Federal Register API Access

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Questions and Answers

Why is programmatic access to FederalRegister.gov and eCFR.gov limited?

To reduce the number of requests made to the site

Due to aggressive automated scraping of the sites (correct)

To allow only official government agencies to access the site

To prevent human users from accessing the site

What is required to access FederalRegister.gov and eCFR.gov?

Providing a government ID

Passing a bot test (correct)

Paying a subscription fee

Completing a registration form

How long is a request to access FederalRegister.gov and eCFR.gov valid for?

One quarter (three months) (correct)

One month

Six months

One year

What should you do if you want to request a wider IP range?

Request access for your current IP and then use the 'Site Feedback' button Signup and view all the answers

What is the purpose of the 'Site Feedback' button?

To request a wider IP range Signup and view all the answers

What is an essential aspect of informed consent in clinical trials?

Providing prospective subjects with adequate information Signup and view all the answers

What is the primary purpose of recruitment advertising in clinical trials?

To determine subjects' eligibility and interest in the study Signup and view all the answers

When does the informed consent process end in a clinical trial?

It is an ongoing process throughout the study Signup and view all the answers

What is the purpose of FDA's 'Recruiting Study Subjects' sheet?

To provide scripts for basic eligibility screening Signup and view all the answers

What regulation governs the protection of human subjects in clinical trials?

21 CFR part 50 Signup and view all the answers

What is a crucial element of informed consent in clinical studies?

Ensuring the participant understands the potential risks and benefits of the study Signup and view all the answers

In which situation may an exception to informed consent be granted?

When the participant is in a life-threatening situation and available treatments are unproven or unsatisfactory Signup and view all the answers

What is an example of undue influence in a clinical investigation?

Offering employees a discount on their health insurance premiums for participating in a study Signup and view all the answers

What should an investigator do if an exception to informed consent is granted?

Promptly communicate in writing with the IRB and a non-participating physician within 5 days Signup and view all the answers

What should be avoided in the informed consent form?

A statement indicating that the participant is giving up their right to sue for negligence Signup and view all the answers

Study Notes

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 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 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

Quiz about accessing FederalRegister.gov and eCFR.gov APIs, limitations and requesting access. Learn about the programmatic access restrictions and the process to gain access.