Midterm 2 - Chpt. 3 Flashcards
Nuremberg code
established in response to human experimentation in established in response to human experimentation in WW2
Catalyst for international debate on how to respect human dignity
Emphasized importance for informed consent & updated international codes of ethics
Countries and scientific societies began codifying ethical practices for all research involving humans
TCPS
The Tri-Council Policy Statement
reminds researchers to consult and follow laws of the jurisdictions in which the research is conducted
3 basic ethical principles:Researchers, in addition, must also comply with the Canadian Charter of Rights and Freedoms, Canadian privacy of information laws, and relevant provincial laws
Varying legal contexts is one of the reasons why the TCPS2 is considered a set of guidelines rather than a set of rules
Adopting guidelines rather than specifying rules acknowledges the reality of research as an innovative and constantly evolving enterprise
Cannot predict every single specific situation posed by all future research questions
3 basic ethical principles:
- Respect for persons
- Concern for welfare
- Justice
Respect for persons
Researchers must respect the autonomy of research participants, and protect those who have “developing, impaired, or diminished autonomy”
Respecting autonomy means enabling people to choose participation freely and without interference
Concern for welfare
Researchers must attempt to minimize risks associated with participating in research, while maximizing the benefits of that research to individual participants and to society
When coupled with respect for persons, participants must be free to choose whether the balance of risk and benefits is acceptable to them
Justice
Researchers must treat people fairly and equitably by distributing the benefits and burdens of participating in research.
Demonstrating justice includes recruitment methods that offer participation to people from a diverse range of social groups, and excluding groups only when scientifically justifiable
Promote concern for welfare by…
minimizing risks and maximizing benefits
Concern for welfare:
refers to the need to maximize benefits and minimize any possible harmful effects of research participation
Risk-benefit analysis:
in decisions about the ethics of research, we are required to calculate potential risks and benefits that are likely to result
Benefits to participants & society:
Benefits include education about the scientific process, acquisition of a new skill, or treatment for a psychological or medical problem
Material benefits: monetary payment, gift, possibility of winning a prize, points toward a course grade
Satisfaction from contributing to a scientific investigation, could yield benefits for society
Risk of physical harm:
Researchers have affected participants physically in the pursuit of science across many different context
Risks of procedures that require that great care be taken to make them ethically acceptable
There would need to be clear benefits of the research that outweigh the potential risks
Risk of psychological stress:
When pursuing concern for welfare, we ask whether subjecting people to such a stressful experiment is justified, and whether the experience might have any long-term consequences for the participants
A potentially stressful form of research involves getting participants bogus tests of personality or ability
Using deception, researchers provide false feedback stating that the participant has an unfavourable personality trait or low ability score
What steps might be taken in the case of psychological stress?
When stress is a possibility, safeguards must be taken to help participants deal with the stress
Typically, a debriefing session following the study designed to address potential stresses that may arise due to research
Risk of losing privacy and confidentiality:
Includes researches to protect “the right to control information about oneself”
However, definitions are changing in the digital age
For our purpose, important to be aware that using data for purposes other than what was agreed to during the informed consent process may breach participants’ privacy and confidentiality, adding in lost of trust
Confidentiality is especially important when studying sensitive topics
Researchers may need to ask people very sensitive questions about their private lives
Important that individual responses to such questions to be confidential
Responses are completely anonymous - no way to connect any person’s identity with any particular data
No identifying information
Carefully design ways of coding data, storing data, and explaining the procedures to participants, to protect the confidentiality of responses and to ensure anonymity, when possible
In what case would we need to identify individual participants?
- Occurs when people are studied on multiple occasions over time, or when specific personal feedback, such as an accurate test score, must be given to individual participants
- Researchers should create a code to identify the individuals, but should separate this code from the actual data
– Data can’t be linked to specific people
Analysis of risks and benefits:
- Assess potential benefits to participants, science, and society
- Assess potential risks to participants
- Assess whether the potential benefits outweigh the risks
- If YES, carry out research
- If NO, study must be modified
TCPS2 principle - respect for persons:
participants are treated as autonomous, capable of making deliberate decisions about whether they wish to participate in research
Most often applied through informed consent - participants should be provided with all information that might influence their decision to participate or not; can then freely consent to participate in research or refuse to do so
7 components of informed consent forms:
- Purpose of research
- Procedures to be used
- Risks/benefits to p and society
- Compensation
- How confidentiality will be protected
- Assurance of voluntary participation and permission to withdraw without penalty
- Contact information
Cases where forms are so loaded with legal terminology that it’s unlikely…
p’s will fully realize what they’re signing
Should be written in simple and straightforward language, avoiding jargon/technical terms (grade 6-8 reading)
Not in first person, but like a conversation with participant
Other means of effective communication
- EX: translations
Possibilities where informed consent is not necessary or possible
- EX: when not manipulating or influencing the people you are observing in any way
Issue with consent - lack of autonomy:
lack of ability to make a free and informed decision to voluntarily participate
EX: minors - parent/guardian required in addition to agreement by the minor (alone, called assent)
Coercion - threat to autonomy:
any procedure that limits an individual’s freedom to consent is potentially coercive
Withholding information:
Providing too much information can be problematic; invalidating the results of the study if knowing all the details would change a person’s behaviour so that it no longer resembles how that person would normally behave
Acceptable to withhold information about hypothesis, or particular experimental conditions in which the person is participating in, when it doesn’t seem likely to affect a person’s decision to participate and when the information will be provided later, usually during a debrief after the study is completed
