4.1/2/3. human research ethics, and important cases - kin 209

define ethics, and describe what ethics policy for research involving humans are focused on

what is good or bad, right or wrong with human conduct

focused on respecting the rights of study participants and protecting them from harm

what were the nuremberg trials, and what resulted from them

the trial were held tp prosecute nazi leaders for their crimes against human, post WW2

the judges developed the nuremberg code

what are the 2 key points of the nuremberg code

- voluntary consent of the human subject is absolutely essential
- the degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved (good must

what are the 3 core principles of the TCPS 2

1. respect for person
2. concern for welfare
3. justice

describe respect for person

- recognizes value of each human
- includes people or data/biological materials
- respect involves voluntary, informed, and ongoing consent

describe concern for welfare

- considers quality of person's experience
- ensure participants are not exposed to unnecessary risks
- maximize benefits
- good must outweigh the bad

describe justice

- obligation to treat people fairly and equitably
- no discrimination

fairness - treat all people with equal respect and concern

equity - distributing the benefits and burdens of research

describe when conflicts of interest may occur

study places researchers or their respective universities, in a conflict with their duties related to research, personal, or institutional interests

describe the difference between passive and active consent

passive - consent implied unless you explicit state you do not

active - must explicitly state that you consent (form or verbal)

how do you go about consent when a child is involved

parent - consent
child - assent (give them brief description and ask if they are willing to participate)

describe privacy

refers to an individual's right to be free from intrusion or interference by others

describe the difference between confidentiality and anonymity

confidentiality - info and data not revealed or shared outside of the research team

anonymity - any part of participant's identity is unknown to researchers

what does the TCPS require, surrounding privacy, confidentiality and anonymity

requires privacy and confidentiality, but anonymity is not a guarantee

describe the Nancy olivieri case (what, ethics concern, principle it relates to)

- olivieri's clinical trial drugs were causing unexpected results
- when olivieri informed her participants like instructed by the REB, the pharmaceutical company sued her, indicating that she violated the confidentiality agreement she signed
- ethics concern is that you cannot sign non-disclosure agreement with external entities, as they create conflicts of interest
- respect for the person (conflict of interest)

describe the minnesota starvation experiment (what, ethics concern, principle it relates to)

- war objectors were given an ultimatum, be in prisoned or participate in the starvation experiment
- participants starved nearly to death to test what the minimum amount of protein needed to survive is
- participants interviewed many years later and they all said they would do it again
- ethics concern is should this data continue to be used since participation and wasn't voluntary and the fact that the participants were under extreme duress
- concern for welfare, justice, respect for person (voluntary participation)

describe the henrietta lacks case (what, ethics concern, principle it relates to)

- cervical cancer cells taken from her without knowledge of consent
- her immortal cells, know as HeLa cells, because one of the most important tools in medicine and continue to be used to this day
- her cells have been bough and sold by the billions, but she has received nearly no recognition and her family hasn't received compensation
- ethics concern is that she did not give consent to them taking or using her cells, and that her family wasnt informed until many years after she passed, that researchers were doing work with her cells
- respect for person (informed consent)

describe the milgram study (what, ethics concern, principle it relates to)

- experimenter persuades participant to give 'shocks' to another participant, who is actually an actor
- actor is pleading for participant to stop, but participant continue based on instruction from experimenter
- participants not debriefed after the fact, and informed that it was just an actor and that they didn't hurt anyone
- ethics concern is the extreme emotional stress suffered by the participants
- respect for the person (debriefing), concern for welfare (extreme duress)