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Questions and Answers
What is informed consent beyond obtaining a signature from research participants?
What is informed consent beyond obtaining a signature from research participants?
What is the main purpose of recruitment advertising?
What is the main purpose of recruitment advertising?
What happens if new safety information is updated in the protocol during the study?
What happens if new safety information is updated in the protocol during the study?
What is the primary responsibility of investigators in the informed consent process?
What is the primary responsibility of investigators in the informed consent process?
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What regulation outlines the Protection of Human Subjects?
What regulation outlines the Protection of Human Subjects?
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What is a condition for waiving informed consent according to 21 CFR 50?
What is a condition for waiving informed consent according to 21 CFR 50?
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What is an example of undue influence?
What is an example of undue influence?
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What should an informed consent form never include?
What should an informed consent form never include?
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What should an investigator do if they need to provide new information about the protocol to a participant?
What should an investigator do if they need to provide new information about the protocol to a participant?
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What is coercion?
What is coercion?
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Study Notes
Informed Consent in Clinical Trials
- Informed consent is not just obtaining a signature, but also providing adequate information, facilitating understanding, and providing opportunities for questions and consideration.
- Provides information related to the clinical investigation process and facilitates the prospective subject's understanding of the protocol and clinical course of the study.
FDA Regulations for Informed Consent
- FDA's informed consent requirements are listed in 21 CFR part 50 on Protection of Human Subjects.
- Additional regulations related to Investigational New Drug (IND) Applications are found in 21 CFR part 312.
- Studies conducted or supported by HHS (Health and Human Services) may be subject to 45 CFR part 46.
Recruitment Advertising and Informed Consent
- FDA considers recruitment advertising as part of the consent process.
- Recruitment materials should match the informed consent document and only include necessary information for subjects to determine interest and eligibility.
Ongoing Informed Consent Process
- The informed consent process is an ongoing exchange of information throughout a subject's participation in a clinical trial.
- If new safety information is updated during a study, participants should be provided with relevant information.
General Requirements for Informed Consent
- No investigator may recruit human participants in a clinical study without obtaining the legally effective informed consent of the subject or their legally authorized representative.
- Sufficient information should be provided to consider participation, and minimize the possibility of coercion or undue influence.
- Information should be in a language understandable to the subject or legally authorized representative.
Exceptions to Informed Consent
- Human subject is confronted by a life-threatening situation necessitating the use of an intervention, and available treatments are unproven or unsatisfactory.
- Inability of research participants to give consent due to their medical condition.
- No reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation.
- Clinical investigation could not practicably be carried out without the waiver.
- Clinical investigation involves no more than minimal risk to the subjects.
Coercion and Undue Influence
- Coercion occurs when an overt threat of harm is intentionally presented to obtain compliance.
- Undue influence occurs through an offer of an excessive, unwarranted, inappropriate, or improper reward or other overture to obtain compliance.
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Description
Understand the importance of informed consent in clinical trials, including providing adequate information and facilitating understanding. Learn about FDA regulations and requirements.
