Research Ethics Flashcards
What is ethics?
An area of study that deals with ideas about what is good and bad behaviour
A branch of philosophy dealing with what is morally right or wrong
What document established the standard for the requirement of voluntary consent from research participants?
The Nuremberg Code
What guideline outlines the requirements for ethical research?
Tri-Council Policy Statement
What groups are involved in the development of the Tri-Council Policy Statement?
Known collectively as the Tri-Council Agencies
- Canadian Institutes of Health Research
- Natural Sciences and Engineering Research Council of Canada (NSERC)
- Social Sciences and Humanities Research Council of Canada
- Research involving humans
What are the three core principles of the Tri-Council Policy Statement?
- Respect for persons
- Concern for welfare
- Justice
What is “Respect for persons”?
It is the intrinsic value of humans
Participants should have autonomy (ability to deliberate about decison and have the freedom to act accordingly)
What is involved with having “Concern for welfare”?
- Have well-being of study participants in mind
- Quality of a person’s experiences of life
- Determinants (housing, employment, education, privacy, control of information)
- Evaluation of risks
- Group and community welfare
What is justice in research ethics?
- Obligation to treat people fairly and equitably
- Be mindful of vulnerable populations and power imbalance
What are some limitations of conducting medical research in smaller cities?
- The number of research participants can be smaller
- If subject of study is complex, there may only be a few specialists qualified to conduct such a study (researchers and clinicians may be the same)
What types of research require research ethics board approval?
- Involving living human participants
- Involving human biological materials, embryos, reproductive materials, stem cells from living and desceased individuals
What is the purpose of research ethics boards?
REBs review the ethical acceptability of all research involvng humans conducted within their jurisdiction (by their faculty, staff, or students regardless of where the research is conducted)
Who is on research ethics boards?
At least five members, including both men and women
- At least two members with expertise in relevant research disciplines
- At least one member is knowledgable in ethics:
- At least one member is knowledgable in the relevant law (mandatory for biomedical research)
- At least one community member who has no affiliation with the institution
What are some requirements for consent?
Must be free and voluntary
- have respect for persons
- Prior to research
- Special cases (power of attorney)
Consent shall be given voluntarily
Consent can be withdrawn at any time (can also withdraw their data from a study)
Should be free from influence and manipulation
Informed
What is clinical equipoise?
This occurs when researchers have genuine uncertainty about which one of their comparator groups will perform better
Do not conduct studies for which you already have answers for
What is duty of care?
It is a clincian’s or researcher’s duty to act in the best interest of the patient balanced with the generation of new knowledge
What is therapeutic misconception?
This occurs when participants are not fully congnizant of the primary goals of clinical trials. They may take inclusion into a clinical trial as equal in intent as clinical treatment. Outcomes are often unknown in clinical trials
The researchers involved are interested in both knowledge gathering and patient care
What are the four stages in clinical trials?
- Phase I
- Phase II
- Phase III
- Phase IV
What are some safety concerns seen in Phase I clinical trials?
This is the first stage where drug is used in human patients
There are some unexpected events that can occur in this stage that were not caught in pre-clinical trials
What are some safety concerns seen in Phase II clinical trials?
This is the first time sick patients are included in the clinical trial
These patients have exhausted every other therapeutic option (treatment resistant patients)
What are some safety concerns seen in Phase III clinical trials?
Large numbers of participants are randomly assigned to comparator or control groups
What are some safety concerns seen in Phase IV clinical trials?
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In what conditions are placebo controlled trials acceptable?
- No established effective therapies for a given population or indication
- Evidence raises doubt on existing therapeutic options
- Treatment resistant patients
- When comparing adjunct therapies, a placebo in addition to established therapeutic agent can be given to maintain blinding
- Patients have refused established effective therapy and witholding therapy will not cause serious or irreversible harm
What are some ethical considerations when it comes to the use of human biological materials in research?
Who can access and use these samples can be concerning to participants
The following can help address these concerns:
- Outline how information will be used
- Ensure patient anonymity
What are some ethical concerns for the collection and storage of human biological materials?
Participants should be able to withdraw their samples, or should become untraceable to original participants
Ethics boards are usually in charge of sample release for research on biological materials (usually impractical to track participants and ask for consent for new study)
