Researcher writes on proposed changes to participant consent regulations

Participants are one of the basic necessities in any research study, but their contribution would be impossible without the government-civilian architecture that regulates their activity, ensuring that both the participants and the researchers are protected. Associate Vice President for Research Dr. Suzanne Rivera recently contributed a chapter to the book “Human Subject Research Regulation: Perspectives on the Future”, proposing changes to these regulations.

The Office for Human Research Protection (OHRP) creates regulations for human subjects. If it wants to alter a rule, the office has to release a notice, called the Advanced Notice of Proposed Rulemaking (ANPRM), which publicizes the proposed changes and opens them to comments from the research community.

Rivera’s involvement comes from a proposed 2012 change, which has been the subject of much debate in the research community. In the past, if a subject gave consent to be studied, the data collected could be used for another study without getting consent from the subject. The change would require that researchers go back and ask the subject again for permission to use already collected data.

Rivera, along with a number of other researchers, were asked to give their opinions at a forum set up by Harvard University. Rivera, who sits on the national advisory committee at the Secretary’s Advisory Committee on Human Research Protections, was invited to share her viewpoint as part of the book.

According to Rivera, requiring this permission from subjects would make it difficult, and sometimes impossible, to conduct research.

“There are many data sets, such as blood specimens, where the identifiers have already been removed,” she said. “There is no way to go back to the original person to ask if they would object to reuse of the specimens.”

In her chapter, she argued that the change would force researchers to throw out certain data that could be reused, asking them to unnecessarily collect more data. She said that the new rules would make data unusable in a majority of cases.

“They may have been imagining a narrow set of circumstances, in which I still have all the identifiers,” she said. “I would have to go back and ask if they would mind if I stripped the identifiers and gave the data to someone else.”

Rivera, however, does think that current consent regulations need some modifications. In her opinion, subjects should be notified when they originally give their information that some data may be used for other studies without their consent. This is a common practice, but it is not mandated by current regulations.

Rivera also thinks that there need to be changes made to reflect the advancements in current technology. According to Rivera, for some types of samples, it is impossible to remove DNA markers which would allow the researchers to identify not only the subjects, but their families as well. Rivera believes that there should be changes to ensure that researchers cannot use this information to circumvent the existing privacy rules.

The change will be further discussed with the release of the Notice of Proposed Rulemaking (NPRM), which would modify the proposal to reflect comments from Rivera and other researchers.