A complete description of the protocol must be submitted with initial applications for IRB or exempt review. The research protocol should provide the information needed for reviewers to determine that the regulatory and Human Research Protection Program (HRPP) policy requirements have been met. There is no required format or template; different sections and formatting may be used, provided the necessary information is included.
I. Objectives
The purpose of the study (research questions and/or study objectives) should be clearly and succinctly stated. In experimental designs, objectives will be stated as hypotheses to be tested.
II. Background and Rationale
Summarize and synthesize the available research (including published data) to provide justification for the study. Evaluate prior research for relevance to the research question under study. When the proposed research is the first of its type to involve human participants, the results of relevant animal studies must be included. Discuss the anticipated results and potential pitfalls. Describe the significance of the research including potential benefits for individual subjects or society at large. Discuss how public health and social welfare might be enhanced.
III. Procedures
The procedures should include the following:
a.
Research Design
- Identify the research design that should be appropriate to answer the research question(s) under study.
- Describe the type of research proposed (e.g. experimental, correlational, survey, qualitative).
- Describe the specific study design that will be used (e.g. pre-test /post-test control group design, cross-sectional design; prospective longitudinal cohort design; phase III double-blind randomized control group design).
b.
Describe the Sampling Approach
- Include justification for sample size determination (for experimental designs).
- Identify the procedures that will be used to recruit, screen, and follow study volunteers.
- Define the study sample:
- number of participants to be enrolled
- characteristics of participants to be included in and excluded from the research.
c.
Measurement/Instrumentation
- Identify the variables of interest and study endpoints (where applicable).
- Justify measurement techniques selected.
- Provide validity and reliability data for selected measures.
d.
Detailed Study Procedures
- Describe the selected methods sufficiently to justify the use of the approach for answering the defined research question.
- Describe methods for study data collection (include how to avoid/minimize subject risks) in detail so that IRB members can assess the potential study risks and benefits.
- Include a timeline for participant evaluations and the duration of project participation in the project.
- Identify the plans for the proposed safeguards for participant confidentiality (plans for coding data and for securing written and electronic subject records).
- Indicate how long personal information will be stored once the study is completed.
e.
Internal/External Validity
- Describe measures that have been taken to avoid study bias (consider the threats to internal/external validity).
f.
Data Analysis Techniques
- Specify the analytic techniques the researcher will use to answer the study questions.
- Indicate the statistical procedures (e.g. specific descriptive or inferential tests) that will be used and why the procedures are appropriate.
- Specify the proposed analytic approaches for qualitative data.