61. When FDA requires subject names, FDA will generally treat such information as confidential, but on rare occasions, FDA may be required to disclose this information to third parties, for example, to a court of law. Alternative Procedures or Treatments 5. Investigators and sponsors can describe other plans in the consent document for informing subjects of the outcomes of the clinical investigation.

Please note that under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, FDA does not need permission to inspect records containing health information (45 CFR 164.512). An explanation of whom to contact with questions about the research. The materials and procedures used for subject recruitment, which typically include advertisements, must be reviewed by the IRB to ensure that these materials are appropriate. Therefore, FDA recommends that whenever subjects who do not understand English are involved in research, appropriate interpreter services be made available throughout the course of the research. 62 (21 CFR 50.55(b).) The informed consent process must clearly describe the expected duration of the subject's participation in the clinical investigation (see 21 CFR 50.25(a)(1)), which includes their active participation as well as long-term follow-up, if appropriate. FDA issues this draft guidance while the agencies continue to explore potential changes to the Common Rule. ), A description of any benefits to the subject or to others which may reasonably be expected from the research. Subjects should be made aware that insurance or other reimbursement mechanisms might not fund the medical care they receive because they are participating in a clinical investigation even when the care is the standard care they would otherwise receive if not participating in a clinical investigation. A statement describing the extent, if any, to which confidentiality of the records identifying the patient will be maintained and that FDA may inspect the records. The Clinical Investigator1. Consent processes that were approved prior to January 21, 2019 must be revised to include the new required elements of informed consent. See section 801(a) of the Food and Drug Administration Amendments Act of 2007, Pub. FDA believes that the discussion of other trials for which the subject may be eligible is best left to the informed consent discussion rather than the informed consent document and may need to include the subject's primary care provider. <>>> The information given to the subject, which could include information provided orally during the consent interview or written information in the consent form, must be in language understandable to the potential subject or legally authorized representative (21 CFR 50.20).