Advice Offered for Sharing Research Results

Whether to provide research results to individual study participants—and, if so, how to do it—vexes scientists, ethicists, and regulators. A recent report from the U.S. National Academies of Sciences, Engineering, and Medicine provides 12 recommendations to help researchers weigh the pros and cons of disclosing results and make sharing research findings easier and more informative for participants (available at http://nationalacademies.org/returnofresults).

Researchers can uncover data that could alert participants or their families to potential health problems. For example, genome sequencing conducted as part of a cancer study might reveal that a patient carries a gene mutation that boosts the risk of cardiovascular disease. However, several obstacles make sharing that information difficult. Among them:

• Regulations on what data researchers can share are contradictory.

• Many researchers don't have the training or the time to explain a finding's implications to participants or to talk them through treatment or prevention options.

• Sharing findings could be harmful—if the results are wrong, for instance.

The new report, drafted by a committee convened by the National Academies, aims to help researchers decide whether to share results and provides advice for simplifying the process. The key first step is harmonizing federal regulations outlining the circumstances under which information can be returned, says Suzanne Bakken, PhD, of Columbia University in New York, NY, one of the committee's 15 members. Currently, the Centers for Medicare and Medicaid Services (CMS) prohibits return of results from labs that aren't Clinical Laboratory Improvement Amendments (CLIA) certified. Many research labs don't have that designation, yet they may have to divulge test results because the Health Insurance Portability and Accountability Act (HIPAA) gives individuals the right to obtain their health information in certain situations.

To ensure that research labs communicate sound information, the report suggests that the NIH create an alternate quality-management system. Under this system, labs that meet certain standards for generating accurate and reliable results, as well as CLIA-certified facilities, could pass on their findings, removing the conflict between CMS and HIPAA.

The report also suggests steps that researchers, institutional review boards (IRB), and other organizations can take after the regulatory changes are complete. For example, investigators should address their strategy for returning results in research proposals and grant applications. IRBs should set up procedures and identify experts to review these plans.

“We are moving into an era of more open science, and part of that includes sharing data with research participants who generated the data. We need to be getting prepared for that,” says Bakken.

“I think they have done a wonderfuljob of reviewing the multiple issues around returning research results,” says Susanne Haga, PhD, of Duke University School of Medicine in Durham, NC, who wasn't involved in drafting the report. How much impact the report will have remains unclear, she says.

Haga estimates that changing the regulations that cover information sharing will take “easily 5 years.” By then, the rapid development of genomic technologies may have rendered moot some of the problems the report considers, she adds. In a few years, for instance, many people may have copies of their full genome sequence, so sharing the results of genomic studies may not be an issue. –Mitch Leslie

For more news on cancer research, visit Cancer Discovery online at http://cancerdiscovery.aacrjournals.org/CDNews.