SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Ethical Principles in Research 1 — Questions and Answers
Question 1: Which ethical principle requires that research participants be treated as autonomous agents capable of making their own decisions about participation?
- Beneficence
- Justice
- Respect for persons (Correct answer)
- Nonmaleficence
Correct answer: Respect for persons
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:
- Clinical laboratory testing of approved drugs
- Medical research involving human subjects (Correct answer)
- Animal studies preceding human trials
- Post-market surveillance of medical devices
Correct answer: Medical research involving human subjects
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:
- A researcher misrepresenting the purpose of a study to obtain funding
- A participant's false belief that research procedures are designed for their personal benefit (Correct answer)
- An IRB misclassifying a study's risk level
- A sponsor concealing negative trial results from regulators
Correct answer: A participant's false belief that research procedures are designed for their personal benefit
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?
- Sponsors must not terminate a trial without regulatory approval
- Investigators must not withdraw a participant's data once collected
- Researchers must ensure participants receive appropriate care if they withdraw or the trial ends (Correct answer)
- IRBs must continue reviewing a study until all follow-up data is collected
Correct answer: Researchers must ensure participants receive appropriate care if they withdraw or the trial ends
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?
- Failing to obtain written consent from all participants
- Using institutionalized or disadvantaged groups to bear the burdens of research while healthful populations received the benefits (Correct answer)
- Conducting research without an independent data safety monitoring board
- Publishing trial results without disclosing conflicts of interest
Correct answer: Using institutionalized or disadvantaged groups to bear the burdens of research while healthful populations received the benefits
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.
Question 6: A Data Safety Monitoring Board (DSMB) serves which primary ethical function in a clinical trial?
- Ensuring the sponsor's financial interests are protected during interim analyses
- Providing independent oversight to protect participant safety and trial integrity through periodic data reviews (Correct answer)
- Replacing the IRB's continuing review responsibility once enrollment begins
- Certifying that the statistical analysis plan complies with FDA regulations
Correct answer: Providing independent oversight to protect participant safety and trial integrity through periodic data reviews
A DSMB is an independent group that reviews accumulating safety and efficacy data at pre-specified intervals to recommend whether a trial should continue, be modified, or be stopped early—fulfilling the ethical duty to minimize harm to participants.
SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Ethical Principles in Research 1
Which ethical principle requires that research participants be treated as autonomous agents capable of making their own decisions about participation?