Updated Rules for Human Research Become Effective in January

After more than six years of extensive deliberation and review, the Department of Health and Human Services (HHS) will finally implement a host of changes to the rules governing the use of human subjects in clinical research. The updated Federal Policy for the Protection of Human Subjects, popularly known as the Common Rule, will go into effect on January 21, 2019.

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These are the first revisions made to the Common Rule since it was officially codified by HHS in 1991. Many of the regulations involving human research subjects, however, had been in place since the mid-1970s.

“The intent of these changes is to streamline the administrative requirements involved in the oversight of clinical trials, while also providing more clarity to participants and researchers about how information and biological specimens can be used,” said Philip Wang, M.D., Ph.D., director of APA’s Division of Research.

The updates were a needed response to the increase in size and complexity of clinical trials over the past three decades. Today, multisite clinical trials and the use of digital tools to create and store large amounts of data are the norm in clinical research. Many researchers believed that the Common Rule requirements have not kept up with these changes, making the administrative portion of clinical trials costly and cumbersome.

The most significant change overall is that multisite clinical studies will no longer require an Institutional Review Board (IRB) at every trial site. IRBs are independent entities that oversee every clinical trial, with the power to stop a trial if deemed necessary. Researchers conducting large, multisite studies will now be able to use a single IRB, which will make coordination much easier. However, since it may take a while for some researchers to select a central IRB and determine how to coordinate information, HHS has pushed back this requirement until January 2020.

For mental health researchers, perhaps the most significant change involves reducing the IRB requirements for studies with minimal risk. Currently, all clinical trials must undergo an annual review. However, starting next year, studies considered “minimal risk” will no longer have this requirement.

One class of studies that falls under this low-risk category is “benign behavioral interventions,” which includes any cognitive or behavioral trial that is not overly long or potentially causing emotional distress in participants.

Research studies that conduct secondary analyses of existing clinical trial data are also exempt from IRB reviews, so long as patient information remains protected.

Another important change is that researchers conducting clinical trials that collect identifiable biospecimens—samples such as DNA that could be traced back to an individual—can ask participants to give “broad consent” on how the biospecimen is used. That way, future trials can use that specimen rather than having to reacquire patient consent or seek a waiver through the IRB.

“This is a sensible change that will greatly benefit research,” Wang told Psychiatric News. “We don’t know what the important research questions in mental health will be five or 10 years from now. Broad consent provides the flexibility to address unexpected changes, while still ensuring that individuals who give samples are protected.”

While researchers will benefit from many of these changes, so will participants. One example concerns today’s overly complex consent forms that can perplex even seasoned lawyers. The updated rule requires consent forms to contain a simple and concise explanation at the beginning of the document about the key elements of the clinical trial. These elements include the purpose of the research, its risks and benefits, and alternative treatments that might be beneficial to the prospective subject. Consent forms must also clearly state the circumstances when clinically relevant research findings (for example, a genetic analysis reveals a strong risk of some disease) will be shared with the subject. ■