Protocol components
A research protocol is a separate document clearly describing the science and the ethics of the project. For assistance in protocol writing, research design, biostatistics, database management and budget preparation, please contact the Director of Clinical Research Services, Julie Gibson at julie.gibson@sickkids.ca.
The scientific aspects of the protocol should include a discussion of ;
- the research problem, background analysis and hypothesis
- the relevant literature including animal and adult literature (where appropriate)
- study objectives
- the research design and methodology (inclusion/exclusion criteria, sample size, justification of statistical methods for assessing results
- a schematic timeline when the protocol proposes multiple interventions or multiple time points
- definition of adverse and serious adverse event
- budget details and available resources
- contract with sponsor (when available)
The ethical aspects of the protocol should include a discussion of;
- potential benefits to subjects and others
- potential harms to subjects and others
- alternative treatments or procedures
- how potential harms will be minimized - including the risk of breech of privacy and confidentiality
- the process for seeking consent and assent
Protocols submitted for review in partial fulfillment of an academic program must be accompanied by written evidence of support from the academic committee chair or supervisor.