Chapter 3 Flashcards
_____ and ____ used interchangeably.
- ethics
- respect
Ethics policies in Canada were developed as a response to…
historical practices of unethical treatment of people in research
Give examples of historical practices of unethical treatment of people in research.
- Nazi medical experiments
- Tuskegee syphilis experiments
- Willowbrook study
- Texas Vampires
- Nutrition studies in Canada
What happened with Nazi medical experiments?
- during WWII
- examine the limits of human endurance at extremely high altitudes
- placed in low pressure chambers
- often led to severe injury or death
What did the Nazi medical experiments lead to?
- Nuremberg Code (1947)
- 10 commandments of ethical human medical research
What happened with the Tuskegee syphilis experiments?
- Alabama 1932-1972
- examined the effects of untreated syphilis among 400 black men
- Penicillin identified as treatment in 1950s, but studies continued
What happened with the Willowbrook study?
- new residents of the Willowbrook institute for people with intellectual impairments were unknowingly /systematically infected with hep virus
- researchers said the patients would eventually contract the disease anyway
- claimed that purposefully infecting the patients would provide opportunities for researcher to monitor the course of the disease = less complications
What happened with the Texas Vampires?
- Baylor College of Medicine in Texas
- study in Newfoundland and Labrador
- studying family members who had a greater than average risk for a genetic heart
- vampires: bled participants to collect their DNA then vanished without sharing results
What happened with the nutrition research in Canada?
- 1940s-1950s
- Indigenous children denied basic health care and dietary requirements
- more than 1000 children in residential schools were given less than half their daily nutritional requirements
- used as the baseline
TCPS 2 stands for:
2nd edition of the “Tri-Council Policy Statement: Ethical Conduct for Researchers Involving Humans)
TCPS 2 was developed to ensure that…
all studies respect humans
What are the 3 core principles of TCPS 2?
- respect for persons
- concern for welfare
- justice
What does respect for persons of the TCPS 2 include?
- intrinsic value of human beings
- obligation to respect the autonomy of individuals who are directly involved in research as participants
- includes those whose data (eg. biological materials) are used in research
What does concern for welfare of the TCPS 2 include?
- quality of that person’s experience of life
- ensuring the benefits of participation outweigh the risks
- ex. physical pain, emotional discomfort
What does ‘justice’ of the TCPS 2 include?
- obligation to treat people fairly and equitably
- certain groups are often treated unequitably and unfairly in research (ex. children, prisoners, elderly)
What are the 2 important ethical standards?
- researchers need to provide the necessary protection of participants
- research needs to result in shared benefits, whereby the research meets the needs and priorities of both researchers and participants
All Canadian universities that govern research have their own ______.
Research Ethics Board (REB)
Biohazard:
- any organism, or its derivative that could negatively influence another organism
- ex. blood, sweat, saliva
- need to consider how to handle, store, and dispose
Researchers might need to adhere to ______ or _____ ethics policies. Give examples.
- organization or community-specific
- ex. hospital based research requires medical institution ethical clearance
- ex. studies in NWT need Scientific Research Licence (familiar with traditions and cultures of local communities)
Researchers need to consider if there are any conflicts of interests that could arise from…
their proposed question and purpose at the beginning of their study
Conflicts of interests might occur when the study…
places researches (or the university they are associated with) in a conflict with their duties related to research, persona, or institutional interests
Give an example of conflicts of interest.
researcher’s economic investments or interpersonal relationships
What does article 7.4 of the TCPS2 say?
- in research proposals submitted to REB, researchers have to disclose any perceived conflicts of interest (individual, institutional) that they are aware of
- REB will determine appropriate steps to manage it
What happened in 1996 with Nancy Olivieri?
- Researcher with U of T and Hospital of Sick Children
- Clinical trials to test a drug that could treat blood disorders
- Found evidence of unexpected medical risks
- Told REB and pharmaceutical company
- REB told her to tell participants
- Pharmaceutical company said she signed a confidentiality agreement
- Olivieri told participants, trials were terminated