CRA Resident Rights & Advocacy 2 — Questions and Answers
Question 1: Under the Common Rule (45 CFR 46), which condition must be met for an IRB to waive the requirement for written informed consent documentation?
- The research involves no more than minimal risk and the waiver will not adversely affect subjects' rights (Correct answer)
- The PI holds a federal research grant exceeding $500,000
- All subjects are adults with full decision-making capacity
- The study is conducted at a single site with fewer than 50 participants
Correct answer: The research involves no more than minimal risk and the waiver will not adversely affect subjects' rights
45 CFR 46.117(c) allows IRBs to waive written consent documentation when the research presents no more than minimal risk and the waiver won't adversely affect participants' rights and welfare.
Question 2: A subject in a longitudinal study withdraws consent mid-study. Which action by the research team is ethically required?
- Continue using previously collected data but collect no new data from that subject (Correct answer)
- Immediately destroy all data already collected from that subject
- Seek IRB approval before honoring the withdrawal
- Notify the sponsor and await guidance before stopping data collection
Correct answer: Continue using previously collected data but collect no new data from that subject
Withdrawal of consent means no new data collection; previously collected data may generally be retained unless the consent form specified otherwise.
Question 3: Which federal principle requires that research subjects be selected equitably so that burdens and benefits are distributed fairly across populations?
- Justice (Correct answer)
- Beneficence
- Respect for Persons
- Non-maleficence
Correct answer: Justice
The Belmont Report's principle of Justice requires fair distribution of research burdens and benefits, preventing exploitation of vulnerable or convenient populations.
Question 4: An advocate notices that a consent form for a drug trial omits information about alternative treatments. Which Belmont element is violated?
- Disclosure of relevant alternatives (Correct answer)
- Voluntariness of participation
- Comprehension of information
- Competence to consent
Correct answer: Disclosure of relevant alternatives
Informed consent requires disclosure of appropriate alternative procedures or treatments that might be advantageous to the subject.
Question 5: What does the concept of 'therapeutic misconception' mean in the context of research subject protections?
- Subjects mistakenly believe research procedures are designed for their individual benefit rather than to generate generalizable knowledge (Correct answer)
- Investigators believe all research will ultimately benefit participants
- Sponsors assume all adverse events are unrelated to the study drug
- IRBs conflate standard-of-care treatment with experimental intervention
Correct answer: Subjects mistakenly believe research procedures are designed for their individual benefit rather than to generate generalizable knowledge
Therapeutic misconception occurs when subjects fail to distinguish research from individualized clinical care, undermining true informed consent.
Question 6: Which mechanism allows a legally authorized representative (LAR) to provide permission for a cognitively impaired adult to participate in research?
- Surrogate consent based on substituted judgment or best interests standard (Correct answer)
- Court-ordered mandatory participation
- Blanket institutional approval for all incapacitated subjects
- Waiver of consent granted automatically by the IRB
Correct answer: Surrogate consent based on substituted judgment or best interests standard
An LAR may provide surrogate consent using substituted judgment (what the subject would have wanted) or best interests when the subject cannot consent independently.
Question 7: A participant advocate discovers that subjects are being pressured by their physicians to enroll in a study. Which ethical principle is most directly compromised?
- Voluntariness (Correct answer)
- Disclosure
- Comprehension
- Beneficence
Correct answer: Voluntariness
Voluntariness requires that participation be free from coercion or undue influence, including influence from treating physicians who hold authority over patients.
CRA Resident Rights & Advocacy 2
Under the Common Rule (45 CFR 46), which condition must be met for an IRB to waive the requirement for written informed consent documentation?