Consent form7/13/2023 ![]() ![]() This guidance has been prepared jointly by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). To discuss an alternative approach, contact OHRP or the FDA office responsible for this guidance as listed on the title page. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. It does not establish any rights for any person and is not binding on OHRP, FDA, or the public. This guidance represents the current thinking of the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) on this topic. Guidance for Institutional Review Boards, Investigators, and Sponsors What materials or documents will FDA require during an inspection? What steps can be taken to ensure the system archives the eIC materials appropriately for FDA-regulated clinical investigations? What eIC documentation does FDA require for submission with applications? What are the IRB’s responsibilities in the eIC process? What eIC materials should the investigator submit to the IRB? Can HIPAA authorizations for research, which are frequently combined with informed consent documents, be obtained electronically? What steps can be taken to help ensure privacy, security, and confidentiality of the eIC information? Should subjects receive a copy of their eIC and have easy access to the materials and information presented to them in their eIC? What special considerations should be given to the use of eIC for pediatric studies? What methods may be used to verify the identity of the subject who will be electronically signing an eIC for FDA-regulated clinical investigations? How can electronic signatures be used to document eIC? ![]() What steps may be taken to convey additional information, including significant new findings, to the subject during the course of the research? What steps may be taken to facilitate the subject’s understanding of the information being presented? 6 How and when should questions from subjects be answered? How and where may the eIC process be conducted? How should information in the eIC be presented to the subject? INSTITUTING AN ELECTRONIC INFORMED CONSENT process Office for Human Research Protections (OHRP)Ĭenter for Drug Evaluation and Research (CDER)Ĭenter for Biologics Evaluation and Research (CBER)Ĭenter for Devices and Radiological Health (CDRH) 71, Room 3128ĬDRH-Division of Industry and Consumer EducationĬenter for Devices and Radiological Healthġ0903 New Hampshire Ave., Bldg. Office of Communication, Outreach and DevelopmentĬenter for Biologics Evaluation and Researchġ0903 New Hampshire Ave., Bldg. Office of Special Medical Programs, Office of Medical Products and Tobacco ![]() Office of Communications, Division of Drug Informationġ0001 New Hampshire Ave., Hillandale Bldg., 4 th Floor ![]()
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