Lecture 7: Research Ethics 2 Flashcards
what are the four main components of a research ethics process (REB)
- application
- review
- revisions
- approval
what are the components of the REB application?
- conflicts of interest
- funding
- regulation (health Canada, NOA)
- study overview
- risk and benefits
- compensation and reimbursement
- privacy and confidentiality
- human biological material
- supporting documents (protocol, ICF, letter of interest)
what are the components of a study overview?
- recruitment
- consent
- study design
- data collection
what do you do if there is no risk of a research when applying to an REB?
there is always a risk (can even be exposure to name)
where is your REB application being reviewed?
with Primary and Secondary Reviewers
what are the components of a review process
- assigned primary and secondary reviewers
- standardized reviews
- documented
- in person vs reported feedback
- online platforms
- full board vs delegated review
what must be met in order to approve a REB application?
the nine criteria
what are the possible decisions/motions of revisions and approvals of REB applications?
- approval (RARELY RARELY RARELY happens)
- approve with modification/conditions
- defer: criteria has not been met. clear instructtions are sent inorder for criteria to be met.
- disapprove (does not happen often)
what is a delegated reviews?
selected among the REB membership and the reviews are conducted independently
what are the studies that may qualify for delegated review?
- are considered ……
- ………………
what are the four criteria needed on a meaningful informed consent form?
- information disclosure
- comprehension
- voluntariness
- competence
What is OCREB?
a central, expert oncology REB serving the hospitals/cancer centres (study sites) in Ontario that conduct oncology clinical trials
