Researchers conducting some classes of research with human participants will have less paperwork under a new federal guideline.Credit: Getty
Many researchers are surprised and relieved over an unusual step taken by the US National Institutes of Health (NIH): the agency is rolling back the red tape on a host of basic-science experiments that involved human participants and had been classified as clinical trials.
The decision, which was announced on 29 January and is part of a broader NIH effort to reduce administrative burden, should free such research from the heavy bureaucratic requirements that are designed for clinical trials but are sometimes ill-suited to other fields, such as basic psychology and behavioural studies. “It was definitely a nuisance,” says Jeremy Wolfe, a cognitive psychologist at Harvard Medical School in Boston, Massachusetts.
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Others, however, say that the agency should refine implementation of the requirements, rather than dropping them altogether. “This is not the right solution,” says Holly Fernandez Lynch, a lawyer and ethicist at the University of Pennsylvania in Philadelphia. “We should go back to why we thought this was an important requirement to impose in the first place and figure out how we can achieve the underlying goal.”
Broad definition
In 2014, the NIH expanded its definition of ‘clinical trial’ to include some studies of foundational biology in order to increase the transparency of research on human participants, says Deborah Zarin, a former director of the NIH database ClinicalTrials.gov. The clinical-trial designation usually comes with an obligation to preregister experiments and publish results on ClinicalTrials.gov.
This was intended, in part, to address the fact that many studies on human participants are never published in academic journals: negative results, in particular, often remained locked away in laboratory notebooks. That made it difficult for researchers to learn from each other’s failed experiments and replicate results, and for participants and ethics committees to fully evaluate a proposed study.
In addition, preregistration of experiments, which is common for clinical trials, can improve the quality of the work by pushing researchers to adhere to their predetermined study designs, making it more difficult to ‘cherry-pick’ results by reporting only positive findings.
Reporting results and ensuring they are analyzed properly are particularly important when it comes to research involving human participants who often offer their time and, in some cases, take on personal risk because they are told that their efforts will advance science, says Zarin.
Inconsistent advice
Many scientists agree with those concerns, says Wolfe: “It seems everybody is basically on the same page on the ethics and the open-science aspects of all of this.” The trouble, he says, was in the implementation of the NIH’s requirements.
