Today the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) published final guidance aimed at providing answers to commonly asked questions about using electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. This guidance finalizes the draft guidance entitled “Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers” issued in March 2015. The final guidance was developed in collaboration with FDA and OHRP and is issued as a joint final guidance.
Final Guidance for Industry: “Use of Electronic Informed Consent--Questions and Answers.”
Federal Register Notice: https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/pdf/2016-30146.pdf
Informed consent is the process of providing a subject with adequate information to allow for an informed decision about his or her voluntary participation in the clinical investigation. FDA believes that informed consent should include a process that facilitates the subject’s comprehension of the information and allows adequate opportunity to ask questions and consider whether or not to participate. Furthermore, this process often continues beyond obtaining the subject’s initial consent at the time of enrollment. It may involve providing information as the clinical investigation progresses or as the subject or situation requires.
This guidance is targeted toward stakeholders in the clinical research community, including potential clinical trial subjects. You may find consumer information at FDA’s Patient Network website: Informed Consent in Clinical Trials.