420. Disclosing Findings to Participants
Updated July 1, 2019
Research findings that may affect management of a study participant's health, safety, or welfare require careful consideration of the risks and benefits of disclosing these findings and if warranted, a disclosure plan.
Researchers may or may not opt to disclose findings that may simply be of interest to participants.
NOTE: The following considerations and recommendations are limited to information specifically derived from research aspects of a study and are not intended to limit an investigator in providing information appropriate to her/his dual role as a research investigator and treating clinician.
Assessing the Need to Share Study Findings with Participants
Multiple variables must be considered by investigators and the IRB in assessing the appropriateness of sharing study findings with participants.
Researchers and IRBs must consider benefits and risks related to disclosure of research findings to participants. Learning about research findings may
- lead participants to obtain lifesaving medical interventions, or help participants make informed medical decisions; or
- lead to further testing, additional incidental findings, costs, anxiety, or distress, potentially with no corresponding medical benefit.
The IRB will consider possible consequences to the health, safety or welfare of participants; and whether or not the participant was aware the research was being performed. As with all aspects of a research project, the prospective benefits of disclosure must outweigh the risks.
Ethical considerations associated with the sharing of study findings with participants include those set forth in the Belmont Report including a responsibility to
- maximize benefits and minimize harms;
- incorporate an intent for reciprocity and justice related to participants' involvement in the research (i.e., consider the potential for participants to benefit from the research);
- treat individuals as autonomous agents by providing participants with information about themselves (as warranted by research design);
- respect self-determination as it relates to participants' needs for information relevant to their health and well-being;
- assess whether a decision to share study findings with a participant may breach her/his trust of the investigator or the research process.
Research-Related Factors for Consideration
Researchers and the IRB must consider the conditions of the research in assessing the appropriateness of disclosing findings to participants, such as:
- the potential usefulness of the information to be disclosed (e.g., clinical significance of findings);
- the extent to which the testing procedures are reliable and valid;
- the extent to which findings are conclusive or investigational;
- the qualifications of the individual who will administer the test;
- the qualifications of the individual who will interpret the clinical significance of the test;
- the identification and qualifications of the individual who will disclose the findings to participants;
- risks of inadvertent disclosure (i.e., false positives or negatives); and
- professional and ethical responsibilities.
Whenever possible, information about clinically meaningful findings should be delivered by a licensed physician (or psychologist, genetic counselor, or other professional as appropriate) or other qualified individual.
Participant-Related Factors for Consideration
In deciding whether or not to disclose findings to participants, researchers and the IRB must consider the characteristics of the sample population including
- the possibility psychological or other harms may result from learning of the results;
- the risk of harm if the findings are left undisclosed or the condition is left untreated;
- individual preferences about being informed of clinically significant findings; and
- referral processes or other resources for participants once the information is known.
Research projects may include a standard plan in which the investigator offers to share individual results with each participant, or to share a summary of findings with all participants or those who express an interest in receiving a summary. In either case, the investigators must ensure that plans for disclosing this information
- are communicated to participants during the consent process;
- are described in the research plan; and
- protect both participant privacy and data confidentiality.
Secondary and Incidental Findings
Secondary findings are those researchers purposely seek to discover in addition to the primary focus of the research. Incidental findings are those which are discovered unintentionally.
Investigators and the IRB should anticipate whether secondary or incidental findings may be of clinical significance to participants. The decision of whether to inform participants of these findings and the plan for doing should be considered by the investigator and presented in the IRB application.
Plans for Disclosing Secondary or Incidental Findings to Participants
Secondary and Anticipated Incidental Findings
Researchers should develop a plan for managing secondary and anticipated incidental findings, and clearly communicate the plan to the IRB and to participants during the informed consent process-even if the plan is not to disclose any secondary or incidental findings. The information provided should be sufficient to allow individuals to choose not to participate in research if they are uncomfortable with the management plan.
Unexpected Incidental Findings
Additionally, researchers should use their professional judgment and experience to consider and plan for unexpected incidental findings (i.e., study findings that emerge during the course of the research which not anticipated either in nature, or in magnitude or frequency of occurrence). Researchers may decide to disclose unanticipated, clinically significant findings, but will not inform participants of unexpected, incidental findings of unknown significance. Requests to share unanticipated study findings with participants must be reviewed and approved by the IRB prior to communicating the results, unless such disclosure is necessary to protect the health and welfare of participants or others.
Plans to share study findings should describe
- the parameters for disclosure of study results (e.g., certain responses on a depression inventory; clear presence of a dark shadow image on x-ray, CAT or MRI scan);
- the information that will be disclosed;
- the time frame for reviewing research data to determine whether clinically meaningful information has been obtained;
- implications of the findings for a participant's (or family members') well-being;
- risks of disclosure of the test result (e.g., anxiety, or impact on insurability, employability or reputation);
- recommendations for follow-up confirmation and clinical assessment or intervention; and
- how and when the communication will occur.
The consent process should indicate whether participants will be offered an opportunity to opt out of receiving such information.
When applicable, participants should be told what study results would require prompt intervention by the investigators (e.g., participant is at imminent risk of suicide).
Investigational or Inconclusive Findings
When the methods used to produce the results are considered investigational (e.g., the test itself is experimental) or when the results may not be clinically meaningful or supported (e.g., a laboratory test performed by a laboratory that is not CLIA-certified, brain scan reviewed by a non-clinician) the IRB will typically request that any communication to participants be accompanied by a referral for follow-up involving standard-of-care testing and interpretation of results by a qualified professional.
When research results are associated with mandatory reporting requirements, the consent form must inform participants about
- the information that will be reported; and
- when, how, and to whom the reporting will occur.
Planning for Participant Opt-Out
Researchers must decide in advance how to respect the wishes of participants who choose to opt out of receiving individualized test results.
The voluntary nature of research requires researchers to allow participants to opt out of research activities. However, when these results may be clinically significant, researchers may feel an ethical responsibility to share this information with participants. The PI should consult with each participant to ensure her/his understanding that the opt-out provision means she/he will be given no information about secondary or incidental findings.
Although the IRB will generally favor not sharing study results with a participant when she or he has expressed a preference to not receive a result, extenuating circumstances in which a study result holds a significant clinical impact warrant further consideration by the investigator and the IRB.
IRB Review of Plans for Disclosing Findings to Participants
When researchers plan to communicate findings to study participants, the plan for disclosing results should be described in the IRB application for IRB review and approval.
The IRB must determine whether sharing study findings is warranted and if warranted, the IRB must confirm the plan for sharing findings complies with applicable regulatory requirements, state and federal laws, University policies, and ethical considerations.
The IRB will generally approve disclosure of clinically significant research findings to participants if
- the research test or evaluation represents standard-of-care (i.e., is NOT experimental);
- the test or evaluation is administered/interpreted by qualified, appropriately credentialed clinician (e.g., physician, psychologist, genetic counselor) in a manner that is consistent with good clinical practice;
- the results suggest a participant or others may be at risk of harm that has the potential to be ameliorated through clinical intervention; and
- the potential benefits to individual participants outweigh risks of disclosure.
When the potential need to share study findings with a research participant arises unexpectedly, the PI should submit a protocol amendment describing the reason and plan for communicating research results to individual participants. If results suggest participants or others may be at immediate risk of harm, the PI may take immediate steps to ameliorate the harm and inform the IRB of the harm and preventative actions.
Contacting Participants about Research Findings
When tests or measures may generate findings requiring disclosure to study participants, PIs should retain a link to participant contact information until the outcome of the research test is known. After disclosure, the contact information should be destroyed, unless required for subsequent research-related activities (e.g., long-term follow-up).
When contact information will be retained and linked to study results, participants must told a mechanism exists to link their contact information with test results and must be informed of
- the circumstances under which the link will be used to contact them, and
- when the link will be destroyed.
Disclosure When Findings Are Anonymous or De-Identified
When data are collected without or immediately stripped of participant identifiers, participants should be told that if the research generates clinically meaningful results the investigators will have no way of associating study findings with individual subjects. In some situations, it may be prudent to provide referral information to all participants (e.g., research to assess prevalence of depression includes crisis call line information).
Disclosure of Findings for Research Involving a Waiver of the Informed Consent Process
Researchers and the IRB must weigh the risks of nondisclosure of study results when assessing the criterion to waive the requirements for informed consent.