Sections on this page:
Informed Consent Process
“Consent” is an ongoing process, not a one-time event.
The signed consent form documents the consent process, but it is not the end of discussion.
Care should be taken to ensure that participants have all of the information available about the results they can receive, and that they understand what they are agreeing to receive or choosing not to receive. This is especially important when returning genomic data.
Just as consent as an ongoing process, we recommend regular check-ins to re-affirm the participant’s decision in regard to IRR or to offer them an opportunity to change their mind. These check-ins should be pre-specified, particularly in the event that a participant initially chooses not to receive their IRR, so that the participant continues to feel that their choice was and is respected and does not interpret the check-in as undue pressure or influence.
In the context of returning IRR, the Informed Consent Form (ICF) should include these components:
- A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to participants, and if so, under what conditions
- A statement that an urgent result generated during the study will be required to be returned, if applicable, regardless of participant preference
- Whether a participant’s healthcare provider will or will not be contacted for an urgent result. This should be made clear even if the participant chooses not to receive other results. In some cases, the research requires the participant to consent specifically to sharing data with the healthcare provider.
- Any foreseeable risks and benefits related to receiving individual results
Either the ICF or an accompanying information sheet (more below) should include a mechanism for participants to choose whether they want to receive any non-urgent IRR that will be made available.
Sample ICF Language is included below
More specific information about returning IRR does not necessarily need to be in the ICF.
Instead, the details can be included in an information sheet that is offered and explained at the time of consent. This sheet can include:
- Which specific results will be available
- Which results won’t be available, and why
- When results will be returned to the participant
- How results will be shared with the participant
- Who will share the results with the participant
- Who will have access to or be allowed to have access to these results (e.g., Healthcare Provider, family, etc.)
- Whether, when, and how a participant will be able to access their results if they choose to withdraw from a study
Either the ICF or accompanying information sheet should include a mechanism for participants to choose whether they want to receive any non-urgent IRR.
An information sheet can also include information about whether and when a participant will have additional opportunities to change their decision.
If appropriate, a note to file could be included to document the information given to and the conversation with the participant.
Health Literacy and Informed Consent
For more specific recommendations about the impact of plain language, numeracy, clear design, and cultural competence on the informed consent form and process, see the MRCT Center Health Literacy website.
This website is focused on integrating health literacy concepts, techniques and best practices into all clinical research communications and interactions.
ICF Sample Language
Result Type: Urgent
Sample: We will [draw blood] [perform tests] that may result in medical information that requires immediate action. We will share this information with you [and your healthcare provider] so that you can get further medical care.
If you agree to take part in the study, you are agreeing to sharing this information with you [and your healthcare provider]. [We will also need your healthcare provider’s contact information]
[If you do not agree with allowing this information to be shared with your healthcare provider, you cannot participate in this study. This is for your safety.
If you do not have a healthcare provider, then…]
[If we cannot reach you to tell you about the result, please provide the name and contact information of someone you trust with whom we can share this information. If we cannot reach you after X attempts by (phone/email/text), we will contact this person.]
Result Type: Actionable
Sample: 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.
Result Type: Personally Valuable
Sample: 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.]
Result Type: No Known Implications
Sample: 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.]