6- Ethics Pt 1 Flashcards
T or F: Research explores the unknown (ie entails risks to volunteers or society); risks can be negligible to profound
T
Both ___________ and _________ are public goods, and both must be protected
knowledge and health
Scientific research improves our ________
lives
Advancements depend on ______________ and __________ need protection because they have a long history of abuse in many different forms; and some continue
human volunteers
volunteers
Ethics is a system of ___________ and _________
moral principles and standards
T or F: ethics is intertwined with the way that we do research (the methods) and the research findings
T
Name 5 principles in the Nuremberg code:
1) The voluntary consent of the human subject is absolutely essential
2) The experiment should be conducted to avoid all unnecessary physical and mental suffering and injury
3) No experiments should be conducted where there’s an a priori reason to believe that death or disabling injury will occur
4) The experiments should be conducted only be scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment.
5) During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems impossible to him
Tuskegee syphilis study occurred between _______
1932-1972
Where did the Tuskegee syphilis study occured:
In the south of the US, in Tuskegee, Alabama
Who conducted the Tuskegee research study?
The United States Public Health Service (PHS) and the Centers for disease control and prevention (CDC) on a group of 400 African Americans with syphilis
What was the study objective of the Tuskegee research study?
- They wanted to study the natural history of untreated syphilis
- Penicillin was discovered during the study but wasn’t given to the participants
- The participants were never told that the study was about syphilis they were told that bad blood was the topic of the study
Who were the participants and why did they participate in the study?
- African americans
- They were poor, vulnerable population, were promised free medical treatments
What were the ethical dilemmas?
- Treatment was withheld
- Were not told what the study was about
- Racism
How did the study end?
Someone leaked information to the New York times and the study was then stopped
___________________ was prompted by Tuskegee
Belmont Report
National Commission for the Protection of human services of biomedical and behavioral research (1974) as first national body to shape bioethics policy
Belmont Report (USA)
What are the 3 Belmont principles:
1) Respect for persons (protect autonomy, treat with courtesy and respect; informed consent; no deception)
2) Beneficence (do not harm; maximize good science and avoid/minimize possible harm to people and society)
3) Justice (reasonable, non-exploitative procedures used fairly; fair and equal distribution of costs/benefits) - vulnerable populations are disproportionally used - taken advantage of by the dominant
What is the TCPS:
Canada Tri-Council policy in Ethics
T or F: TCPS applies to all research conducted, and funded by the agencies
T
- Ensure protection and promotion of human subjects research in institutions
- Ensure that proposed work complies with regulations, guidelines and ethical principles
Research ethics board (REB)
Research boards are comprised of:
- scientists
- ethicist
- lawyer
- community member
REB composition (article 6.4):
- 5 members including men and women, of whom:
- 2+ have expertise in relevant disciplines, fields and methods covered by the REB
- 1+ member knowledgeable in ethics
- 1+ member knowledgeable in the relevant law
- 1+ community member with no affiliation with institution
What research is covered by REB?
- involves living human participants
- human biological materials, as well as embryos, fetuses, fetal tissue, reproductive material and stem cells from living and deceased
What research involving humans is exempted from REB?
- publically available information
- observing people in public places with no intervention or identification
- secondary use of anonymous information or biospecimens
- creative works
- program evaluation, educational requirements
T or F: Zero risk is possible
F
defined as research in which the probability and magnitude of possible harms implied by the participation in the research is no greater than those encountered by participants in those aspects of everyday life that relate to the research
minimal risk
Consent shall be informed means:
- an invitation to participate
- statement of the research purpose in plain language
- identity of researcher and sponsor
- expected duration and nature of participation
- description of procedures
- explanations of participants responsibilities
- risks and benefits to participants and society
- assurance they are not obligated to participate and can withdraw anytime
- payments and incentives
