2011/2012
INSTITUTIONAL REVIEW BOARD
Exemption application for research with human participants
This form is to be completed if you are conducting a research project involving human
participants, and you think the project is exempt from federal regulations (please see IRB
Application Instructions and carefully follow the directions). All forms must be completed in
full to be reviewed by the IRB. You may not begin your research until you gain full IRB
approval.
Principal Investigator:
Department:
Address:
Phone Number:
Email:
Faculty Sponsor*:
Phone Number:
Department:
Email:
Address:
*All applications from individuals who are not Providence College faculty or staff must include a faculty
sponsor. By sponsoring a project the sponsoring faculty member is endorsing the project.
Other individuals involved in the project*:
Project Title:
Type of Project:
Faculty/Staff Research
Student Research
Independent Study
Course Requirement
Duration of Project:
Other (
(course #:
)
)
Desired Starting Date:
Expected End Date:
I certify that to the best of my knowledge the information presented herein is an accurate reflection of the
proposed research project. I accept the responsibility for the conduct of this research, the supervision of human
subjects and maintenance of informed consent documentation as required by the IRB. I certify that the research
procedures for this project and the method of obtaining consent (if any), as approved by the IRB, will be
followed during the period covered by this research. Any future changes will be submitted for Board review
and approval prior to implementation.
Principal Investigator
Date
Faculty Sponsor (If PI is not
PC faculty or staff)
Date
***********************************************************************************
Study deemed exempt
Study deemed exempt with contingencies
(see attached comments)
Not exempt (see attached comments)
______
Chairperson, IRB
Date
2
Exemption claimed:
1. The research will be 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. The research involves 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. The research involves the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behavior that is
not exempt under paragraph (2) of this section, and:
(i) the human subjects are elected or appointed public officials or candidates for public
office.
4. The research involves the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, and these sources are publicly available or the
information is recorded by the investigator in a manner such that subjects cannot be identified,
directly or through identifiers linked to the subjects.
3
Application for Review
The following information will allow the IRB to determine whether or not your research is consistent
with the exemption claimed.
A. Project Description
Provide a brief, non-technical description of the background, significance, and purpose of your study
(Make sure the following information is included: hypothesis or purpose statement, description of all
variables, how data will be analyzed, and the importance of the research). If the research is to be
conducted as part of an on-going student research course, please provide a general description of a
typical student project.
B. Participants (include all materials related to participant selection in Appendix B – e.g.,
advertisements, contact letters)
Provide a brief description of the following:
 Participant selection criteria (who is eligible/ineligible?)
 Target sample size and sample characteristics
 Recruitment strategy (how will you contact potential participants?).
C. Consent procedure (include all materials related to the consent procedure in Appendix C – e.g.,
written consent form, oral consent script)
Exempt research must be minimal risk, meaning that the risk of harm or discomfort from participating in
the research does not exceed the risk ordinarily encountered in daily life. Minimal risk research does not
require written documentation of informed consent. However, it is typically good practice to provide
participants with an explanation of the purpose of the research, a description of the procedures to be
followed, and the expected duration of the participation. In addition, participants should be provided
with a statement that participation is voluntary, and refusal or discontinuation will involve no penalty or
loss. Finally participants must be provided with contact information for the investigator and the
Providence College IRB. A consent template is provided on the PC IRB website.
Describe your consent procedure, or provide your rationale for not obtaining informed consent.
D. Data collection procedure and data management (attach all study materials and stimuli as
Appendix D)
a. Describe everything the participant will do and experience. Will participants be audio and/or
videotaped, photographed? If the research is to be conducted as part of an on-going student research
course, describe the procedure for a typical student project.
b. Describe data management procedures including what happens to the data that has been collected,
who has access to the data, where will it be stored, and how will it be secured.
E. Appendices
Cut and paste the following Appendices into this document:
Appendix A – certificate of on-line tutorial completion
Appendix B – participant recruitment materials
Appendix C – consent materials (if any)
Appendix D – study materials (e.g., surveys, interview questions, stimulus materials)
Please feel free to submit any questions or constructive comments about this form to the IRB chair at
IRB@providence.edu.