28 Questions
What does research ethics encompass?
Protection of human participants and animals during research
What is the main learning objective of Good Research Practice (GRP)?
To understand different types of research approval necessary for work involving human participants
What is meant by 'informed consent' in research?
Participants are fully aware and agree to participate in the research
Which unethical experiment involved deliberately infecting patients without their consent to prove the cause of leprosy?
Norwegian physician's experiment in 1879
What was the unethical action in the US Public Health Service's experiment in 1932?
Infecting low-income African American males with syphilis without informing them
What does ethics require in relation to research participants?
Never treat research participants as objects
Who was the first to propose ethical guidelines for medical research?
Dr. Thomas Percival
In which year did President Clinton apologize for the Tuskegee Syphilis Studies?
1997
What is the emphasis of the Nuremberg Code?
Informed consent and non-maleficence
What was the focus of the Canadian Study funded by the CIA in the 1960s?
Giving LSD and other hallucinogens to subjects without their consent
Who is considered the founder of experimental medicine and believed in ethical conduct of experimentation?
Claude Bernard
What are the key ethical principles in research mentioned in the text?
Respect for persons, beneficence, and non-maleficence
What is the primary purpose of informed consent in research?
To inform potential participants of the purpose of the study, risks, benefits, and their right to withdraw
What do comprehensive guidelines for research practice include?
The planning, conduct, and reporting of research, ethical approval, and data security
What does research governance aim to ensure?
The management and conduct of research through clear documentation, adherence to safety standards, and ethical review
What is the role of National Research Authority in NHS since 2015?
To approve all research projects, audits, and service evaluations conducted in the NHS since 2015
What does the main role of the Research Ethics Committees (RECs) entail?
Reviewing applications for research projects involving human subjects and NHS patients
What are the two main types of RECs mentioned in the text?
NHS-NRES and FacultyREC
Who is required to submit full applications for studies involving human subjects?
Students, staff, and the general public
What aspects does the REC consider when assessing research applications?
Whether the study has a clear question and is well-designed
What is required by MSOP procedures for research projects?
Submission of project details by project supervisors
Who is responsible for familiarizing themselves with approved processes, submitting contracts, and acting ethically in research projects?
Students and staff involved in the research
In Case Study 1, what ethical issue does Researcher Tom potentially compromise?
Research integrity and honesty
What issue arises in Case Study 2 that indicates a need for clearer communication?
'Mrs. MJ forgetting about participating in a clinical trial'
In Case Study 3, what issue raises questions about the benefits and potential risks of the clinical trial?
'Severe side effects experienced by participants'
In Case Study 4, what concern does the investigator raise when wishing to perform additional analysis on archived tissue samples without explicit consent from original participants?
Informed consent and data security
What ethical standards apply to all researchers according to the text?
All researchers must adhere to ethical standards including honesty and avoiding fraudulent behavior
What is required from students and staff involved in research projects according to the text?
Familiarizing themselves with approved processes, submitting contracts, and acting ethically
Study Notes
- Research ethics committees (RECs) review applications for research projects involving human subjects and NHS patients.
- Two main types of RECs: NHS-NRES and University-based (e.g., FacultyREC, MSOPREC).
- RECs consider applications for studies relating to human subjects not selected by virtue of NHS services.
- General public, students, and staff require full applications for studies involving human subjects.
- RECs assess if the research is needed, has a clear question, is well-designed, and outlines methods for subject recruitment, informed consent, and work conduct.
- MSOP procedures require project supervisors to submit project details.
- Ethical standards apply to all researchers, including honesty and avoiding fraudulent behavior.
- Students are responsible for familiarizing themselves with approved processes, submitting contracts, and acting ethically.
- Case study 1: Researcher Tom decides to extrapolate results from 45 mice instead of completing tests on the remaining 5, potentially compromising ethical research standards.
- Case study 2: Elderly Alzheimer's patient Mrs. MJ forgets about participating in a clinical trial, indicating a need for clearer communication and potential follow-up.
- Case study 3: Pharmacist in charge of a clinical trial discovers three times as many participants in the experimental group experienced severe side effects, raising questions about the benefits and potential risks.
- Case study 4: Investigator wishes to perform additional analysis on archived tissue samples without explicit consent from original participants, raising concerns about informed consent and data security.
- Familiarize yourself with principles of good research practice, different types of research approval, and informed consent, confidentiality, and security of personal data in research.
Explore the principles of Good Research Practice, types of research approval required for work involving human participants, informed consent, and ensuring confidentiality and security of personal data in research.
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