Ethical Standards & Compliance Flashcards

The Nuremberg Code was primarily a response to which historical event?

Answer: Nazi medical experiments conducted on prisoners during World War II

The Nuremberg Code (1947) was drafted in response to the Nazi doctors' trial to establish voluntary consent and scientific necessity as bedrock research ethics principles.

When a study protocol is amended to add a new measurement instrument, which IRB action is typically required?

Answer: Submission of a protocol modification for IRB review and approval before implementation

Protocol amendments must be reviewed and approved by the IRB before implementation, as new instruments may affect risk or consent adequacy.

A researcher conducting a survey about HIV status is required to report results to public health authorities by state law. How must the consent form address this?

Answer: Clearly disclose the limits of confidentiality including mandatory reporting requirements

Informed consent must disclose limits of confidentiality, including any mandatory reporting requirements that override researcher confidentiality promises.

A researcher wishes to recruit economically disadvantaged participants for a paid study offering $200. The primary ethical concern is:

Answer: Undue inducement that compromises voluntariness of consent

High payments to economically disadvantaged people can constitute undue inducement, undermining truly voluntary informed consent.

Under the Declaration of Helsinki, placebo-controlled trials are ethically permissible only when:

Answer: No proven effective intervention exists, or withholding it causes only minor reversible harm

The Declaration of Helsinki restricts placebo use to situations where no proven treatment exists or where methodological reasons for placebo are compelling and no serious harm results from withholding treatment.

A researcher shares de-identified data with a colleague who then re-identifies participants using an external dataset. The original researcher's primary ethical obligation was to:

Answer: Prevent re-identification through data use agreements and de-identification verification

Researchers must implement data use agreements and verify de-identification robustness before sharing to prevent foreseeable re-identification.

An IRB's continuing review process serves primarily to:

Answer: Ensure ongoing protection of participants as the study evolves over time

Continuing review allows the IRB to reassess risk-benefit balance, consent procedures, and participant safety as a study progresses.