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Rowan University
Institutional Review Board
Instructions for Completing
the Human Research Review Application
Some of the following documents are provided in PDF format. You will need the free Acrobat Reader software at the Adobe Website.
Click for printable version: PDF Word
Checklist for Human Research
Review Application (Click for Word
version)
Sample Informed Consent Forms (Click
for Word version)
Do I need the permission of the Institutional Review
Board to conduct my research?
All research involving human participants conducted by Rowan University faculty and staff is subject to IRB review.
The Rowan University IRB defines "research" as a systematic investigation designed to develop or contribute to generalizable knowledge. All research involving human participants conducted by Rowan University faculty and staff is subject to IRB review.
Some, but not all, student-conducted studies that involve human participants are considered research and are subject to IRB review. Student research that is subject to IRB review includes research:
- Intended to satisfy the academic requirements for the Master's
Thesis/Project or Doctoral Dissertation;
- Intended or expected to result in publication, presentation
outside the classroom, or public dissemination in some other form;
- Conducted outside the classroom and/or departmental research
participant pool if they involve:
- minors (i.e., persons under the age of 18),
- a targeted population of adults whose ability to freely
give informed consent may be compromised (i.e., persons
who are socioeconomically, educationally, or linguistically
disadvantaged; cognitively impaired, elderly, terminally ill,
or incarcerated),
- pregnant women and/or fetuses who may be put at risk of
physical harm,
- a topic of a sensitive or personal nature, the examination
or reporting of which
may place the research participant at more than minimal risk,
or
- any type of activity that places research participants at
more than minimal risk.
Student-centered research that is conducted solely within the confines of the classroom or within a departmental research participant pool
and:
- is a general requirement of a course,
- has the sole purpose of developing the student's research skills,
and
- will be overseen by a faculty member;
may not be subject to IRB review. Check with your class instructor for guidance as to whether you must submit your research protocol
for IRB review. If you or your instructor have any doubts, apply for an IRB review.
If you need to apply for IRB approval, access the "Human Research Review Application" on the Compliance page. You can complete the form on-line or download and complete the form.
Note: The IRB will not accept handwritten submissions.
1. Complete the identifying information for your proposal, including:
- Project title
- Responsible Researcher (individual conducting the research)
- Any co-investigators
- Faculty sponsor (must have a sponsor if an undergraduate or
graduate student)
2. Determine if you believe your research is eligible for an exemption
from a full IRB review or for an expedited review. Check the category
under which you believe your research may be eligible for an exemption
or an expedited review.
Note: The IRB makes the final determination as to whether your research proposal is eligible for an exemption from full review
or for an expedited review.
3. Complete Questions 1-5:
Objective: Describe the objective/s of your research.
Design: Including research methodology, procedure, instruments.
Note: If you have developed your own research instrument or
made modifications to a published instrument, you must submit
it with your application. If you are using a published instrument,
include the complete citation for that instrument (author, publisher,
date of publication) and a brief description of the instrument
with your application.
Subjects: Describe the subjects, including the number to
be included, their age, gender, any special characteristics (e.g.
persons who are socioeconomically, educationally, or linguistically
disadvantaged, cognitively impaired, elderly, terminally ill,
or incarcerated), pregnant women and/or fetuses who may be put
at risk of physical harm.
Recruitment: Describe how subjects will be recruited.
Location: Describe where the research will be conducted
4. Include information about how you will elicit informed consent:
- Permission Letter: If your research is being conducted
at an institution other than Rowan (for example, a K-12 school,
a hospital, or a social service agency) you must attach a permission
letter from an administrator of that institution indicating that
you have permission to conduct that research.
If the research is being conducted at another university, a
signed copy of the IRB approval form from that university must
be attached to the Rowan IRB application form.
- Consent Form: Attach a copy of your consent form (see
examples in Appendix). The Consent Form must address the following:
1. A statement that the study involves research, an explanation
of the purposes of the research, and the expected duration of the
prospective participant's involvement in the study; a description
of procedures to be followed; and the identification of procedures
which are experimental;
2. A description of any reasonable foreseeable risks and/or discomforts
to the research participant;
3. A description of any benefits to the research participant or
to others which may reasonably be expected from the research;
4. A disclosure of appropriate alternative procedures or courses
of treatment (if any) that might be advantageous to the research
participant;
5. A statement describing the extent (if any) to which confidentiality
of research records identifying the research participant will be
maintained;
6. An explanation as to whether any compensation and/or medical
treatments are available if any injury occurs and, if so, what they
consist of, or where further information may be obtained;
7. An explanation of whom to contact for answers to pertinent questions
about the research and the research participant's rights, and whom
to contact in the event of a research-related injury to the participant;
8. A statement that participation is voluntary and that refusal
to participate will involve no penalty or loss of benefits to which
the research participant is otherwise entitled; and the research
participant may discontinue participation at any time without penalty
or loss of benefits to which he/she is otherwise entitled; and
9. A statement that the research participant will receive an executed
copy of the informed consent document.
In some cases you may not need a permission form. If the only
identifying link between the subject and your research procedure
would be the consent form, you may obtain consent simply by informing
the participant about your research project.
Example: You are conducting a survey and are not asking
for any identifying
information from participants. In this case, using a consent
form would require that the participants reveal their identity
by signing the form. As long as the survey did not put the participants
at more than minimal risk, the IRB may determine that a consent
form is not required.
If the IRB grants permission to use an alternative method to
obtain consent, you must state the following at the top of the
instrument you are using to collect data or on an accompanying
cover letter on department stationary:
- A statement that all participation is voluntary
- A statement that you are conducting research and the reason
for it (e.g., master's thesis, publication, etc.)
- Purpose of the research - what you are investigating
- A statement that all responses will be kept anonymous and
confidential
- A statement that participants need not respond to all questions
- If participants are your own students, a statement that class
standing will not be affected in any way based on participation.
- The name and telephone number of the Principal Investigator
(PI) and faculty sponsor (if applicable)
- Parent Permission: If your research is with children
or with any other group who may not be able to provide informed
consent, you must get signed permission from a parent or legal
guardian.
5. If you cannot claim one of the exemptions, complete the remainder
of the "Human Research Review Application," answering all
of the questions.
6. All researchers must complete the certifications page. You must
attach a copy of your certificate of training. Students must have
their faculty advisor's signature and certificate of training.
7. Submit an original and two copies to the:
Office of the Associate Provost for Research,
The Graduate School, Memorial Hall
You can complete the form on-line or copy the form to your computer
and complete it off-line. The form must be typed. The IRB will
not accept handwritten applications.
Make a copy to keep for your own records.