Ethical Standards & Compliance Flashcards

Which of the following best describes 'assent' in pediatric research?

Answer: A child's affirmative agreement to participate, obtained in addition to parental consent

Assent is a child's affirmative agreement to participate; it is required in addition to, not instead of, parental permission for most pediatric research.

A researcher uses a social media platform's public posts for research without notifying users. Under current ethical standards, this practice:

Answer: May require IRB review depending on sensitivity of content and context of original posting

Even publicly accessible data can raise ethical concerns; IRB review considers the sensitivity of content and whether users had a reasonable expectation of privacy.

The concept of 'therapeutic misconception' in research ethics refers to:

Answer: Participants incorrectly believing study procedures are tailored to their individual therapeutic needs

Therapeutic misconception occurs when participants fail to distinguish research procedures from individualized clinical care, undermining truly informed consent.

A drug company asks researchers to omit adverse event data below a certain severity threshold from a journal article. The researchers should:

Answer: Refuse and report all adverse events as required by publication ethics and regulatory standards

Selective omission of adverse event data constitutes reporting bias and violates research integrity standards and FDA reporting requirements.

A researcher who suspects a colleague of data falsification should FIRST:

Answer: Report concerns through the institution's research integrity officer or established misconduct reporting channels

Suspected research misconduct should be reported through institutional channels, typically the Research Integrity Officer, who can investigate formally.

In research with prisoners, federal regulations require that the IRB include:

Answer: At least one prisoner or prisoner representative as an IRB member

45 CFR 46 Subpart C requires that the IRB reviewing prisoner research include at least one prisoner or prisoner advocate as a member.

A researcher retains identifiable participant data for 20 years beyond the approved retention period 'just in case it becomes useful.' This practice violates which principle?

Answer: Data minimization and the principle of limiting retention to the stated purpose

Retaining identifiable data beyond the approved period violates data minimization principles and the consent under which data was collected.