6- Ethics Pt 1

Question 1

T or F: Research explores the unknown (ie entails risks to volunteers or society); risks can be negligible to profound

Answer 1

T

Question 2

Both ___________ and _________ are public goods, and both must be protected

Answer 2

knowledge and health

Question 3

Scientific research improves our ________

Answer 3

lives

Question 4

Advancements depend on ______________ and __________ need protection because they have a long history of abuse in many different forms; and some continue

Answer 4

human volunteers

volunteers

Question 5

Ethics is a system of ___________ and _________

Answer 5

moral principles and standards

Question 6

T or F: ethics is intertwined with the way that we do research (the methods) and the research findings

Answer 6

T

Question 7

Name 5 principles in the Nuremberg code:

Answer 7

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

Question 8

Tuskegee syphilis study occurred between _______

Answer 8

1932-1972

Question 9

Where did the Tuskegee syphilis study occured:

Answer 9

In the south of the US, in Tuskegee, Alabama

Question 10

Who conducted the Tuskegee research study?

Answer 10

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

Question 11

What was the study objective of the Tuskegee research study?

Answer 11

• 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

Question 12

Who were the participants and why did they participate in the study?

Answer 12

• African americans

- They were poor, vulnerable population, were promised free medical treatments

Question 13

What were the ethical dilemmas?

Answer 13

• Treatment was withheld
• Were not told what the study was about
• Racism

Question 14

How did the study end?

Answer 14

Someone leaked information to the New York times and the study was then stopped

Question 15

___________________ was prompted by Tuskegee

Answer 15

Belmont Report

Question 16

National Commission for the Protection of human services of biomedical and behavioral research (1974) as first national body to shape bioethics policy

Answer 16

Belmont Report (USA)

Question 17

What are the 3 Belmont principles:

Answer 17

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

Question 18

What is the TCPS:

Answer 18

Canada Tri-Council policy in Ethics

Question 19

T or F: TCPS applies to all research conducted, and funded by the agencies

Answer 19

T

Question 20

• Ensure protection and promotion of human subjects research in institutions
• Ensure that proposed work complies with regulations, guidelines and ethical principles

Answer 20

Research ethics board (REB)

Question 21

Research boards are comprised of:

Answer 21

• scientists
• ethicist
• lawyer
• community member

Question 22

REB composition (article 6.4):

Answer 22

• 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 23

What research is covered by REB?

Answer 23

• involves living human participants
• human biological materials, as well as embryos, fetuses, fetal tissue, reproductive material and stem cells from living and deceased

Question 24

What research involving humans is exempted from REB?

Answer 24

• 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

Question 25

T or F: Zero risk is possible

Answer 25

F

Question 26

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

Answer 26

minimal risk

Question 27

Consent shall be informed means:

Answer 27

• 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