Submitting a Proposal
SUBMISSION CHECKLIST
Before you submit a proposal to irb@lewisu.edu for initial review, please be sure to collect all of the following information:
- Form A (Request for Initial Review of Exempt Studies)
- Form B (Request for Initial Review of Expedited or Full Review Studies)
- Form C (Request for Continuing Review)
- Form D (only if the study involves deception)
- Research Protocol (see guidelines below)
- Data collection instruments (copyrighted instruments also require a letter giving written approval for use)
- Informed Consent documents (see guidelines below)
- CITI training certificates for all researchers
- Responsible Conduct of Research
AND
- Discipline-specific training module
THE RESEARCH PROTOCOL
The Research Protocol should be detailed enough for the IRB members to fully understand who the subjects are, the benefits and risks to those subjects, and the procedures the researchers will follow to minimize risk, to maintain privacy and confidentiality, and to mitigate any adverse effects. The list of protocol requirements below is intended to ensure that the IRB members have enough information to evaluate those risks.
Note: It is NOT in the purview of the IRB to evaluate experimental design, so IRB approval does not imply endorsement of methods.
The Research Protocol should include:
- A brief background section. This is required to demonstrate knowledge of the current body of literature and provide the board with essential context to understand the rationale, significance, and prior research supporting the proposed study. This background helps the IRB members evaluate:
- the relevance and need for the study.
- the study’s goals and whether the potential benefits justify the risks.
- any specific ethical challenges and assess if the proposed safeguards are adequate.
- if the methods are informed by prior work, which helps the board determine if the research is likely to produce meaningful and valid results without unnecessary risks to participants.
- The setting of the research (school, clinic, classroom, hospital, etc.)
- Anticipated dates of study, which should be consistent with the dates listed in Form A and should be after anticipated IRB approval.
- Complete subject description including:
- Number of subjects
- Ages (e.g. adults over 18, minors over 12, vulnerable populations, etc.)
- Characteristic information (e.g. ESL students, athletes, specific occupation, etc.)
- How subjects will be identified, recruited, and selected
- All research procedures including:
- Permissions from the site used (if applicable)
- Methods for obtaining informed consent
- Informed consent letter
- Methods for protection of anonymity or confidentiality
- Methods for protection from, or in response to, harm
- Data collection procedures (when, who, and how)
- Data analysis methods
- All instruments, tools, and materials that participants will interact with (survey/interview questions, recruitment flyers, debrief paperwork, etc.)
- All possible benefits and risks to subjects
- Where results will be disseminated
- Where data/results will be securely stored for 3 years
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