Biology Quantative protocol draft assignment
How to Create a Research Protocol
The Research Protocol is a statement of the researcher's project design and a description of
his/her responsibilities toward the human subjects involved in the research.
To ensure an effective review by the Institutional Review Board, a full description of the planned
research must be submitted with the Application for IRB Review. A research protocol provides
the reader with background information of the problem under study, including the study
rationale, a detailed plan for conducting the research involving human research participants, and
a discussion of the potential importance of the research.
1. Objectives
The purpose of the study (research questions and / or study objectives) should be clearly and
succinctly stated. In experimental designs, objectives may be stated as hypotheses to be tested.
2. 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. Describe the significance of the research including potential benefits for individual
subjects or society at large.
3. Procedures
The procedures should include the following:
a) Research Design
The research design should be identified and should be appropriate to answer the research
question(s) under study. Describe the type of research proposed (e.g. experimental, correlational,
survey, qualitative) and specific study design that will be used.
b) Sample
Describe the sampling approach to be used. Identify the procedures that will be used to recruit,
screen, and follow study volunteers. Specifically define the study sample (number of subjects to
be enrolled, characteristics of subjects to be included in and excluded from the research, and
whether this will be a random or convenience sample).
c) Measurement/Instrumentation
Identify the variables of interest and study endpoints (where applicable). Justify measurement
techniques selected. Provide information regarding the validity and reliability of selected
measures.
d) Detailed study procedures
Methods for collecting data and for avoiding / minimizing subject risks should be included.
Include a timeline for subject participation in the project. Identify how subject confidentiality
will be safeguarded (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.
Methods will vary with the research approach used (qualitative, quantitative). The selected
methods should be sufficiently described to justify the use of the approach for answering the
defined research question. Methods should also be described in adequate detail so that IRB
members may assess the potential study risks and benefits.
e) Internal Validity
Threats to internal / external validity should be considered. Describe measures that have been
taken to avoid study bias.
f) Data Analysis
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. For qualitative data, specify the proposed analytic approaches.
4. Bibliography
Include a reference list of literature cited to support the protocol statement.