Lecture 5: ETHICS IN RESEARCH (PART 1 OF 2)

Question 1

What is ethics?

Answer 1

Ethics is a system of moral principles and standards

Question 2

What is Nuremberg (Doctors’) Trials?

Answer 2

• Unethical research led by Nazi German physicians
• Military tribunals by Allied Forces against 23 leading German physicians and administrators
• Base of the 10 Nuremberg Code

Question 3

What are the 10 principles of the 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.
3. The experiment should be so designed and based on the results of animal experimentation
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 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.
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 has probable cause to believe, in the exercise of the good faith,
    superior skill and careful judgement required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Question 4

Where did Tuskegee Syphilis Study (1932-1972) occur?

Answer 4

Alabama

Question 5

Who conducted the Tuskegee Syphilis Study?

Answer 5

the U.S. Public Health Service

Question 6

What was the study objective of Tuskegee Syphilis Study?

Answer 6

The purpose of this study was to observe the natural progression of untreated syphilis in rural African-American men in Alabama under the guise of receiving free health care from the United States government. The study was conducted to understand the disease’s natural history throughout time and to also determine proper treatment dosage for specific people and the best time to receive injections of treatments.

Question 7

Who were the participants of the Tuskegee Syphilis Study?

Answer 7

African-American men

600 black men – 399 with syphilis, 201 who did not have the disease.

Question 8

What were the ethical dilemmas in Tuskegee Syphilis Study?

Answer 8

The study was conducted without the benefit of patients’ informed consent.
they did not receive the proper treatment needed to cure their illness.
there was no evidence that researchers had informed them of the study or its real purpose. In fact, the men had been misled and had not been given all the facts required to provide informed consent.

Question 9

How did the Tuskegee Syphilis Study end?

Answer 9

whistle blower

Question 10

What is Belmont Report (USA)?

Answer 10

• National Commission for the Protection of Human Services of Biomedical and Behavioral Research (1974) as first US national body to shape bioethics policy
• Prompted by Tuskegee

Question 11

What are the 3 principles of Belmont Report?

Answer 11

Respect for Persons: protect autonomy; treat with
courtesy & respect; informed consent; no deception

Beneficence: do not harm; maximize good science and avoid/minimize possible harm to people & society

Justice: reasonable, non-exploitative procedures used fairly; fair and equal distribution of costs/benefits

Question 12

The Belmont Report stems from 3 principles:

Answer 12

• Obtain consent from research participants
• Assess risks and benefits of projects
• Select participants in a just way
• Establish independent and external review committees

Question 13

What is Canada Tri-Council Policy on Ethics?

Answer 13

• Policy is joint between CIHR, NSERC, SSHRC
• 1998; revised in 2010
• Applies to all research conducted, and funded by the agencies

Question 14

What is Research Ethics Board (REB)? What are their job? Who consists the REB?

Answer 14

• Ensure protection and promotion of human subjects research in Institutions
• Ensure that proposed work complies with regulations, guidelines and ethical principles
• Board is comprised of scientists, ethicist, lawyer, and community member
• AKA Institutional Review Boards (IRB)
• Federal Worldwide Assurance (FWA)
• For profit?

Question 15

What are the REB groups at McGill?

Answer 15

REB I
REB II
REB III

Question 16

What is the exact REB composition?

Answer 16

• 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

Question 17

What research is covered (Art 2.1) in Canada Tri-Council Policy on Ethics?

Answer 17

1) Involves living human participants;
2) Human biological materials, as well as embryos, fetuses, fetal tissue, reproductive material, and stem cells; from living and deceased

Question 18

What research is exempt (Art 2.2-2.6) in Canada Tri-Council Policy on Ethics?

Answer 18

• publically available information;
• observing people in public places with no
intervention or identification;
• secondary use of anonymous information or biospecimens;
• program evaluation, educational requirements;
• creative works

Question 19

What is minimal risk?

Answer 19

the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research

Question 20

What are the types of harm?

Answer 20

• Physical – pain, discomfort, injury
• Psychological – experience negative emotions, self-
esteem, etc.
• Social (loss of privacy) – confidential information
• Economic/Legal – overlaps with confidential

• Magnitude or Seriousness (minimal to substantial)
• Probability of Occurrence (likelihood, evidence- based)

Question 21

What are the 3 key points in consent?

Answer 21

• Consent shall be given voluntarily
• Consent can be withdrawn anytime
• If a participant withdraws consent, the participant can also request the withdrawal of their data or human biological materials.

Question 22

What should a consent form include?

Answer 22

• an invitation to participate
• statement of research purpose in plain language
• identity of researcher and sponsor
• expected duration and nature of participation
• description of procedures
• explanation of participant responsibilities
• risks and benefits for participants AND society
• assurance they are not obligated to participate and can withdraw anytime
• Information on potential commercialization
• dissemination plans (to participant and others)
• contact information of researcher & ethical officer
• explanation of what information will be collected and how confidentiality will be protected how long will it be kept
• payments and incentives
• statement that by consenting participants have not waived legal rights to recourse