Return of Research Results to Study Participants
Individuals invest a great deal to participate in clinical research, undertaking risks and burdens, while giving of their time and energies to advance scientific knowledge and the public good. Empirical research into participant views and experiences has consistently shown participants desire to learn the results of research to which they’ve contributed.
Despite efforts in recent years to facilitate return of research results to participants, many studies still involve no plans or concerted effort to disseminate results in this way. This may be attributable, in part, to ethical uncertainty over a number of sensitive issues implicated by return of results, especially for participant-level research results like individual labs or screens, biomarker tests, or other individual assessments.
Aggregate and Individual Research Results
There are two types of research results to consider for return to participants: aggregate and individual.
Aggregate results are the study outcomes, including whether or not the study met its endpoints and confirmed the hypothesis it set out to evaluate. Aggregate results do not contain reference to individually identifiable data.
In viewing aggregate results, participants can learn about study outcomes they may care about (e.g., whether an experimental intervention was found to be effective) without necessarily learning how their own data contributed to these conclusions (e.g., in a blinded study, without learning whether they were in the active or control arm).
Historically, aggregate results have been primarily communicated in academic journal publications. More recently, in the United States, federal laws require listing aggregate results of many studies on ClinicalTrials.gov. Since many participants will not access these venues, research sponsors and investigators should ideally make additional efforts to communicate aggregate results to participants. Such efforts show respect for participants and treat them as partners in the research enterprise, acknowledging their crucial role and investment in research, while promoting transparency and public trust.
When returned directly to participants, aggregate results should be packaged and communicated in user-friendly formats, such as in newsletters or web pages constructed with readability and health literacy principles in mind.
Individual results, by contrast, report the outcomes of research assessments and interventions administered to individual participants. These results are identifiable and may in many cases be relevant for assessing the personal health status of individuals enrolled in research. For example, the results of a research-required magnetic resonance imaging (MRI) or X-ray screen may be returned to participants; similarly, standard lab results of blood draws required for a study may be returned (e.g., results including liver function, white blood cell count, etc.).
Reasons Supporting Return of Individual Research Results
There are good ethical reasons to return individual results in at least some circumstances. In addition to participants’ preferences to receive their individual results, some in the community go further and suggest participants have a positive right to control the data they generate, both generally and during research. In addition, results bearing on the health or well-being of individuals and are clinically actionable, such as an MRI scan showing treatable tumors, should typically be disclosed to participants.
Notably, participants may have an interest in receiving results even if they are not clinically actionable. For example, people with rare diseases for whom there exists no cure may participate in multiple research studies over the course of their lives, some of which may require similar tests or assessments. Providing participants with the results of past assessments may permit them to forego those same assessments in future studies, thereby minimizing these individuals’ risks, burdens, and time commitments.
Complexities with Return of Individual Results
Returning individuals’ results is more complex, and requires greater care and forethought, than returning aggregate results.
Within the category of individual research results, there is an important distinction between results generated on the basis of validated tests or interventions, and results generated on the basis of investigational tests. The results of glucose monitoring with a continuous glucose monitor (GCM) already approved by the Food and Drug Administration (FDA) is an example of a validated result. Conversely, a CGM not yet FDA-approved assessed in the study for reliability, would yield an investigational result.
The importance of this distinction is reflected in federal law requiring the results of certain tests (e.g., blood labs and genomic sequencing) to be processed in a Clinical Laboratory Improvement Amendment of 1988 (CLIA)-certified lab before being returned to patients or participants. One aim of this law is to ensure the results returned to participants are accurate and reliable. There is some controversy over the correct interpretation of the law in light of the HIPAA Privacy Rule, which grants participants a right of access to information in their medical record. For this reason, any proposals to return individual research results should be considered carefully by the site’s or sponsor’s legal and privacy teams.