Ethical Conduct in Research Involving Humans Flashcards
Three core principles:
Respect for Persons (consent, autonomy, informed choice, without coercion/influence)
Concern for Welfare (give them adequately and enough info to be able to assess risk/harm and potential benefit)
Justice (fairness, equity and vulnerability)
Determinants of welfare include:
privacy housing emplyment security family life community membership social participation
One important difference that must be considered for fairness and equity is
Vulnerability
REB review is not required
where research uses exclusively publicly available information that may contain identifiable information and for which there is no reasonable expectation of privacy.
REB review is required in situation that are publicly accessible digital sites but where there is a reasonable expectation of privacy: eg.
Internet chat rooms
self-help groups with restricted membership
Personal information denotes
Identifiable information about an individual.
Individual are considered participants when
they are themselves the focus of the research. eg. individuals who are asked for their personal opinions about organizations or who are abserved in their work setting.
Potential benefits
Much research offers little or no direct benefit to participants but primary benefits produced are for society and for the advancement of knowledge.
Risk is a function of
The magnitude or the seriousness of the harm
The probability of occurrence of the harm
Harm may be transient such as
a temporary emotional reaction to a survey question
Harm may be longer lasting such as
the loss of reputation following a breach of confidentiality, or a traumatic experience
Minimal risk
search in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research (vulnerable population).
The proportionate approach to REB review requires
that a project have a favourable balance of risks and benefits in order to receive REB approval.
Foundation for the proportionate approach to REB review:
The concept of minimal risk
General principles of Consent:
- Shall be given voluntarily
- Shall be Informed
- Should not be giving undue influence (position of authority or dependency) or coercion.
- Shall be an ongoing process (Can be withdrawn at any time/also request the withdrawal of their data or human biological materials)
- Shall be documented
Coercion is
a more extreme form of undue influence, involving a threat of harm or punishment for failure to participate.
Incentives
are anything offered to participants, monetary or otherwise, for participation in research
Incentives should NOT
be so large or attractive as to encourage reckless disregard of risk.
For consent to be informed:
prospective participants shall be given adequate time and opportunity to assimilate the information provided, pose any questions they may have, and discuss and consider whether they will participate.
Language barriers necessitate the assistance of an intermediary for communication between the research team and participant may rise to issues related to
Confidentiality.
Potential or perceived conflicts of interests related to
role as researcher vs others roles eg. nurses, teachers, therapist, supervisors..
indirect expenses refer to
losses that arise from participation (e.g., taking unpaid leave from work)
Direct expenses are
costs incurred because of research participation(e.g., paying for transportation to, or parking at, the research site
Incidental findings:
Eg.:
describes unanticipated discoveries made in the course of search but that are outside the scope of research.
Eg: participant anxiety, unnecessary costs and burdens of f/u or may affect eligibility to employement or insurance.
