LLY Eli Lilly and Co

By Daniela Hernandez and Amy Dockser Marcus 

The National Institutes of Health has established sweeping new rules governing research conducted on humans, requiring scientists who receive federal funding to publicly disclose more of their research -- and causing confusion and consternation at some institutions.

The guidelines expand what constitutes a clinical trial and require scientists to register a larger swath of human research on the public online repository for clinical trials, Clinicaltrials.gov. Researchers must now report their findings on the site within a year of study completion or risk losing future funding. Previously, they were only required to post results of certain studies submitted to the U.S. Food and Drug Administration, with the expectation that results would be published in academic journals.

The new rules are part of a push for greater transparency and accountability for the NIH's huge investment in biomedical research. In the past, many organizations have failed to properly register studies and report their findings, actions that NIH officials say result in misspent funds, potential human harm and a lack of public trust in science. NIH invests about $3 billion annually in biomedical research.

"This suite of policies was designed to begin to solve some of these problems," said Carrie Wolinetz, NIH's associate director for science policy, adding that it will help the agency keep a better record of the number and kind of trials it funds. Ultimately, the goal is to improve the quality of science nationwide, she said.

The changes, which have been in the works for years, became official in January but the effects will roll out over time as researchers begin to propose, conduct and publish new research.

Some scientists say the changes add undue burdens, especially for behavioral scientists and psychologists doing research, such as questions related to human development or basic brain function, that hasn't traditionally fallen under the definition of a clinical trial. Under the new rules, a study is considered a clinical trial if the work involves humans, assigns volunteers to an intervention before the start of the study, evaluates the effect of an intervention on volunteers, and measures health-related biomedical or behavioral outcomes.

The new guidelines would make basic behavioral and functional research subject to more stringent registration and reporting requirements. But such studies don't pose the same risks to humans as a traditional clinical trial, according to a letter sent to the NIH last year by four organizations that represent hundreds of academic and medical institutions, expressing concern about the rules.

Some academic medical and pharmaceutical companies said they have increased their staff to handle the additional paperwork or had current employees take on more responsibilities.

Stanford University School of Medicine is "adding five or six full-time employees to our overall infrastructure for human research," said Mark Cullen, senior associate dean for research.

Dr. Cullen said many of his researchers are still worried and confused about how the new policies will affect their work; the new hires are meant to add to an existing support system made up of roughly 100 staffers.

Universities and research organizations are also updating websites and forms to reflect the new requirements, holding town halls to answer questions and train investigators, and providing information through online training, according to Evan Mayo-Wilson, an assistant scientist at Johns Hopkins Bloomberg School of Public Health and a co-author of a letter published in Nature Human Behaviour arguing that the NIH policy presents challenges for behavioral scientists.

Dr. Mayo-Wilson said he was working with a national group of administrators to determine if academic organizations have the staff and resources they need to insure compliance. They are planning a follow-up study in the spring.

Eli Lilly & Co. has about 10 people companywide involved with "transparency and reporting," and those employees "have picked up a little more work," said Ben Rotz, the drugmaker's senior adviser for global medical strategy and operations. But, he added, Lilly is already experienced with Clinicaltrials.gov and has "already gone beyond" the new requirements.

Some scientists say they fear the reporting requirements could hurt their prospects for future funding if they have to post all studies that yielded negative results. Under the old rules that required publication in journals, negative results often remained undisclosed because journals prefer to publish positive findings.

"The release of negative results not only prevents duplication and potential unnecessary risk to human volunteers, it also advances our understanding of the science," said NIH's Dr. Wolinetz.

Another question in scientists' minds: Will these new rules be enforced?

Rules will drive change only if the NIH and the FDA, which approves human trials, are willing to enforce compliance, medical ethicists said. In the past, NIH has been reticent to police scientists who don't share their results, some scientists said. Dr. Wolinetz said NIH was "fully prepared to enforce our policies."

Write to Daniela Hernandez at daniela.hernandez@wsj.com and Amy Dockser Marcus at amy.marcus@wsj.com

(END) Dow Jones Newswires

February 03, 2018 08:14 ET (13:14 GMT)

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