FOR THE PROTECTION OF HUMAN SUBJECTS
Request for Review of Research Involving Human
Participants (Form A)
Your request must contain the information requested below. The original
and two copies of the request should be forwarded to the current chair of
the IRB (for the name and address of the current chair, see the IRB
website at http://www.unca.edu/irb). Be as
brief and nontechnical as possible, and avoid jargon. Keep in mind that
the proposal will be read by people outside your field. Unless otherwise
indicated, all questions must be answered. Requests will not be reviewed
if they are incomplete or not professionally presented.
Please type responses to the questions below on a separate sheet
of paper. Please precede each question with its heading.
PART I
Principal Investigator :
Faculty Advisor (if Principal Investigator is a student):
Department:
Telephone Number/E-mail of Principal Investigator and Faculty Advisor
(if applicable):
Project title:
PART II
1. Project Description: Include (a) Purpose and hypotheses or research
questions, and (b) Procedures (i.e., what participants will be told, what
will be done with them, and what they will be asked to do). Please attach
a copy of any survey or questionnaire to be used in the study. Your
description should include sufficient background and detail to evaluate
issues of merit and risk to participants. Extended background should not
be included.
2. Participants: Include (a) Age, sex, and approximate number, (b)
Inclusion/exclusion criteria, if any, (c) Method of recruiting, and (d)
Inducement of participation. If advertisements are used to recruit
participants, copies of the ads must be included.
3. Are participants at risk? Answer "yes" if they are exposed to
the possibility of physical, mental, or social discomfort, harm or danger,
or any other risk that is more than minimal. (Note: Minimal risk is defined
as harm or discomfort that is "no greater than that encountered in daily life or during the performance of
routine physical or psychological tests.")
If risk is more than minimal, clearly explain the risk(s) and describe
all steps taken to minimize risk. If necessary, attach a justification for
the procedures based on scientific literature.
4. Are illegal activities involved? Answer "yes" if the research will
deal with illegal activity or potential illegal activity by the
participants (e.g., drug use, truancy, underage drinking). Describe the
nature of these activities.
5. Is deception involved? If the answer is "yes,"
indicate its nature, why it is necessary, and the form that subsequent
debriefing will take. When deception is involved the investigator incurs a
special responsibility to protect the rights and welfare of the
participants and to fully debrief participants before they are dismissed
from the study. The use of deception in no way obviates or reduces the
need for informed consent. Deception includes not only the presentation of
false information to participants, but also the intentional withholding of
information in a manner designed to mislead participants. Under no
condition can deception involve the withholding or falsification of
information likely to affect the willingness of participants to
participate in the research.
6. What are the anticipated benefits to participants and/or society?
(This is optional unless you answered "yes" to questions 3 or
5. In this case, your description of benefits is crucial to the
IRB's risk/benefit judgment.)
7. How will prior consent be obtained? Describe how informed
consent will be obtained, emphasizing how potential participants will have
adequate time and information to make a fully informed decision regarding
participation. Attach consent statement or form to be used; consent forms
should follow the format presented in the model (see Appendix). A
consent form is mandatory for all studies involving greater than minimal
risk (i.e., a "yes" response to question 3). For minimal risk research, consent may be
implicit or oral; however, a written statement regarding consent that will
be given to participants is required.
Investigator Assurance
Each investigator agrees to submit any significant and relevant changes
in the procedures and/or instruments already approved for this protocol to
the IRB Committee for additional review. Each investigator further agrees
to report any significant participant complaints to the IRB immediately
after they occur.
Principal Investigator Signature(s)
______________________________________
Faculty Advisor(s) Signatures ______________________________________