Protecting Patient Volunteers

Health research can’t be done without the patients who participate in studies as subjects. Participation in a research study may confer benefits to a patient, but it may also increase risks and lead to harm. In many cases, it has no net effect on participants. Thus, although clinical research is always intended to help improve the ways we prevent, diagnose, and manage various diseases and conditions, no one knows at the outset of any particular study whether the approach being tested will work. That’s why the study is done.

So at PCORI, we are grateful that the US Department of Health and Human Services and other federal agencies have completed the thoughtful, painstaking process of updating the Common Rule, the main federal regulation designed to protect participants as they consider participating in research, and as they participate.

We at PCORI, the nation’s leading funder of research designed to compare which care approaches work best for whom, have always taken this matter very seriously. Patient-Centered is our first name, after all.

Understandable Information

We were especially pleased to see that the revised rule enhances patient protection by including directives that simplify consent forms to make them more patient-centered. For example, the revised rule requires that consent forms begin with a short, focused presentation of key information that people are likely to want in order to make an informed decision about participating.

We were especially pleased to see that the revised rule enhances patient protection by including directives that simplify consent forms to make them more patient-centered.

Too often previously, these consent forms—which patients must read and sign to indicate their agreement to take part in a study—were too long and complex for a layperson to grasp. But under the revised rule, participants must receive understandable information, including the purpose of the research and potential benefits and risks of taking part. This requirement will make it easier for patients to know what they’re signing up for.

More Efficient Research

PCORI-funded researchers will appreciate parts of the revised rule that reduce administrative burden and make research more efficient. For instance, the revised rule seeks to provide increased flexibility for researchers to store and reuse identifiable data or biospecimens that were collected for one study for future research studies. Under the revised rule, the researchers would still need to obtain broad consent from patients. In such circumstances, full review by an institutional review board is not required.

The revised rule also streamlines institutional review of ongoing studies, a process designed to ensure that oversight of research is commensurate with potential risks to participants. Previously, institutional review boards (IRBs) had to follow studies regularly—at least annually—as long as they continued. The revised rule allows that review process to stop when studies are finished engaging with patients and are performing only such activities as data analysis.

The revision also requires that, by 2020, all multisite studies within the United States streamline their review process and use a single, centralized IRB. This is a long-time goal of the research community that recognizes the changing nature of research. Previously, research was often conducted at a single institution. Many studies now recruit patients from dozens of institutions. This change in institutional review has been resisted by many institutions, largely out of inertia and a mistaken sense of greater control with local IRB approval. The federal support reflected in this rule change is an important step toward making this reasonable goal attainable.

Nothing could be more important than fully protecting the people who volunteer to join research studies.

The revised rule applies only to federally funded clinical trials. Nonetheless, PCORI—as a nonprofit research funder—has always required our research awardees to comply with the Common Rule. That will include the revised version when most of its provisions take effect in January 2018.

We are glad to see the added safeguards for patients included in this update, as well as streamlining of the research process with the ultimate goal of improved patient care. Nothing could be more important than fully protecting the people who volunteer to join research studies. They are helping to provide future patients with the information they will need to make confident, evidence-based health decisions.