cientists spoke, the feds listened: With only two days left in office, the Obama administration on Wednesday issued new rules intended to protect people who participate in scientific research, stepping back from proposals that would have imposed significant new regulatory requirements on scientists.
In particular, the administration abandoned a proposal that would have required researchers to obtain written consent before using cells, blood, tumor samples, DNA, or other “biospecimens” obtained during medical procedures, even when the samples were stripped of the person’s name and other identifying information, or obtained from earlier studies the person had participated in. That was intended to prevent outrages such as the unauthorized use of cancer cells from patients like Henrietta Lacks, the African-American tobacco farmer whose tissue was taken in the 1950s without her permission or even her (or her family’s) knowledge.
Scientists argued that requiring them to track down such donors if, say, they wanted to run a different study on samples for which consent had been given for an initial study, would stifle research. It would have meant trying to track down patients and seek permission to use the samples. If they didn’t or couldn’t, the specimens would have been off-limits.
With the White House’s cancer moonshot, Precision Medicine Initiative, and other research efforts depending on huge numbers of samples, the requirement would have impeded investigations in cancer, neuroscience, genetics, and other fields, scientists told STAT last year.
Allowing researchers to study such biospecimens without written consent “is the most substantive change from the proposed regulation,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. Although the group had supported the effort to require such consent, Carome called the final rule “clearer, simpler, easier to understand, and appropriate.”
“This is a big win for science and therefore a big win for patients,” said bioethicist Holly Fernandez Lynch of Harvard Law School.
The proposed changes to the “Common Rule,” which has been in place in its current form since 1991 and governs research on people and human biological specimens, drew just over 2,100 comments during the 90-day public comment period after they were released in September 2015. Many raised what the Department of Health and Human Services, which oversees most federally funded research, called “concerns.”
In response, HHS explained in a statement, it revised the proposed rules not only to allow use of de-identified biospecimens without further consent but in several other ways.
The final rule does not expand regulations on human subjects research to cover clinical trials that are funded with private money, usually from pharmaceutical or biotech companies. Many patient advocates had supported that extension, especially in the wake of patient deaths in some clinical trials.
The new regulations also require researchers to work with a single institutional review board — the panels of experts and, usually, laypeople whose permission is required to run a study involving people — when a study is being conducted at several sites, as is often the case in large cancer, heart disease, and genetics studies. That is meant to insure that a single study is not subject to different, even conflicting, IRB decisions on whether patients are being properly protected. But unlike the 2015 proposed rule, the final one exempts some studies from this requirement.
Under the new rule, consent forms must give potential participants a better, clearer understanding of a study’s risks and benefits.
Allowing scientists involved in a clinical trial that recruits patients at multiple hospitals, doctors’ offices, and universities to get approval from a single IRB rather than the IRBs at every site “could invite IRB shopping,” said Carome of Public Citizen. “Researchers could choose the IRB with the lowest common denominator” in terms of how stringently it tried to protect volunteers.
Most of the provisions in the new rule will go into effect next year.
In November, congressional Republicans asked the administration not to finalize any of the proposed rules in the regulatory pipeline in its final months in office.