Report suggests revisions to rules for human subject research

The National Research Council released a report on Thursday outlining a set of revisions to regulations in place regarding the use of human subjects for scientific research at institutions such as Boston University.

The report is a response to a 2011 Department of Health and Human Services proposal that sought to revise the Common Rule, or the regulations under which human subjects can be used for research, by excusing a research category that would lessen the Institutional Review Board Process for low-risk research.

Michael Lyons, professor of psychology at Boston University, said the revisions will increase efficiency by loosening regulations while protecting human subjects.

“They [the revisions] streamline the process and remove a number of unreasonable requirements,” Lyons said. “They remove sources of ambiguity about the process, so I think this will facilitate researchers being able to do their research efficiently without reducing at all the protection of subjects.”

The report also suggests that some types of research should be excused or subject to less scrutiny in the review process.

Human subjects research excludes research that is dependent on publicly available and observable information and research that collects or relies on personally identifiable information, said Susan Fiske, chair of the NRC committee that drafted the report.

“There are a lot of regulations, many which are needed and many which are not needed,” she said. “So we’re aiming for a balance we are trying to strike between facilitating research and preventing human subjects harms.”

Fiske said she hopes lawmakers will take the report’s suggestions into consideration when making changes to the Common Rule.

“What we are hoping is that the thoughtfulness and carefulness and evidence we draw on will influence the government agencies that are revising the Common Rule to make it more responsive to the social and behavioral sciences and both facilitate research and protect people better,” Fiske said.

The report also recommends reorienting the review process, which previously favored biomedical research, to a process better suited to research in the social and behavioral sciences where low-risk human subject research is more common, Fiske said.

“The protection of human subjects tends to focus on the biomedical side and not so much on the social and behavioral side,” Fiske said. “… The biggest risk to people participating in our kind of [social and behavioral sciences] research is likely to be information risk … and information risk is your data gets publicized.”

Lyons said the revisions suggested by the NRC would be particularly helpful in streamlining research projects where many different institutions are involved.

“Our projects are a least half a dozen institutions, different universities participating in this research project, and for each university and each institution, the research has to go through IRB review and that can take an awful lot of time,” Lyons said. “Now, the proposed regulations state that a multi-site study will be reviewed by one primary IRB. It won’t be necessary to get half a dozen IRB approvals. For a study like ours, that could really be a huge benefit.”

Leonard Glantz, a professor of health law, bioethics, and human rights at BU’s School of Public Health, said research regulation is necessary to prevent researchers from abusing their subjects.

“Research is regulated to keep good people [researchers] from misusing subjects as a result of overzealousness for the research,” Glantz said. “… The history of research abuse is the history of good people doing things that are not so good. Every research abuser, even the Nazi doctors, believed they were doing something of social importance and utility.”