, GWG members consider the scientific merit of each application, as reflected in the scientific score, as well as any programmatic issues raised.”

The chairman of the CIRM Scientific Subcommittee is a patient advocate, Jeff Sheehy, who is also vice chair of the review group and plays the leading patient advocate role in the CIRM working group. Additionally, Sheehy, a communications manager at UCSF and nationally known HIV/AIDs advocate, almost invariably leads the full board discussion prior to action on grant applications.

In addition to the meeting location, the public can participate in the session at a teleconference site at UC Irvine. The address can be found on the agenda.