Returning Research Results to Participants

 

Background: The purpose of this information is to provide guidance on the return of research results to participants. This guidance addresses federal requirements for the return of results in the medical record to patients, exceptions to the requirements in the context of clinical research studies, and research data that is not included in the participant’s medical record.

An individual research result is any information collected, generated, or discovered in the course of a research study that is linked to the identity of a research participant.

These may be results that are:

  • Collected at the beginning of a study to determine if a person meets inclusion and exclusion criteria for the research
  • Generated about a participant during the progress of the research
  • Discovered in the course of the research that are beyond the aims of the research but have potential health or reproductive importance (often called “incidental findings”)
  • Identified, collated, or interpreted after analysis of the collected data has been completed

 

A clinically relevant research result refers to any test or imaging result generated during the conduct of a study that may be used to monitor participant health status or guide clinical decision-making.

“Clinically relevant research results, including individual research results,” are referenced in the revised Common Rule (rCR), sometimes known as “the Final Rule.” It states that, for federally funded research, the informed consent document must include “… a statement regarding whether clinically relevant research results, including individual research results, will be disclosed to research participants, and if so, under what conditions.” [1]

Research Participant Rights

The Health Insurance Portability and Accountability Act of 1996 (HIPAA, or the Privacy Rule) [2] and the 21st Century Cures Act (the Cures Act) require, among other things, that patients have access to their Protected Health Information (PHI) upon request. Hence, research records or results that are maintained by the covered entity as part of a designated record set (i.e., are included in the EMR) would be accessible to research participants unless one of the Privacy Rule’s or Cures Act’s permitted exceptions applies.

One of the permitted exceptions applies to PHI created or obtained by a researcher during the course of clinical research. The Privacy Rule and the Cures Act permit the individual’s access rights in these cases to be suspended while the clinical research is in progress, provided the research participant agreed to this denial of access when consenting to participate in the clinical research study. In addition, the research study team must inform the research participant that the right to access protected health information will be reinstated at the conclusion of the clinical trial.

Incidental FindingsDuring the course of the research, there is a chance the study team will find something unexpected that may require clinical follow-up. Participants in research studies can obtain incidental findings from the research if they are part of the EMR, but these results may also be withheld while the research is being conducted. Depending on the immediacy of the need to take appropriate clinical action, however, concerns over study integrity must be balanced against participant safety, and participant safety must always be factored into any decision regarding return of incidental findings.
PHI versus RHIThe Privacy Rule and the Cures Act apply only to information, including research results, that is contained in the covered entity’s EMR. Research data that is not included in the participant’s EMR is considered Research Health Information (RHI) and is not subject to these disclosure rules. RHI does not need to be released to participants, either during or at the conclusion of the research, by federal regulations. However, unless the consent form specifically states that research results will never be released, then RHI containing PII may be requested by a participant and will need to be provided under CIPA. The exception to such required release, as indicated above, is if the investigator determines that disclosure would be detrimental to the person. In such cases, if the consent form did not provide for indefinite withholding of research results, the investigator would cite the Civil Code when declining to provide the results. Study teams should describe in the consent form whether RHI will be provided, under what circumstances, and when.
Unvalidated or investigational testsUnder no circumstances will the IRB permit disclosing individual participant data associated with investigational or unvalidated assays, as they can be harmful when used to guide clinical decisions. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) prohibit the return of individual research laboratory results to research participants unless the results were generated by a CLIA-certified laboratory. Additionally, the FDA has specific requirements for and restrictions on the use of an investigational assay, or an approved assay used in an investigational manner, as a diagnostic procedure.

Issues to consider when contemplating the release of individual research results:

  • Lack of Context: Participants may lack the necessary context or understanding to interpret the results correctly.
  • Potential for Harm: If participants act on these results without proper guidance, it could lead to unnecessary anxiety, inappropriate self-medication, or other harmful behaviors.
  • Unvalidated Results: Research results may not have undergone rigorous validation. Acting on such results may lead to misinterpretation or incorrect conclusions by participants.
  • Breach of Protocol: Protocols typically include plans for how and when results are communicated to participants, ensuring that disclosures are handled responsibly and ethically.
  • Informed Consent Issues: Participants may not have consented to receive individual results, or they may not have been adequately prepared to receive results. Additionally, regulations state that "When individual research results are offered, participants have the right to decide whether to receive or to share their results.”
  • Impact on the Research: Unauthorized release of results could affect the integrity of the study. Participants who receive premature information might change their behavior or withdraw from the study, potentially biasing the results and compromising the validity of the research.

 

A 2018 National Academies of Sciences, Engineering, and Medicine report contains relevant, detailed recommendations and guiding principles.

Determining whether participant results will be returned:The action of returning or sharing results with research participants should be thought of as offering the results. When individual research results are offered, participants should be given the opportunity to decide whether or not to receive the results, rather than automatically receiving them.
When a participant specifically requests their data:

If a participant requests their individual research data that is being withheld, the IRB may determine that a participant’s request may be accommodated based on:

  1. Whether the data collection tools are validated
  2. How the data are planned to be used. The IRB may determine that it is not appropriate to release individual participant data if there is a possibility that the data may be misused (e.g., for clinical purposes when not appropriate or possibly harmful).
  3. Evaluating the process for sharing the data. One of the considerations in evaluating whether the process for sharing is appropriate is based on whether the study team possesses appropriate expertise to provide counseling for the participant. The IRB may require that key personnel be added to the study to facilitate appropriate sharing.
IRB responsibilities
  • Ensure that researchers have a plan for results that will be offered for return, including an assessment of clinical actionability and urgency
  • Assess plans for sharing other types of research results and determine whether such sharing should be permitted
  • Review all plans for the return of results in consideration of the risk of returning the results versus anticipated benefits
  • Review the consent process to determine if the information provided to participants addressing the conditions of sharing of results are appropriate, including the ability of participants to opt out of the return of non-critical results
Investigator responsibilities

If your study requires results to be withheld from participants in MyChart,  you may request an opt-out from automatic result release. To initiate this request, please submit a ticket to the APeX Research team using the following link: Research Release Restriction Request.

The APeX Research team will promptly review your request and adjust the release settings for your study. You may choose one of the following opt-out durations:

  • While the patient is on the study
  • For the active period of the study
  • Indefinitely

For questions about automatic release of MyChart results please contact: [email protected] 

Consent Form Requirements:

If you plan to withhold research results from participants, this must be clearly stated in the consent form. If using the currently posted plain language consent form template and companion document, this is addressed in section 7.2, “Will clinically relevant research results be shared with me?” Appropriate answers in section 7.2 are:

  • “No.” or
  • “No. Research results, including clinically-relevant or individual research results, will not be shared with you or your clinical care team, including results of tests that would have been available to you if you weren’t in this study. Once the study is over, you will have access to any research test results that have been added to your medical record.”

If appropriate, add how incidental findings or immediately actionable results will be addressed, for example:

“However, there is a chance the study team will find something unexpected that may require follow-up with your doctor, or that you may need to take an action on. If that happens, we will contact you to talk about the results.”

If your consent forms predate the plain language consent form template, there should be a statement about sharing research results in the “Research Results” section.

This guidance has benefitted from the University of Washington’s extensive guidance.

[1] 45 CFR 46.116(c)(8)

[2] 45 CFR 164

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