HOW WE DEFINE ACTIONABLE RESULTS
An actionable result is one that has medical or personal decision-making utility, notably when additional diagnostic or preventive measures are needed or when alternative treatment is available.
- A Hemoglobin AIC (or HbA1c) blood test, a measure of average blood sugar, is above normal, and may indicate diabetes or pre-diabetes.
- Genetic screening of an individual who has been personally unaffected by cancer returns the presence of BRCA1, a breast cancer susceptibility gene.
Reviewing the Basics for Returning Actionable Results:
How to Prepare and Additional Points to Consider
Man of the considerations for Urgent Results apply for any research result. These should be reviewed in addition to considerations for non-urgent, actionable results. Learn more here about preparing to return urgent results.
It is likely that any study returning actionable results may also need to be prepared to return urgent results. Therefore, review the urgent result ICF requirements.
Many details specifically around returning urgent results (e.g., the necessity of obtaining and retaining information about the HCP) will need to be in an ICF, while other details can often be communicated outside of an ICF. Separating these details will reduce the length and complexity of the ICF without compromising accessibility of the information. It will depend study-by-study which details need to be in the ICF, and which do not.
The ICF may state that the participant will receive a separate information sheet (see an example here) that explains other relevant details, such as which results that they will be able to receive and what choices they have, when to expect results, etc. While this does not need to be part of the ICF, the information sheet should be reviewed and approved by the cognizant IRB/ethics committee. We recommend that the process be determined in study planning and presented to the participant during the informed consent discussion.
You will receive an Individual Results Return information sheet during X visit. This sheet will explain the type of information about you that you can choose to receive or not from this study. This information may be helpful for your health in the future, or you might just find it interesting. Some people find this kind of information confusing or stressful. You can choose whether or not to receive this information.
Regulatory Requirements & CLIA Confirmation
A research result that falls within the category of actionable must comply with necessary regulatory requirements (e.g., the test was performed in a CLIA lab) in order to be returned to the participant. It can be returning during the study if feasible and unrelated to study integrity and/or outcomes. If it is related to study outcomes or will impact study integrity, it should be returned only after the study.
If the research result will NOT comply with necessary regulatory requirements for return, the research team should consider changing the plan for the initial test or procedure to bring it into compliance.
See more here about regulations that pertain to IRR.