CIP Human Subjects Protection & Safety 3 — Questions and Answers
Question 1: A researcher plans to enroll pregnant women in a study that offers the prospect of direct benefit only to the fetus. Under Subpart B (45 CFR 46), this is permissible only if:
- The risk to the pregnant woman is minimal and the study is fully blinded
- The risk to the fetus is minimized and the fathers have provided consent
- The risk to the fetus is minimized and both the mother and father consent where feasible (Correct answer)
- The IRB grants a waiver based on scientific necessity
Correct answer: The risk to the fetus is minimized and both the mother and father consent where feasible
Subpart B requires that when research holds direct benefit only for the fetus, risk to the fetus must be minimized and consent must be obtained from both the pregnant woman and the father where feasible.
Question 2: Which of the following is an example of 'therapeutic misconception' in research?
- A researcher inflates the benefit of a study drug in the consent form
- A subject believes research participation is the same as receiving individualized medical treatment (Correct answer)
- A sponsor withholds interim data from the DSMB
- An IRB approves a study without adequate scientific justification
Correct answer: A subject believes research participation is the same as receiving individualized medical treatment
Therapeutic misconception occurs when subjects fail to distinguish research participation from individualized medical care, attributing therapeutic intent to research procedures.
Question 3: Under the revised Common Rule (2018), a single IRB (sIRB) review is REQUIRED for:
- All FDA-regulated research regardless of funding source
- Cooperative research funded by a U.S. federal department or agency conducted at multiple domestic sites (Correct answer)
- Any multi-site study involving more than 100 participants
- International collaborative research funded by NIH
Correct answer: Cooperative research funded by a U.S. federal department or agency conducted at multiple domestic sites
The 2018 Common Rule mandates sIRB review for cooperative research conducted at multiple domestic institutions and funded by a federal department or agency covered by the rule.
Question 4: When a subject withdraws consent from an ongoing study, the researcher must:
- Destroy all previously collected data to protect the subject's privacy
- Cease collecting new data from the subject, but may retain previously collected data (Correct answer)
- Seek IRB approval before honoring the withdrawal
- Attempt to persuade the subject to continue for at least 30 days
Correct answer: Cease collecting new data from the subject, but may retain previously collected data
Withdrawal of consent stops future data collection but does not require destruction of data already collected, which may be retained for analysis consistent with the consent form.
Question 5: Which of the following best describes an 'unanticipated problem involving risks to subjects or others' (UPIRTSO)?
- Any adverse event occurring in a study participant regardless of expectation
- An unexpected occurrence that is related to the research and suggests increased risk (Correct answer)
- A protocol deviation that was not approved in advance by the IRB
- A conflict of interest identified after a study begins
Correct answer: An unexpected occurrence that is related to the research and suggests increased risk
A UPIRTSO must be unexpected, related or possibly related to the research, and suggest that participants or others are at greater risk than previously recognized.
Question 6: The Justice principle in the Belmont Report primarily addresses:
- Ensuring all study procedures have favorable risk-benefit ratios
- Fair distribution of research burdens and benefits across population groups (Correct answer)
- Guaranteeing that consent is truly voluntary and free from coercion
- The requirement that research designs be scientifically valid
Correct answer: Fair distribution of research burdens and benefits across population groups
Justice requires equitable selection of subjects so that no group bears a disproportionate burden of research risks while others receive the benefits.
Question 7: An IRB conducting continuing review must evaluate which of the following at minimum?
- Updated financial disclosures from all co-investigators
- The number of subjects enrolled, any adverse events, and any new information affecting risk-benefit (Correct answer)
- A statistical power re-calculation submitted by the sponsor
- Confirmation that federal funding has not lapsed
Correct answer: The number of subjects enrolled, any adverse events, and any new information affecting risk-benefit
At continuing review, the IRB must assess enrollment status, adverse events and protocol deviations, and any new findings that could alter the risk-benefit assessment.
CIP Human Subjects Protection & Safety 3
A researcher plans to enroll pregnant women in a study that offers the prospect of direct benefit only to the fetus.
Under Subpart B (45 CFR 46), this is permissible only if: