Chapter 4 - Research Ethics and TCPS 2

Question 1

What are the principles that serve in research?

Answer 1

-respect for persons (allowing people to put themselves at whatever risk they choose)
-concern for welfare (avoiding unnecessary risks)
-justice (dual obligation to treat persons as well as groups/communities)

Question 2

who has to follow TCPS 2?

Answer 2

anyone who conducts research under an eligible institution.

Question 3

define research

Answer 3

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

Question 4

what does and doesn’t need a REB?

Answer 4

initial exploratory work to help design a study doesn’t, but pilot studies (smaller group, less time involved) do require a REB.

Question 5

define human participation

Answer 5

are those individuals whose data, biological materials, or responses to interventions, stimuli, or questions by a researcher, are relevant to answering the questions.

Question 6

what are the 3 cases you don’t need a REB?

Answer 6

1. info that is legally accessible, with no expectation of privacy
2. observations of people in public places (involving any stage intervention)
3. secondary use of anonymous info or human biological materials (info that has never has any identifier to be attached too them)

Question 7

define potential benefits

Answer 7

impacts that positively affect the welfare of participants, communities, or society as a whole through the advancement of knowledge for generations

Question 8

define risk

Answer 8

possibility of the occurrence of harm to participants

Question 9

define minimal risk

Answer 9

research in which the probability and magnitude of possible harms implied by participation in the research are no greater than those encountered by participants in those aspects of their everyday life

Question 10

define consent

Answer 10

the means by which individuals express their willingness to participate in research

Question 11

what are the 2 key ethics?

Answer 11

appropriate inclusion and exclusion of human participants

Question 12

define privacy

Answer 12

an individual right to be free from intrusion or interference by other

Question 13

define confidentiality

Answer 13

the obligation of an individual or organization to safeguard entrusted info

Question 14

define conflict of interest

Answer 14

imcompatability of two or more duties, responsibilities or interest… of an individual or institution as they relate to ethical conduct of research, such that one cannot be fulfilled without compromising another

Question 15

Who may face a conflict of interest?

Answer 15

REB members may face this in realtion to an application submitted for ethics review. Each member must disclose any such conflicts.

Resaerchers may face this with relationships, partnerships, ecomnic interest, and academic interests.

Question 16

What is the role of an REB?

Answer 16

REVIEW ETHICS BOARD, they are the bodies that are established by institutions to rpivde ethics oversight for all research projects that involve human participants. They have the mandate to review the research proposal and determine its ethical acceptability.

Question 17

How do REB conduct its review?

Answer 17

1. determine the appropraite elvels of review
2. default level is full review

-consist of at least 5 members and they each have their own part in the review. as REB increase, the number of people increase.

Question 18

define community

Answer 18

a group of people with shared identity or interest that has the capacity to act or express itself as a collective

-territorial
-organizational
-interest based

Question 19

define respect for persons

Answer 19

proving fully informed consent for the participant. Must avoid being misleading about risk/benefits. avoid corcion

Question 20

define concern for welfas=re/beneficence

Answer 20

protecting participants from harm and ensuring their well-being. carefully evaluate the risks and benefits, whilst having continual monitoring during the study for risks

Question 21

define justice

Answer 21

being sure there is a fair balance between people who participate in the research and people who benefit from it.

want you sample to represent the population that will benefit from the research

Question 22

what are some examples of experiments that were conducted that created a concern to create TCPS?

Answer 22

Nurmeburg Code: experiements were done on people at concentration camps without their consent that resulted in death
Thalidomide: patients were not informed what drug they were ingested, never consented either. many babies born without limbs
Syphilis: patients were never told they had syphiliis, never consented to any treatment. almost 600 men had died.

Question 23

define research ethics board

Answer 23

REB, is apart of institutions that receive federal research funds. consist of a minimum of 5 people and they are there to evaluate risks/benefits and approve of consent forms.

Question 24

what are the sections of a consent form?

Answer 24

information
risks
benefits
confidentiality
compensation
contact
participation
feedback and publication
consent

Question 25

what are teh 2 types of deception that can be used in research?

Answer 25

via omission: telling people that there are certain things they cannot know, but it will all be disclosed at the end of the study (debrief)

via commission: actively lie/makeup something so they don’t know a complete truth, still tell them the truth after the fact

Question 26

what are the 3 R’s when it comes to animal care guidelines in research?

Answer 26

Replacement: try to find alternatives to animals when possible
Refinement: eliminate distress as much as possible
Reduction: try to use as few animals as possible

Question 27

define data fabrication and falsification

Answer 27

fabrication: making up/inventing data to support your hypothesis

falsification: altering/omitting data to make results look better

Question 28

How does the syphillis study demostrate three major ethics violations?

Answer 28

1. men were not treated respectfully, they were lied to about the nature of the participation and withheld info (such as penicillin being a cure for the disease). men were not able to make a fully informed decision on whether or nit to consent.
2. they were harmed, they were subjected to painful and dangerous tests.
3. researched targeted a disadvantaged social group, poor and black men, in order to help the whole population of men in general.

Question 29

define debreifed

Answer 29

to inform participatns afterwards about the true nature of the study, with the details and hypothesis

Question 30

define anonymous study

Answer 30

where researchers do not collect any potentially identifying info such as name, birthday or any photos.

Question 31

define confidential study

Answer 31

where researchers collect some identifying info (for later contact) but prevent it from being disclosed.

Question 32

what are the apa ethical principles under beneficence?

Answer 32

-beneficence and nonmaleficence: treat people to benefit them
-fidelity and responsibility:accept responsibility for professional behaviour
-interity: accurate and truthful

Question 33

what are the apa ethical principles under justice?

Answer 33

justice: treat all groups of people fairly

Question 34

what are the apa ethical principles under respect for persons?

Answer 34

-respect for people’s rights and dignighty: recognize that people are autonomous agents, they have a right to their privacy and to give consent

Question 35

define institutional review board

Answer 35

IRB, committee responsible for ensuring that research using human participants is conducted ethically

Question 36

define deception

Answer 36

withholding of some detials of a study from participants (omission) or the act of actively lying to them (commission)