human research Flashcards
what are the 10 principles of nuremberg code?
- Voluntary Consent
Essential for ethical research; participants must willingly consent.
2. Research
- based on previous knowledge
Must be scientifically justified and based on previous knowledge. - Minimize Suffering
Avoid unnecessary physical/mental suffering.
5. Death Avoidance
Research with risk of death or serious injury is prohibited if likely.
6. Risk Mitigation
Risks must be minimized and proportionate to the benefits.
7. Adequate Facilities
Properly equipped facilities are required for safe research.
8. Qualified Personnel
Only trained and competent individuals may conduct studies.
9. Participant Withdrawal
Subjects can stop participating at any time.
10. Scientist Responsibility
Researchers must end studies if they foresee risks of harm.
What significant document did the Nuremberg Code influence, and why?
The Helsinki Declaration, which provides specific ethical guidelines for doctors who act as both clinicians and researchers. It has been revised multiple times to adapt to evolving ethical concerns in medicine, such as informed consent and patient welfare.
Define “human participant” in the context of research studies.
any living person, recently deceased individuals (cadavers, remains, body parts), embryos, and fetuses. Human participants can be involved directly (through in-person presence) or indirectly (through the use of stored tissues, bodily fluids, or personal health data).
Explain the concept of “Informed Consent” and its essential steps.
the process of providing potential participants with full details of a study so they understand the implications and can voluntarily decide to participate. The steps include:
1.Providing clear and thorough information about the study.
2.Engaging in discussion to clarify and review this information.
3.Obtaining written and/or verbal consent.
4.Ensuring ongoing consent through a process of revalidation.
What is Gillick Competence, and how does it relate to informed consent for children?
a legal standard in the UK that assesses whether a child under 16 has sufficient understanding to consent to medical treatment. In research, children under 16 often require both their own assent and their parent/guardian’s consent, although Gillick Competence allows for exceptions if the child is deemed capable of making informed decisions.
Who are considered “vulnerable adults” in research, and what laws protect them?
include those with temporary (e.g., unconsciousness, mental illness) or permanent (e.g., cognitive impairments) limitations that affect decision-making. Protections are provided by the Mental Capacity Act 2007 and the Medicines for Human Use Regulations 2004, ensuring their rights are respected, and inclusion in research is ethically managed.
Describe the importance of HeLa Cells in scientific research.
HeLa Cells, derived from Henrietta Lacks’ cervical cancer cells, were the first immortal human cell line and are invaluable in scientific research. They replicate indefinitely and have contributed to breakthroughs in fields like cancer, virology, and space biology, including testing in the polio vaccine development and the effects of zero gravity on human cells.
Summarize the Alder Hey Organ Retention Scandal and its outcome.
From 1988-1996, organs were collected from deceased children at Alder Hey Hospital without parental consent. This led to public outrage and the creation of the Human Tissue Act 2004, which established strict regulations on the use and storage of human tissues from both living and deceased individuals for medical research.
What is “Inducement” in research, and what are the ethical considerations?
refers to offering incentives to encourage participation in research. Ethical considerations include ensuring incentives do not coerce individuals or influence their decision-making unduly. Any plan to offer inducements must receive ethical approval to confirm it aligns with fair practice.
Describe the unethical practices of the Tuskegee Syphilis Study (1932-1972) and its consequences.
study involved 600 Black men, many with syphilis, who were recruited under false pretenses of receiving free healthcare. Researchers withheld treatment even after a cure was available, leading to deaths and transmission of syphilis to partners and children. The scandal resulted in stricter ethical regulations in research.
What is the General Data Protection Regulation (GDPR), and why is it important in research?
a regulation for data protection and privacy in the EU, governing how personal data is collected, stored, and processed. It mandates compliance with principles like transparency, accuracy, data minimization, and accountability, especially critical in research involving identifiable and sensitive information.
Explain the Thalidomide Scandal and its significance in drug regulation.
Thalidomide, used for morning sickness in pregnant women in the 1950s, led to severe birth defects in thousands of babies due to inadequate safety testing. This prompted the Medicines Act 1968, requiring thorough clinical trials and establishing strict safety standards for drugs before market approval.
What is the UK Policy Framework for Health and Social Care Research (2018)?
This framework sets standards for the ethical conduct of research, covering areas like safety, transparency, and informed consent. It emphasizes participant protection, integrity in research, and ensuring findings are accessible to benefit public health.
Northwick Park incident in London, 2006.
Six healthy volunteers received TGN 1412, an experimental antibody drug for autoimmune disorders. They suffered severe immune reactions within hours, with symptoms including intense pain, low blood pressure, and difficulty breathing. All required intensive care, leading to increased caution in early-stage human trials.
