HUMAN SUBJECTS
REVIEW COMMITTEE
(HSRC)
PROTOCOL
EXEMPTION FORM
WILMINGTON UNIVERSITY
HUMAN SUBJECTS REVIEW COMMITTEE (HSRC)
HSRC-2
Table of Contents
HSRC Protocol Exemption Form Completion Overview ........................................................... 3
HSRC Protocol Exemption Form Use Parameters ..................................................................... 4
Academic Level .......................................................................................................................... 5
Forms Check List ........................................................................................................................ 5
RECORD AND REVIEW OF RESEARCH PROTOCOL ...................................................... 6
Contact Information .................................................................................................................... 6
Exemption Category ................................................................................................................... 6
Project Information ..................................................................................................................... 6
External Research ....................................................................................................................... 7
Research Protocol ....................................................................................................................... 8
Obligations of Principal Investigator .......................................................................................... 9
PROTOCOL REVIEW .............................................................................................................. 10
WILMINGTON UNIVERSITY
HUMAN SUBJECTS REVIEW COMMITTEE (HSRC)
HSRC-3
HSRC Protocol Exemption Form Completion Overview
The information and question responses provided by the person or persons submitting this form
must be accurate and complete. Be sure to review the Protection of Human Subjects Policies and
Procedures document on the University’s webpage for additional information
(http://www.wilmu.edu/academics/humansubjects/materials.aspx) prior to submitting this
document.
This document is set up as a fill-in form. Your mouse pointer and a “left click” will select fields
within the document or you can press the “tab” key to advance the cursor between fields in the
form. All fields requiring lengthy responses (paragraphs v. sentences) will automatically expand
to accept your information along with adjusting the document pagination. Please note
information can be copied (cut and pasted) into any field of the document and the instructions
shown in red text will not appear on printed pages.
Information added to this form must be typed, with the exception of signatures. Typed
signatures are not acceptable. In addition, the information should be thoroughly reviewed for
correct grammar, spelling, and punctuation prior to submitting the document to the Human
Subjects Review Committee.
Researchers using one or more instruments (e.g., survey, questionnaire, interview, test,
experiment, observation, discussion, etc.) to collect data for the purpose of measuring variables
must submit each instrument to the HSRC for review as part of their HSRC Protocol packet.
Data cannot be collected prior to the HSRC’s review and approval of the HSRC Protocol packet.
WILMINGTON UNIVERSITY
HUMAN SUBJECTS REVIEW COMMITTEE (HSRC)
HSRC-4
HSRC Protocol Exemption Form Use Parameters
All research using this HSRC Protocol Exemption Form and submitted to the University’s HSRC
for review must conform to the U.S. Department of Human Services, Office for Human Research
Protections (OHRP) Exempt Categories 45 CFR 46.101(B) - (HRP-312) found at
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.101. The
list below is a synopsis of the exempt categories. Research not conforming to one or more of the
exempt categories cannot use this HSRC Protocol Exemption Form.
1. Research conducted in established or commonly accepted educational settings, involving
normal educational practices, such as (i) research on regular and special education
instructional strategies, or (ii) research on the effectiveness of or the comparison among
instructional techniques, curricula, or classroom management methods.
2. Research involving the use of 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 the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public behavior
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 the confidentiality
of the personally identifiable information will be maintained throughout the research and
thereafter.
4. Research involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if these sources are publicly available
or if the information is recorded by the investigator in such a manner that subjects cannot
be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are 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 Food and Drug
Administration or approved by the Environmental Protection Agency or the Food Safety
and Inspection Service of the U.S. Department of Agriculture.
WILMINGTON UNIVERSITY
HUMAN SUBJECTS REVIEW COMMITTEE (HSRC)
Academic Level
☐
1. Doctoral Dissertation/Capstone
☐
2. Master’s Thesis/Capstone
☐
3. Undergraduate
☐
4. Faculty
☐
5. Other
Forms Check List
Assemble materials in the order shown below
☐
1. Human Subjects Protocol
☐
2. Human Subject Certificate
☐
3. Instrument(s)
☐
4. Other
HSRC-5
WILMINGTON UNIVERSITY
HUMAN SUBJECTS REVIEW COMMITTEE (HSRC)
HSRC-6
RECORD AND REVIEW OF RESEARCH PROTOCOL
Contact Information (Type or print the information into the appropriate areas)
Principal Investigator:
(Last)
(First)
(Middle)
Student ID: W
Exemption Category
Select your OHRP research exemption category as defined on page 4 of this document:
☐ Exemption Category 1
☐ Exemption Category 2
☐ Exemption Category 3
☐ Exemption Category 4
☐ Exemption Category 5
☐ Exemption Category 6
Instructor or assigned faculty sponsor:
Project Information
Title of study (12 to 15 words max):
Research purpose or issue:
WILMINGTON UNIVERSITY
HUMAN SUBJECTS REVIEW COMMITTEE (HSRC)
HSRC-7
External Research
If the research will involve other organizations, it is necessary to obtain permission from these
organizations prior to collecting data. Some organizations have Institutional Review Boards
(IRBs), and it may be necessary to obtain formal approvals from these IRBs. In other cases, a
document from an appropriate organizational executive specifically approving the research
would be sufficient. The researcher is responsible for determining what type of approval is
required and obtaining the approval.
In cases where approval from Wilmington University’s HSRC is required as a precondition to
obtaining approval from another organization, the HRSC’s approval will be provisional,
requiring the additional step of obtaining research approval documents from other organizations
before receiving full approval from Wilmington University’s HSRC.
If the research involves other organizations, please fill out this section.
YES
NO
☐
☐
Do these organizations require approval by their IRBs?
☐
☐
Has IRB approval been obtained? If YES, please attach the approval to this
submission
☐
☐
Have other permission documents been obtained? If YES, please attach the
approvals to this submission.
Other relevant information or comments:
WILMINGTON UNIVERSITY
HUMAN SUBJECTS REVIEW COMMITTEE (HSRC)
HSRC-8
Research Protocol Please answer yes or no to all questions below.
Does this research involve:
YES
NO
☐ ☐
prisoners, probationers, pregnant women (if there is a medical procedure or
special risk relating to pregnancy), fetuses, the seriously ill or mentally
or cognitively compromised adults, or minors (under 18 yrs) as participants
☐ ☐
the collection of information regarding sensitive aspects of the participants
behavior (e.g., drug, or alcohol use, illegal conduct, sexual behavior)
☐ ☐
the collection or recording of behavior which, if known outside the research,
could place the participants at risk of criminal or civil liability or could be
damaging to the participant’s financial standing, employability, insurability, or
reputation
☐ ☐
procedures to be employed that present more than minimal risk1 to
participants
☐ ☐
deception or coercion
☐ ☐
benefits or compensation to participants (beyond the general benefits of the
knowledge to be gained or small gifts/lottery prizes)
☐ ☐
a conflict of interest (e.g., teacher/student, employer/employee; could there be
perceived coercion to participate; is there any financial interest in this research)
If you selected “YES” for any of the questions above, you cannot use this HSRC Protocol
Exemption Form.
1
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the proposed research
are not greater than those ordinarily encountered in everyday life or during the performance of routine physical or
psychological examinations or tests
WILMINGTON UNIVERSITY
HUMAN SUBJECTS REVIEW COMMITTEE (HSRC)
HSRC-9
Obligations of Principal Investigator:
Any substantive changes made to the research protocol must be reported to college
representatives of the HSRC for review prior to implementation of such change. Any
complications, adverse reactions, or changes in the original estimates of risks must be reported at
once to the HRSC chairperson before continuing the project.
I have read and understand my obligations as an investigator and certify that the information
contained in this document is accurate and complete.
Print name:
Signature:
Date:
Instructor or Assigned Faculty Sponsor:
Print name:
Signature:
Date:
WILMINGTON UNIVERSITY
HUMAN SUBJECTS REVIEW COMMITTEE (HSRC)
HSRC-10
PROTOCOL REVIEW
This section must be completed by a Human Subjects Review Committee Member.
Principal Investigator:
Date Submitted:
The protocol and attachments were reviewed:
The proposed research is approved as:
☐
Exempt
The proposed research was disapproved:
☐ See email and/or attached letter for more information.
HSRC Chair
or Representative
Printed Name
Signature
Date