July 15, 2019
This monthly feature presents a variety of questions from clinical trial professionals with answers from WCG Clinical’s expert staff. To ask a question of WCG’s experts, click here: https://bit.ly/2XB9F6R.
When a research activity includes a translated consent form, does the principal investigator need to sign both the translated consent form and the English consent form? — Director, state university human research protections program
The regulations for informed consent are divided into those that govern the contents of informed consent documents and those that describe the requirements for documenting consent (i.e., signing informed consent forms). There are no regulations that specifically address translations. In fact, the word “translation” does not appear in the regulations.
As a result, the requirements for signing translated consent forms are no different than they are for original forms. In an FDA-regulated clinical trial, both the participant and the person obtaining consent should sign and date the consent document that was used to facilitate the process with the participant. If a consent process was conducted in Korean using a Korean-language document, then that is the document that should be signed.
In addition to the standard approach to documenting informed consent, 21 CFR 50.27(b)(2) also permits the use of a short-form consent document. Short-form consent documentation is typically used when an individual participant speaks a language for which there is no prepared translation.
In this situation, the research site may utilize a short-form written consent document stating that the elements of informed consent have been presented orally to the participant or the participant’s legally authorized representative.
The short-form process also requires the presence of a witness to the oral presentation. When the short-form approach is used, there are additional documentation requirements. In these situations, the short form is signed by the participant (or the representative) and the witness. In addition, the witness also signs the English-language consent document along with the person obtaining the consent. A copy of both the English-language consent document and the short form must be given to the participant. Many IRBs have short-form templates in several foreign languages.
In addition to consent process considerations, the enrollment of non-English speaking participants should be approved by the sponsor and consideration should be given to the impact of the language barrier on data collection. For example, participant diaries and other instruments may only be available in English.
We would recommend that you work closely with the IRB of record and the sponsor as requirements may vary when it comes to documentation of consent. — David Borasky, vice president of IRB compliance, WCG Clinical
I am working with a study where a new informed consent form 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
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 the 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). The FDA also announced in late 2018 that it 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 the 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. — Lindsay McNair, chief medical officer, WCG Clinical