The key attachment to the iRIS submission is the Research Protocol. It is considered the “gold standard” document for all other procedural and methodological references.
The protocol provides context and specifies the research question while outlining what will be done and how information will be processed to reach a conclusion. It serves as the source of information for review by two groups:
- Senior Scientists, for design/methodology; all protocols must be reviewed and approved for scientific merit before they go to IRB/IACUC (see below)
- the HHC Institutional Review Board (IRB, for human subjects’ research) or Institutional Animal Care and Use Committee (IACUC, for animal studies) for patient safety and ethical considerations
A protocol comprises the following sections:
- Literature Review and Background – a minimum of three relevant citations is usually requested
- Specific Aims/ Hypotheses
- Clinical Significance/ Translational Relevance
- Research Design Overview
- Sampling—Enrollment Criteria (inclusion/exclusion)
- Methods of Data Collection
- Data use, security, storage and privacy
- Use of BioSpecimens (if applicable)
- Power/Sample Size Estimate
- Statistical Analysis Plan
- References (should be full references, any consistent format, to match citations)
Depending on funding status and/or risk level of your study, you may be asked for additional information, such as:
- Safety/adverse events
- Risks/benefits (these will match what’s in your informed consent form)
- Resources
- Time line
- Funding
- Appendices
A more in-depth description of research protocol contents and each of these sections can be found here >>