TCPS 2: CORE

Module 3:

Assessing Risk & Benefit

SUBMIT

Revisiting Risk & REB Review: Health Sciences

The proposed study is a clinical trial of a drug believed to be an effective prevention of stroke for people who are susceptible to strokes. Patients who have had a stroke or a mini-stroke within the past year will be invited to participate. Half will be assigned to receive the drug (the treatment 'arm'). The other half will receive a placebo (the control 'arm'). Each participant will need the approval of their family doctor to be in the study. In addition to taking the pills provided for the sixteen-week trial, participants will be asked to report to the clinic once a week for a thorough assessment of their physical condition, including an MRI to observe any changes in the brain (duration = three hours). Any participant who appears to be suffering from any of the indicated side effects (e.g. nausea, headaches, joint pain, confusion, etc.) will be withdrawn from the study immediately.

Your Response:

This proposal should be considered:

Minimal Risk

Above Minimal Risk

Explain your answer in terms of the level of foreseeable risk the proposal may hold for participants and say whether it should receive delegated or full-board review: