Shame, Shame, Shame

If you accept CIRM's arguments for withholding grant applicant information, the San Diego Stem Cell Consortium has taken an enormous risk that it could shame itself in public.

The consortium says it is seeking $50 million from CIRM for new lab construction, according to a report by Terri Somers of the San Diego Union-Tribune. The new building would give 110 scientists a place to work. It would be built on UC San Diego property with construction beginning in 2009. The San Diego Supercomputer Center and Craig Venter, the biologist who was a primary driver of the Human Genome Project, also plan to contribute to the project.

All of that is considered confidential information by California's stem cell agency, which plans to give away $263 million in public money next year for new lab construction. CIRM considers the information so sensitive that the release of it would severely embarrass the consortium if its request for funds is turned down.

Balderdash, is what we say.

Fresh Link to More on Lab Grants

Here is a link to the news release by the Foundation for Taxpayer and Consumer Rights on today's disclosure of the identities of 12 of the institutions seeking $262 million from CIRM.

We must renege on our earlier promise to publish more on this subject today. Other responsibilities have risen to a higher level.

Names Disclosed of 12 Applicants for $260 Million in Lab Grants

The California stem cell agency today identified the 12 institutions recommended for consideration in the second round of competition for $260 million in grants to build new stem cell research labs.

They are the University of California campuses at Berkeley, Davis, Irvine, Los Angeles, Merced, Santa Barbara, Santa Cruz and San Francisco, the University of Southern California, Stanford, the Buck Institute and the San Diego Consortium for Regenerative Medicine, which includes UC San Diego, Burnham, Salk and Scripps.

The institutions were recommended for funding by the Grants Working Group, which conducted a scientific review of the proposals earlier this year. They will go to the Oversight Committee in January and, if successful, to the Facilities Working Group in the spring. Then the plans will come back to the Oversight for final action in April.

The California Stem Cell Report and the Foundation for Taxpayer and Consumer Rights have advocated release of the names for months.

John M. Simpson, stem cell project director for FTCR, said, today's announcement was "completely inadequate."

In response to a query, he said,

"We don't know what the universities asked for. We only know what the scientific reviewers in their closed, clubby, secret meeting decided to recommend.

"Even worse, we don't know the five institutions that were excluded from CIRM's club of chosen ones.

"This is no way to spend more than $250 million in public money. Frankly it looks like the only reason the names are being released is so the lucky institutions can go forward and hit private donors up for more money before the tax year ends."

In response to a question, Ellen Rose, interim communications officer for CIRM, said the institution was releasing the names "because we want to give them as much time as possible to most effectively fund-raise for the project leverage portion that they will be raising for the new facilities."

CIRM plans to look more favorably on applicants that have raised large sums to contribute to the building projects.

The agency did not release the names of the five institutions that were turned down. We will have more on the CIRM announcement later today.

(Editor's note: An earlier version of this omitted Stanford from the list of 12.)

Proposed Lab Grant Review Procedures Posted

The California stem cell agency has posted more information on its proposed procedures for the facilities group review of applications for $227 million in grants for construction of stem cell research labs.

You can see the 18-page Power Point presentation here. The San Francisco meeting to consider them is Nov. 15.

More Details Due Friday on Lab Grant Meeting

Regarding the $227 million lab grant item below, Richard Murphy, interim president of CIRM, just sent us the following:

"The slides with the specifics for the meeting are in the process of being edited and should be available on the Web Friday."

How to Wrestle with Requests for $227 Million: CIRM Agenda Vague

The California stem cell agency will deal once again next week with its plans for its largest round of grants ever, but exactly what is on the agenda is a virtual mystery.

No matter. If you are looking for some cash to build labs, you better be at the Facilities Working Group session Nov. 15. The details are what counts here, and missing one could mean the loss of tens of millions of dollars.

On the agenda is something listed only as "Consideration of Process and Procedures for Major Facilities Grants Review Meeting." We queried CIRM for more details. None were forthcoming. Perhaps they will be available in time for applicants and other interested parties to make plans to be in San Francisco.

The facilities group will be dealing with the applications for $227 million in lab construction grants next year, following the scientific review and the first cut in January by the Oversight Committee. The scientific review will be behind closed doors but the facilities group session is scheduled to be public.

Secrecy: A Recipe for Scandal

Seventeen California universities and research institutions have applied to the California stem cell agency for $227 million to build major new labs throughout the state.

It is single biggest round of grants in CIRM's short life.

As usual, CIRM refuses to release the names of the applicants, making it difficult for the public to comment, support or express reservations on the grants during the most critical stage of reviews. However, it is fair to say that any institution with a significant stem cell research presence will have applied along with those who are seeking to build that capacity. It is also fair to say that public disclosure of names of grant applicants, prior to formal review, would have avoided the flap earlier this year about a $2.6 million grant to CHA RMI in Los Angeles.

In the case of the lab grants, applicants are certain to include nearly all the University of California campuses, Stanford, USC and the San Diego stem cell consortium, which includes Salk, Scripps and Burnham in addition to UC San Diego.

So if you readers have any reservations about the ability of those institutions to make good use of a $20 million or so lab grant, you can email or write CIRM, whose web site -- www.cirm.ca.gov -- carries all the contact information.

Earlier this week, the California Stem Cell Report and the Foundation for Taxpayer and Consumer Rights appealed to the agency to reconsider its secrecy policies in connection with the use of $227 million in taxpayer funds. No, was CIRM's response.

The secrecy policies, however, fly in the face of the spirit if not the letter of the California Constitution, which states that the people of the state have a "broadly construed" right to access to information involving the public's business. The amendment to the constitution was approved by 83 percent of voters in 2004. That was the same year voters approved creation of the stem cell agency by only 59 percent.

CIRM is an agency controlled by a 29-person board that is riddled with conflicts of interest. Ultimately it is in the agency's own best interests to operate with more openness. Handing out hundreds of millions of dollars behind closed doors with no public disclosure of the conflicts involving reviewers is a recipe for scandal.

No Support From CIRM Group on Public Disclosure on Lab Grants

A move to reveal the identities of the major universities and research institutions seeking $227 million in California taxpayer funds for stem cell lab construction was turned aside today by a key committee of the state's stem cell agency.

The Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca., and the California Stem Cell Report appealed to the Grants Working Group to make an expression of support for public disclosure of the names of institutions and for opening review of their applications to the public.

The group took no action on the requests. Only two members of the group responded. Marie Csete(see photo), a scientist from Emory University, said the most important elements of the review involve the work that is proposed at the facilities – not the labs themselves, which she described as "tools." She also noted that the reviewers are funding the work of their "competitors." California stem cell Chairman Robert Klein endorsed Csete's remarks in a brief comment.

Our comment. One of the stronger arguments for public disclosure and review is the fact that the scientific reviewers are dealing with the livelihoods of their professional competitors. While the reviewers are all from out-of-state, the stem cell world is truly global. It is also small and intensely competitive. We should also note that the reviewers are not eligible for funding from California. That contrasts with the NIH, whose grant reviewers are eligible for funding from that agency. At the California stem cell agency, scientific reviewers receive only a small stipend and expenses for the time they spend away from their own work. They basically do it for free with perhaps the major benefit coming from a chance to see interesting proposals from California scientists and meet with their peers at CIRM expense.

Below are the statements read to the grants group this morning.

Text of Statement by CSCR on Open Review of Lab Grants

Here is the statement by the California Stem Cell Report at the Oct. 23, 2007, meeting of the Grants Working Group of the California stem cell agency.

By way of introduction, my name is David Jensen and I publish the California Stem Cell Report on the Internet. I have followed the affairs of the California stem cell agency since December 2005 and have published nearly 1,400 items involving CIRM.

First, I want to express my appreciation for the work you are doing here today and tomorrow, especially to those of you from out-of-state. Spending two days in a hotel reviewing complex grant proposals – taking time away from your own work and families – is not a minor matter. Thank you.

My main point today involves the openness and transparency of the proceedings of the California Institute for Regenerative Medicine, an agency unlike any state department in California history. As a result of the enactment of Proposition 71, CIRM operates outside of much of the normal state government oversight and is virtually independent of the governor and legislature. At the same time, it is overseen by a board that includes employees of institutions that stand to benefit financially from the CIRM actions. In the case of the upcoming round of $222 million for lab construction, 17 of the 27 current members of the Oversight Committee could see their connected institutions benefit from a facilities grants.

Currently, review of applications from individual researchers is conducted behind closed doors. CIRM has decided to keep the discussions private in order to encourage maximum candor and frankness about the work of individuals, which would be discouraged if the reviews were conducted in a public.

However, applications for the major lab grants – which you will be reviewing in the not-too-distant future – are much different than those from the men and women who direct stem cell research labs. The applications for lab construction funds will come from huge institutions such as the University of California and other major educational and research enterprises. Their names and applications should be part of the public record. And your review of those applications for $222 million in public funds should be conducted in public.

It is hard to see a justification for a closed-door review of a lab grant application, for example, from UC Berkeley. In fact, the review of the lab grants will become public – but only after your group performs the most critical segment of the review. And that is where the public's interest is the greatest. One can argue that individual researchers and their applications should be discussed behind closed doors to avoid embarrassment and to encourage frankness. But that hardly applies in the case of an institution such as Berkeley, which regularly comes under the harshest form of public criticism with nary a flesh wound inflicted. Equating the sensitivities of UC Berkeley or other likely institutional applicants for lab grants to the sensitivities of an individual researcher would seem to defy common sense.

The California stem cell agency has a special public trust. One of its missions is to encourage public support and understanding of human embryonic stem cell research. And it should not hand the foes of good science additional weapons that can be used to attack such research. Conducting grant reviews unnecessarily behind closed doors only feeds suspicion and the worst sort of speculation. Openness and transparency inspire public confidence and make it clear to all that no mischief is afoot.

I urge you to consider making an informal expression of sentiment to CIRM and the Oversight Committee in favor of publicly identifying applicants, publicly releasing their applications and conducting the scientific review of the lab proposals in public. If there are segments of the applications that must be examined in private, that can easily be done in an executive session, just as the Oversight Committee does when it considers applications after your work is done.

Opening the doors on the lab grant review would reflect well on the agency and be an important step in fulfilling CIRM's promise of adherence to the highest standards of openness and transparency. Thank you.

Text of FTCR Statement on Open Review of Lab Grants

Here is the statement by the Foundation for Taxpayer and Consumer Rights presented at the Oct. 23, 2007, meeting of the Grants Working Group of the California stem cell agency.

First, I’d like to apologize for not being able to be present today and thank David Jensen of The California Stem Cell Report for reading this on my behalf. Second, I’d like to thank all of you for serving on the Grants Working Group. We truly appreciate your efforts.

By way of introduction, I’m John M. Simpson director of the Foundation for Taxpayer and Consumer Rights Stem Cell Oversight and Accountability Project. Funded by the Nathan Cummings Foundation since December 2005, the project seeks to ensure that the taxpayers funding California’s landmark $6 billion stem cell research program have affordable access to any of the discoveries they have funded. As part of the project we have challenged the validity of the stem cell patents held by WARF.

In a few minutes you will enter closed session to review the scientific merit of applications for New Faculty Awards. While I don’t agree, I understand the argument that the applicants’ names and the deliberations should be confidential to protect individual researchers from possible embarrassment.

I don’t intend to reargue that issue now. Rather, I’d like to ask you to look ahead a bit. Soon you will be weighing the scientific merit of requests from various California universities and research institutions for their share of $225 million in grants to build laboratories. As it now stands those institutions are not being identified and the reviews will be done in secret.

Ironically, the applications will be publicly reviewed later in the process by the Facilities Working Group when it weighs the proposals on their technical merits of design, construction and such.

To this outside observer that means it's OK to embarrass an institution because it can't design and build a decent building, but it's not all right to embarrass its scientists.

Sadly the public will inevitably view this as a remarkable self-serving, in-bred club that is doing scientific reviews. That's the real embarrassment. If scientists’ egos are so fragile they can't stand public scrutiny, they ought not to have a shot at public money. Nor should the institutions that employ such tender souls.

I ask you to please strike a blow for transparency that publicly funded stem cell research requires. Take the opportunity to show the public how the scientific review process works. Please take a vote amongst yourselves that urges the facilities applicants be identified and the scientific review be public.

Thank you.

More Openness Emerging at CIRM?

The California stem cell agency has long concealed the identities of applicants for millions of dollars in grants even when the applicants are such public entities as the University of California.

But there are signs of changing sentiment on CIRM's Oversight Committee. At the board's August meeting, some members indicated that they favored disclosing the names of institutional applicants for $222 million in lab grants and at least some portion of their applications.

For example, Oversight Committee member Francisco Prieto, a Sacramento physician, asked his fellow committee members,

"Why could we not release the names of the applying institutions and the outlines of the proposals without actually opening up the actual review? I understand that in the review of the RFAs and within the meetings that there are comments made about strengths and weaknesses of individual investigators and teams and things that could affect people's careers, but the institutions and the outlines don't have any personal interest. "

In response, Chairman Robert Klein said the matter would be brought up at next week's Oversight Committee meeting in San Diego. He said,

"I personally think that we have an opportunity here to have some more disclosure, that while protecting confidential information, proprietary information, personnel information of people that are being hired, etc."

Later David Kessler, an Oversight Committee member and dean of the UC San Francisco School of Medicine, indicated he was sympathetic to providing the names and some information concerning the institutions' applications.

Kessler made his comments after John M. Simpson, stem cell project director of the watch dog group, the Foundation for Taxpayer and Consumers Rights, noted that lab grant process has two steps. The first is a closed- door scientific review of applications from institutions, whose names are also secret. The second is public review of the actual construction proposal with the names disclosed.

Simpson said the board was

"...setting up a procedure by which, as I see it right now, you cannot risk the embarrassment of a university because it can't do science, but you can embarrass them because they don't know how to build a building. That just doesn't make sense. It doesn't serve the scientists, nor the architects, especially the public at large."

Last month, the California Stem Cell Report called on CIRM directors to make more information public concerning the identity and proposals of applicants for the lab grants.

Lab Grant RFA Now Available

The California stem cell agency has posted the request for applications for $227 million in lab construction grants, the largest round in its history. Letters of intent are required by Sept. 26. The news release can be found here. The RFA can be found here.

CIRM Overseers to Consider More Public Disclosure on Lab Grants

California stem cell Chairman Robert Klein has put off requests to open up the lab grant process until the October meeting of the Oversight Committee, but says he is "supportive" of increasing public access to information.

In response to our letter last week asking that the names of applicants, their letters of intent and applications be designated as public records, Klein replied by email Tuesday, saying:

"Your letter has been provided to all ICOC board members. I’m supportive of increasing access to information on the major facilities grants. I will ask the board to formally consider this policy as an agendized issue with a staff report at the October 2007 board meeting."

Public access to lab grant review proceedings came up during the Oversight Committee hearing on Wednesday. John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, asked that all meetings in which grant applications are reviewed be open to the public.

Klein pointed out that only the scientific review sessions are closed. The reviews by the Facilities Working Group are open and the names of applicants would be disclosed at that point.

Simpson said that argument seems to mean that you can't embarrass the institutions about "not doing good science but you can for doing bad facilities." The board has also emphasized that the scientific review is paramount in assessing the applications.

Arlene Chiu, interim chief scientific officer for CIRM, opposed opening the scientific review meetings to the public. She said full candor is needed to evaluate the programs at various institutions. That is not likely to occur if it is done in public, she said.

Our view is that the scientific review should be open, but we understand her argument. Sensitive or "proprietary" information, however, could be evaluated in private, if necessary, with the bulk of the review sessions in public. The same logic could also apply to information on applications, although full disclosure is preferred.

During Wednesday's meeting, Michael Friedman, an Oversight Committee member and president of the City of Hope, said the lab grant process is "the most politically charged" of CIRM's activities. That reflects the fact that 15 out of the 29 members of the Oversight Committee have ties to institutions that could stand to benefit from the grants.

Following Wednesday's meeting, Klein told the California Stem Cell Report that he wanted to "make steady progress towards more disclosure." But he said it may take some time for all to become "more comfortable" with complete openness.

What do you think? Should universities and research institutions seeking $227 million in public funds be required to publicly disclose their identities and other information? You can comment clicking by on the word "comment" below. Ironically, our blog host, Google, permits anonymous postings but, of course, most of you will want to identify yourselves, right? Fire away.

Sharpen the Pencils, Line Up the Finest Grant Writers!

Lab builders around California can expect to see the detailed requirements for $227 million in grants from the California stem cell agency in a couple of weeks.

On Wednesday, the Oversight Committee for the institute gave the go-ahead on the proposal, but with not without some changes. One boosted the funding range on the size of some of the grants. In the CIRM Institute category, the top of the range moved from $40 million to $50 million. In the Center of Excellence category, the top rose from $20 million to $25 million.

Ed Penhoet, vice chairman of the agency, said $40 million might not be enough. He said the board wanted to encourage collaboration on the labs but that if grant size were not large enough, each institution instead might submit separate applications. Jeff Sheehy noted that only one "true" consortium seems to currently exist. That is in the San Diego area and involves UC San Diego, Salk, Burnham and Scripps.

John Reed, another Oversight Committee members and president of Burnham, unsuccessfully sought to change the proposed scoring to give 20 instead of 15 points out of 100 in the "shared resources" category. He argued that would reflect the board's strong encouragement of collaboration. John M. Simpson, stem cell project director for the Foundation of Taxpayer and Consumers Rights, noted the change would help tilt scoring towards consortiums.

The board approved virtually all of the other elements of concept plan for the lab grants, and CIRM staff said the RFA would be out within a couple of weeks. Final approval of the grants is scheduled for next April, with an initial screening of the scientific portions of the applications at a January meeting of the Oversight Committee.

FTCR: Open Up $227 Million Lab Grant Program

A watchdog of the California stem cell agency today called for making public the names of applicants for the institute's massive $227 million lab construction program.

Writing in an op-ed piece in The Sacramento Bee, John M. Simpson of the Foundation for Taxpayer and Consumer Rights said:

"Putting scientific review on a pedestal behind closed doors does nothing to help the public's understanding of, and therefore faith in, the process. Looming over it all is the legally mandated, conflicted structure of the board. Virtually all of the university and research institutes represented on the board will seek money for buildings. It behooves members in their own best interest to demonstrate pure motives by keeping the process completely transparent.

"The stem cell committee should direct that scientific review of building projects be handled like the facilities review -- in public. As it stands now, the two-step process is apparently premised on the notion that it's unwise to risk embarrassing an institution for its lack of scientific ability, but it's all right to say it doesn't know how to construct a decent building. That approach serves neither scientist nor architect, but especially not the public."

Simpson's position echoes ours. We sent a letter last week to the Oversight Committee, asking it to take action on the matter at its meeting Wednesday in San Francisco.

$5 Million Boost for Major Lab Building Proposal?

The California stem cell agency has posted a "concept plan" for a $227 million lab grant proposal that contains more details, definitions and timelines.

It also includes proposed breakdowns for the various funding categories (CIRM institutes, centers of excellence and special programs). Institutes would compete for grants each of $25 to $40 million, centers of excellence for $10 to $20 million and special programs for $5 to $10 million.

However, the concept plan, available on CIRM's website, said:

"There is no analytical basis at this time to determine the appropriate amount of funds to be allocated to each category, and this information will not be available to the ICOC until the GWG (grants working group) submits its recommendations."

The document went on to say that CIRM staff “has evaluated several scenarios for funding” and recommends that the Oversight Committee on Wednesday adopt the ranges above, presumably for the time being.

CIRM also said that the agency committed less than expected in its earlier shared lab proposal, making another $5 million available for the latest grant effort. It recommended that the Oversight Committee commit the additional funds to the major lab grant effort.

Much of the material in the plan duplicates earlier documents, but, as they say, the devil is in the details, plenty of which are contained in the concept plan.

Time for More Openness in $220 Million Grant Program

The California Stem Cell Report today formally called on directors of the California stem cell agency to open up the $220 million lab grant process by making the names of applicants and other related information a matter of public record.

In a letter to California stem cell Chairman Robert Klein, David Jensen, publisher of the report, said such action would conform to the letter and spirit of the California Constitution, which guarantees the public a broadly construed right of access to information about “the conduct of the people's business.” He also said opening up the information would help to preserve public confidence in embryonic stem cell research.

Here is the text of the letter:

"This letter is to request that the Oversight Committee -- as part of the RFA to be considered for major labs at the Aug,. 8 meeting -- stipulate that the names of the applying institutions, their letters of intent and applications are a public record when they are received by the California Institute for Regenerative Medicine.

"Such action by the ICOC would serve the best interests of CIRM and its goal of adherence to the highest standards of openness and transparency. It would also comply with the letter and spirit of the California Constitution, which declares that the people of California have “the right of access to information concerning the conduct of the people’s business” -- a right that is to be “broadly construed.” As you know, 83 percent of voters approved that constitutional right of access in November 2004 when they passed Prop. 59.

"In many ways, the California Institute for Regenerative Medicine is very open, which is a tribute to the Oversight Committee's commitment to transparency.

"But now, as the agency embarks on its single largest round of grants, it is time to take another step to protect the public interest and the agency itself as well. Fifteen members of the Oversight Committee have ties of one sort or another to institutions that may well seek funds in this round of lab grants. The entire University of California system is represented on the board, along with Stanford University, the Burnham Institute and other well-regarded institutions. On Aug. 8, the board will set the rules under which employers of many of its members stand to benefit by tens of millions of dollars. Combine all that with the critically important but closed-door, scientific review of the applications, and you have an information void that can only lead to the worst sort of speculation. Making the applicant names and other information public goes a long way in helping to prevent such a situation.

"In the past, CIRM has made a case for privacy on research grant applications from individual scientists. But applications from government and nonprofit institutions are fundamentally different. They are not subject to the same concerns that individual researchers might have regarding their reputations or work.

"We urge you to act in the public's best interest and open up the $220 million lab grant process by making public the names, letters of intent and applications from all institutions seeking funds. Such a move will enhance CIRM's reputation and help to maintain public confidence in embryonic stem cell research."

Golden Eggs on The Stem Cell Blog

Time to move off this channel briefly and visit The Stem Cell Blog (published by Chris Scott of Stanford) to read a guest posting from this writer on the $220 million lab grant program at the California stem cell agency. It begins:

“You could call it a stem cell variation of the chicken and egg question.

“But in this case, it involves edifices – not eggs. And researchers – not roosters. Which is more important?”

A little later this afternoon we will have an update right here on this site concerning this morning's developments at CIRM. The Facilities Working Group modified the rules for making the lab grants and moved them along to the full Oversight Committee for consideration Aug. 8. The intention is to see at least some institutions begin construction on their approved facilities in January.

Lab Grant Evaluation Standards

The evaluation standards for the $220 million lab grant program have now been posted on the CIRM website and are available here.

Upcoming This Week: Japanese Stem Cell Lines, Lab Grants and Presidential Search

From $220 million in lab grants and Japanese stem cell lines to the latest chapter in the search for a CEO, the California stem cell agency is set for a busy week.

We want to point out the background material prepared for the Standards Working Group meeting on Friday. Posted last week well before the meeting, the paper neatly summarized the history behind the matters being considered, touched on the issues involved and offered up draft language to deal with the problem in two cases. It was a good example of staff work that improves the decision-making process.

The standards group, which regulates CIRM-funded research, will consider whether to include some Japanese stem cell lines as "approved" for study. They would join some lines from Great Britain and Canada as ready to use. That means that research using them does not have to go through a more lengthy review process. Specifically, the Japanese lines being considered are ones derived under the "Japanese Guidelines for Derivation and Utilization of Human Embryonic Stem Cells."

The group is also scheduled to consider a problem in connection with informed consent requirements and research involving somatic cell lines. The agency's regulations created a situation in which "existing somatic cell lines obtained with informed consent may not be available for reprogramming experiments unless consent was obtained in accordance with the exact requirements of section 100100 (of CIRM regulations)."

The staff report said,

"The SWG might consider a more flexible standard for use of somatic cells. Interviews with leading researchers suggest the inability to utilize commonly available commercial somatic cells (non-covered stem cell lines) lines would limit CIRM-funded researchers from attempting to replicate studies."

On Wednesday, CIRM will conduct a session for "interested parties" on the $220 million lab grant effort. Proposed evaluation standards are scheduled to be posted Monday on the CIRM web site. Earlier, the agency posted the criteria and scoring. On July 30, the Facilities Working Group will wrestle with the subject once again, but the ball is rolling faster, so you applicants should pay close attention. Don't be shy about communicating with the agency if you can't be at the meetings.

On Tuesday, the Oversight Committee will convene for the third time in a month for a special, teleconference meeting to consider presidential compensation and candidates. They are legally equipped to come to a decision in their seven-month effort. But our bet is that no new president will be announced.