Federal Register API Access

FederalRegister.gov and eCFR.gov Access

• Programmatic access to FederalRegister.gov and eCFR.gov is limited due to automated scraping.
• Access can be requested by completing a CAPTCHA (bot test) to add an IP address to the allowed list.
• Each IP address requires a separate access request, which is valid for approximately three months.
• The access request process may need to be repeated every quarter.
• To request access for a wider IP range, first request access for the current IP and then use the "Site Feedback" button.

Important Details

• FederalRegister.gov and eCFR.gov are official websites of the United States government.

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.