21 CFR 50 Flashcards
What is 21 CFR Part 50?
A federal regulation that outlines the requirements for obtaining informed consent from human subjects participating in clinical research.
Who is responsible for obtaining informed consent from research subjects in accordance with 21 CFR Part 50?
The investigator or their designated representative is responsible for obtaining informed consent.
What is the primary purpose of informed consent under 21 CFR Part 50?
The primary purpose of informed consent is to ensure that research subjects are fully informed about the study, its risks and benefits, and voluntarily agree to participate.
What are the 8 basic elements of informed consent?
1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental
2) A description of any reasonably foreseeable risks or discomforts to the subject
3) A description of any benefits to the subject or to others which 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, if any, 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 any 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 whom 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.
When can informed consent be waived or altered under 21 CFR Part 50.20?
The IRB may waive or alter the requirements if the research involves no more than minimal risk, the waiver will not adversely affect the rights and welfare of subjects, and obtaining informed consent is impracticable.
What are the requirements for obtaining the informed consent of children participating in research under 21 CFR Part 50?
Informed consent from children requires both parental/guardian permission and the child’s assent, depending on their age and maturity.
How should informed consent be documented under 21 CFR Part 50?
Informed consent should be documented by a written, signed consent form, and a copy must be provided to the subject.
What is “comprehension” in the context of informed consent under 21 CFR Part 50?
Comprehension refers to the subject’s ability to understand the information presented during the informed consent process.
What are the consequences of not obtaining proper informed consent under 21 CFR Part 50?
Failure to obtain proper informed consent can result in regulatory violations, invalidation of study data, and harm to research subjects.
How often must informed consent be renewed according to 21 CFR Part 50?
Informed consent should be periodically reviewed and re-obtained if there are changes to the study, risks, or benefits.
What is the title of 21 CFR Part 50?
Protection of Human Subjects
According to 21 CFR Part 50, what is informed consent?
Informed consent is the voluntary agreement, documented by written, signed, and dated consent, of a subject to participate in research after understanding the purpose, risks, and potential benefits.
What are the basic elements that must be included in the informed consent form, as outlined in 21 CFR Part 50?
A statement that the study involves research
Explanation of the purpose, duration, and procedures
Description of foreseeable risks or discomforts
Description of any benefits
Disclosure of alternative procedures or treatments
Explanation of the voluntary nature of participation
Statement about confidentiality
What is the role of the Institutional Review Board (IRB) in relation to 21 CFR Part 50?
The IRB is responsible for reviewing and approving the informed consent process and ensuring that it meets the requirements outlined in 21 CFR Part 50.
How does 21 CFR Part 50 address the inclusion of vulnerable populations in research?
It emphasizes the need for additional protections for vulnerable populations, such as children, prisoners, and individuals with impaired decision-making capacity.
