Stem cell agency’s DEI program still a work in progress

They were perfect 10s. And the chair of the $12 billion California stem cell agency made a point of bringing that to public attention.

The occasion was a meeting of directors of the agency last month to approve $50 million in awards to researchers. The 10 was the score chalked up by two then unidentified applicants to study HIV and leukemia. The perfect marks came on the DEI (diversity, equity and inclusion) portion of the application.

“I wonder if we’ve ever had a meeting with so many high-scoring DEIs presented at the same time,” said Vito Imbasciani, who has been chair of the agency only since early this year.

The California Stem Cell Report also believes the scores are unique, having sat in on virtually every meeting during which the agency approved awards since 2020.

It was then that the agency, the largest such state program in the nation, began to require scientists applying for millions in research funds to include plans that would generate measurable results – not platitudes – in boosting diversity and equity.

The push for diversity and equity has been much in the news recently. In June, the U.S. Supreme overturned affirmative action programs at universities and colleges. In March, Texas A&M removed DEI from its admissions and employment practices. And in California, a federal court recently ruled that California’s diversity mandates for corporate boards violate the federal constitution.

It is a trend that the state’s stem cell agency does not intend to join based on its performance over the last three years. But there is clinker in the CIRM effort – secrecy.

Since 2020, the agency, formally known as the California Institute for Regenerative Medicine (CIRM), has increased its rigor involving DEI under the direction of its 35-member board, particularly involving Ysabel Duron, a patient advocate member of the board, president of the Latino Cancer Institute and a member of  President Biden’s National Cancer Advisory Board.

She led the way in 2020, insisting that the application review process require plans to deal with diversity and equity in the research process. She is not alone. Others have stepped forward as well, particularly former board member Al Rowlett, another patient advocate member of the board and head of Sacramento’s Turning Point Community Programs.

Since 2020, the agency, formally known as the California Institute for Regenerative Medicine (CIRM), has increased its rigor involving DEI….But there is clinker in the CIRM effort – secrecy.

“I am proud that CIRM has also demonstrated a strong commitment throughout its programs to address diversity, equity and inclusion,” Duron said in an article last year dealing with CIRM and DEI.

“(We) should spotlight and SHARE (Duron’s capitalization) best DEI practices, be it those that CIRM adopts or that a researcher implements. Racial and ethnic communities should hold us accountable since it is their taxpayer dollars as well that make the invaluable work of CIRM and the funded researchers possible!”

However, CIRM is yet to share its files detailing the “best DEI practices.”

In biomedical research and medicine, DEI has a different significance than in many other enterprises. It can involve life, death, pain and suffering, During the COVID-19 pandemic, “gravely disparate outcomes” were reported for people of color. Failure to include representation of different groups in clinical trials leads to imperfect medicine, an array of research shows.

However, CIRM placed the DEI plans in the application review process, which is conducted in private. Applications are secret and are not reviewed by the entire board, but only by 15 or so scientific reviewers whose identities are withheld. Six patient advocate members may participate but vote only on the DEI component of the application.

A 19-member subset of the full board ratifies the decisions of the reviewers later during a public meeting. But it does not see the names of the applicant scientists, their institutions or the full application – only a public summary of the reviews compiled by the CIRM staff.  (See here for the summary from the July 27 public award meeting with the two perfect 10s.)

Prior to submitting applications, scientists are provided with written instructions and definitions of what is needed for the DEI component of their applications. For clinical trial applications, which can range up to $20 million, scientists are asked to demonstrate a commitment “to developing a therapy that will ultimately serve the unmet medical needs of the diverse California population, including underserved and disproportionately affected populations.

DEI plans are different than the tricks of the scientific research trade and do not amount to commercial scientific property, which is also kept under wraps.

“Teams are asked to describe disparities that may impact populations that would ultimately utilize their product, set reasonable trial enrollment targets, and allocate appropriate resources to meeting DEI goals within their project.”

Plans are evaluated during the closed door review to determine how likely they are “to achieve inclusive outreach, engagement, enrollment, and retention of trial participants from underserved or disproportionately affected populations.”

Applicants must also show “how well the proposal addresses and will increase cultural sensitivity on the project team and at partner institutions.”

CIRM has a general commitment to openness and transparency. In the last three years, it has stepped up requirements for scientific data sharing in hopes of speeding development of revolutionary therapies. CIRM is also committed to building databanks that are based on a national data sharing standard called FAIR.

But the agency is also committed to protecting proprietary information and trade secrets. That is the justification for much of the secrecy in the application review process.

However, DEI plans are different than the tricks of the scientific research trade and do not amount to commercial scientific property, which is also kept under wraps.

Secrecy in science should not stand in the way of equity in medical treatment, DEI supporters argue. What better way to help solve these equity issues than to lay out in public the very best DEI proposals submitted to CIRM. Creating a sound DEI plan that can be successfully executed is no small matter. Larger institutions with their greater resources usually can craft better plans.

Duron and others argue that releasing them to the public in a databank would serve CIRM and California well by helping to develop therapies that can be used with all persons in our society. The plans could serve as templates, a road map to equality that would assist all public and private institutions that are attempting to devise DEI plans that truly work.

And that brings us back to the two perfect 10s. Both plans were submitted by researchers Elizabeth Budde and John Zaia at the Beckman Research Institute at the City of Hope in Duarte, California. Both applications involved clinical trial awards for $12 million. You can find the CIRM review summaries of the plans here. (Search on the application numbers CLIN2-14748 and CLIN2-15087. The summaries do not identify the researchers by name.)

CIRM’s DEI requirements are a work in progress. They have been altered significantly since 2020. More changes are likely in the future to assist researchers in pulling them together. Plus the agency is interested in revisiting the results to see their impact and what more can be improved. Whether CIRM will release the secret plans remains up in the air.

Jensen has covered the state stem cell and gene therapy program since 2005 on his newsletter, The California Stem Cell Report. He also authored a history of CIRM’s first 16 years, “California’s Great Stem Cell Experiment.”