Informed Consent in Clinical Trials

10 Questions

Providing adequate information and facilitating understanding

To determine interest and eligibility of potential subjects

Participants are provided with relevant information

Facilitating understanding of the study's protocol and clinical course

21 CFR part 50

The clinical investigation could not practicably be carried out without the waiver.

Offering an excessive reward to enroll in a clinical investigation.

Language that makes it seem like the participant is giving up their right to sue for negligence.

Govern through an ethics committee.

When an overt threat of harm is intentionally presented to obtain compliance.

Study Notes

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'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.

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.

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.

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.

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 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.

10 Questions