I am working with a study where a new ICF has come out. We have subjects who are just waiting for a final phone call and no more on-site visits are required. Can the ICFs be discussed with the subjects over the phone and answer any questions they have and then mail the ICF to them for signature and return?
- Clinical Research Associate, CRO
This is a good question. Technically, there are no regulatory requirements that address the issue or process for “re-consenting” participants in an ongoing study. This obligation really stems from the required element of consent which states that if there is new information that becomes available during the study which might affect the participants’ decision about whether to continue in the research, that information will be provided promptly.
When there is an update to informed consent information, the first question to consider is which of the study participants may need to know this information. If the change is related to screening procedures, then participants who are already on study drug won’t reconsider study participation because of that change. A revision to the drug dosing schedule won’t matter to participants who have completed dosing and are in the follow-up phase. New information that secondary cancers may be seen in people who receive this class of drug, even years later, would be important to future, current and past participants; if they’ve finished dosing, it can’t affect their decision about being in the study, but it may impact their future clinical care.
In this case, if participants are just waiting for a final follow-up call, do the changes to the consent information impact their participation or their future clinical care? If not, it may be reasonable to say that they don’t need to be reconsented at all. But if it does impact them, then the next question is the process.
FDA regulations allow a waiver of documentation of informed consent, which means that the consent process can be conducted verbally and a note can be written to document that the participant provided consent, without having their actual signature (56 CFR 109.1). FDA also announced in late 2018 that they will allow a waiver of informed consent in certain circumstances.
In your example, if it is appropriate to inform the participants in follow-up, it may be that obtaining verbal consent with documentation of that agreement in their research record is sufficient, and it is not necessary for the informed consent document to be mailed and returned. It may even be better to rely on verbal consent, as some organizations are uncomfortable with obtaining signatures remotely, as there is no way to tell who actually wrote the signature when it is unwitnessed.
Usually, the reviewing IRB will include directions for who needs to be reconsented when they approve the revised consent information, but not all IRBs do this. The sponsor can certainly suggest a plan for who should be reconsented and how reconsent will be obtained (e.g., signing the new written consent form for new participants and those on study drug, and waiver of documentation of consent requested to allow verbal reconsent by phone for participants off study drug but in long term phone follow-up), which may be logistically feasible and less burdensome on both staff and participants. The WCG IRBs are always happy to consider these suggestions, and willing to discuss the possible plans with sponsors before they submit, to ensure that what they propose is compliant and includes the specific terminology that corresponds with the determinations the IRB will have to make.