New Final Rule for Research Participant Protection

HHS, FDA and 13 other federal agencies have issued a final rule updating regulations that safeguard individuals who participate in research. The agencies say that most provisions in the rule take effect in 2018.

“The new rule strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research,” a HHS statement says. “It also allows more flexibility in keeping with today’s dynamic research environment.”

The final rule will now generally expect consent forms to include a concise explanation, at the beginning of the document, of the key information that would be most important to individuals contemplating participating in a study, including the research’s purpose, the risks and benefits, and appropriate alternative treatments that might be beneficial to the prospective subject, the statement says.