Returning results with no known implications

HOW WE DEFINE RESULTS WITH NO KNOWN IMPLICATIONS

A result with no known utility or value has unclear significance to a participant’s current or future health, at least as is currently known.  These data include but are not limited to exploratory endpoints and may be generated during or after the study.

Examples:

  • A minimally high-density lipoprotein (HDL) of uncertain significance.
  • Initial genetic research studies that are trying to uncover associations between differences in our DNA and response to an investigational drug.

Review the Basics for Returning Results with No Known Implications:

Points to Consider & the Decision to Return or Not

The return of these types of results should be done with caution and care.

These results may be confusing to participants and/or their healthcare provider and may cause stress to participants from not knowing how or when to act upon their results.

That being said, participants may still want to have this information for the future. These results can be returned if logistically feasible and if the participant chooses to receive them, unless there is a specific reason to withhold the information. It is important to communicate the quality and validity of any data returned particularly those data with no known utility or value, and document that communication. The limitations of the interpretation of the data should be made clear.

Returning exploratory results encourages continuing engagement in research as well as responsible stewardship of personal and family health. If it is decided not to return these data, it should be made clear to the participant for transparency.

Participant Choice

It is especially important to offer participants a choice as to whether or not to receive these types of individual research results, as they carry a risk of confusion, dissatisfaction, and unpleasant reactions.

There are 4 ways outlined to obtain this choice from participants – depending on the nature of your results the risk/benefit ratio may not warrant return.

See more here about participant choice.

Informed Consent

If offering to return this information, it is important that participants understand its limitations, the absence of current and future interpretation, and that they have a choice whether or not to receive it.

Sample language:

During this study, we may learn things about you that you may find interesting but probably will not help you. Health care providers may not know what the information means or what to do about it. Examples include [describe].

Some people find this kind of information confusing or stressful. You can choose whether to receive this information. [Include appropriate language for participants to indicate whether they want to receive information, per your plan.]

See more here about informed consent.

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