Create your IRB submission as a single document made up of: [a] this completed cover page, followed by [b] the text of
your IRB protocol, and [c] all research materials such as surveys, interview guides, consent forms, and permission letters.
Submit this document [faculty only via Firefox] to the GRASP Office via the link found here:
http://www.csub.edu/grasp/IRBHSR/IRB%20html/ProtHumSub.htm.
“Human
Subjects Protocol” Cover Page
Title of Project:
Responsible Investigator (Faculty Research Mentor if Student Research)
Name:
E-Mail:
Department or Program:
Name:
Department Chair or Program
Director
Name:
Student
Researcher
E-Mail:
E-Mail:
Requested Level of
Review: Expedited
Exemption from Full Review
Standard
Describe how human subjects will be involved in the proposed research:
This Section for GRaSP Office Use
Responsible Investigator has affirmed accuracy and truth [check]
Date
Department Chair has acknowledged submission [check]
Date
Assigned Level of Review:
Standard
Expedited
Exemption from Full Review
"Human Subjects Protocol" Instructions (revised June 2012)
Use the following underlined headings as an outline. Provide the information requested under each heading to
describe your proposed research. The IRB conducts a cost/benefit analysis. The potential costs to subjects are
weighed against the potential benefits of the research. Therefore, the content of the "Purpose" section is
important.
I.
Title (of the proposed research activity)
II.
Professional Qualifications (to do the proposed research), including a description of any necessary
support services, facilities, and equipment. A vita (optional) should be limited to qualifications applicable to
the proposed research.
III. Sponsor if the research is grant-supported or contract research.
IV. Purpose of the proposed research, in the context of a summary of previous research, with an explicit
statement of what is and is not known about the topic. Indicate what the proposed research could add,
stated as benefits to be gained by the discipline and by the subjects.
V.
Methods of the proposed research activity, including appropriateness of the design. Refer to the content of
Section 4 as needed for clarification.
VI. Procedures to be used, focusing on the experiences of the subjects in the research.
VII. Information Security with respect to collection, handling, storage, reporting, and destruction of research
data and consent forms. Describe specific steps that will be taken to enhance confidentiality and protect the
privacy of the participants.
VIII. Subjects
a. Subject Selection Criteria for participation
b. Subject Exclusion Criteria from participation and justification
c. Vulnerable Populations justifying use of subjects such as children, pregnant women, ethnic minorities,
prisoners, mentally disabled persons, economically or educationally disadvantaged persons, students
in the classroom, or employees in their workplace.
d. Risks to Subjects including psychological harm and possible breaches of confidentiality. Explain
precautions taken to minimize risk.
e. Managing Adverse Reactions physical or emotional, of subjects due to participation, and how they will
be dealt with
IX. Informed Consent (see online examples of consent forms and consent procedures)
a. Circumstances Surrounding the Process including:
Recruitment of subjects, environment or setting, time frame, condition of prospective subjects, primary
language of prospective subjects, autonomy of prospective subjects
b. Elements of Informed Consent included in the procedure used, in accord with Paragraph 46.116 of the
Code
c. Informed Consent Documented in written form in accord with Paragraph 47.117 of the Code