Irb Research Proposal Format Form printable pdf download

INSTRUCTIONS FOR

THE IRB RESEARCH PROPOSAL FORMAT

The IRB protocol is the formal design or plan for the proposed experiment or research activity. A protocol is a

document that describes the parameters of a research experiment in specific detail. The protocol includes a

description of the research design or methodology to be employed, the eligibility requirements for prospective

subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the

collected data. The information provided must be descriptive enough to facilitate the understanding of a reviewer

without leaving too many unanswered questions.

Note: A well-designed research study seeks to protect the rights of a human subject.

The following format is required for submission of an IRB proposal. Insert your title where indicated. Please

replace the bulleted information provided under each heading with your research information.

Please Delete All Information Above This Line. This information should not appear on the proposal you are

submitting for review.

Insert Your Research Proposal Title Here

RESEARCH OBJECTIVES:

Provide background data that supports the objectives of the protocol.

Provide a brief description of the theoretical and empirical goals of this research project.

Describe the purpose of this research project. The research objectives should be directed

toward the involvement and benefits towards the research subject(s) not the overall goals

of the project.

SUBJECT RECRUITMENT:

Information: Recruitment refers to the contact and the communication that takes place between

the investigator and a potential participant. Recruitment occurs prior to the introduction of the

consent process. Recruitment methods include but are not limited to verbal exchanges and

advertisement. Recruitment processes should avoid the appearance of coercion or undue

influence.

Include estimated number and description of types of subjects (e.g., normal volunteers,

pregnant women, students), age and sex.

Describe the source of potential subjects (e.g., referral sources).

Describe where and how potential subjects will be contacted, and what information they

will be given about the study prior to obtaining consent.

Provide eligibility criteria (inclusion and exclusion criteria). Exclusion of a population

should be justified.

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Proposal Format

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Irb Research Proposal Format Form