Exam Numero Uno Flashcards
(135 cards)
Nuremberg Code
a set of research ethics principles for human experimentation set as a result of the subsequent Nuremberg trials at the end of the Second World War. - consent necessary
Declaration of Helsinki
The World Medical Association’s international ethical guidelines for medical professionals researching human subjects
What are the issues addressed in the declaration of Helsinki?
Research proposals must be reviewed by independent committee
- informed consent is necessary
- risks should not outweigh benefits
Tuskagee Syphilis Study
Another origin of research participant protection.
In 1977, president of the U.S. admitted wrong doing and formally apologized to participant-victims. From 1929 to the 70s, U.S. Public Health Service sponsored a study in which poor, uneducated African-American men in Alabama suffered and died of untreated syphilis while researchers studied the severe phys disabilities that appear in advanced stages of the disease. Even when penicillin to treat the disease was available, the study began long after its availability.
National Research Act
A set of regulations for the protection of human participants in research, mandated by Congress in 1974.
Belmont Report Principles
- Respect for persons
- Beneficence
- Justice
What does respect for persons mean?
individuals should be treated as autonomous agents, they should give their full informed consent
What does beneficence mean?
Do good, welfare of others is the primary concern, risks vs benefits must be outweighed
what does justice mean?
the benefits and risks must be distributed fairly
Tri-Council Policy Statement
In Canada, the official statement of ethical conduct for research involving humans; researchers and institutions are expected to adhere to this document to receive federal research funds.
Tri-Council agencies
- natural sciences and engineering research council of canada
- social sciences and humanities research council of canada
- canadian institutes of health research
Research Ethics Board (REB)
Research oversight group that evaluates research to protect the rights of participants in the study
Respect for human dignity
Includes the right to self-determination and the right to full disclosure
- the fundamental principle behind modern research
respect for free and informed consent
Respecting the exercise of individual consent
Freedom to withdraw
experimenters’ ethical obligation to allow their subjects to discontinue participation in the research project
Removal of harmful consequences
if a participant could suffer long term consequences as a result of serving in an experiment the investigator has the responsibility to remove those consequences
respect for justice and inclusiveness
the benefits and burdens of research should be distributed fairly across individuals and groups in society
Respect for Confidentiality
what a subject does in an experiment should be confidential unless otherwise agreed
balancing harms and benefits
Foreseeable harms should not outweigh anticipated benefits
minimizing harm
The duty to avoid, prevent, or minimize harm to others; subjects must not be subjected to unnecessary risks of harm
maximizing benefit
a duty to benefit others and to maximize net benefits; human research is intended to produce benefits for subjects themselves, for other individuals or society as a whole, or for the advancement of knowledge
informed consent
an ethical principle that research participants be told enough to enable them to choose whether they wish to participate
what is the problem with informed consent?
From a researchers point of view the problem with asking for informed consent is that it may spoil the research.
Reactivity
the problem of a participant changing behaviour as a result of being measured, observed, or studied, invalidating the results of a study