Master Medical Research Ethics and Law: Ethical and Legal Considerations in Medical Research

Question 1

In the UK, which body is responsible for reviewing and approving research proposals involving human participants?

Accepted Answer

The Health Research Authority (HRA)

Answer

The National Health Service (NHS) Research Ethics Committee

Answer

The Medicines and Healthcare products Regulatory Agency (MHRA)

Answer

The General Medical Council (GMC)

Question 2

The use of placebo controls in clinical trials may be ethically justified when:

Accepted Answer

Both options a and c are correct.

Answer

No effective treatment is available.

Answer

The placebo is harmless.

Answer

Participants are fully informed about the use of placebo.

Question 3

Discuss the key ethical challenges arising from the use of big data in medical research.

Accepted Answer

Data privacy and security

Accepted Answer

Informed consent and transparency

Accepted Answer

Bias and discrimination

Accepted Answer

Research integrity and accountability

Question 4

Which international legal framework is widely recognized as the most comprehensive and influential in shaping ethical guidelines for medical research globally?

Accepted Answer

Declaration of Helsinki

Answer

Nuremberg Code

Answer

Belmont Report

Question 5

What is the primary function of an Institutional Review Board (IRB) or Research Ethics Committee (REC) in medical research?

Accepted Answer

Provide ethical guidance and oversee research proposals

Answer

Authorize research studies independently

Answer

Provide funding for research studies

Answer

Conduct independent investigations for research studies

Question 6

What is the primary purpose of the Declaration of Helsinki in medical research ethics?

Accepted Answer

To establish ethical guidelines for the conduct of medical research involving human subjects.

Answer

To protect the rights of vulnerable populations, such as children and prisoners, in medical research.

Answer

To provide a framework for responsible research involving human tissues and genetic information.

Answer

To regulate the use of animals in medical research.

Question 7

What is the concept of 'equipoise' in clinical trials?

Accepted Answer

A state of genuine uncertainty about the relative benefits and risks of the interventions being compared.

Answer

A requirement that all participants in a trial must receive the experimental treatment.

Answer

A method for ensuring that the trial is fair and impartial.

Answer

A guarantee that the trial will produce statistically significant results.

Question 8

What are the four key ethical principles that should guide the design and conduct of medical research?

Accepted Answer

Beneficence, non-maleficence, justice, and autonomy.

Answer

Confidentiality, privacy, informed consent, and equipoise.

Answer

Utility, feasibility, generalizability, and validity.

Answer

Transparency, accountability, sustainability, and equity.

Question 9

In clinical trials, what is the main ethical purpose of equipoise?

Accepted Answer

Creating a fair comparison between different treatments.

Answer

Ensuring researchers are impartial towards the treatments being studied.

Answer

Allowing researchers to randomize participants without informed consent.

Question 10

Which of the following **is NOT** a fundamental principle of ethical medical research?

Accepted Answer

Obedience

Answer

Respect for autonomy

Answer

Beneficence

Answer

Justice

Question 11

In medical research, what is particularly crucial for ensuring the ethical treatment of vulnerable populations?

Accepted Answer

Obtaining informed consent from legally authorized representatives when necessary

Answer

Providing detailed information about research procedures to participants

Answer

Minimizing the use of placebos in research

Answer

Ensuring that research benefits outweigh the risks

Question 12

Which of the following is a fundamental principle of informed consent in medical research?

Accepted Answer

Participants must be provided with sufficient, clear, and understandable information about the study to make an informed decision about participation.

Answer

Consent is not required if the research poses minimal risk.

Answer

Researchers must obtain consent from participants' legal guardians.

Question 13

Which of the following is a potential ethical dilemma in medical research?

Accepted Answer

Balancing the potential benefits of research against the potential risks to participants.

Answer

Choosing the most cost-effective research methods.

Answer

Selecting the most appropriate statistical analysis.

Answer

Deciding the appropriate sample size for a study.

Question 14

What is a primary purpose of an ethics committee in medical research?

Accepted Answer

To review and approve research proposals to ensure ethical standards are met and that participants' rights are protected.

Answer

To provide legal advice to researchers.

Answer

To conduct the research studies themselves.

Question 15

Which of the following is a key element of the Declaration of Helsinki?

Accepted Answer

Research participants should be treated with respect for their autonomy, dignity, and privacy.

Answer

Informed consent is not always required.

Answer

Animal research should be banned.

Question 16

What are the potential legal consequences for researchers who violate ethical and legal guidelines in medical research?

Accepted Answer

Criminal prosecution, civil liability, loss of research funding, and/or suspension of research privileges.

Answer

Only a warning or reprimand.

Question 17

Which of the following is a key principle of data protection in medical research?

Accepted Answer

Data should be collected, stored, and used in a secure manner that protects participants' privacy and confidentiality.

Answer

Data may be shared with third parties without participants' consent if it is anonymized.

Question 18

What is research misconduct?

Accepted Answer

Intentional or negligent actions that violate ethical or legal standards in the conduct or reporting of research.

Answer

Any deviation from the approved research protocol.

Answer

Unintentional errors made during the research process.

Question 19

Which of the following is a common ethical concern in medical research involving human subjects?

Accepted Answer

Exploitation of vulnerable populations.

Answer

Difficulty in recruiting participants.

Answer

Technical challenges in conducting the research.

Answer

Unexpected findings.

Question 20

What is the role of research ethics training in promoting ethical conduct in medical research?

Accepted Answer

To educate researchers about ethical principles and guidelines, and to develop their skills in ethical decision-making.

Answer

To ensure that researchers are aware of all the legal requirements.

Question 21

In medical research involving animals, which ethical principle should be the primary concern for researchers?

Accepted Answer

Minimizing harm to animals

Answer

Obtaining statistically significant results

Answer

Employing cost-efficient research methods

Question 22

The Declaration of Helsinki is a set of guidelines that primarily provides researchers with ethical guidance on:

Accepted Answer

Conducting research involving human subjects

Answer

Animal welfare in research

Answer

Data protection

Answer

Clinical trial design

Question 23

What is the primary responsibility of an ethics committee in medical research?

Accepted Answer

To review and approve research proposals to ensure they meet ethical standards

Answer

To conduct research on the ethical implications of medical research

Answer

To provide legal advice to researchers

Question 24

Which of the following is a legal requirement for researchers conducting medical research in the UK?

Accepted Answer

To register the research with a health research authority

Answer

To have a license from the General Medical Council

Answer

To have a degree in a relevant field

Answer

To obtain insurance against negligence

Question 25

What is the common misconception known as 'therapeutic misconception' in medical research?

Accepted Answer

Patients' misunderstanding that the primary goal of a research study is to benefit them directly

Answer

Researchers' belief that their research will have a positive impact on the lives of patients

Answer

The ethical dilemma of balancing research with clinical care

Question 26

What is the principle of 'beneficence' in medical research?

Accepted Answer

Researchers must strive to maximize the benefits and minimize the harms to participants

Answer

Research should never involve any risk to participants

Answer

Researchers must always act in the best interests of the participants

Question 27

Which of the following is a potential limitation of utilitarianism in medical ethics?

Accepted Answer

It can justify actions that harm individuals for the greater good

Answer

It is a clear and objective framework for making ethical decisions

Answer

It emphasizes the importance of individual autonomy

Question 28

What is the main purpose of a Data Protection Impact Assessment (DPIA) in medical research?

Accepted Answer

To identify and mitigate potential risks to participants' privacy and data protection

Answer

To ensure that research data is stored securely

Answer

To obtain consent from participants for the use of their data