What is the primary purpose of medical research involving human subjects?
- Understand the causes, development, and effects of diseases
- Improve preventative, diagnostic, and therapeutic interventions
- Evaluate interventions for safety, effectiveness, accessibility, and quality
These purposes guide the ethical conduct of medical research.
Who is responsible for the protection of research subjects?
Physicians or other health care professionals
They must ensure the safety and rights of participants in research.
Medical research must minimize possible harm to the environment. True or False?
TRUE
Ethical research practices include consideration of environmental impacts.
What should be assessed before proceeding with medical research?
- Predictable risks and burdens
- Forceable benefits
- Measures to minimize risks
Continuous monitoring of these factors is essential.
Define vulnerable groups in the context of medical research.
Groups that may have an increased risk of being wronged or incurring additional harm
Special ethical considerations are required when conducting research with these groups.
Medical research with vulnerable groups is justified if it addresses their health needs and benefits them. True or False?
TRUE
Research must prioritize these groups and cannot be conducted in non-vulnerable groups.
Research protocols must be submitted for approval to the research committee prior to a study beginning. True or False?
TRUE
The committee monitors ongoing studies and must approve any amendments to protocols.
What is informed consent?
Individuals should be informed of the aims, goals, adverse effects, and risks associated with the study
Consent should be documented preferably in writing.
If a subject cannot give informed consent, who can seek it on their behalf?
Someone legally authorized to be a representative
This is only if the study will benefit them and contain minimal risk.
What should be tested against a placebo in medical research?
- Benefits
- Risks
- Burdens
- Effectiveness of a new intervention
A scientifically sound alternative intervention can also be used for comparison.
What provisions should be made prior to a trial for post-trial access?
Provisions for access for all participants who still need an intervention identified as beneficial
This ensures continuity of care for participants.
What does the Belmont Report identify?
- Respect for persons
- Beneficence
- Justice
These are basic ethical principles addressing issues in research with human subjects.
The Nuremberg Code states that human subjects must be able to _______ from a research study at any time.
withdraw
This principle emphasizes the importance of voluntary participation in research.
What is the role of the IACUC?
Oversees animal research within an institution
Ensures ethical treatment of animals in research.
Chronological ordering of documents: Nuremberg Code, Declaration of Helsinki, Belmont Report. True or False?
TRUE
This order reflects the evolution of ethical standards in research.
What is the GERON ethics advisory board view on human blastocysts?
Human life begins at conception, but personhood occurs later in development
This perspective influences ethical discussions in reproductive research.
