The U.S. federal government is preparing to launch a set of sweeping new regulations that will have a major impact on how biomedical researchers and social scientists work. It will require researchers to change how they get ethics approval, how they collect informed consent from participants, and more.
“[rquote]These proposed rules are the first major changes in more than 40 years to the laws on how researchers get permission for studies[/rquote],” said Laura Stark, assistant professor of medicine, health and society, who has closely followed the evolution of research protocols and wrote a recent book on ethics regulations. “The results will be substantial.”
“The new rules apply to social scientists, psychologists, people running clinical trials, anyone using biospecimens – things like blood and tissue samples – anybody doing anything having to do with humans as a researcher.”
The new rules, which have been compiled over the past four years by the federal Office for Human Research Protections (OHRP), are now going through a 90-day comment period. The rules will take effect one year after the government edits the proposed rules based on those comments. Stark estimates that OHRP will release the final version of the rules next spring, which means they would go into effect the spring of 2017.
The OHRP is a division of the U.S. Department of Health & Human Services.
“I think the timetable for compliance will have institutions scrambling,” Stark said. “A year is a pretty short time frame to change how universities, administrators and scientists work in a day-to-day sense. Universities will need to change their forms and build new technologies, and researchers will have to learn new protocols, basically to reprogram a system that’s antiquated and hasn’t been touched for decades.”
The current situation
Researchers in the United States have long been required to get permission from their institution and their subjects for research involving humans. This differs from most of the rest of the world, where generally the federal government or an apparatus of it serves this function.
Universities and other research institutions in the United States are required by law to form Institutional Review Boards (IRBs), to whom researchers submit their plans for experiments involving human beings. The IRBs decide if the research can go forward.
“Researchers, as a rule, don’t like IRBs,” Stark said. “No institutions or universities want to get sued on behalf of their researchers, so the IRBs have become incredibly strict.
“It’s been very cumbersome to get approvals.”
Complicating things further, university and institution IRBs are not consistent with each other in their decisions, so what may be approved for one researcher at one university might be banned for another researcher somewhere else. This can complicate or stymie collaborations with colleagues at other institutions.
What the new rules say:
The proposed new rules will be mostly a boon for researchers, with some reservations. Among those who will be happy are:
- Researchers who can successfully use a web-based tool to quickly find out for themselves, rather than be told by IRB administrators, if they must seek an IRB approval for their research. This assumes the government designs a good tool;
- Social scientists who will no longer have to get any permission at all for studies that involve only interviews;
- Large institutions which can take advantage of “centralized IRBs,” group permissions for all researchers across different institutions working on the same thing;
- Researchers who will now be able to ask people for “blanket consent” to use biospecimens and other human samples, instead of the current system in which they have to know in advance what they want to do or seek fresh approval for each new experiment that they decide they want to run;
- People who agree to let researchers experiment on them, who will have simplified and clearer consent forms and procedures; and
- Researchers who want to collaborate with colleagues at other institutions and in other nations, who should find it easier to arrange.
Those who might not be so happy are:
- Patient activists who don’t agree with the default being blanket consent for the use of biospecimens;
- Researchers and human subjects with limited access to the Internet because much of the new system is housed on the web, or those who find the digital tool cumbersome;
- Smaller institutions who can’t take advantage of centralized IRBs; and
- Clinical trials researchers who have to post consent materials online.
“On the whole, I think these changes are a good thing,” Stark said. “I think that the regulations, although they add a lot of word count, clarify a lot of questions and address new ways of researching. So far, researchers have been cobbling together research standards and relying on federal guidance, which does not have the weight or legal protection of law.
“There will be, and deserves to be, some serious concern about some of the specifics, especially the idea of blanket consent for biospecimens.”
Stark published a book in 2012 showing how Institutional Review Boards work from the inside and how they came to operate. The book is called Behind Closed Doors: IRBs and the Making of Ethical Research. It is based on her yearlong observations of decision-making inside three IRBs, and on her historical research using previously unknown internal NIH records as a Stetten Fellow at NIH’s Office of NIH History.
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