HOW WE DEFINE PERSONALLY VALUABLE RESULTS
A personally valuable result is information that might be of value to the participant or their healthcare provider regardless of whether the result is actionable. These results do not require immediate action.
- Genetic screening of a normal individual returns cystic fibrosis carrier status.
- The participant is found to have Gilbert’s syndrome with an abnormal bilirubin secondary to a variant of a gene but one that does not cause liver disease. It is important to know, however, so that unnecessary tests are not performed.
- The participant is found to have a rare blood type.
Review the Basics for Returning Personally Valuable Results:
How to Prepare and Additional Points to Consider
It is likely that any study returning personally valuable 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 by choice, when to expect them, 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.
During this study, we will learn things about you that you may find interesting but are unlikely to require immediate action. Some people find this kind of information confusing or stressful, other people appreciate receiving this information about themselves. You can choose whether to receive this information. You can also choose whether or not you wish your healthcare provider to have this information.
[Include appropriate language for participants to indicate whether they want to receive information, per your plan.]
Regulatory Requirements & CLIA Confirmation
A research result that falls within the category of personally valuable 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 all necessary regulations for return, the resources needed to return it may not be justified. This is dependent on the study and the priorities of the study population, and should be considered on a study-by-study basis.
See more here about regulations that pertain to IRR.