Class 3

Question 1

Why talk about Legal and Ethical Issues? 4

Answer 1

All research has the potential to impose some measure of harm

Necessary to ensure the protection of research participants

Informed consent and patients’/clients’ rights

End research if pt is harmed potentially

Question 2

What happened in each case

Tuskegee Syphilis Study in Alabama (1932-1973)
Sterilization experiments in Auschwitz (1940-1944)
Dr. E. Cameron’s psychiatric experiments in Montreal (1950s-1960s)
Willobrook Hospital Study (1972)
AIDS/AZT case in Ivory Coast, Africa (1994)

Answer 2

Tuskegee – people with syphilis were not being told there was a drug to treat them

Sterilization experiments - during this time there was forced sterilization for people that were not to be considered to be apart of the arian race (people that were blind, etc.), this further moved into
Auschwitz to test levels of radiation that would kill the ovum but not kill the participant and the people were not aware that they were apart of this study

Dr E Cameron – ECT unable to walk, feed themselves

Willobrook – children with mental incompetence weer taken to the hospital and were told they wouldn’t be put into the treatment facility until they agreed to put they child into a study with hepatisis so their children were infected with hepatitis

AIDs – people with HIV were given placebo even tho their was a treatment because they wanted to see what would happen if they were not treated

Question 3

Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10”, Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949 outlined 10 rules known as Nuremberg code

Answer 3

1. The voluntary consent of the human subject is absolutely essential
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature
3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study, that the anticipated results will justify the performance of the experiment
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury
5. No experiment should be conducted, where there is an a priori (prior knowledge) reason to believe that death or disabling injury will occur…
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment
7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment
9. 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 seemed to him to be impossible (???)
10. During the course of the experiment, the scientist in charge must be prepared to terminate the experiment at any stage, if he [or she] has probable cause to believe… that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject

Question 4

Also present in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) states three ethical principles

Answer 4

Respect for Persons AKA Freedom to participate or not participate in research

Beneficence AKA Obligation to do no harm

Justice AKA Fair treatment of human subjects

Question 5

5 basic human rights

Answer 5

1. Self-determination
2. Privacy and Dignity
3. Anonymity and confidentiality
   - Anonymity - Protecting the anonymity of the patient
   - Confidentiality Whatever you say will not be shared with someone (there is a limit of what is kept confidential, within data you can share as long as the cell size is bigger than 5 people because than you can’t identify who said what within the study)
4. Fair treatment
5. Protection from discomfort and harm

Question 6

There must be informed consent3
process consent
and assent 3

Answer 6

Informed consent

• Potential risks and benefits
• Confidentiality and anonymity
• Voluntary participation

Process consent
-Voluntary continued participation

Assent

• A basic understanding of what the child will be expected to do and what will be done to the child
• A comprehension by the child of the basic purpose of the research
• An ability of the child to express a preference regarding participation

Question 7

Review slide on elements of informed consent

Answer 7

10 of them

Question 8

Research with Indigenous Peoples

Answer 8

Research involving Aboriginal peoples in Canada has been defined and carried out primarily by non-Aboriginal researchers. The approaches used have not generally reflected Aboriginal world views, and the research has not necessarily benefited Aboriginal peoples or communities. As a result, Aboriginal peoples continue to regard research, particularly research originating outside their communities, with a certain apprehension or mistrust”

pg 132-133

Question 9

Research involving animals or human genome related materials

Who governs it

Answer 9

Canadian Council on Animal Care (CCAC, 2016) is an independent body funded by CIHR, with detailed guidelines for animal-based research

Tri-council CIHR (2014) guidelines for research involving human gametes, embryos, or fetuses

See text page 132-133

Question 10

Scientific Misconduct
(AKA Fraud, Fabrication, Falsification)
-What is it
-When does is happen 3

Relates to what we do with new evidence

• Who discovered DNA double-helix structure
• Andrew wakefield
• Dr Chandra

Regulated by Committee on Publication Ethics (COPE)

Answer 10

DNA- Rosalind Franklin discovered it and James Watson, Francis Crick stole it I think

Andrew – claimed to link the vaccine to colitis and autism spectrum disorders. The paper was retracted in 2010 is still cited by anti-vaccinationists.

Dr. Chandra - Study the effects of formula for infants, can infant formula help protect babies against allergies. Dr. Chandra hired a nurse: Marline Harvey was supposed to find participants for this study (looking for infants that have chosen this formula) and she had concerns, she found that 2 formulas could protect from allergies and 1 would not protect from allergies despite the fact that all three brands had the same ingredients. She didn’t think that results were matching up and later found out that Dr. Chandra was creating infant participants that didn’t exist (wanted a larger sample size but didn’t have one) paper was published in 1989 and was retracted in 2016