Why to get started

While there are a variety of challenges involved with returning individual research results (IRR) to participants, none of these challenges are insurmountable. The practice of returning IRR has been identified consistently by participants as something that is desired and, often, expected. Returning IRR is an important element of participant-centricity and respect.

Increased adoption of return of IRR practices can benefit individuals, communities, and the research enterprise by increasing trust and transparency in research and by adding value.  All stakeholders play a role in promoting and integrating the return of IRR.

Sections included on this page:

Ethical Reasons for Returning Results

Foundational ethical principles in research identified by the Belmont Report, The Council for International Organizations of Medical Sciences, and the Declaration of Helsinki can be applied to the return of individual research results to participants. These applications have been reviewed in-depth (see MRCT Center, NASEM (Institute of Medicine) and SACHRP (Secretary’s Advisory Committee on Human Research Protections)) and key points will be briefly summarized here:

Respect for persons, or respect for autonomy, means that individuals have the right to make decisions about what happens to them, and that right cannot be abrogated for convenience or other purpose.

Participants should choose whether to receive individual research results. Conversely, if some or all individual research results will not be offered or returned, participants should be informed and be able to factor this into their decision-making before agreeing to participate in a given study.

Since consent is an ongoing process, participants should also be free to change their initial decision or delay any decision until the appropriate time, as applicable.

Beneficence refers to the sponsors’ and researchers’ duty to protect participants’ rights and well-being in research by maximizing the possible benefits to participants and minimizing risk of harm.

At a minimum, therefore, there is a duty to provide and act upon urgent, actionable findings for the study participant. Beyond urgent results, a participant’s health and well-being may be impacted by additional information, including information that is not necessarily medically actionable but is personally important.

In clinical research, a risk/benefit assessment compares the risks and burdens of participating in the study to the potential benefit to the individual, the study population, and society from the knowledge that the trial would generate.

A risk to the participant of receiving results that are unexpected and/or upsetting can potentially be mitigated by a robust plan and anticipation of results that will be generated and returned, an informed consent process that discusses this possibility, using language that is understandable to the participant, and an opportunity for participants to decide whether or not to receive results. There should also be opportunities for this decision to be reviewed and changed throughout the course of the study as a participants’ perspective may evolve. Continued conversations and decision-support tools are encouraged.

There are also risks related to data privacy and confidentiality, as well as other implications (e.g., life insurance) for certain types of results. These can again be mitigated by clear informed consent and mid-study decision-review processes that outline these risks to allow participants to decide for themselves.

Returning results that are useful or actionable for the participant can be considered a “benefit,” especially (but not only) if that information would not have been available to the patient in the absence of participation in the trial.

Non-maleficence means that research participants should not be intentionally harmed; researchers have an obligation not to cause harm to research participants. The health of participants should always be prioritized. Thus, results that have urgent relevance to a participant’s medical care must be communicated.  In addition, there are other examples where non-maleficence is relevant in the decision to return individual research results. Some results are not considered urgent but may impact the health of a participant (e.g., the finding of a harmful variant in a cancer susceptibility gene, such as BRCA1).

Transparency in the context of return of individual research results means that the decisions about which results will or will not be returned will be made with all available information at the time, using decision-making processes that are as forthright as possible and engaging appropriate stakeholders, including participants. It also means that decisions not to share results with participants are based on scientifically or ethically valid reasons that are made clear to participants prior to consenting to participate in a given trial.

It is important to recognize that transparency in the context of returning (or not returning) individual research results will promote trust, accountability, and community engagement in research and in the research enterprise itself.

Concordance with participant wishes & returning value to communities

Empirical research demonstrates that study participants would like to receive their research results. The rationale varies, ranging from a sense of individual ownership of their data, potential personal benefits, learning and sharing important information with their family members, and an expectation of respect and mutual trust.1,2,3

Returning individual research results honors the essential contributions and voluntarism of study participants in clinical trials, while providing additional value to participants in exchange for their participation.

Participants may also want to receive their results as a benefit to the community they represent.3 This is especially important with regard to underserved groups in research, wherein the individual may feel that their own experience could be helpful to the community.

It is incumbent upon the research enterprise to support engagement, enrollment, and trust, and meet the expectations of participants. Conversely, the consequence of failing to meet expectations can lead participants to withdraw from the research, be unwilling to participate in future research, and even discourage participation from other people in their community.

Evolving expectations & regulations around data

Expectations about data transparency and ownership are evolving in society; returning individual research results anticipates and responds to those expectations.

For example, online patient portals are enabling transparent and timely review of medical information by patients. Smartphones and wearable devices offer real time data with options to share, download, and customize those data. Prominent technology companies (such as Apple, Google, and Facebook) are allowing individuals to access, control, change, and/or delete their personal data. These advancements both deliver on, and help shape, the priorities and expectations of consumers for data access, control, and transparency.

Regulations around the world that support data access and transparency are more common as well. A few examples are as follows:

The forces behind these changing expectations and the shifting regulatory landscape are already in motion. To respect participants and anticipate/prepare for potential future requirements, the research enterprise should heed these signals, adopt the return of individual research results, and start now.

1. Edwards KL, Goodman D, Johnson CO, Wenzel L, Condit C, Bowen D. Controversies among Cancer Registry Participants, Genomic Researchers, and Institutional Review Boards about Returning Participants’ Genomic Results. Public health genomics. 2018;21(1-2):18-26.
2. McElfish PA, Purvis RS, Scott AJ, Haggard-Duff LK, Riklon S, Long CR. “The results are encouragements to make positive changes to be healthier:” qualitative evaluation of Marshallese participants’ perceptions when receiving study results in a randomized control trial. Contemporary Clinical Trials Communications. 2020 Mar 1;17:100543
3. Purvis RS, Abraham TH, Long CR, Stewart MK, Warmack TS, McElfish PA. Qualitative study of participants’ perceptions and preferences regarding research dissemination. AJOB empirical bioethics. 2017 Apr 3;8(2):69-74.