research ethics Flashcards
clinical study
involves research using human volunteers (participants) that is intended to add to medical knowledge.
clinical trial
participants recieve specific interventions according to plan by researchers.
intervention can be medical producs, procedures, changes to participants’ behaviour (diet)
can compare a new medicine - standard medicie - placebo
try to determine safety and effects
clinical trials used in drug development are sometimes described by phase
observational study
investigators assess health outcomes in groups of participants according to a research plan or protocol
may receive interventions
but participants are not assigned to specific interventions by the investigator
ex) investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health
what is ethics?
the study of standards of right and wrong; that part of science and philosophy dealing with moral conduct, duty and judgement
main issues of ethics in research
- treatment of humans and non-humans
- assurance of data quality
- fair reporting of data and results
who makes the decisions on what is considered ethical?
all research studies involving humans and non-human animals must be approved by an institutional research ethics board (“REB”)
- purpose of REB is to approve, advise and oversee ethical aspects of human and non-human participants
- ethics approval involves submitting an application to the REB, which assesses the standards for Canadians
- risk, benefits, suitability of participants
- information that will be provided at the start and end of the research, advertising media, consent to participate and answering questions
policy for ethical research
- tri-council policy statement describes a set of policies for ethical conduct for research involving humans
- underlying value is respect for human dignity (worth)
3 core principles:
- respect for persons
- concern for welfare (risks and benefits)
- justice
respect for persons
- treat individuals as autonomous beings, free to make informed decisions
obtain consent to participate that is:
- free: voluntary, without coercion or pressure
- informed: based on an understanding of the research purpose, risks and benefits
- ongoing: able to be revoked at any time, or upon new information
consent forms
consent forms must include:
- general purpose or goal of research
- description of potential participant experience
- statement of foreseeable risks and benefits
- alternatives to participation
- contact information for researcher and approving research ethics board
- statement of ability to withdraw consent at any time
issues with obtaining consent
free consent may be compromised
- usually attractive incentives to participate
- authority relationships and undue influence
individuals, may not have capacity to consent
- children
- mental disabilities
deception or minimal consent may be desirable to maintain study and data integrity
- avoidance of changes in behaviour due to observation
- some psychological experiments involve deception
concern for welfare
an obligation to design and conduct research in manner that protects participants from unnecessary risks and maximizes benefits
considering risks:
- probability of risk occurring
- magnitude and duration of risk
- strive for ‘minimal risk’ (no greater than everyday life)
considering benefits:
- direct and/or indirect benefits
- advancement of knowledge
justice
requires understanding the vulnerable circumstances of prospective participants and ensuring equitable distribution of risks and benefits
- treat participants fairly and equitably
considers:
- who may be invited to participate
- who should be avoided due to vulnerability
protecting personal information
sharing personal information creates a trust relationship between participant and researcher
- protect the privacy of participants
research may be:
- confidential: information is not shared in a manner that identifies the individuals
- anonymous: information has never had individual identifiers
issues with equity
- treating individuals with equity does not require equal treatment, but takes into consideration that the population can understand
ex) making a survey question easy to understand even for a child
data quality and fair reporting
How might the integrity of data be compromised?
- experimenter effects/bias
– personal, political, and/or financial motives
– research misconduct (e.g. fabrication or manipulation of data)
Data should be reported fairly and accurately
– selective exclusion of data from analysis/report
– misinterpretation or representation of data
– alteration or fabrication of data
