Investigator Checklist
Student Applicants:
Undergraduate and Master’s students first submit this application to your department/college review
committee, if your department has such a committee. See Student Investigator page for a list of
committees.
 Communicate with your advisor regarding submission procedures for departmental review. The
submission procedures described below are for University IRB submission ONLY.
If research is determined to be non-exempt by your Departmental/College Research Review Committee,
students must have their Committee sign this application prior to University IRB submission. See the Student
Investigator page for more information.
All Applicants:
After July 1, 2015, training will be required before new application submissions are reviewed. Please see our
Training & Education page for learner group courses and links. Training must have been completed within the
last three years from the date of this application’s submission to be valid.
Applications must be typed. Handwritten application will not be accepted. Use of jargon and acronyms will
hold-up the review process.
Evaluation of risks in your research should consider all possible risks associated with your research. See FAQ’s
for description of risks and safeguards.
You must attach your informed consent form, all data collection tools, interview questions, and/or
recruitment flyers/emails.
o Informed consent forms must disclose the same risks and benefits as listed in your application.
 Disclosing all possible risks to participants ensures you, the researcher, and Sacramento State,
have complied with the Belmont Principle of Respect for Persons so your participants may
make an educated decision whether to participate or not.
Please be aware of copyright issues when using other’s materials. Visit the copyright resources webpage for
more information.
University IRB Submission (these are not submission procedures for departmental review of student research. See
Student Applicants above for directions):
One hardcopy with original signatures must be submitted to the Office of Research Affairs, Bookstore suite
3400*.
*Please note that exempt and expedited research can be submitted at any time and will be reviewed on a first come,
first serve basis outside of IRB meetings. Research posing greater than minimal risk must be reviewed at IRB meetings
and will need to be submitted by the deadlines posted on the Review Categories & Timeline page.
Questions regarding application procedures may be directed to:
Leah Vargas
Human Subjects Website:
leah.vargas@csus.edu
http://www.csus.edu/research/irb/
Office of Research Affairs
Research Integrity and Compliance Analyst
Bookstore suite 3400
(916) 278-5674
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Institutional Review Board (IRB)
FWA00003873
Protocol #: 15-16Office Use Only
2015-2016 Human Subjects Research Application
See appropriate signature page for submission requirements
A. Investigator Information
Principal Investigator*:
Email:
College/School:
Department:
Status:
Faculty
Staff
Doctoral Candidate
Undergrad or Master’s Student
(submit this application to your
departmental review committee first)
(Tip: to check boxes, double click over box and select “checked”)
Student’s Advisor:
Advisor’s email:
Co-Investigators and/or all
other personnel involved in
data collection/analysis*:
Training completed within
the last three years?
Please attach certificate or
report to this application.
Yes
No
Training is required; applications will not be reviewed until completed.
See Training & Education page for appropriate Learner Group course.
B. Project Information
Project Title:
Anticipated Start Date (see
review timeline and set
date accordingly):
Duration of Study:
Review Category (see
review categories for
assistance):
Are you receiving external
funding to conduct this
research?
Are other
institutions/organizations
involved?
Funded
Unfunded
Pending
Agency:
Six-digit account #:
(please ask your SRO if you are unsure)
Project Title (if different from IRB title):
No
Yes: List name of institution/organization:
Sacramento State affiliates whose off-site collaborators already obtained IRB approval
from another institution should use the Cooperative Research Agreement.
Off-site investigators please do not complete this form and forward your IRB approval
letter to irb@csus.edu for verification of your home institution’s IRB review.
Office of Research Affairs | Hornet Bookstore, Suite 3400 | 6000 J St. | Sacramento, CA 95819-6111
Phone: 916-278-5674 | Email: irb@csus.edu | Web: http://www.csus.edu/research/irb/
C. Project Overview
I.
Purpose and Objectives of the Research
Please write this application in a way someone outside your field of study can understand. Refrain from using jargon and
acronyms throughout this application.
II.
Main Research Question or Study Hypotheses
III.
Development of or Contribution to Generalizable Knowledge
Generalizable knowledge means conclusions, facts, or principles derived from particulars (individual subjects, medical records, etc.) that are
applicable to or affect a whole category (members of a class, kind, or group, a field of knowledge, etc.) and enhance scientific or academic
understanding. If your intent is not to contribute to generalizable knowledge, this may not be research according to the federal definition.
IV.
Study Design/Methodology
Please describe the study design and methodology for the entire project.
D. Subject Population
I. Who are the subject groups?
II. How are they recruited?
(include copy of flyer or email if
advertising for subjects)
III. Maximum enrollment:
IV. Criteria for selection*:
V. Criteria for exclusion*:
*Attach participant screening form for inclusion/exclusion, if applicable.
VI. Will any special population be
included?
Children (under 18)
n/a
VII. Is an incentive offered?
No
Yes, describe:
Prisoners
Pregnant women, fetuses,
neonates
VIII. How will real or perceived
conflicts of interest as a
researcher be avoided?
(e.g. role, power relationships,
monetary)
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E. Participant Experience
IX. From the Participant’s Perspective (boxes expand, please include all necessary information):
a) How long will participation take?
b) Where will the study be conducted and why?
c) Who is involved in the data collection? Did all of
those involved complete the training
requirement?
d) From the participant’s perspective, describe
what their participation entails beginning with
the informed consent process through
completion of participation.
e) Other important information regarding
participation in your study (approvals from
cooperating entities; alternatives to research
activity if they decline participation; etc.).
F. Data Collection
I. How will data be collected (notebook, computer files, audio tapes, online or paper surveys and questionnaires,
etc.)? Attach all collection tools to the back of the application.
a) If paper based, describe how data collection tools and informed consent forms will be collected, and by whom if
different from the Investigator. Consider how to protect anonymity of participants during the collection
process.
b) If using online surveys, which program will you use?
Select Survey/ Class Climate/ Snap Survey
Survey Monkey
Qualtrics
Other:
If Other, I ensure this site is secure (https) and the IP address will be masked.
II. Will direct or indirect identifiers be collected (i.e. name, age, address, ethnicity, profession, other demographic
information)?
Yes  If yes, is it likely that identification of one or more subjects is possible based on the identifiers and other
No
demographic information collected and the size of your maximum enrollment?
No
Yes  Keep this in mind while completing Section H. Benefits and Risks below.
III. Will medical records or other patient data be accessed?
Yes – include a copy of the HIPAA Authorization Guide if the questionnaire determines one is needed.
No
G. Data Storage and Security
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Consider the following: What data are needed to validate the research, what data directly support publications based on the
research, how long does data need to be retained and in what form (identified or de-identified), and what data have the greatest
potential for reuse by others?
If identifiers (direct and indirect information and/or
demographics which can be linked to an individual) are
collected, who will have access to the raw data and why?
How will you maintain (i.e. store, secure) raw data to
protect participants? How long will you maintain raw data?
When and how will identifiers be removed? What steps
will be taken to remove identifiers?
How long will you maintain de-identified data? How will it
be stored?
H. Benefits and Risks
I. Describe the benefits to the individual (if any) and to society:
II. Physical Risk (i.e., devices, drugs, pharmaceuticals, exercise)
Not applicable
Minimal
Greater than Minimal
a) Describe minimal or
greater than minimal risk:
b) Describe how this risk will
be addressed/minimized:
III. Psychological Risk (i.e., anxiety, stress, embarrassment)
Not applicable
Minimal
Greater than Minimal
a) Describe minimal or
greater than minimal risk:
b) Describe how this risk will
be addressed/minimized:
IV. Sociological and Economic Risk (i.e., employability, reputation, financial standing, criminal prosecution)
Not applicable
Minimal
Greater than Minimal
a) Describe minimal or
greater than minimal risk:
b) Describe how this risk will
be addressed/minimized:
V. Confidentiality Risk (i.e., collection of identifiable information, data safety and storage, potential access to data
from outside parties)
Not applicable
Minimal
Greater than Minimal
a) Describe minimal or
greater than minimal risk:
b) Describe how this risk will
be addressed/minimized:
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I. Informed Consent
I.
Procedure for obtaining informed consent from subjects (see guidance below):
Use a template based on your review category. Attach a copy of the informed consent form, email, or script.
II.
Indicate rationale for any special conditions relating to informed consent if study is not exempt (i.e., waiver of
documentation, waiver of consent, or any deviation from the informed consent form).
Guidance on Informed Consent:
Regulated Research – (Expedited and Full Board Review)
Regulated research must collect signatures of participants on an informed consent form unless sufficient justification is
provided for special conditions (i.e. online data collection, methodology, etc.). Informed consent forms must include
several components to meet regulatory requirements. Please use our informed consent form templates for Regulated
Research on the Forms & Procedures page, which include all the required components for your convenience.
Exempt Research
Exempt research must have an informed consent process, although there is flexibility as exempt research is not
governed by the regulatory requirements. Below are examples of various ways to respect participant autonomy:
 Use the Exempt Research informed consent form templates on the Forms & Procedures page.
o If identifiers will be collected, it is best to obtain signatures.
o If you are conducting anonymous paper or online surveys in which identifiers are not collected, alter the
informed consent form so signatures are not required. The collection of signatures in this case would be
the only identifiers, thus placing them at risk for loss of confidentiality. Informed Consent forms can be
kept by the participant as an information sheet and their participation serves as consent.
o In some cases, verbal informed consent is the best option, although this is rare. Use the Exempt
Research Template as a script and ask for a verbal “Yes” or “No” for participation. Scripts will also need
to be submitted with this application.
Remember: Informed consent forms are the only document your participant will see regarding your study. Respect your
participants by using common language and ensuring they have all the necessary information to make an informed
decision to participate or not participate. Please contact Leah Vargas (leah.vargas@csus.edu) with any questions.
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J. Faculty/ Staff/ Doctoral Candidate Investigator Signature Page
Submit one paper copy with signatures to the Office of Research Affairs, Bookstore suite 3400.
Investigator Agreement
In submitting this proposed project and signing below, I certify that:
1. I will conduct the research involving human subjects as presented in the protocol and approved by the academic
unit, faculty supervisor (if a doctoral candidate), and IRB;
2. I will present any proposed modifications in the research to the IRB for review prior to implementation;
3. All conflicts of interest between myself and any funding agencies have been resolved to the satisfaction of the
Office of Research Affairs, and,
4. I will report to the IRB any problems or injuries to subjects.
X___________________________________________________
Investigator Signature
Date
Dissertation Chair Agreement for Doctoral Candidate Investigators (N/A for faculty and staff)
I will supervise this student’s research project and hereby confirm the research complies with federal and University
policies regarding protection of human subjects.
X___________________________________________________
Dissertation Chair Signature
Date
Department Chair/Head Agreement
I confirm that I have had an opportunity to read this human subjects application and am aware of the research to be
conducted by the Investigator listed above.
X___________________________________________________
Chair/Dept. Head Signature (cannot be Investigator)
Date
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K. Undergraduate and Master’s Student Investigator Signature Page
Undergraduate and Master’s students first submit this application to your department/college review committee, if
your department has such a committee. See Student Investigator page for a list of committees. If you
department/college does not have a committee, submit to the Office of Research Affairs.
Investigator Agreement
In submitting this proposed project and signing below, I certify that:
1. I will conduct the research involving human subjects as presented in the protocol and approved by the academic
unit, faculty supervisor, and Committee/IRB;
2. I will present any proposed modifications in the research to the Committee/ IRB for review prior to
implementation;
3. I will report to the Committee/IRB any problems or injuries to subjects.
X___________________________________________________
Investigator Signature
Date
Faculty Advisor Agreement for Student Investigators
I will supervise this student’s research project and hereby confirm the research complies with federal and University
policies regarding protection of human subjects.
X___________________________________________________
Faculty Advisor Signature
Date
Research Review Committee (RRC) Determination
The Research Review Committee has reviewed this application and has determined one of the following:
Approval as exempt research (send Exemption Determination Form to leah.vargas@csus.edu).
Determination of research as non-exempt and advancement to the University IRB for further review.
____________________________________________________
Name of Committee Reviewer
X_______________________________________________
Signature of Committee Reviewer
E-mail address
Date
Chair/Dept. Head Agreement (only for students without a Committee)
I confirm that I have had an opportunity to read this human subjects application and am aware of the research to be
conducted by the Investigator listed above.
X___________________________________________________
Chair/Dept. Head Signature
Date
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