Research Ethics and Governance Flashcards
What year was the Declaration of Helsinki created?
1964
Which of the following would be considered to be an ethical problem related to the Tuskegee Syphillis Study?
- The study continued despite an effective known treatment being available.
- Participants were coerced to take part
- The participants gave informed consent
- The participants knowingly infected their sexual partners
The study lacked informed consent, intentionally withheld treatment, and exploited vulnerable individuals.
- The study continued despite an effective known treatment being available.
- Participants were coerced to take part
What do you understand by the terms beneficence and non-maleficence.
Beneficence: the principle of “doing good” and acting in ways that promote the well-being and welfare of others
Non- Maleficence: the duty to avoid causing harm to others, including potential harm from unintended consequences or malicious uses.
Which ethical principle is being described here: the degree of risk should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
Non-maleficence
What are the four pillars of medical ethics?
Non-maleficence
Beneficence
Justice
Autonomy
Which of the following arise because of our ethical obligation when doing research? (Choose all that apply)
Ensuring participant anonymity
Maximising publication output to enhance the reputation of the researcher and organisation
An independent ethics committee should review a studies methods and intended outcomes before it commences.
Streamlining data collection to reduce project costs
An independent ethics committee should review a studies methods and intended outcomes before it commences.
Which of the following projects should have ethical approval before commencing?
An audit
A case control study
A service evaluation
A quality improvement project
A case control study
Why might a service evaluation require ethical approval? Write several sentences.
This essay has a maximum word count of 200.
Which ethical principle emphasizes respecting a patient’s right to self-determination?
Autonomy
Beneficence
Non-maleficence
Justice
Autonomy
What is informed consent?
A hospital’s standard treatment protocol
Patient agreement to treatment after understanding the risks and benefits
A description of the procedure provided to the patient
The healthcare professional making a decision about the best treatment
Patient agreement to treatment after understanding the risks and benefits
We are setting up a clinical trial. The active treatment is quite likely to take them into a period of remission from their cancer. It will also cause them significant pain for the several weeks. What are the two ethical principles that need to be considered by the ethics committee before deciding whether to recommend the trial can go ahead.
Beneficence and maleficence
Briefly explain how the Mental Capacity Act 2005 (MCA) applies to health research involving individuals who lack capacity to consent.
Which of the following must be included for consent to be informed?
Voluntary nature of participation
The researcher’s opinion on the likely outcome of the study
A guarantee of a positive outcome
The potential and actual risks and harms of taking part
Voluntary nature of participation
Potential and actual risks and harms of taking part
Describe the process of obtaining informed consent for a research study when a potential participant lacks mental capacity.
