Faculty Handbook

Human Subjects Research Review Form (Hum-1)

Proposal #
___________


WESTERN CONNECTICUT STATE UNIVERSITY
Human Subjects Research Review Form (Hum-1)


Information
Principal Investigator(s) _______________________________________
_______________________________________________________________
If the PI is a student, Faculty Supervisor: ______________________________
Project Title: ____________________________________________________
_______________________________________________________________
Department _____________________________________________________
Address (Where the reviewed application should be sent):
_______________________________________________________________
_______________________________________________________________
E-mail __________________________________
Phone number: ___________________________
Is this grant funded? YES NO If yes, Grant agency: ________________


I. Purpose of IRB Review


The role of the WCSU Institutional Review Board (IRB) is to review and to approve,
when in compliance, all proposed research at WCSU or by WCSU faculty, staff or
students to ensure that the research meets Federal standards for the safety and
protection of any human subjects involved in the research.


The WCSU IRB operates in compliance with the U.S. Code of Federal Regulations,
Department of Health and Human Services (DHHS) Title 45 Part 46, entitled,
“Protection of Human Subjects.” A link to the DHHS regulations may be found on the
WCSU IRB website. WestConn’s IRB is registered with the Office of Human
Research Protections (OHRP) and has an approved assurance from OHRP (Federalwide
Assurance or FWA).


The IRB is responsible for determining that:
 The rights and welfare of the subjects are adequately protected
 The risks to subjects are outweighed by the potential benefits of the research
 The selection of subjects is equitable
 Informed consent will be obtained and, when appropriate, documented



To help the IRB fulfill its role, WCSU requires all researchers to submit their
research protocol for review and approval. All applications must include the
completed HUM-1. The human subjects research application you submit must
describe the research activity, including a protocol, and especially the plan for ensuring
the protection of human subjects (please refer to the Research Application Guide for
complete instructions).


The WCSU IRB is unlikely to reject an application without first discussing its concerns
about the research with the investigator. However, applications may be deferred for
review at another meeting if substantial issues need to be resolved. Researchers are
encouraged to attend the regularly scheduled IRB meetings at which their application
will be considered in order to address any concerns directly. You will be informed of
the IRB’s decision regarding your application as expeditiously as possible. Failure to
submit applications for review by the published deadlines may result in a delay in the
review process. It is required that researchers ensure that their application is submitted
by the first of the month in which the next IRB meeting is scheduled.


II. Application for IRB Review Checklist
Before submitting your research application for review by the IRB, please make sure
the following steps have been completed.


1. Ensure that everyone involved in the research has completed WCSU IRB human
subjects research training requirements (including researcher, student’s instructor,
research assistants and department chair). If you have any questions concerning
whom should complete human subjects research training, please contact the Office
of Grants and Research for guidance.


Attach human subjects research training certificates for all such research personnel
to your application.


WCSU is part of the Collaborative Institutional Training Initiative (CITI)
program. You can sign up for and complete CITI human subjects training via the
link on the WCSU IRB website http://www.wcsu.edu/irb/
Information about this training is provided in the Frequently Asked Questions link
on the IRB website.


2. Indicate the category under which you believe your study should be reviewed.
There are three choices. See the WCSU IRB Guidelines for Researchers (pages
6-11) to determine the requirements for each category.
Is this a new research project? YES NO
If so, are you applying for?
______ Exempt Review
______ Expedited Review
______ Full Review



Is this research a Continuation of previously reviewed research? YES NO
Is this research a Modification of previously reviewed research? YES NO


3. Submit a Research Application (see the WCSU IRB Research Application
Guide).


4. Attach to your application any survey or questionnaire instruments that will be
given to subjects, or any protocols describing assessments to which they will be
subjected. When an instrument must be purchased or is not yet available, you may
describe the instrument in lieu of attaching a copy.
**Note: You must cite the source for any instruments you are using if they have
been developed by others.


5. Attach your Informed Consent Form, or an explanation of why the signed Informed
Consent requirement can be waived (see the WCSU IRB Informed Consent
Guidelines
).


III. Signatures

The principal investigator must sign this form.  If the P.I. is a student, his/her faculty supervisor must also sign.


Assurance of continued compliance with regulations regarding the use of human
subjects.


I certify that the information provided in this application is accurate. If the procedures for
obtaining consent of subjects change, or if the risk of physical, psychological, or social
injury to the research subjects increases, or if there should arise unanticipated problems
involving risk to subjects or others, I shall promptly report such changes to the
Institutional Review Board. I shall report promptly any unanticipated injury to or harm of
a subject to my Department Chair and to the Institutional Review Board.


Principal Investigator’s Name_____________________________


Principal Investigator's Signature __________________________ Date ___________


Faculty Supervisor’s ____________________________________ Date ___________
Name and Department
Faculty Supervisor's Signature ___________________________ Date ___________

(if PI is a student)

------------------------------------------------------------------------------------------------------------------------------------------------------------

Committee Action:


__ Approved through exempt review
__ Approved by full committee review
__ Approved through expedited review
__ Not approved; clarification/modification required

IRB Chair's Signature_____________________________ Date ___________

Rev. 6/10




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