Additional principles for research with medical care MCQs With Answer

Introduction

The following MCQ set on Additional principles for research with medical care is designed for M.Pharm students to deepen understanding of ethical, scientific and regulatory considerations specific to clinical and healthcare-linked research. Questions focus on concepts that go beyond core research ethics—such as clinical equipoise, therapeutic misconception, ancillary care obligations, post-trial access, vulnerable populations, data monitoring, and stopping rules—emphasizing their application in pharmaceutical and clinical trials. Each question targets decision-making, protocol design, and participant protection in real-world medical research settings, helping students prepare for clinical study design, ethical review, and regulatory compliance.

Q1. Which concept requires genuine uncertainty within the expert clinical community about the preferred treatment before enrolling patients into a randomized clinical trial?

• Therapeutic misconception
• Clinical equipoise
• Informed consent
• Beneficence

Correct Answer: Clinical equipoise

Q2. What is the primary ethical concern when using placebo controls in trials where an effective standard therapy exists?

• Scientific validity
• Risk of therapeutic misconception
• Withholding effective therapy and causing harm
• Data confidentiality

Correct Answer: Withholding effective therapy and causing harm

Q3. Which term describes participants’ failure to understand that research procedures are aimed at producing generalizable knowledge rather than individualized clinical care?

• Therapeutic misconception
• Clinical equipoise
• Ancillary care
• Assent

Correct Answer: Therapeutic misconception

Q4. Which principle best describes the obligation of researchers to minimize foreseeable risks and maximize potential benefits to participants?

• Justice
• Non-maleficence
• Beneficence
• Autonomy

Correct Answer: Beneficence

Q5. What is meant by ‘ancillary care obligations’ in clinical research?

• Providing participants with unrelated health care services only if funded by sponsors
• Researchers’ responsibilities to address health needs discovered during research that are not part of the study protocol
• Obligation to share raw study data with participants
• Requirement to pay participants for any out-of-pocket expenses

Correct Answer: Researchers’ responsibilities to address health needs discovered during research that are not part of the study protocol

Q6. Which additional principle relates to ensuring fair participant selection so that burdens and benefits of research are equitably distributed?

• Scientific validity
• Social value
• Justice
• Respect for persons

Correct Answer: Justice

Q7. In trials with potentially serious adverse events, what committee is commonly required to independently review safety data and recommend trial continuation or stopping?

• Institutional Review Board (IRB)
• Data Safety Monitoring Board (DSMB)
• Sponsor project team
• Steering committee

Correct Answer: Data Safety Monitoring Board (DSMB)

Q8. Which justification is generally required for enrolling vulnerable populations (e.g., pregnant women, children, cognitively impaired) in clinical research?

• That the research imposes no risk
• That the research offers direct benefit or is necessary to obtain knowledge relevant to that population
• That the participants are easy to recruit
• That compensation will be provided

Correct Answer: That the research offers direct benefit or is necessary to obtain knowledge relevant to that population

Q9. What is a key ethical requirement regarding post-trial access for participants who benefit from an experimental intervention?

• Participants must be given study drugs for free indefinitely
• Investigators should plan reasonable post-trial access if the intervention is beneficial and feasible
• No obligation for post-trial access exists after study completion
• Participants should be referred to other trials instead

Correct Answer: Investigators should plan reasonable post-trial access if the intervention is beneficial and feasible

Q10. Which practice improves scientific validity and reduces bias by pre-specifying outcomes and analysis plans before data collection is complete?

• Trial registry and protocol pre-registration
• Post-hoc subgroup analysis
• Flexible endpoint selection
• Investigator-initiated amendments after unblinding

Correct Answer: Trial registry and protocol pre-registration

Q11. What is the ethical rationale for independent ethical review of research protocols by an IRB/REC?

• To provide legal advice to sponsors
• To independently evaluate risks, benefits, consent processes, and subject protections
• To increase recruitment speed
• To draft scientific manuscripts

Correct Answer: To independently evaluate risks, benefits, consent processes, and subject protections

Q12. Which approach balances individual patient care and generalizable knowledge when designing trials embedded in routine clinical practice?

• Explanatory randomized controlled trials
• Case series
• Pragmatic clinical trials
• Cross-sectional surveys

Correct Answer: Pragmatic clinical trials

Q13. What is the recommended action if interim analysis shows clear and substantial benefit of an experimental treatment?

• Continue the trial unchanged to gather more safety data
• Consider early termination or modification to offer the effective treatment to control group
• Hide results until study completion
• Increase sample size only

Correct Answer: Consider early termination or modification to offer the effective treatment to control group

Q14. Which measure protects participants’ privacy when reporting trial results or datasets?

• Publishing full participant identifiers for transparency
• Anonymization or de-identification of personal data
• Sharing raw data without consent
• Using participant initials only

Correct Answer: Anonymization or de-identification of personal data

Q15. When is surrogate consent typically considered acceptable for enrolling a participant into research?

• When no research staff are available to obtain consent
• When a legally authorized representative provides consent for those lacking capacity and the research meets ethical criteria
• When the participant expresses prior dissent
• Only for non-interventional studies

Correct Answer: When a legally authorized representative provides consent for those lacking capacity and the research meets ethical criteria

Q16. What is meant by ‘proportionality’ in risk assessment for clinical research?

• Risks should be minimized regardless of potential benefits
• Expected risks must be proportionate to the potential benefits and importance of the knowledge sought
• All studies must have zero risk to participants
• Risk assessment is unnecessary for minimal-risk studies

Correct Answer: Expected risks must be proportionate to the potential benefits and importance of the knowledge sought

Q17. What additional responsibility do researchers have when conducting studies in low-resource settings?

• To ignore local healthcare standards and apply only international norms
• To engage with local communities, consider local standards of care, and plan fair benefits or capacity-building
• To recruit only international participants
• To avoid ethical review altogether due to logistics

Correct Answer: To engage with local communities, consider local standards of care, and plan fair benefits or capacity-building

Q18. Which action is expected of investigators in reporting adverse events during a clinical trial?

• Report only unexpected adverse events
• Timely and complete reporting of all required adverse events to regulators, IRBs, and DSMBs as specified
• Delay reporting until study end to avoid alarm
• Report only if the sponsor requests it

Correct Answer: Timely and complete reporting of all required adverse events to regulators, IRBs, and DSMBs as specified

Q19. Which principle supports requirement for trial registration and public disclosure of protocol and results?

• Respect for autonomy
• Scientific validity and transparency to prevent selective reporting and publication bias
• Beneficence only
• Commercial confidentiality

Correct Answer: Scientific validity and transparency to prevent selective reporting and publication bias

Q20. What is the ethical importance of ensuring culturally appropriate informed consent processes in multinational trials?

• To expedite enrollment irrespective of understanding
• To ensure true understanding, voluntary participation, and respect for local values and language
• To use a single consent form translated by machine only
• To substitute community consent for individual consent always

Correct Answer: To ensure true understanding, voluntary participation, and respect for local values and language

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