class 2

Question 1

violation of subject rights

Answer 1

scientific misconduct
i.e. fraud, falsifying or fabricating data

Question 2

NL ethics board

Answer 2

Health Ethics Research Board (HERB)

Question 3

who serves on an ethics board

Answer 3

researchers, clinicians, lawyers, ethicists, and kay people

Question 4

function of an ethics board

Answer 4

-protect of rights and welfare
-voluntary informed consent
-benefits exceed risks

Question 5

how does a research ethics board (REB) determine if a study is fit for ethical approval

Answer 5

-read proposals carefully
-think about procedures
-consider how data is collected
-determine if subjects put at undue risk or rights are violated
-ensure consent contains all necessary elements and is understandable

Question 6

examples of unethical studies

Answer 6

-nazi medical experiments
-tuskeegee syphilis study
-texas vampires
-texas newborn bloodspot saga
-dr.chandra nutrition studies
-residential school nutrition studies

Question 7

ellen roche

Answer 7

24 yr old volunteer in an asthma study who died in 2001 because she inhaled hexamethonium a med for high BP in the 50-60s

Question 8

ethical codes & regulations

Answer 8

-nuremberg code
-declaration of helsinski
-tri-council policy statement: ethical conduct for research involving humans

Question 9

tri-council policy statement 2: research involving first nations in Canada

Answer 9

-community engagement and collaboration
-indigenous/tradition knowledge

Question 10

CNA code of ethics for Registered Nurses

Answer 10

-safe, competent, and ethical care
-health and well-being
-choice
-dignity
-confidentiality
-justice
-accountability
-quality practice environment

Question 11

principles of ethical decision making

Answer 11

-respect for persons (autonomy)
-concern for welfare (beneficence)
-justice

Question 12

respect for persons (autonomy)

Answer 12

-self-determination
-fully informed, right to withdraw
-no coercion
-fully disclosure, no deception

Question 13

right to privacy

Answer 13

-anonymity
-confidentiality
-subjects do not have to fully disclose

Question 14

respect for culture

Answer 14

-respect for continuity for distinct cultures and identities
-respect for traditional/history ways of knowing
-respect for authorities and knowledge holders

Question 15

principle of beneficence (concern for welfare)

Answer 15

-freedom from harm
study may have:
-no anticipated effects
-temporary discomfort
-unusual levels of temporary discomfort
-risk of permanent damage
-certainty of permanent damage

Question 16

principle of beneficence (concern for welfare) - freedom from exploitation

Answer 16

-risk/benefit ratios
-high anticipated benefit may balance high risks

Question 17

principle of beneficence (concern for welfare) - concern for collective welfare (i.e. community)

Answer 17

-consideration of participant environment
-preservation and enhancement of community/environment (e.g. indigenous culture)
-considering indigenous ways of knowing and two-eyed seeing
-must be focused on decolonization reserach ethics

Question 18

principle of justice

Answer 18

-fair treatment : even if a person chooses not to participate, subject selection, intermediary
-protection from incompetence
-fair representation

Question 19

special ethical considerations

Answer 19

-old or young
-indigenous peoples
-participants who lack decision-making capacity
-institutionalized persons
-terminally ill
-pregnant women
-students

Question 20

4 types of informed consent

Answer 20

1. essential information for consent
   2.comprehension of consent information
   3.competency to give consent
   4.voluntary consent

Question 21

elements of informed consent

Answer 21

-statement that this is research
-general purpose of the study and clear description of what the participant is expected to do
-forseeable risks and potential benefits
-alternative to participation
-extent to which privacy will be maintained
-contact information of the researcher
-contact of the relevant REB
-assurance that participation is voluntary and partipants can withdraw at any time without penalty

Question 22

informed consent

Answer 22

-who signs for whom: consent vs assent
-language
-written vs oral consent
-witneess

Question 23

ethical issues related to research

Answer 23

-scientific misconduct
-use of animals in research
-fetal tissue research
-genetic research
-privacy protection