Federal regulations for obtaining informed consent of research participants require that, when appropriate, “significant new findings developed during the course of the research that may relate to the participant’s willingness to continue participation will be provided to subjects”. The regulations do not, however, stipulate what qualifies as a significant new finding that may relate to a participant’s willingness to continue participation or how the new information should be conveyed.

This guidance provides study teams with points to consider when determining if new information should be presented to participants and how the new information should be presented.

What information should be provided to already enrolled participants during the course of the study?

Most frequently, information provided to participants during the course of their participation relates to new or updated risk information, changes to study procedures/interventions or to the time commitment required of participants, or updates to how their data or samples may be used or shared. Less frequently, information pertaining to alternatives to participation (e.g. approval of a new medication for the treatment of the disease under study) may arise. New information may apply to subjects who are actively participating and/or to subjects who have already completed their participation.

Information related to reportable events may also impact a participant’s willingness to continue participation and in those cases, should be conveyed to participants. Examples include breaches of confidentiality or other information related to unanticipated problems posing risks to subjects or others.

There is also information that typically does not need to be communicated to already-enrolled research participants. Examples include changes to the inclusion criteria that have no impact on previously enrolled participants (e.g., increase to upper age limit from 60 to 70), an increase in the overall number of participants, or revised procedures that will affect only newly enrolled participants.

How will the information be communicated?

There are generally three pathways in which to provide participants with new information, and the choice of pathway may be influenced by factors including the nature of the new information, its perceived impact on currently enrolled participants, and the status of the research (e.g., enrolling, long term follow-up only, near completion).

Full consent form: Consent documents are revised to include the new information. Participants go through a complete consent process that supersedes the original consent using a document or oral process that contains all required elements of consent and is documented in accordance with the federal regulations. This is often referred to as “reconsent.” The consent process includes highlighting the changes for existing participants and obtaining a signature on the revised form or obtaining oral consent as allowable under federal regulations. Typically recommended when:

• The information affects both current participants and participants enrolled in the future.
• The information is significant or complex in nature (e.g. substantive new risk information, new or changing procedures or visits scheduled)

Information sheet/letter/Consent addendum: The new information is communicated through a written document that is not a full consent form. Consent addendums require a signature, while a mailed letter or information sheet may not. The document should include enough detail to provide context to the new information so that participants can evaluate their continued participation. It is acceptable to cite portions of the original consent that are still valid, but study teams should consider providing a reference copy of the consent form, especially if it has been some time since the subject was enrolled. This method may be appropriate when:

• Participants are in long-term follow-up or not being actively seen
• There is no need to revise the consent form (the study is permanently closed to enrollment)
• The new information is straightforward and does not require revisions to the main consent form to provide context.

Verbal communication with documentation in the study record: New information is communicated orally to participants. Participants are provided with an opportunity to consider the information and reaffirm their willingness to continue participating in the research. Typically recommended when:

• The information is urgent in nature and requires timely disclosure to participants (may be necessary to follow-up with written documentation using one of the methods described above, particularly when new risks are involved)
• The information is easily conveyed verbally, does not include additional risks, and does not require revision to the full consent form (e.g., adding a short questionnaire to a visit that is consistent with those already described in the consent and that doesn’t add significant time to participation).

The choice of pathway should focus on the most effective way to communicate the new information to participants considering the status of the participant and the nature of the new information.

Who should be provided with new information and when?

Study teams should consider the status of the study when deciding which participants need to be informed and how. Different methods may be appropriate for participants who have completed participation, those who are in follow-up, and those who are still actively participating. Also important is whether the study is still enrolling new participants.

When presenting a process to the IRB, study teams should describe the following:

• The nature of the changes or new information.
• The urgency of the information and timeline for informing participants. Please see the reporting guidance on when a New Information report may also be necessary.
• Which participants will be informed (e.g. all participants, current participants only)
• How will they be informed (e.g. reconsented with revised consent forms, use of consent addendum, provision of an information sheet, telephone call).

Resources

The Secretary’s Advisory Committee for Human Research Protections provides a Table of Options based on the significance of the change and whether the information is time-sensitive, also taking into account the recruitment status of the study. SACHRP Reconsent Appendix 2