week 2 ethics

Question 1

What is ethics?

Answer 1

the study of morality and ethical reasoning

Question 2

what is clinical ethics

Answer 2

concerned with ethical conduct and decision making in relation to the delivery of health care

Question 3

what is research ethics

Answer 3

concerned with ethical conduct and decision making in
undertakings intended to extend
knowledge through a disciplined inquiry and/or
systematic investigation

Question 4

what are the principles of ethical conduct in research?

Answer 4

• Scientific merit & integrity
• Respect for persons
• Beneficence/Concern for Welfare
• Justice

Question 5

responsibility conduct of research

Answer 5

At a minimum, researchers are responsible for the following:
* Rigour: Scholarly and scientific
* Record keeping
* Referencing
* Authorship
* Acknowledgement
* Conflict of interest management”

Question 6

The research ethic board must have 5 members who….

Answer 6

• Two members with expertise in relevant research disciplines, fields and methodologies covered by the REB
• One member knowledgeable in ethics
• One member knowledgeable in law
• One community member with no affiliation with the institution

Question 7

ethical decisions - 4 types

Answer 7

provisos - withheld until applicant fixes items listed
approved
deferral - withheld due to significant changes that require full board
rejected - not approved

Question 8

what happens post approval

Answer 8

TCPS2 requires appropriate, adequate, regular monitoring and reporting of approved research.
* Monitoring is a researcher AND institution responsibility
- if anything happens in the study you must advise your supervisor as soon as possible

Question 9

must tell ethics institution about…

Answer 9

• Amendments
• Annual renewals
• Adverse events
• Protocol deviations
• Acknowledgement
• Study completion

Question 10

the wheel of science includes

Answer 10

theories
- deduction
hypothesis
observations
- induction
empirical generalizations

Question 11

3 core principles of conduct of research - ethics

Answer 11

1.
* *
2.
* *
Respect for persons
Acknowledging the value of the human study participant Providing the opportunity for informed consent
Concern for welfare
Respecting the quality of people’s lives Striving to protect participants from harm
3. Justice
* Treating people fairly and equitably
* Not excluding or including people from your study for arbitrary reasons

Question 12

types of risk in studys

Answer 12

Physical
Side effects
Psychological
Traumatic events revisited
Economic
Job loss due to known participation
Social
Exclusion due to known participation
Legal
Researcher can be subpoenaed for their data

Question 13

Indirect identifying information

Answer 13

when info is grouped together, you know who the person is - DOB

Question 14

coded information

Answer 14

You replaced the identifying info with a study ID in the dataset but you have a separate list of the study IDs and who they correspond to

Question 15

anonymized information

Answer 15

Same as coded except you throw away the master list and therefore can never link the study IDs back to the individuals

Question 16

anonymous information

Answer 16

You never collected any identifying information (e.g. survey)

Question 17

assent

Answer 17

When a participant is not able to provide consent,
their next of kin can provide consent
* E.g. is in a coma, has a severe mental illness, is a child…
If the participant is conscious, they must provide
assent
* If they dissent, they are not included in the study

Question 18

fabrication

Answer 18

• Making up data, methods, or findings

Question 19

Falsification

Answer 19

• Manipulation or omission of data, methods, or findings without appropriate disclosure

Question 20

What is the mechanism that is most often used to mitigate the risks associated with research?

Answer 20

INFORMED CONSENT

Question 21

What is the difference between confidentiality and anonymity?

Answer 21

Confidentiality = a researcher’s obligation to safeguard and protect a study participant’s personal information.

Anonymity = when study data does not contain identifying information. The researcher does not know who the participant is so there is no risk of breaching confidentiality.