Returning Research Results

First, identify the research results that will be generated by your study procedures and determine their relevance for research participants.

• Consider results to be generated throughout the entire course of your study (e.g. recruitment and screening, intervention, follow-up, after interactions/interventions are completed).
• Consider all kinds of results, including²:
  • Anticipated research results: information generated about a particular participant during the course of a study to help answer the research question or otherwise support the study objectives (e.g., determine eligibility, ensure ongoing participant safety, etc.)³
  • Secondary results: results that are not the primary objective of the research but are actively sought by the researcher
  • Incidental findings: results that are generated during the course of research but are outside of the original purpose for which the test or procedure was conducted; may be anticipated or unanticipated
• Keep in mind that researchers are not ethically required to try to generate data that might be relevant to an individual’s healthcare but would not otherwise be generated during the planned research project (i.e. no “duty to hunt”). You are therefore not obligated to:
  • Conduct additional tests or analysis to provide clinically helpful information if doing so requires steps that are beyond those required to complete the planned research. For example, a study team conducting MRIs in healthy undergraduate students is not obligated to have those scans read by a board-certified radiologist just to identify incidental findings.
  • Update results when new technology or new tests offer a more comprehensive, more detailed, or more specific result. For example, if a researcher conducts and reports the results of a genetic test and new information about the gene becomes available after results were generated, the researcher is not obligated to retest the samples and/or report updated knowledge on this gene to study participants.
  • Return results generated during secondary analysis of research data
• Consider whether results were generated in a CLIA-certified lab. The Clinical Laboratory Improvement Amendments (CLIA) ensure the accuracy and reliability of patient test results. Any lab reporting patient-specific results must be CLIA-certified and meet CLIA requirements. Research results generated by a non-CLIA lab should not be returned to participants; however, participant safety may dictate otherwise when results may be critical to a participant’s health. If research tests conducted by a non-CLIA lab generate results that have an immediate and critical impact to a participant’s health:
  • Attempt to validate the result via retesting by a CLIA-certified lab.
  • If retesting is not possible, consider notifying the participant that an abnormal result has been obtained and encourage the participant to follow up with a health care provider.
  • If your research is likely to generate critical results from a non-CLIA lab, consider identifying a mechanism for CLIA-certified validation prior to beginning the research.

If your study will not generate any results that could be relevant for research participants, your informed consent statement should simply indicate that no results will be returned – see the HRPP Informed Consent Templates in Forms & Templates for examples of appropriate informed consent language.

Categorize potentially relevant results and determine whether to return them, based on the considerations raised by the following four categories

• Information critical to the management of a participant’s health in the immediate/near future.
  • These results indicate a life-threatening or significant risk to the participant and are actionable, i.e. further testing or treatment exists that could reduce the risk. You must plan to return these results immediately to an individual who can take appropriate steps for the participant’s treatment.
• Results that have a known implication about health or risk, and are clinically actionable but not emergent (e.g. not severe or particularly time sensitive).
  
  • Results in this category are valuable to a participant’s future health and actionable, but they don’t require immediate action.  Study teams should plan to return these results to participants, whenever feasible. If you decide not to return these results, the IRB may request further justification.
  • As you decide whether to return these results, consider:
    • Whether your research project has appropriate resources to return these results.
    • How you can help facilitate appropriate next steps in your participants’ healthcare.
• Results that have a known implication about health or risk, but are not clearly clinically actionable.
  • These results may provide valuable information about a participant’s health but are not actionable. For these results, it is ethically acceptable for you to plan to return these results to participants, or not return them. Some results in this category may cause emotional trauma for your participants, or may be too complicated for your study team to explain, and you may decide not to return them. The IRB will not comment on your decision to return these results or not, unless it clearly affects the risk/benefit ratio for research participants.
  • As you decide whether to return these results, consider:
    • Any risks to participants (e.g. emotional trauma, stress) from gaining this knowledge.
    • What actions participants might take based on this information.
    • How you can help facilitate appropriate next steps in your participants’ healthcare.
    • Whether your research project has appropriate resources to return these results and adequately explain them to participants.
• Results that do not have a known implication for health or risk.
  • Results in this category do not have clearly defined significance to participants’ health. Study teams should be cautious about returning results in this category. Carefully consider whether the results may be misleading or misunderstood. The IRB will not comment on your decision to return these results, unless it clearly affects the risk/benefit ratio for research participants.
    • Be cognizant of special considerations relating to this category, including:
      • Whether the results can have any value to participants, even just to satisfy curiosity.
      • Whether participants are likely to understand the information or its implications.
      • What resources participants might need to understand the information.
      • Any risks to participants (e.g. emotional trauma, stress) from gaining this knowledge.
      • The ability of your study team to adequately explain the information.
      • The ambiguity that may exist in interpreting the results impact for research participants.

You and your study team are responsible for deciding how to categorize individual results. Recognizing that categorization is a subjective decision, the IRB will not comment on which category a specific result should be placed into, and will rely on you to make appropriate judgment calls for your study. Some results may be especially difficult to categorize or may raise additional complexities. Examples include results with potential reproductive impacts (e.g. genetic carrier status) or implications for participants’ family members, and results obtained during childhood indicating diseases that may manifest during adulthood.

For help categorizing these results and planning for their return, contact the Bioethics and Subject Advocacy Program (BSAP) of the Indiana CTSI to request a free consultation.

Once you have identified which possible results will be returned, create a detailed plan for your study team that includes all of the following.

• Who (e.g. individual or role/position), will communicate results, considering when results are available and how quickly research participants need them:
  • Results that are immediately clinically actionable should be communicated by a medical professional who can suggest appropriate next steps or make a referral for treatment.
  • Results that are clinically relevant but not as timely or severe could be communicated with less urgency, to the participant or a healthcare provider.
  • You may need to obtain additional expertise to help you explain results to participants, especially if the results are complex, or if the significance of the information isn’t immediately clear (e.g. genetic results). Consider having a study team member with specific expertise in the area communicate results, or recruit someone with special expertise to train your study team or help you create materials to communicate the information. You may need to budget for additional expertise.
  • You may need to provide referrals to appropriate care providers, or advice on how to obtain more information. However, you are not obligated to offer medical treatment.
  • If results are returned after the study is complete, sponsors may communicate the results directly to research participants. Communicating results after a study’s completion isn’t a research activity and doesn’t require IRB approval or continued IRB approval.
• Which participant groups will receive results and which will not. For example, if you plan to return results only to symptomatic participants and not healthy controls, your plan should include that information.
• How results will be communicated, e.g., verbally over the phone or in person, in writing via a letter, etc.
  • For results that require immediate action, results should be communicated in a way that gets the information into the right hands as soon as possible – often directly to a provider. Therefore, you should plan ahead so that your consent prepares participants for the responsibility they have in updating any changes to their contact information with study personnel immediately.
  • Results that don’t require immediate action may be best communicated in writing so research participants can refer back to the information when they’re ready. Your team may decide to be creative. Consider sharing results via an easy-to-read report card, or secure website/patient portal. Please note that the IRB isn’t required to review and approve written materials for this purpose. Use of a secure website/patient portal may also require additional technology approvals by IU Health and/or IUSM.
• How you will track participant consent related to receiving results and ensure their wishes are honored
  • Unless results are immediately critical to a participant’s health, participants should be given an opportunity to choose whether to receive results. Your plan should detail the level of specificity of choice you will offer your participants – whether they can choose which specific results to receive, or whether they will be required to receive all results or not receive all results.
  • Think carefully about your resources and the tracking mechanisms available to you.
  • The more choices you offer participants, the more resources your study team will need. For example, if you allow participants to choose whether to receive results, you will need procedures for tracking each participant’s choice, communicating that choice amongst study staff, and ensuring compliance with that choice.
  • The appropriate level of specificity of choice is dependent on the study design, the type of results being returned, and the resources available to you. Create a plan that allows your participants autonomy without compromising your resources. For some studies, participants who are not comfortable with the plan for returning results may need to make a choice not to enroll in the study.
• Factors for researchers to consider as they may have an effect on team resources (descending in order):
  • What results participants receive:
    • Participants can choose what results they will or will not receive from a menu of available results.
    • Participants must make an active choice whether or not to receive results (yes or no).
    • Participants will receive results unless they opt out.
    • Participants will not receive results unless they opt in.
    • Participants will receive X information or will receive no information; if they disagree, they do not participate.
  • Who will receive results:
    • Participants can identify individuals to receive their results if the subjects is no longer able.
    • Participants can identify additional individuals who should receive their results.
    • Some possible results are provided to the participants themselves only.
    • No information is provided to participants.
• What resources you need to return results in a valuable way, and which should be included in your budget:
  • Identifying results -
    
    • Radiologists to review scans
    • Using a CLIA-certified lab to validate critical lab results
  • Communicating results -
    • Tracking systems, to track participant opt-outs or follow up
    • Graphic designers, for written communication
  • Helping research participants understand results -
    • Genetic counselors
    • Mental health professionals or counselors
    • Social workers
    • Health literacy or communications experts

Make participants aware of your plan by disclosing it in the informed consent and ensuring it is part of the informed consent process. Research participants should be aware that critical results (i.e. those critical to the management of their health in the near future) will be returned to them or their health care provider (i.e. they will not be asked to opt-out of receipt of these results). Participants who are not comfortable receiving critical results should consider not participating in the research.

For all other categories of results, the informed consent process should include disclosure of what results may be returned, whether research participants can opt in or opt out of receipt, and who should receive results (e.g. subjects, care providers, family members, etc.). Unless results are immediately critical to a participant’s health, you should provide a mechanism for participants to choose whether to receive results. The appropriate mechanism depends on the specificity of choices you plan to offer participants, as discussed above, and each mechanism may require different informed consent language.

As you draft your consent, consider how you will approach potential deviations. For example, if your consent form includes a mechanism for participants to document their choice, but one participant fails to complete that portion of the consent form, how will you choose to return results? Will you attempt to reconsent? Will you choose to not return any results? Having a plan for deviations before they happen can ensure consistency across your study team and result in less reported noncompliance to the IRB.

Options for facilitating participant choice

1. Choosing from a menu

If your study will generate a myriad of results that you’d like to return and you have systems in place that would allow you to carefully track participants’ choices, you could consider allowing participants to choose which results they’d like to receive. Include a list of available results and ask participants to initial next to any results they would like to receive. Include a choice that allows participants to refuse all results.

2. Forced choice (Yes/No)

If you have results available but will limit participants’ choice to receive or not receive all results (all or nothing), ask participants to initial indicating their choice.

3. Opt In or Opt Out

You can offer a default choice, and allow subjects to opt in or out. Ask participants to initial if they disagree with the default option you are offering. This type of mechanism can be confusing for participants and difficult to track, so consider carefully whether this option is right for your study. 

4. No option, other than not participating

Not all study teams have the resources to offer and track participant choices, and offering a choice may not be appropriate for all study designs. If you will not offer a choice, simply describe your plan for returning results, or indicate results will not be returned. Potential participants should take that plan into consideration when deciding whether or not to participate in the study. Individuals who are uncomfortable with your plan may decide not to participate.

See Table 1 (below) and the IU HRPP Informed Consent Template for examples of appropriate informed consent language for each category. As always, these are examples only and language should be carefully tailored to your study to ensure that participants and IRB members understand your plan. The IRB will use the information in your informed consent to confirm that you have engaged in a thoughtful process to complete step 2, but doesn’t need to know all the details.