Ethical Conduct in Research Involving Humans

Question 1

Three core principles:

Answer 1

Respect for Persons (consent, autonomy, informed choice, without coercion/influence)
Concern for Welfare (give them adequately and enough info to be able to assess risk/harm and potential benefit)
Justice (fairness, equity and vulnerability)

Question 2

Determinants of welfare include:

Answer 2

privacy
housing
emplyment
security
family life
community membership
social participation

Question 3

One important difference that must be considered for fairness and equity is

Answer 3

Vulnerability

Question 4

REB review is not required

Answer 4

where research uses exclusively publicly available information that may contain identifiable information and for which there is no reasonable expectation of privacy.

Question 5

REB review is required in situation that are publicly accessible digital sites but where there is a reasonable expectation of privacy: eg.

Answer 5

Internet chat rooms

self-help groups with restricted membership

Question 6

Personal information denotes

Answer 6

Identifiable information about an individual.

Question 7

Individual are considered participants when

Answer 7

they are themselves the focus of the research. eg. individuals who are asked for their personal opinions about organizations or who are abserved in their work setting.

Question 8

Potential benefits

Answer 8

Much research offers little or no direct benefit to participants but primary benefits produced are for society and for the advancement of knowledge.

Question 9

Risk is a function of

Answer 9

The magnitude or the seriousness of the harm

The probability of occurrence of the harm

Question 10

Harm may be transient such as

Answer 10

a temporary emotional reaction to a survey question

Question 11

Harm may be longer lasting such as

Answer 11

the loss of reputation following a breach of confidentiality, or a traumatic experience

Question 12

Minimal risk

Answer 12

search in which 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 (vulnerable population).

Question 13

The proportionate approach to REB review requires

Answer 13

that a project have a favourable balance of risks and benefits in order to receive REB approval.

Question 14

Foundation for the proportionate approach to REB review:

Answer 14

The concept of minimal risk

Question 15

General principles of Consent:

Answer 15

1. Shall be given voluntarily
2. Shall be Informed
3. Should not be giving undue influence (position of authority or dependency) or coercion.
4. Shall be an ongoing process (Can be withdrawn at any time/also request the withdrawal of their data or human biological materials)
5. Shall be documented

Question 16

Coercion is

Answer 16

a more extreme form of undue influence, involving a threat of harm or punishment for failure to participate.

Question 17

Incentives

Answer 17

are anything offered to participants, monetary or otherwise, for participation in research

Question 18

Incentives should NOT

Answer 18

be so large or attractive as to encourage reckless disregard of risk.

Question 19

For consent to be informed:

Answer 19

prospective participants shall be given adequate time and opportunity to assimilate the information provided, pose any questions they may have, and discuss and consider whether they will participate.

Question 20

Language barriers necessitate the assistance of an intermediary for communication between the research team and participant may rise to issues related to

Answer 20

Confidentiality.

Question 21

Potential or perceived conflicts of interests related to

Answer 21

role as researcher vs others roles eg. nurses, teachers, therapist, supervisors..

Question 22

indirect expenses refer to

Answer 22

losses that arise from participation (e.g., taking unpaid leave from work)

Question 23

Direct expenses are

Answer 23

costs incurred because of research participation(e.g., paying for transportation to, or parking at, the research site

Question 24

Incidental findings:

Eg.:

Answer 24

describes unanticipated discoveries made in the course of search but that are outside the scope of research.
Eg: participant anxiety, unnecessary costs and burdens of f/u or may affect eligibility to employement or insurance.

Question 25

Exception to the requirement to seek prior consent:

Answer 25

Must demonstrate that the benefits of the research whether direct, indirect or societal, justify any risks associated with no prior consent. Eg. Study on environment toxin on members of communities (could lead to general panic)

Question 26

exclusion/inclusion of group of participant can be unfair:

Answer 26

Women (base on sexe, pregnant, breastfeeding)
Children (base on age and development stage)
Elderly (base on age)

Question 27

Inclusion and exclusion criteria is base on

Answer 27

the principle of justice (a duty on researchers to not exclude individuals or groups from participation for reasons that are unrelated to the research)

Question 28

Inappropriate exclusion:

Answer 28

Researchers shall not exclude individuals from the opportunity to participate in research on the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity, linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.

Question 29

During the inclusion and exclusion criteria decision, need to take in account:

Answer 29

Participants who lack decision-making capacity (individual with cognitive impairment or intellectual disabilities)
Participants’ vulnerability
Equitable distribution of research benefits

Question 30

Privacy

Answer 30

individual’s right to be free from intrusion or interference by others.

Question 31

Ethical duty of Confidentiality

Answer 31

refers to the obligation of an individual or organization to safe-guard entrusted information.

Question 32

Security

Answer 32

refers to measures used to protect information. It includes physical (location of computers, locked filing cabinets), administrative (organizational rules) and technical safeguards (computer passwords, anti-virus software).

Question 33

Identifiable information is related to

Answer 33

personal information

Question 34

Type of information

Answer 34

• Directly indentifying information (name, social nsurance number)
• Indirectly identifiying information (date of birth, place of residence)
• Coded information (Direct info removed and replaced with a code–> possible to re-identify specific participant)
• Anonymized information (a code is not kept to allow future re-linkage)
• Anonymous information (anonymous surveys)

Question 35

Directly indentifying information

Answer 35

(name, social nsurance number)

Question 36

Indirectly identifiying information

Answer 36

(date of birth, place of residence)

Question 37

Coded information

Answer 37

(Direct info removed and replaced with a code–> possible to re-identify specific participant)

Question 38

Anonymized information

Answer 38

(a code is not kept to allow future re-linkage)

Question 39

Anonymous information

Answer 39

(anonymous surveys)

Question 40

Therapeutic misconception is

Answer 40

subject tendency to believe that participation in a research trial will offer them a direct benefits, despite an adequate informed consent process.