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Questions and Answers
What is usually required for consent in trials of medicinal products or medical devices?
What is usually required for consent in trials of medicinal products or medical devices?
According to the Mental Capacity Act (2005), what constitutes a lack of capacity?
According to the Mental Capacity Act (2005), what constitutes a lack of capacity?
Which principle of the Mental Capacity Act assumes individuals have capacity?
Which principle of the Mental Capacity Act assumes individuals have capacity?
Which factors are most likely to lead to a lack of capacity in individuals with mental illness?
Which factors are most likely to lead to a lack of capacity in individuals with mental illness?
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Under what conditions can individuals who lack capacity be included in research?
Under what conditions can individuals who lack capacity be included in research?
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How is consent typically obtained for children under the age of 16 in research?
How is consent typically obtained for children under the age of 16 in research?
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What is meant by 'double consent' in the context of minors participating in research?
What is meant by 'double consent' in the context of minors participating in research?
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What should a research team do if they observe signs of resistance from a participant lacking capacity?
What should a research team do if they observe signs of resistance from a participant lacking capacity?
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What is one essential element that a patient information sheet must include?
What is one essential element that a patient information sheet must include?
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How is the potential benefit of participating in a clinical trial typically presented?
How is the potential benefit of participating in a clinical trial typically presented?
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Which of the following is NOT typically covered in a patient information sheet?
Which of the following is NOT typically covered in a patient information sheet?
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What does informed consent require from the participant?
What does informed consent require from the participant?
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What aspect must be addressed regarding confidentiality in clinical trials?
What aspect must be addressed regarding confidentiality in clinical trials?
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For which group must special considerations be made in research, particularly in obtaining consent?
For which group must special considerations be made in research, particularly in obtaining consent?
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What might participants of the self-management app trial be alerted about?
What might participants of the self-management app trial be alerted about?
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What is one method for assessing a participant's capacity to make decisions?
What is one method for assessing a participant's capacity to make decisions?
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What is a key consideration for NHS research ethics committees regarding the research team?
What is a key consideration for NHS research ethics committees regarding the research team?
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Which of the following is NOT an issue that ethics committees consider in an application?
Which of the following is NOT an issue that ethics committees consider in an application?
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What is an essential quality of a good patient information sheet?
What is an essential quality of a good patient information sheet?
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How can researchers ensure the patient information sheet is appropriate for its audience?
How can researchers ensure the patient information sheet is appropriate for its audience?
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What is a potential hazard that ethics committees are concerned about?
What is a potential hazard that ethics committees are concerned about?
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What does balancing brevity and sufficient information depend on in a patient information sheet?
What does balancing brevity and sufficient information depend on in a patient information sheet?
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Which of the following practices should be avoided when drafting a patient information sheet?
Which of the following practices should be avoided when drafting a patient information sheet?
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What is a primary goal when preparing information sheets for research ethics applications?
What is a primary goal when preparing information sheets for research ethics applications?
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What is required for research involving participants under the age of 16?
What is required for research involving participants under the age of 16?
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Which of the following scenarios typically does not require full NHS ethical procedures?
Which of the following scenarios typically does not require full NHS ethical procedures?
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What is one key characteristic of an audit as opposed to research?
What is one key characteristic of an audit as opposed to research?
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Which type of research may be approved by university ethics committees?
Which type of research may be approved by university ethics committees?
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What must researchers report after receiving ethical approval?
What must researchers report after receiving ethical approval?
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What happens if reports requested by the ethics committee are not provided?
What happens if reports requested by the ethics committee are not provided?
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How does UCL's ethics process compare to NHS's ethics process?
How does UCL's ethics process compare to NHS's ethics process?
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Which type of research typically requires local approval in addition to university ethics approval?
Which type of research typically requires local approval in addition to university ethics approval?
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What was established in 1948 to set basic standards for medical research following war crimes tribunals?
What was established in 1948 to set basic standards for medical research following war crimes tribunals?
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Which of the following historical studies involved unethical treatment of participants through untreated disease?
Which of the following historical studies involved unethical treatment of participants through untreated disease?
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Which type of participants are often the subject of special ethical considerations in research?
Which type of participants are often the subject of special ethical considerations in research?
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What significant ethical concern arose from medical experiments conducted in concentration camps during the 20th century?
What significant ethical concern arose from medical experiments conducted in concentration camps during the 20th century?
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Which ethical principle is likely addressed when creating patient information sheets for research?
Which ethical principle is likely addressed when creating patient information sheets for research?
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What was the primary goal of the 1991 Department of Health’s 'Red Book'?
What was the primary goal of the 1991 Department of Health’s 'Red Book'?
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Which year marked the establishment of the National Research Ethics Service in the UK?
Which year marked the establishment of the National Research Ethics Service in the UK?
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Which of the following statements reflects a significant change in research ethics following late 1960s?
Which of the following statements reflects a significant change in research ethics following late 1960s?
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What role do universities have when ethics committees are unavailable?
What role do universities have when ethics committees are unavailable?
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What did the European Directive on Clinical Trials establish in 2004?
What did the European Directive on Clinical Trials establish in 2004?
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What must take precedence over the interests of science and society according to the Declaration of Helsinki?
What must take precedence over the interests of science and society according to the Declaration of Helsinki?
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Which principle emphasizes that each person should have the opportunity to make their own decisions?
Which principle emphasizes that each person should have the opportunity to make their own decisions?
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What should not be applied to prospective research participants to ensure informed consent?
What should not be applied to prospective research participants to ensure informed consent?
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Which of the following considers potential physical and psychological harms to research participants?
Which of the following considers potential physical and psychological harms to research participants?
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What is a primary concern regarding confidentiality in research data management?
What is a primary concern regarding confidentiality in research data management?
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According to ethical research principles, which group requires special consideration in the consent process?
According to ethical research principles, which group requires special consideration in the consent process?
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What is one requirement for ethics applications in the NHS approval process?
What is one requirement for ethics applications in the NHS approval process?
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What must researchers ensure about the quality of their research?
What must researchers ensure about the quality of their research?
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How long can the NHS ethics approval process typically take?
How long can the NHS ethics approval process typically take?
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What is a potential benefit to research participants according to ethical guidelines?
What is a potential benefit to research participants according to ethical guidelines?
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What type of research does university ethics committees primarily regulate?
What type of research does university ethics committees primarily regulate?
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What aspect do both NHS and university ethics committees prioritize when assessing research proposals?
What aspect do both NHS and university ethics committees prioritize when assessing research proposals?
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Which of the following is a factor that research ethics committees evaluate?
Which of the following is a factor that research ethics committees evaluate?
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What is the role of lay people in ethics committees?
What is the role of lay people in ethics committees?
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What may impact the approval timeline for university ethics committees?
What may impact the approval timeline for university ethics committees?
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What must be included in a participant information sheet to ensure clarity?
What must be included in a participant information sheet to ensure clarity?
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Study Notes
Research Ethics Applications
- Preparing research ethics applications involves understanding principles and practicalities.
Learning Objectives
- Familiarize students with principles for research ethics approval and information sheet preparation.
- Help students consider questions and dilemmas in research ethics.
Practical Exercise 1
- Present group views on ethical committee discussions and conclusions regarding a research application.
- Present group views on whether to approve the application.
Major Questions Considered by NHS Research Ethics Committees
- Staff qualifications, experience, insurance, and resources for project execution.
- Conflicts of interest within the staff.
- Relevance and design of the research, including whether it will generate significant evidence.
- Benefits to participants and other patients (current and potential future).
- Potential hazards and discomfort, and measures to minimize them.
- Accessibility and clarity of patient information for informed decision-making.
- Pressure exerted on potential participants.
- Confidentiality and anonymity safeguards during recruitment.
Practical Exercise 2
- Present views on the patient information sheet.
- Highlight good and not-so-good points of the sheet.
Patient Information Sheet Qualities
- Presentation as a polite invitation with a balanced view.
- Employ concise, plain language with few technical terms (using a readability tool to ensure appropriate complexity is helpful).
- Tailoring the language to the target patient group (e.g., children, individuals with intellectual disabilities).
- Active participation of study participants in development and review of the materials.
- Balanced approach between brevity and comprehensive information (e.g., length of information sheets will vary based on study complexity).
- Including a brief summary (at the start is helpful).
- Testing the materials with the target audience (ideally).
What a Patient Information Sheet Should Cover
- Title describing the study.
- Initial paragraph inviting participation while ensuring volunteerism.
- Summary of the whole study's purpose.
- Detailed explanation of the research project (point of study, potential participant's actions resulting from agreement, potential benefits for participants and others, potential hazards and how to minimize them, and safeguarding confidentiality and anonymity).
Practical Exercise: Writing Patient Information
- Example of a pilot randomized controlled trial on a self-management app for young people in psychosis services.
- The app allows documenting relapse signatures, monitoring relapses, and notifying related parties.
- Outcomes measured include psychotic symptom severity, social functioning, and well-being.
- Tasks include creating a paragraph of invitation, an overall summary, and an explanation of participant actions, potential benefits, potential harms, and minimizing them for specific assignments (e.g. invitation, overall summary, explanation of participant actions, potential benefits, potential harms, and minimizing them).
Key Questions on Research Ethics
- Define informed consent.
- Describe capacity assessment methods.
- Investigate if mental illness impairs decision-making capacity.
- Examine inclusion of individuals lacking capacity in research.
- Outline the process for including children in research.
- Examine the necessity for all research to undergo NHS ethical approval.
- Describe the post-ethical approval process.
What is Informed Consent?
- Consent must be given by someone with decision-making capacity (understanding consequences and realistically weighing them).
- Consent must be voluntary, without pressure.
- Participants should be informed adequately, including access to information on withdrawal from the research.
- A patient information sheet is crucial, often supplemented with conversations for participants to ask any questions, ideal in writing unless it's a medication trial.
How is Capacity to Make Own Decisions Assessed?
- The Mental Capacity Act (2005) provides the framework for determining incapacity.
- Lack of capacity involves impairment in brain function (physical or mental illnesses, cognitive impairment, intoxication).
- Capacity depends on the ability to understand and retain essential information, weigh it up, and communicate the resultant decision.
- There is a presumption of capacity unless evidence proves otherwise.
- Necessary support for maximum capacity should be provided, and there is a right to make unconventional decisions.
Does Having a Mental Illness Impair Capacity to Make Decisions?
- Most depressed and schizophrenic individuals (70-80%) maintain capacity.
- Negative symptoms, cognitive deficits, and lack of insight may contribute to reduced capacity.
- People often misunderstand research aspects, even without current impairment.
- Capacity can be enhanced through appropriate interventions for supporting and educating people.
Can People Who Lack Capacity be Included in Research?
- Potentially, if the ethics committee deems that no substantial harm results and the research is particularly suitable for the patient group.
- Research should relate to the patient's condition, which cannot be realistically accomplished with fully capable participants.
- Benefits must clearly outweigh the risks.
- Carers or nominated representatives should act as consultants to assess the potential participant’s preferences concerning participation.
- Resistances against participation should be considered.
- Advance directives are useful, particularly for participants who may transiently/permanently lose capacity.
How Can Children Be Involved in Research?
- Individuals 16-17 generally have capacity unless proven otherwise.
- Children under 16 can consent if demonstrating appropriate understanding and reasoning ability; however, parents or appropriate guardians are typically involved unless the child objects.
- Children under 16 lacking capacity require parental consent but should have the opportunity to express assent whenever possible.
- Parents or appropriate guardians' consent is legally required in cases of under 16 participants in trials involving medicinal products.
Does All Research Need to Go Through Full (NHS) Ethical Procedures?
- Not required for research with minor ethical implications (system of proportionate review; light touch approach), not suitable for mental health populations, or studies where NHS members are not actively recruited.
- Studies appropriate for university ethics committees for general populations, NHS staff, or other cases that don't necessitate special NHS criteria.
- Research generating new knowledge, testing hypotheses, or investigating treatment efficacy or service effectiveness (e.g., audits or service evaluations lacking random allocation to treatments) may not require comprehensive NHS ethical review.
University Ethics Committees
- University ethics committees can approve research conducted by university staff or students with human participants, social care, or ministry of defense populations.
- University ethics committees can also approve general population studies, student or school samples, surveys, and research involving NHS staff within the University's jurisdiction.
- Any NHS R&D processes may still apply to research involving NHS staff.
What Happens After Approval Is Given?
- Committees and local R&D offices demand regular reports.
- Ethical permission can be revoked due to significant protocol changes or delays.
- Adverse incidents, such as deaths or violence, require mandatory reporting.
- Public disclosure of study results is a crucial aspect of ethical research conduct.
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Description
This quiz delves into the essential principles, questions, and practicalities involved in preparing research ethics applications. Students will explore ethical dilemmas and weigh the factors impacting approval from NHS Research Ethics Committees. Engage in discussions around staff qualifications, risks, and the overall importance of ethics in health research.
