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How To Create A Research Protocol: (This Information Is Adapted From)

The document provides guidance on how to create an effective research protocol for Institutional Review Board review. An effective protocol includes: (1) clearly stating the study objectives and research questions/hypotheses; (2) providing background and justification for the study by summarizing previous relevant research; (3) detailing the study procedures including research design, sampling, measurements, timeline, ensuring confidentiality, and addressing internal/external validity threats. The protocol should also specify the planned data analysis techniques.

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91 views2 pages

How To Create A Research Protocol: (This Information Is Adapted From)

The document provides guidance on how to create an effective research protocol for Institutional Review Board review. An effective protocol includes: (1) clearly stating the study objectives and research questions/hypotheses; (2) providing background and justification for the study by summarizing previous relevant research; (3) detailing the study procedures including research design, sampling, measurements, timeline, ensuring confidentiality, and addressing internal/external validity threats. The protocol should also specify the planned data analysis techniques.

Uploaded by

Lord Emerson Reyes
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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How to Create a Research Protocol

(This information is adapted from The Ohio State University IRB)


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.

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