Return of Individual Results: Principles and Approach
Background:
The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) engages diverse stakeholders to define emerging issues in global clinical trials to create and implement ethical, actionable, and practical solutions. To that end, the MRCT Center identified a need to engage stakeholders on the topic of returning individual results to clinical trial participants. The output of this working group will be a recommendations document and toolkit to create a harmonized approach for how individual results are reported to participants. The foundation of the document will be a set of 8 principles that are directly relevant to the return of individual results. These principles are now open for comment.
Please send comments to by September 1, 2016 with the subject line IRR Principles.
Returning individual results to research participant can occur as early as pre-screening for study qualification and extend past the conclusion of the clinical trial (Figure 1). This includes routine lab results and non-urgent incidental findings (Part A), urgent results and incidental findings (Part B), individual study results about study arm and endpoints (Part C), and exploratory results (Part D). The determination of whether, when and how to return individual results will be made at least in part by the nature of the result and its significance, as discussed below. Notably, the principles do not address return of aggregate results (i.e. independent of information specific to the individual) of the clinical trial (Part E)—a separate but related imperative—that we have addressed elsewhere.[1]
Figure 1: Overview of individual results
Principles:
1. Returning individual results maintains the autonomy of clinical trial participants.
Clinical trial participants and advocacy groups have expressed a growing interest in receiving individual results that stem from participation in research. Currently standardized criteria or processes do not exist to meet this expressed need.
2. Return of results should be integrated into the clinical trial and proactively planned.
In the planning stage, consideration should be given as to whom will deliver each individual research result in addition to when and how results will be provided.
In some settings, it is anticipated that results will not be returned. In that case, the informed consent should be clear that some or all results will not be returned; the participants can then choose whether or not to volunteer in full appreciation of the limits of participation.
3. It is the participants’ right to choose whether to receive the information.
Individuals should determine whether they wish to receive results, either by “opting in” to receive or “opting out” of an automatic process. Research participants should be asked and their decisions respected.
4. The participants or their designees should be the ultimate recipient of the results returned with appropriate guidance.
Results should be returned to the participants (or, in appropriate situations, the Legally Authorized Representative, the parent or guardian) and provided with the appropriate context. The study physician should be involved in the process to assist with contextualizing the results. In addition, and with the participant’s permission, a healthcare provider may be notified directly in order to ensure continuity of care and to expedite potential medical intervention. Participants are encouraged to seek professional medical input into the interpretation of results.
5. Given that clinical research differs from clinical care, sponsors and investigators have the duty to return results responsibly taking into account the validity and utility of the results.
In determining which results to return, consideration should be given to the validity of the test and to the medical, social, or personal usefulness of the results to participants. We propose a tiered approach to manage the type and amount of data that might be shared with the participant. Sharing data without clinical validity may be problematic and sharing too much data without interpretation has the potential to result in information overload and distress.
6. Results should be returned as soon as appropriate, consistent with scientific integrity of the study and the ethical principle of beneficence.
The safety and welfare of the research participants take priority over the value of the research. Timely return will help to ensure that any direct or indirect benefits from the results to the participants will be attained. In some situations however, return of individual results may compromise data integrity or the research aims. The data type and the medical importance of the finding may influence the timing of return (see Figure 1).
7. Return of individual level research results does not constitute personal medical advice.
The purpose of research is to generate generalizable knowledge to the benefit of society. This differs from medical care that is directed to the benefit of individuals. While some interpretation may be provided when individual research results are shared, this form of results return is not meant to constitute medical advice. To determine how individual results may impact medical management, the research participants should involve their medical care team.
8. Return of results should be planned and executed in compliance with institutional policies and local, regional, and national laws and regulations.
Any recommendations for return of individual results defer to institutional policies and the sovereign law and regulations of the country in which the participant resides.
We anticipate a toolkit and resource document focused on the return of individual results to be issued in December 2016 that will detail key considerations for these principles.
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Summary of Principles / Version 2016-07-27
[1] http://mrctcenter.org/projects/return-of-results-to-participants/