Chapter 17 - Ethics Flashcards
What are the 10 points of the Nuremberg Code (regarding ethics in research studies in general)?
1) People need to be well informed and know what they are consenting to at full legal capacity and it needs to be voluntary
2) Experiment should aim at positive results in society that cannot be obtained in any other way
3) Experiment should be based on previous knowledge
4) Experiment has to be set up in a way that avoids unnecessary physical and mental suffering and injuries
5) It should not be conducted when there is any reason to believe that it implies a risk of death or disabling injury
6) The risks of the experiment should be in proportion to (but not exceed) the expected humanitarian benefits
7) Subjects should be cared for and protected by the facilities against experiment risks and preparations should be provided
8) Staff who conduct or take part in the experiment must be fully trained and qualified
9) The human subjects should be free and allowed to quit the experiment whenever they want
10) The medical staff must stop the experiment at any point when they observe or can tell that continuing the experiment may be dangerous to continue
What was the Tuskegee Syphilis study?
A study that studied the natural history of untreated Syphilis in rural African-American men in Alabama, but lacked informed consent and was under the guide of “free treatment”
What was the Declaration of Helsinki?
Ethical principles developed by the World Medical Association that was more targeted to Medical Communities (e.g. physicians conducting clinical trials)
What were the 3 core principles of the Belmont Report and in biomedical research in general now? Define them.
1) Respect for people
2) Beneficence
3) (Distributive) Justice
What do the following ethical research principles mean:
1) Respect
2) Autonomy
3) Beneficence
4) Nonmaleficence
5) Distributive justice
1) Respect emphasizes autonomy, informed consent, voluntariness, and protection of potentially vulnerable individuals.
2) Autonomy means an individual (or his or her legal guardian) is authorized to decide whether to volunteer to participate in a research study
3) Beneficence means maximizing benefits and minimizing harm
4) Nonmaleficence basically means doing no harm
5) Distributive justice emphasizes all participants being treated fairly
What is Equitable Burden?
It means that vulnerable populations should not be preferentially selected as the source population for a study targeting the general population, because that might unfairly burden a disadvantaged population group (like marginalized people)
What is Equitability?
Members of under-studied populations who happen to be sampled at random for a study of the general population should not be excluded from participation
What is Voluntariness vs. Coercion?
- Voluntariness means an individual can decide if they wanna participate in a study from their own free will without outside influence
- Coercion is the opposite, compelling someone to participate in a research study. It violates the principles of autonomy, respect and voluntariness
What is informed consent?
an individual’s voluntary decision to participate in a research study after reviewing essential information about the project
What are the 10 points of content included on Informed Consent
1) Research
2) Purpose (Aims/goals of the research process)
3) Participants (why they were invited for this)
4) The Study Procedures
5) Benefits
6) Risks
7) Confidentiality
8) Voluntariness statement
9) Contact details
10) Signature
What are the 3 different forms of informed consent?
- Paper documentation,
- Verbal/oral
- Asking for a Thumbprint mark
What is the IRB/Research ethics committee and what do they do?
The International Review Board, a.k.a the Research ethics committee, is a group responsible for protecting the participants
What are the IRB’s three primary goals to protect?
1( Protect the “human subjects” who will participate in research
2) Protect researchers by preventing them from engaging in activities that could cause harm
3. Legally protect the researcher’s institution from the liability that could occur as a result of research activities
What is the difference between Expedited Review and Full Review?
- Expedited Review is a determination when a Review Ethics Board (REB) determines that a proposal requires review BUT doesn’t need a review by the whole committee
- Full review is a determination by the REB where the whole committee has to discuss a study protocol
What is Confidentiality and Privacy (note the difference)?
- Privacy is the assurance that individuals get to choose what information they reveal about themselves.
- Confidentiality is the protection of personal information provided to researchers.
