List the 8 basic requirements of informed consent delineated in
21 CFR 50.25 (FDA's regulation)
1. A statement that the study involves research and an explanation of the purposes, procedures, and expected duration of the study.
2. A description of any reasonably foreseeable risks or discomforts to the subject.
3. A description of any benefits to the subject or others that may reasonably be expected from the research.
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
5. A statement describing the extent to which confidentiality of records identifying the subject will be maintained.
6. For research involving more than minimal risk, an explanation as to whether any compensation or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights and who to contact in the event of a research-related injury to the subject.
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
The 8 basic requirements of informed consent delineated in 21 CFR 50.25, which is the FDA's regulation, are as follows:
1. Informed Consent Document: The informed consent process must involve a written consent document that includes all the essential elements required by 21 CFR 50.25.
2. Information Disclosure: The investigator must provide the subject with all the pertinent information necessary for them to make an informed decision. This includes information about the nature of the study, its purpose, duration, the potential risks and benefits, and any alternative procedures or treatments.
3. Comprehension: The subject must have the opportunity to ask questions and receive satisfactory answers regarding the study. The investigator must ensure that the subject understands the information provided.
4. Voluntary Participation: The subject's participation in the study must be voluntary, free from coercion or undue influence. They should have the freedom to withdraw from the study at any time without penalty or loss of benefits.
5. Privacy and Confidentiality: The subjects' privacy and confidentiality must be protected. Any personal information collected during the study should be kept confidential and shared only with authorized individuals.
6. Consent by Legally Authorized Representative: If the subject is unable to provide informed consent, their legally authorized representative (e.g., parent, guardian) must provide consent on their behalf. The representative must also be provided with all the necessary information to make an informed decision.
7. Documentation: The informed consent process must be properly documented. The consent form should include the date of consent, the signature of the subject or their legally authorized representative, and a copy of the consent document should be provided to the subject.
8. Continuing Consent: The investigator must keep the subject informed of any new information that may affect their willingness to continue participating in the study. This includes changes in the study protocol, significant new findings, or unforeseen risks. The subject must be given the opportunity to re-evaluate their decision to participate and provide ongoing consent if desired.
It is important to consult the official FDA regulations and guidelines for accurate and up-to-date information regarding informed consent requirements.