SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Ethical Principles in Research 1

Question 1

Which ethical principle requires that research participants be treated as autonomous agents capable of making their own decisions about participation?

Accepted Answer

Respect for persons

Answer

Respect for persons is the Belmont Report principle that recognizes individuals as autonomous agents entitled to make their own choices, and requires that those with diminished autonomy receive additional protections.

Question 2

The Declaration of Helsinki, adopted by the World Medical Association in 1964, primarily governs ethical standards for:

Accepted Answer

Medical research involving human subjects

Answer

The Declaration of Helsinki establishes ethical principles for medical research involving human subjects, including requirements for informed consent, independent ethics committee review, and favorable risk-benefit assessments.

Question 3

In clinical research ethics, the concept of 'therapeutic misconception' refers to:

Accepted Answer

A participant's false belief that research procedures are designed for their personal benefit

Answer

Therapeutic misconception occurs when research participants incorrectly believe that decisions about their care are being made based on their individual clinical needs rather than the protocol's research objectives, compromising true informed consent.

Question 4

Which of the following best describes the ethical obligation of 'non-abandonment' in clinical research?

Accepted Answer

Researchers must ensure participants receive appropriate care if they withdraw or the trial ends

Answer

Non-abandonment requires that researchers ensure participants have access to continued care or appropriate referrals if they withdraw from a study or if the study is terminated, protecting their wellbeing beyond the trial itself.

Question 5

Under the principle of justice as described in the Belmont Report, which of the following historical practices was most directly identified as a violation?

Accepted Answer

Using institutionalized or disadvantaged groups to bear the burdens of research while healthful populations received the benefits

Answer

The Belmont Report cited the unjust selection of research subjects—such as prisoners, the poor, or racial minorities bearing research burdens while more advantaged groups reaped the benefits—as a key injustice the principle of justice was designed to address.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Ethical Principles in Research 1