Ethical Principles in Research Flashcards

When a U.S.-funded clinical trial is conducted in a developing country, the ethical standard for participant protections must be:

Answer: At least equivalent to the standards that would apply in the United States

The Common Rule and ICH GCP require that research conducted abroad with U.S. funding afford protections equivalent to those required domestically.

The Nuremberg Code was developed primarily in response to which historical event?

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

The Nuremberg Code (1947) was established after the Nuremberg Doctors' Trial revealed the atrocities of Nazi medical experimentation.

A local community in a low-income country has no access to the experimental treatment being tested in a trial conducted there. The Declaration of Helsinki requires that:

Answer: Post-trial access to beneficial interventions for study participants and communities should be considered during the design phase

The Declaration of Helsinki (2013 revision) states that provisions for post-trial access to beneficial interventions should be addressed in the study protocol.

In international multicenter trials, which document harmonizes GCP standards across the US, EU, and Japan to ensure consistent participant protections?

Answer: ICH E6(R2) Guideline for Good Clinical Practice

ICH E6(R2) is the internationally harmonized GCP guideline developed through the International Council for Harmonisation to align standards across major regulatory regions.

A participant in a cross-cultural study belongs to a community where individual decision-making is traditionally deferred to a community elder. The ethical approach to informed consent in this context is to:

Answer: Respect community consultation processes while still ensuring individual participants provide voluntary personal consent

Cultural practices must be respected, but individual voluntary consent remains a non-negotiable ethical requirement; community approval supplements but does not replace personal consent.

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

Answer: Participants mistakenly believing the primary purpose of the research is to benefit them personally rather than generate generalizable knowledge

Therapeutic misconception occurs when participants conflate the research protocol with personalized medical care, potentially compromising true informed consent.

Which of the following best describes the ethical principle of 'equipoise' as it applies to clinical trials?

Answer: A genuine state of uncertainty in the expert medical community about the comparative merits of experimental and control treatments

Equipoise means there is genuine uncertainty about which treatment arm is superior, which ethically justifies randomizing participants between them.