WORCESTER STATE UNIVERSITY
HUMAN SUBJECTS REVIEW BOARD (HSRB)
APPLICATION FOR EXEMPT STATUS
FOR RESEARCH INVOLVING HUMAN PARTICIPANTS
Cover Page and Instructions
This application covers exempt status research protocols as well as modifications and
continuations for studies previously granted exempt status – researchers seeking expedited or
full review of research protocols will need the separate application designed for that purpose. If
you are unsure, consult the HSRB Instructions Packet, which is available for download. In
addition to meeting Federal guidelines for exempt statues (provided below), Worcester State
University (WSU) policy states that research involving NO RISK is eligible for exempt status.
Studies involving minimal risk or greater must apply for expedited or full review by using the
appropriate application. Worcester State University (WSU) regards faculty supervisors of
student projects as Principle Investigators who are responsible for the research conducted under
their supervision. All student research is required to have such supervision. In order to be sure
your application is processed efficiently, please be sure to follow the instructions below.
1. Double-check that you are using the correct application as there are separate forms for both
types of exempt status applications, versus the application for expedited and full
reviews.
2. Type directly into the necessary fields of application (the first page, below). Do not submit
a separate document in lieu of this application.
3. Attach all ethics certificates, any relevant documentation of permission to recruit,
instruments/surveys or study materials, advertisements, and project description materials
as PDF or Word files
4. Email your application to hrsb@worcester.edu
5. Be sure to print one hard copy of the application and all attachments and sign it using
BLUE ink. Make sure the printed version matches the online version exactly.
6. Send the hard copy, signed in BLUE ink, to the HSRB Coordinator, Denise Thomas, in the
WSU Academic Affairs Office.
If you have any questions, please contact the HSRB Chair, Andrea R. Bilics, at
abilics@worcester.edu.
1
WORCESTER STATE UNIVERSITY HUMAN SUBJECTS REVIEW BOARD (HSRB)
APPLICATION FOR APPROVAL OF RESEARCH INVOLVING HUMAN PARTICIPANTS
Please type into the form. Do not use shaded areas.
TYPE OF REVIEW: Check only one. Refer to instructions packet or the HSRB Charter for definitions of each
New: Project # __________________
(do not write in above space)
Continuation: Project # _____________
(do not write in above space)
___ Exempt from review
To complete your submission: 1) Upload
your completed application to IRBnet.org.,
and 2) Print one additional paper copy of
the application plus all attachments, signed
in blue ink, and submit it to the HSRB
Coordinator .
___ No modifications
___ Modified (provide explanation)
(Only two continuations will be granted,
then a new application must be submitted)
Action Taken:
(do not write in this box)
____ Disapproved
____ Approved from dates
_______________ to
_______________
Chair:___________________
1. PROJECT TITLE:
2. INVESTIGATOR:
(name, department, campus office address, telephone):
If student investigator, provide faculty supervisor’s name,
department, campus office address, and telephone:
____ check here if student investigator
3. FUNDING SOURCE: Include grant or contract numbers for all current funding and any pending applications
for funding.
4. DATES APPROVAL REQUESTED
(maximum of one year from the present date)
From: __________________ to _______________
5a. PROJECT DESCRIPTION: Complete the application pages provided here to complete your project description.
5b. SPECIAL CONSIDERATIONS: On page two of this form, check off any special considerations that apply to the
proposed project.
SIGNATURE OF INVESTIGATOR:
Date _____
SIGNATURE OF FACULTY ADVISOR :
Date____
3
What Makes a Study Exempt – Federal Guidelines
Title 45, Part 46, Protection of Human Subjects. See the full DHHS Office of Human Research
Protections document, here: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
§46.101: To what does this policy apply?
(b) Unless otherwise required1, research activities in which the only involvement of human subjects
will be in one or more of the following categories are exempt from this policy:
(1) Research conducted in established or commonly accepted educational settings, involving normal
educational practices, such as (i) research on regular and special education instruction strategies, or (ii)
research on the effectiveness of instruction techniques, curricula, or classroom management methods.
(2) Research involving educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures or observation of public behavior, unless (i) information obtained is
recorded in such a manner that human subjects can be identified, directly or through identifiers linked
to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could
reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects'
financial standing, employability, or reputation.
(3) Research involving educational tests (cognitive, diagnostic, aptitude, achievement), survey or
interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of
this section, if (i) the human subjects are elected or appointed public officials or candidates for public
office; or (ii) federal statute(s) require(s) without exception that confidentiality will be maintained.
(4) Research involving the collection or study of existing data, records, specimens, specimens, if
these sources are publicly available or if the information is recorded by the investigator such that
participants cannot be identified.
(5) Research conducted by or subject to the approval of department or agency heads, and which are
designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii)
procedures for obtaining benefits or services under those programs; (iii) possible changes in or
alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment
for benefits or services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods
without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below
the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or
below the level found to be safe, by the FDA or approved by the EPA or the Food Safety and
Inspection Service of the U.S. Department of Agriculture.
(c) Department or agency heads have final judgment of whether a particular study is covered by this
policy.
1
These exemptions do not apply to research involving prisoners, subpart C. The exemption for research involving survey
or interview procedures or observation of public behavior does not apply to research with children, subpart D, except for
research involving observations of public behavior when the investigator(s) do not participate in the activities being
observed.
4
5a. PROJECT DESCRIPTION: Attach a PDF or Word document that provides a complete project
description. Please use clear, layperson language at the 8th grade level to address the following:
1. Overview of the study
a. Brief literature review – scientific significance of the study, 3-5 references
b. Study design
c. Goal/Purpose
d. Research questions and hypotheses
2. Participants
a. Types of people to be recruited, including permission to recruit
a) Inclusion/exclusion criteria
b. How participants will be recruited, including documentation of permission to conduct
research at sites other than WSU, copies of all advertisements, posters, sign-up sheets,
etc.
3. Instruments and Materials
a. Instruments
a) Copies of instruments or surveys
b) Title, authors, description, validity, and reliability
c) Reference, if published
d) Permission for use or evidence of reasonable effort to obtain such permission
b. Materials
a) Copies of visual or audio material
b) Description of purpose
c) Reference/Source
d) Permission for use or evidence of reasonable effort to obtain such permission
4. Procedures
a. Details on all procedures with which human participants are involved
5. How participants’ confidentiality will be maintained
6. Potential risks and benefits to participants
a. Benefits
b. Risks – note: WSU policy states that research involving NO RISK is eligible for exempt
status. Studies involving minimal risk or greater must apply for expedited or full review
by using the appropriate application.
Make sure you provide:
 Copies of all interviews, surveys, questionnaires, advertisements etc.
 Documentation of human participants ethics training for all researchers, including any faculty
supervisors.
 Documentation of written permission to conduct study in an organization off campus;
documentation of written permission to recruit participants.
5