Research Ethics

Question 1

What do we have research ethics?

Answer 1

to prevent bad research

Question 2

what are the 3 significant codes?

Answer 2

Nuremberg code
Declaration of Helsinki
Belmont report

Question 3

what is the Nuremberg code?

Answer 3

-a set of guidelines formed following WWII to ensure the atrocities committed by the nazi researchers would not be repeated.

-Human beings MUST consent voluntarily to research before they are enrolled to participate

Question 4

what is the declaration of Helsinki?

Answer 4

-developed by the world medical association in 1964

• outline ethical principles to follow when conducting research with human participants
• the main focus of the document was the ethical complexities of conducting human participant research in foreign countries and ensuring that the protection for human participants not be lessened by things such as national ethical, legal, or regulatory requirements

Question 5

what is the Belmont report?

Answer 5

• the Tuskegee experiment

-formation of the national research act (US) in 1974

Question 6

what are the principles of the Belmont report?

Answer 6

-respect for persons: respects the autonomy of people and provides protection for those with diminished autonomy

-benefience: do no harm, maximize benefits and minimize risks

-justice: fair, equal - balance of the burdens and benefits of research

Question 7

what does respect for persons highlight?

Answer 7

autonomy
voluntariness of participation
informed choice
capacity

Question 8

what does concern for welfare highlight?

Answer 8

risk must be in proportion to benefits

no unnecessary risks

consideration of the impact of participation on a participant and the community they are part of

Question 9

what does justice highlight?

Answer 9

fair and equitable treatment

equal distribution of risks and benefits

protection of vulnerable populations

justifiable inclusion

managing power imbalances

Question 10

what research requires ethical review?

Answer 10

research involving living humans
research involving human biological materials including embryos, fetuses, fetal tissues, reeproductive materials and stem cells

Question 11

what is research according to ethics review?

Answer 11

an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation

Question 12

who are human participants according to the ethics review?

Answer 12

those individuals who’s data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question

Question 13

what are the expcetions when the review this board does not have to be involved?

Answer 13

publicly available information, documents

observation of people in public places

secondary use of de-identified information

Question 14

what does the REB consider when it reviews research?

Answer 14

protection of human subjects

assess risks and benefits

assess research design to ensure minimal risk and meet objectives

review subject recruitment to ensure informed consent

protect vulnerable groups

Question 15

what does informed consent entail?

Answer 15

participants must be told exactly what is going to happen to them

participants ar always free to choose to participant, end, or withdraw consent to use data collected from them

consent should be voluntary

there should be no undue influence, coercion, incentives

participants should be confident that their anonymity and confidentiality it respected and protected

Question 16

what is considered coercion?

Answer 16

overwhelmed by institutional approval

fear of loss of health benefits, employment, or educational status

obligation to participate

financial gain

Question 17

what are ethical issues if you are a clinician researcher?

Answer 17

role as a clinician/researcher gives you an “insider status”

participants are likely to have knowledge of your position

you need to separate your role as a clinician and researcher

identify your role in the context of the research

make your involvement in the research obvious

Question 18

what are some suggestions for acting as a clinician researcher?

Answer 18

do not wear professional attire

do not answer questions as an OT

reflect on feelings, biases, and power issues

make these explicit and express them

Question 19

how might there be power issues in research with your clients?

Answer 19

you have access to client files and data

in research you need to protect their confidentiality so you cannot access this information without permission

need to navigate dual relationship

Question 20

what is coercion?

Answer 20

threat of harm

Question 21

what is undue influence?

Answer 21

promise of unfair benefit

Question 22

what are power issues in multi-disciplinary teams?

Answer 22

hierarchical relationships among health professionals