Investigator Checklist

Student Applicants:
Undergraduate and Masters 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
applications 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 FAQs 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 others 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:
[email protected] http://www.csus.edu/research/irb/
Office of Research Affairs
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Research Integrity and Compliance Analyst
Bookstore suite 3400
(916) 278-5674

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 Institutional Review Board (IRB)
FWA00003873

Protocol #: 15-16-
Office 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
Masters Student
(submit this application to your
departmental review committee
first)

(Tip: to check boxes, double click over box and select checked)
Students Advisor:
Advisors email:
Co-Investigators
and/or all other
personnel involved in
data
collection/analysis*:
Training completed Yes No
within the last three
years? Training is required; applications will not be reviewed until completed.
See Training & Education page for appropriate Learner Group course.
Please attach
certificate or report to
this application.

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 Funded Unfunded Pending
external funding to Agency:
conduct this research? Six-digit account #: (please ask your SRO if you are unsure)
Project Title (if different from IRB title):
Are other No Yes: List name of institution/organization:
institutions/organizati
ons involved? Sacramento State affiliates whose off-site collaborators already obtained
IRB approval from another institution should use the Cooperative
Office of Research Affairs | Hornet Bookstore, Suite 3400 | 6000 J St. | Sacramento, CA 95819-6111
Phone: 916-278-5674 | Email: [email protected] | Web: http://www.csus.edu/research/irb/
Research Agreement.

Off-site investigators please do not complete this form and forward your
IRB approval letter to [email protected] for verification of your home
institutions IRB review.

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 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.

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 VI. Will any special Children (under 18) Prisoners Pregnant
population be women, fetuses,
included? n/a
neonates
VII. Is an incentive offered? No
Yes, describe:

VIII. How will real or

perceived conflicts of
interest as a
researcher be avoided?
(e.g. role, power
relationships,
monetary)

E. Participant Experience
IX. From the Participants 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 participants 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.

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 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
No identifiers and other 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

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:

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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
:

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.

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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 ([email protected]) with any questions.

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 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

J. Faculty/ Staff/ Doctoral Candidate Investigator Signature Page

Submit one paper copy with signatures to the Office of Research Affairs, Bookstore suite
3400.

Dissertation Chair Agreement for Doctoral Candidate Investigators (N/A for faculty and
staff)
I will supervise this students 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 Masters Student Investigator Signature Page

Undergraduate and Masters 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 students 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 [email protected]).

Determination of research as non-exempt and advancement to the University IRB for further
review.

____________________________________________________
Name of Committee Reviewer E-mail address

X_______________________________________________
Signature of Committee Reviewer 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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