Podcast
Questions and Answers
What should take precedence over the interest of science and society in research involving human participants?
What should take precedence over the interest of science and society in research involving human participants?
Which principle emphasizes that each person should have the respect and opportunity to make their own decisions?
Which principle emphasizes that each person should have the respect and opportunity to make their own decisions?
What must researchers do when participants lack the capacity to provide informed consent?
What must researchers do when participants lack the capacity to provide informed consent?
Which document must clearly outline the purpose of the study and ensure no pressure is exerted on participants?
Which document must clearly outline the purpose of the study and ensure no pressure is exerted on participants?
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What is the primary role of ethics committees in the NHS regarding research?
What is the primary role of ethics committees in the NHS regarding research?
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Which of the following is NOT a component that ethics committees consider before approving research involving patients?
Which of the following is NOT a component that ethics committees consider before approving research involving patients?
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Which principle ensures that data collected during research is protected and handled according to regulations?
Which principle ensures that data collected during research is protected and handled according to regulations?
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What action should participants be able to take without penalty in a research study?
What action should participants be able to take without penalty in a research study?
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What is the primary focus of a good information sheet for potential study participants?
What is the primary focus of a good information sheet for potential study participants?
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Which of the following is a principle of the Mental Capacity Act (2005)?
Which of the following is a principle of the Mental Capacity Act (2005)?
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Involving children in research requires what for those under 16 without capacity?
Involving children in research requires what for those under 16 without capacity?
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What condition must be met for research involving individuals lacking capacity, according to ethics committees?
What condition must be met for research involving individuals lacking capacity, according to ethics committees?
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What is one key feature that should be included at the start of an information sheet?
What is one key feature that should be included at the start of an information sheet?
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Which statement is true regarding the consent process for those with cognitive impairments?
Which statement is true regarding the consent process for those with cognitive impairments?
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What action must researchers take if there are major changes in the research protocol after approval?
What action must researchers take if there are major changes in the research protocol after approval?
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What is one characteristic of research that does not need to go through NHS ethical procedures?
What is one characteristic of research that does not need to go through NHS ethical procedures?
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Which of the following groups is expected to engage in developing and reviewing the information sheet?
Which of the following groups is expected to engage in developing and reviewing the information sheet?
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The most frequent causes of lack of capacity in individuals with mental illness are related to what?
The most frequent causes of lack of capacity in individuals with mental illness are related to what?
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What is a primary consideration for ethics committees when evaluating a research project?
What is a primary consideration for ethics committees when evaluating a research project?
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Which principle of ethical research emphasizes fairness and the need to ensure no harm to participants?
Which principle of ethical research emphasizes fairness and the need to ensure no harm to participants?
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What must researchers ensure when participants are unable to provide informed consent?
What must researchers ensure when participants are unable to provide informed consent?
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What role does confidentiality play in ethical research?
What role does confidentiality play in ethical research?
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Which of the following represents an essential component of an information sheet provided to potential participants?
Which of the following represents an essential component of an information sheet provided to potential participants?
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What should research involving topics related to vulnerable groups ensure?
What should research involving topics related to vulnerable groups ensure?
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Which aspect is not typically assessed by ethics committees during the evaluation process?
Which aspect is not typically assessed by ethics committees during the evaluation process?
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How should researchers handle changes to the research protocol post-approval?
How should researchers handle changes to the research protocol post-approval?
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What is a crucial aspect of a good information sheet for potential participants?
What is a crucial aspect of a good information sheet for potential participants?
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How should researchers address individuals who may lack capacity?
How should researchers address individuals who may lack capacity?
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What must be included in the initial paragraph of an information sheet?
What must be included in the initial paragraph of an information sheet?
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What is the primary principle regarding capacity as per the Mental Capacity Act (2005)?
What is the primary principle regarding capacity as per the Mental Capacity Act (2005)?
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When involving children in research, what is required for those under 16 without capacity?
When involving children in research, what is required for those under 16 without capacity?
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Which of the following is a requirement before research involving individuals who lack capacity can proceed?
Which of the following is a requirement before research involving individuals who lack capacity can proceed?
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Which population does NOT require NHS ethical review for their research?
Which population does NOT require NHS ethical review for their research?
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What should be prioritized when balancing brevity and sufficient information in an information sheet?
What should be prioritized when balancing brevity and sufficient information in an information sheet?
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If there is a major change in research protocol after approval, what must researchers do?
If there is a major change in research protocol after approval, what must researchers do?
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What kind of educational interventions can potentially improve the capacity of individuals with mental illness?
What kind of educational interventions can potentially improve the capacity of individuals with mental illness?
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Study Notes
Nuremberg Code and Ethical Research
- Established basic standards for medical research following Nazi war crimes tribunal
- Declaration of Helsinki emphasizes participant well-being over scientific/societal interests; participants' well-being must take precedence.
- Benefits must outweigh risks
- Informed consent is crucial from volunteers; participants must be informed volunteers
- Appropriate care for participants and consent from legal representatives for those lacking capacity; those lacking capacity must have consent from a legally recognized representative
- Research should be high quality, yield useful data, and be disseminated; research must be of good quality and likely to yield useful evidence and disseminated
Ethical Research Principles
- Autonomy: Respect for person's right to make independent decisions; requires complete information, voluntary participation, easy withdrawal, and assessment of capacity to make decisions; each person should be given the respect, time and opportunity to make their own decisions; prospective participants must be given all the info they will need; there should be no pressure to participate; withdrawal should be easy and without penalty; informed consent only possible when someone has capacity to make decision
- Justice: Fairness in research design and selection of participants, balancing risk and benefits, ensuring confidentiality, and giving particular attention to vulnerable groups (children, those lacking capacity, prisoners); Do not harm; balance risk and benefits
- Confidentiality: Strict adherence to GDPR regulations; thorough data storage, access, and retention protocols are essential; safeguarding data (GDPR – general data protection regulation); storing data; whether it is identifiable; how long it is kept; who has access
NHS Ethics Approval Process
- Oversees research involving NHS patients/carers following national standards; governs research involving patients and carers in the NHS; centralized and governed by national standard operating procedures; any committee can approve any application
- Centralized approval system with committees composed of lay people, researchers, and clinicians; mix of lay people, researchers and clinicians
- Essential requirements include sponsorship, data protection approvals, researcher checks, and site confirmation; need: sponsorship, data protection approvals, checks for researchers, site confirmation
- Evaluates scientific merit, risk assessment, feasibility, and consent procedures, including information sheets, confidentiality, and conflicts of interest; Scientific merit; Evaluation of risk; Whether project is feasible; clear consent procedures; information sheet; Confidentiality – GDPR compliance; any conflicts of interest
Information Sheets & Consent Forms
- Should be accessible, using plain language, avoiding technical jargon, and adapted to the target audience (considering specific needs for children or those with intellectual disabilities); polite invitation; plain English; short sentences – one main idea per sentence; avoid or explain technical terms; adapt to patient group; seek advice with children/people with intellectual disability
- Must include title, invitation to participate, summary, research purpose, procedures, benefits, risks, confidentiality, and withdrawal right; Purpose of study; What will happen to the participant; Benefits and risks; Confidentiality and data; no pressure; the right to withdraw; Title of study, initial paragraph inviting people to take part; Summary paragraph; Details of What is the point of the research; What will happen; Benefits; Hazards; Confidentiality and anonymity
Major Questions in NHS Ethics Review
- Staff qualifications, experience, and resources; Are staff qualified, experienced and resourced?
- Significance, relevance and well-designed research; Is research relevant and well designed – significant evidence?
- Potential benefits and harms - patient accessible information; What benefits are likely to result?; What hazards or discomfort may result?; Is patient information accessible?
- Potential pressures (e.g., to participate); Any pressure being exerted?
- Confidentiality and anonymity; Confidentiality and anonymity?
Capacity and Consent
- Mental Capacity Act 2005: Presumption of capacity; need to support participants to maximize their capacity when necessary; protects people who may lack capacity; lack of capacity: impairment in functioning of brain; consequent inability to understand and retain information; Principles: presumption of capacity; capacity is relative; need to give people necessary support to maximize capacity
- Capacity is relative, assessed on an individual basis; individuals with mental illness, especially with negative symptoms/cognitive deficits, can frequently have capacity; most depressed individuals (70-80% with schizophrenia) have capacity; Negative symptoms, cognitive deficits, poor insight are most frequent causes of lack of capacity; Those that lack capacity don’t understand the research they’re agreeing to; capacity improves with educational interventions
- Carers/representatives can act as consultees; Carers/nominated representatives act as consultees
- Advance directives for future participation; Advance directives – allow people to express wish to participate if they lose capacity
Vulnerable Groups (Children and Those Lacking Capacity)
- Individuals 16-17 yrs old are generally assumed to have capacity, unless indicated otherwise; 16–17-year-olds assumed they have capacity unless contrary evidence
- Children under 16: Consent if demonstrating understanding and reasoning; parent/guardian consent required for medicinal product trials; involvement with child encouraged; under 16 – can give consent if evidence of good understanding and reasoning; under 16 without capacity – consent from parents but involve kids; Parents must consent for under 16s in trials of medicinal products
- Participants without capacity, research should have minimal harm, related to the condition, and benefit outweigh risk; Yes, if ethics committee agrees that: no substantial risk of harm; relates to patient’s conditions and cannot be done in a valid way in a sample where all have capacity; benefits outweigh the risk
- Consent from a legally recognized representative; involvement encouraged; withdraw if signs of resistance
General Research Ethics
- Research not requiring NHS ethics approval (proportionate reviews in place); does not involve NHS participants; audits and service evaluations; generates knowledge; Not if: no material ethical issues – system of proportionate review; not recruiting NHS service users; doesn’t meet criteria for research; research generates new knowledge; audit and service evaluation
University Ethics Committees
- Approves research conducted by staff or students, excluding NHS-specific research; Can approve research that: is conducted by staff or students; is not the remit of NHS ethics; general population student and school samples, online surveys, NHS staff in UCL
Post-Approval Procedures
- Reports required; significant protocol changes and adverse incidents (death, violence) must be reported; delayed submission of research reports and results may be considered unethical; Reports provided; Major delays/changes in protocol must be reported; Adverse incidents must be reported (death/violence); Unethical not to make available to the public report on study results
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Description
Explore the core principles of ethical research, including the Nuremberg Code and the Declaration of Helsinki. This quiz delves into the significance of informed consent, participant autonomy, and the necessity of justice and confidentiality. Test your knowledge on standards that safeguard participant rights in research.
