As per 45 CFR 46.117(a), informed consent needs to be documented by the use of a written informed consent form (ICF) approved by the IRB (Institutional Review Board) and signed (including in an electronic format) by the subject or the subject’s legally authorized representative. A written copy has to be provided to the person signing the informed consent form. A well-authored ICF plays a key role in ensuring that the patient has an opportunity to be an informed participant in his/her healthcare decisions. This requires the ability to translate complex scientific data into simple lay language, addressing critical aspects related to health literacy and numeracy, while informing the trial participant of:
- The nature of the research
- The potential benefits and risks involved
- The fact that participation in the trial is voluntary
To ensure the equitable selection of trial participants, it is important that the ICF provided is in a language understandable to the subjects or their representatives. The FDA recommends that the IRB review, and if appropriate, approve procedures for ensuring that the translations will be prepared by a qualified individual or entity. Investigators are also required to provide the IRB with a description of how interpreters would be made available to subjects during the research. To address contingencies requiring the unexpected enrollment of subjects who do not speak English (and when there is inadequate time to translate the form into the desired language and obtain IRB approvals), IRBs may arrange for the advance translation of a generic short form into multiple languages. In this situation, the investigator would present the oral translation of the IRB-approved English version of the long form (the standard ICF) with the assistance of an interpreter, and the trial participant would sign the translated short form (which states that the elements of the consent document have been presented orally to the subject or the subject’s representative).
Informed consent is a critical step in the clinical trial process, and among the top findings during FDA inspections. To ensure success, sponsors and sites must seek out partners with expertise in authoring these documents, as well as in translating them.
CSOFT Health Sciences’ comprehensive expertise in authoring, translating, and interpreting ICFs enables us to provide:
- Experts that can contribute to the development of ICFs
- Native, in-country linguists that can translate the ICFs into over 250 languages
- In-country review by a local, non-scientific panel, that can ensure that the content has been localized effectively
- Interpreters to support the oral translation of the ICF when required
- Creative content developers for the development and review of other patient-centric material