CIP CIP Informed Consent Process & Documentation 3 — Questions and Answers
Question 1: What is the purpose of a 'capacity assessment' in the informed consent process?
- To determine whether a prospective subject can understand and make a voluntary decision about participation (Correct answer)
- To evaluate the scientific merit of the research
- To assess the subject's physical ability to complete study procedures
- To verify the subject's identity and eligibility criteria
Correct answer: To determine whether a prospective subject can understand and make a voluntary decision about participation
A capacity assessment evaluates cognitive and decisional ability to ensure truly voluntary and informed consent.
Question 2: Which of the following is NOT a required basic element of informed consent under 45 CFR 46?
- A description of the investigator's financial conflicts of interest (Correct answer)
- A description of the purpose of the research
- An explanation of expected benefits
- A statement that participation is voluntary
Correct answer: A description of the investigator's financial conflicts of interest
Financial conflicts of interest are not listed among the eight basic elements of informed consent required by the Common Rule.
Question 3: A consent form that is written at a reading level above the average subject's comprehension level violates which principle?
- The requirement that information be presented in a language understandable to the subject (Correct answer)
- The Belmont principle of beneficence
- The principle of justice
- The requirement for IRB approval of the form
Correct answer: The requirement that information be presented in a language understandable to the subject
Regulations require that consent information be presented in language understandable to the subject, which includes appropriate reading level and vocabulary.
Question 4: When is a certificate of confidentiality (CoC) required for federally funded research?
- When the research collects or uses identifiable, sensitive information and is funded by a US federal department covered by the 21st Century Cures Act (Correct answer)
- Only when the IRB specifically requests one
- Whenever participant data is stored electronically
- Only for clinical trials with FDA oversight
Correct answer: When the research collects or uses identifiable, sensitive information and is funded by a US federal department covered by the 21st Century Cures Act
The 21st Century Cures Act mandates CoCs for all NIH-funded research collecting identifiable, sensitive information, protecting data from compelled disclosure.
Question 5: Which of the following best describes 'therapeutic misconception' in the informed consent process?
- A subject's mistaken belief that the research is designed to benefit them individually rather than generate generalizable knowledge (Correct answer)
- A researcher's assumption that subjects understand the consent form
- The IRB's failure to account for treatment risks in minimal-risk determinations
- A sponsor's incorrect claim about the study's commercial intent
Correct answer: A subject's mistaken belief that the research is designed to benefit them individually rather than generate generalizable knowledge
Therapeutic misconception occurs when subjects conflate research participation with individualized clinical care, undermining truly informed consent.
Question 6: Under 45 CFR 46.116(c), which of the following is an additional element of informed consent that must be included when appropriate?
- A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus) which are currently unforeseeable (Correct answer)
- The IRB protocol number
- The complete list of study exclusion criteria
- The sponsor's contact information for regulatory questions
Correct answer: A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus) which are currently unforeseeable
When applicable, subjects must be informed of unforeseeable risks, including reproductive risks, as an additional consent element.
CIP CIP Informed Consent Process & Documentation 3
What is the purpose of a 'capacity assessment' in the informed consent process?