After nine years in draft form and 127 comments received from stakeholders, the FDA has finalized its guidance on informed consent, adding a question-and-answer section that addresses specific issues.

The 66-page final guidance, first issued in draft form in 2014, covers FDA requirements for informed consent, including basic elements, documentation requirements, stakeholder responsibilities and alternative ways to obtain informed consent. The 16 questions added to the guidance address such additional informed consent considerations as consenting non-English speakers, individuals with low literacy or numeracy skills and vulnerable populations, including children and disabled individuals.

It also covers statutory changes that allow the FDA to waive informed consent requirements for certain minimal-risk trials as well as clarification on financial payments to participants and potential costs they may face from taking part in a trial.

The guidance also notes that the informed consent process should explain whether the patient’s insurance will cover trial-related complications or injuries or detail any trial funds set aside for patient costs not covered by insurance.

“Because these issues may be complex, it may be appropriate to refer the subject to a knowledgeable financial counselor or reimbursement specialist to explain the costs and the insurance and reimbursement issues prior to signing the consent form,” the FDA recommends.

This guidance supersedes the agency’s 1998 guidance, “A Guide to Informed Consent.”

Read the full guidance here.