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Transcript
Elon University Institutional Review Board
RESEARCH PACKET INFORMATION
Revised:
07/10/1998 12/8/2006
07/24/1998 5/21/2007
02/24/1999 12/10/2007
07/26/1999
07/13/2000
08/06/2001
10/03/2003
08/18/2004
08/29/2005
11/03/2005
02/17/2006
09/28/2006,
1
PURPOSE
The purpose of this packet is to summarize and clarify the full Academic Memorandum on Ethical
Principles and Review Procedures for Human Participants in Research (Memorandum). A copy of
the Memorandum is on file in the library and in the Faculty Development Center. Faculty and
research investigators are encouraged to read the full Memorandum.
Forms that will be used by the IRB throughout the research process are presently found in this
packet only.
RESPONSIBILITIES OF IRB
It is the responsibility of the Institutional Review Board (IRB) to provide independent initial and
continuing review of research involving human participants. The IRB has been delegated by Elon
University (the University) to protect the rights and welfare of human participants recruited for
research activities conducted under the auspices of the University. The IRB has the right to
approve, require modifications in, or disapprove all research activities that fall within its jurisdiction
as specified by both the federal regulations and local institutional policies. The fundamental
responsibilities of the IRB are to assess the risks and potential benefits of the investigation, ascertain
the appropriateness of the methods used to gain participant consent, and to protect the rights and
welfare of the individuals involved.
MEMBERSHIP AS OF SPRING 2008
Mathew Gendle, Chair
Psychology, 2337 CB
[email protected]
x6431
Gregory Haenel
Biology, 2625 CB
Tonya Riney
Business Administration, 2075 CB
Michael Skube
Communications, 2850 CB
Jack Smith
Performing Arts, 2800 CB
Deborah Stetts
Physical Therapy, 2085 CB
Susan Walton (voting, community representative)
Bonnie S. Bruno (non-voting, Ex-officio)
Sponsored Programs, 2610 CB
2
RESEARCH / TEACHING TOOL
The IRB will review only those assignments, activities, or investigations that are defined as
research. “Research” as defined by federal administrative bodies is “a systematic investigation
designed to develop or contribute to generalizable knowledge” (45 CFR 46.102).
 Research: those studies that are systematically designed to add to the general body of knowledge
will be subject to IRB review (See Types of Review). Those studies designed as research in
nature may be 1) a component of a content based course, 2) the primary focus of a research
based course or 3) unassociated with a course of study.
 Teaching Tool: course projects whose primary intent and design is pedagogical. The original
design and intent are not to contribute to the body of knowledge. Although such activities are
generally not subject to review, it is the position of the IRB that the individual faculty
member retains ethical responsibility for the proper conduct of such instructional
studies and that the ethical principles set forth in the Memorandum addressing the
dignity and welfare of others and the respect for their right to confidentiality and
freedom from undue harm are always to be followed.

Teaching Tool:
 Primarily pedagogical focused on non-research content: classroom or class projects that
encourage students to connect course material with specific applications from their own lives
or the lives of others. For example, in a course examining patterns of courtship and dating,
students may be asked to interview someone from a different generation or cultural
background to learn more about variations in dating norms.
 Primarily pedagogical focused on research skill acquisition: in which the primary focus is not
the acquisition of new knowledge, but rather the development of procedural, research skills
 Ethical responsibility of individual faculty member: in each of the above instances, it is
the position of the IRB that the individual faculty member retains ethical
responsibility for the proper conduct of such assignments. The faculty member has a
definite obligation to use such opportunities to instruct students in issues of ethical
scholarship. The faculty is strongly encouraged to consult with departmental
colleagues and/or members of the IRB in deciding whether a study is primarily
pedagogical for the teaching of research skills or primarily research oriented and in
assuring that the ethical principles stated in the Memorandum have been properly
addressed.
TYPES OF REVIEWS
There are three types of research reviews:
 Exempted
 Expedited
3
 Full
The primary investigator will recommend whether the proposal qualifies as exempt or qualifies for
expedited or full IRB review. The IRB certifies the final status of the proposal.
Exempted Review
 Exempted: those research activities seen to involve minimal risk falling under the following
categories:
1. Use of routine educational tests, surveys, or interviews.
2. Research conducted in established or commonly accepted educational settings examining
pedagogical methods or questions.
3. Research involving collection or study of existing data, documents, records, pathological
specimens, diagnostic specimens, if these sources are publicly available.
4. Research involving observation of public behavior (or participant observation).
Exceptions
 The above proposals are not exempt if:
1. Data are recorded in such a manner that the identity of the particular participants can be
determined, directly or through other information linked to the specific participants.
2. The data could reasonably place the participant at risk of criminal or civil liability or be
damaging to participant’s financial standing or employability.
3. The research deals with sensitive aspects of the participant’s own behavior or
experiences, such as illegal conduct, drug use, or past psychological experience.
4. The class of participants are considered vulnerable (children, prisoners).
Expedited Review
 Expedited: those research activities involving no more than minimal risk falling under the
following categories:
1. The research proposals that do not meet the criteria for exemption as defined above.
2. Collection of excreta and external secretions including sweat and saliva if the information is
recorded by the investigator in such a manner that participants can be identified, directly or
through identifiers linked to participants.
3. Recording data using non-invasive procedures such as surface application of sensors and
anthropometric measurements (such as weighing)
4. Voice recordings made for research purposes.
5. Moderate exercise by healthy volunteers.
6. Research on individual or group behavior or characteristics of individuals, such as studies of
perception, cognition, game theory, or test development, where the investigator does not
manipulate participants’ behavior and the research will not involve stress to the participants.
7. The study of existing data, documents, or records if the information recorded in such a
manner as to identify the participants (directly or through identifiers).
Full Review
 Full: those research activities
1. Involving more than minimal risk
2. Involves interventions or interactions not specified in any of the statements under Exempted
or Expedited Review
4
REVIEW PROCEDURES
♦Exempted
 Reviewed by IRB Chair and one other member
 Possible outcomes
 Exemption certified
 Certified contingent upon specific modification/clarification
 Referred for expedited or full IRB review
♦Expedited
 Reviewed by IRB Chair and at least two other members
 Possible outcomes
 Approved
 Approved contingent upon specific modification/clarification
 Referred for full IRB review
♦Full
 Reviewed by full IRB
 Possible outcomes
 Unconditional approval (2/3 majority)
 Conditional approval (2/3 majority)
 Rejection (less than 2/3 majority approval based on noncompliance with policies of
guidelines)
 Tabled (requires significant amount of additional information)
CRITERIA FOR APPROVAL

Complies with ethical principles stated in the guidelines, specifically:
1. Risks to participants are minimized.
2. Risks are reasonable in relation to anticipated benefit.
3. Participants are recruited honestly, equitably, and without coercion.
4. Elements of informed consent via the consent form are present.
5. The investigator(s) have submitted the required paperwork.
INSTRUCTIONS TO AUTHORS
All proposals must be submitted to the Chairperson of the IRB. See ‘Type of Review’ on cover
sheet for number of copies to be submitted.
 Cover Sheet
1. Fill out cover sheet (see attached form in Appendix C). Cover sheet includes:
a) Title of the study
b) Name, address, social security number, and phone number of principal investigator
5
c)
d)
e)
f)
g)
h)
i)
Status of principal investigator
Student information, if student is primary investigator
Name(s) and phone number(s) of other researcher(s)
Estimated beginning and ending date of study
Academic purpose of research
Sponsor/grant information
Type of review (exempted, expedited, full)
NOTE: In order to facilitate timely reviews and reduce paper waste, electronic submissions are now
used. While one signed and complete paper copy of each application is still required, electronic
submission takes the place of the multiple hard copies that used to be required for exempted and
expedited reviews. IRB applications should be submitted to the chair of the IRB. Electronic copies
should be submitted to the chair via e-mail as .pdf or .doc files. Refer to the list below to determine
how many paper and electronic copies are required for each proposal type.
Type of review expected:
Exempted (Provide the original and 1 electronic copy)
Expedited (Provide the original and 1 electronic copy)
Full (Provide the original, 7 paper copies, and 1 electronic copy)
 Body of proposal
2. A written proposal should be submitted to the IRB and shall contain the following:
a) Statement of the research problem
b) Description of the study population, sampling methodology, and specific criteria for
selection of the participants
c) Detailed description of the research design
d) Your assessment of the risk and risk management (how risk is to be minimized)
e) Potential benefits to human participants (even if there is/are none)
f) Informed consent procedure
(i)
how investigator intends to obtain informed consent
(ii)
copy of consent form if written
g) Describe procedures for insuring the confidentiality of data and anonymity of participants
h) Length of time that records will be kept, where kept, by whom the records will be kept, and
time and methods of destroying the data (can be included in confidentiality section)
i) Feedback sheet or explanation of procedures for participant feedback (how will you provide
individual and/or study results back to the subjects)
j) Other documentation that the researcher feels would help the IRB better evaluate the
proposal.
k) Statement of compliance. The following statement of compliance must appear on all
proposals submitted for review:
To the best of my knowledge, the plan of conduct for this research conforms with the
policies and procedures for the use of human participants at Elon University.
_______________________________
Signature of the Primary Researcher
_________________
Date
6
l) Faculty/Staff sponsor statement of approval. Proposals submitted by undergraduate and
graduate students must be sponsored by a member of the faculty or staff. Sponsors of
student research must submit an approval statement that describes briefly the nature of the
project (e.g., senior seminar project; independent research project), the faculty or staff
member’s relationship to the project (e.g. instructor, supervisor), and the procedures for
monitoring student work on the project. The sponsor must also include the following
statement of compliance in his or her approval statement:
To the best of my knowledge, the plan of conduct for this research conforms with the
policies and procedures for the use of human participants at Elon University.
_______________________________
Signature of the Faculty/Staff Sponsor
_________________
Date
 Informed Consent
3. Copy of Informed Consent.
Informed consent shall be obtained from all persons participating as subjects in a research study.
Most of the time, this will be obtained through the use of a written consent form. The form should
be titled “Consent Form” NOT “Informed Consent”. The form is a means of achieving informed
consent. (One is the action of obtaining the other.) The full procedures for obtaining informed
consent are:

Procedures: informed consent shall consist of any of the following:
1. Written consent document embodying the elements of informed consent.
2. ‘Short form’ written document which states that the elements of informed consent have
been presented orally to the participant.
(Note: Participants have to sign the forms used in # 1and 2 above.)
3. An alternative informed consent procedure provided that the proposal adequately
documents a compelling reason for such alteration. For example, certain investigations of
large numbers of people engaging in naturally occurring, public behavior might preclude
obtaining prior informed consent from all persons present. Alternative informed consent
procedures including waivers of informed consent as specified in the guidelines.

Elements of Informed Consent
1. Any language used in a consent form must be understandable by participants.
2. Must include a statement that indicates the study involves research and states the purpose(s)
of the research. You may want to add some general things the subject should know about
research.
3. Must include how long the subjects’ participation will last (and sometimes where
appropriate, the approximate number of subjects that will participate).
4. Must include a description of the procedures of the study. This should include what will be
required of, or done to, the research subject. Identify any procedures that are experimental
(that deviate from standard care or practice).
5. Must include a statement of risk(s) (reasonable and foreseeable) to participant followed by an
explanation of the steps to be taken to protect the subjects from these risks.
6. Must include a statement of possible benefit(s) to participant even if there are none.
7
7. Must include a statement describing alternative procedures if the research involves clinical
trials or there is more than one means of achieving an effect or treatment.
8. Must include a statement addressing the confidentiality of records including storage, length
records are kept, access to records, where the data is stored, and how that data may be
destroyed if not stored. Can be included as part of risk statements.
9. Statement regarding any possible compensation for participation.
10. If research involves more than minimal risk, an explanation of what should happen if the
subject is injured during the research – if there is any compensation or treatment and where
further information can be obtained.
11. Statement specifying contact personnel for answers to questions about the research (usually
primary or secondary investigators) and participants’ rights (usually the Chair of the IRB).
12. Must include a statement that participation is voluntary and that the participant is free to
withdraw from the study at any time without penalty of any kind which includes grades in
class.
In certain circumstances, additional elements may be included in the consent form:
1. Include an explanation of the circumstances in which the investigator(s) may terminate
the subject’s participation without regard to the subject’s consent.
2. Any additional costs to the subjects that may result from participation in the research.
3. An explanation of the consequences of a subject’s decision to withdraw and the
procedures for terminating the subject’s participation.
4. A statement that new findings or new information gained during the course of the study
may affect the subject’s willingness to participate in the study.
See Appendix B for an example of the elements to be included in of one type of consent form.
Note that this example is explicit in detail that may not apply to all studies. However, the questions
that are underlined address the elements of informed consent that must be included in all consent
forms.
DEADLINES FOR THE ACADEMIC YEAR
At present, the IRB only officially meets in session during the regular academic year (fall and spring
semesters). However, the IRB attempts to be flexible in meeting the needs of the research
investigators and tries to review proposals during non-academic times (Winter term and summer).
The IRB meets every month. Contact the Chair or other members for specific dates.
Deadlines for investigators to submit their proposals for consideration by the IRB are:
 Full Review – not less than 8 working days prior to the published meeting dates
 Expedited or Certification for Exemption – may be submitted to the Chairperson at other times
and all attempts will be made to process these proposals in a timely manner
DEADLINES FOR CLASS PROJECTS CLASSIFIED AS RESEARCH
The IRB attempts to notify investigators of the status of their proposals in a timely manner.
However, when multiple proposals are received for immediate review, it is difficult for the reviewers
8
to meet time restrictions. This is especially true when proposals are received when IRB members
themselves have projects or activities that may take them out-of-town.
Therefore, the IRB respectfully requests that faculty members who will be employing original
research as a classroom function to submit to the IRB a rough timetable of the research deadlines. If
the IRB is aware that it will be receiving 8 reviews in a given time frame and that decisions are
needed by another given time frame, it will help expedite the entire process.
FILES / RECORDS
By law (45 CFR 46.115), the IRB is required to maintain records of IRB activity including copies of
all research proposals reviewed, minutes of meetings, and copies of correspondence between IRB
and investigators.
ONGOING RESEARCH
In the upcoming year, all research projects that have been proposed since the inception of the IRB
will be subject to review for continuation or termination. This is in accordance with the federal
guidelines.
MISCELLANEOUS
There are topics that have not yet been addressed or clarified in the Academic Memorandum
(ongoing reviews, more details on children as participants) that the IRB acknowledges may be
instrumental in a given research proposal and for grant applications. The IRB intends to address
these issues in its meetings and to propose amendments to the Academic Memorandum.
The IRB works with the Director of Sponsored Programs who is a non-voting, ex-officio member.
The IRB utilizes the services of Sponsored Programs as a clearinghouse for proposals and as a
central agency for all ongoing research.
9
APPENDIX A
i
Definitions

Research
A systematic investigation designed to develop or contribute to generalizable knowledge.

Human Participant
A living individual about whom an investigator conducting research obtains:
a) data through intervention or interaction with the individual
b) identifiable private information

Minimal Risk
Any harm anticipated in the proposed research is neither more probable nor of greater
magnitude than that ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tests.
** The IRB acknowledges that information used in the preparation for this packet was obtained
from:
1. Federal documents governing the policies and procedures of any IRB (45 CRF 46,
Belmont Report, etc)
2. Elon University Academic Memorandum on Ethical Principles and Review Procedures
for Human Participants in Research
3. University of North Carolina Academic Affairs Institutional Review Board Manual
4. Texas Woman’s University, Denton campus, Human Subjects Review Committee
ii
APPENDIX B
SAMPLE COPY OF CONSENT FORM
iii
Elon University
Consent to Participate in a Research Study
Adult Subjects
_____________________________________________________________________________
(DELETE THIS AND ALL OTHER INSTRUCTIONS IN ITALICS)
IRB Study #_____________________ (Leave blank if new submission)
Consent Form Version Date: ______________ (Enter or update for all submissions)
Title of Study:
Principal Investigator: (name and degree)
Elon University Department:
Phone number:
Co-Investigators: (names and degrees)
Sponsor: (National Cancer Institute, Name of Pharmaceutical Company, etc)
_____________________________________________________________________________
You are being asked to take part in a research study. The investigators listed above are in charge of
the study; other professional persons may help them or act for them.
What are some general things you should know about research studies?
Research studies are designed to gain scientific knowledge that may help other people in the future.
You may or may not receive any direct benefit from participating. There may also be risks associated
with participating in research studies.
Your participation is voluntary. You may refuse to participate, or may withdraw your consent to
participate in any study at any time, and for any reason, without jeopardizing your future care at this
institution or your relationship with your doctor. If you are a patient with an illness, you do not
have to participate in research in order to receive treatment.
Details about this particular study are discussed below. It is important that you understand this
information so that you can decide in a free and informed manner whether you want to participate.
You will be given a copy of this consent form. You are urged to ask the investigators named above,
or staff members who may assist them, any questions you have about this study at any time.
Page 1 of __
(repeat on each page)
iv
What is the purpose of this study?
The purpose of this research study is ...
(If applicable, include a statement that the study involves testing an investigational device, or an approved
device whose use in this study is investigational. Bear in mind, in this section and all others, that you are
describing complex concepts to laypeople.)
How many subjects will participate in this study?
(For single-center studies)
If you decide to participate, you will be one of approximately (number) subjects in this research
study.
(For multi-center studies)
A total of approximately (number) subjects at (number) institutions will take part in this study. A
total of approximately (number) subjects from this institution are expected to participate.
How long will your participation last?
Your participation in this study will last for approximately ...
(How long entire study is projected to run is less important than this individual subject’s participation, in
hours, days, months or years. Include required follow-up)
What will happen if you take part in the study?
During the course of this study, the following will occur:
(Describe in lay language, step-by-step, what will be required of, or done to, the research subject. This should
include, but need not be limited to:
Overall design. Methods and probability of assignment, randomization and placebos. If
applicable, blinding procedure, and a statement that a research subject's treatment can be
determined rapidly in case of emergencies.
Procedures to be performed, including frequency and follow-up.
Differentiate between procedures/test articles that are investigational or included solely for
research purposes and those that are standard clinical care.
Research medications or supplements to be administered and method, dose and frequency of
administration.
Number, frequency and duration of visits, if known.
Specific requirements of the research subject, such as post-treatment follow-up, diary cards,
questionnaires, etc.
In research involving patients as subjects, provide the name of the physician responsible for
the patient's welfare during the study.
Specimens to be collected including frequency and size/amount.
v
Are there any reasons you should not participate?
You should not participate in this study if…
(List only those exclusion criteria about which subjects will know, and that may be unknown to the
investigator. Do not necessarily list all the exclusions shown in the Master Protocol, for which investigators
will screen every subject.)
What are the possible risks or discomforts?
This study might involve the following risks and/or discomforts to you:
(For each research procedure/intervention, describe immediate and long-term physical, psychological, social
and reproductive risks/discomforts. If frequency of such risks or discomforts is known from previous studies,
provide estimates of frequency. It may be more meaningful for subjects to see side effects grouped as Common,
Uncommon, Rare, etc, as opposed to a long unbroken list of every side effect ever noted.)
(If women of childbearing age are included as subjects and the research procedure/drug/device may cause
harm to an unborn fetus or breast feeding child, state whether pregnancy or breast-feeding excludes
participation, whether birth control is required (and if so, which method), and that the P.I. should be notified
immediately if the subject becomes pregnant.)
In addition, there may be uncommon or previously unrecognized risks that might occur.
What are the possible benefits?
The benefits to you of participating in this study may be…
(Describe potential benefits that might reasonably be expected to result from this research. Identify those that
might accrue to the individual subject as well as those that might benefit society in general. If the individual
subject will receive no direct benefit, make a statement to that effect.)
If you choose not to participate, what other options do you have?
You do not have to participate in this research study in order to receive treatment. Other
procedures/treatments that are available are…
(For research that does not involve treatment, eliminate this section. For protocols involving treatment,
describe any alternative procedures or courses of treatment that might be available to the subject. For some
terminally ill patients considering a treatment trial, supportive care only may be an alternative.)
What if we learn about new risks during the study?
You will be given any new information gained during the course of the study that might affect your
willingness to continue your participation.
vi
How will your privacy be protected?
No subjects will be identified in any report or publication about this study. Although every effort
will be made to keep research records private, there may be times when federal or state law requires
the disclosure of such records, including personal information. This is very unlikely, but if
disclosure is ever required, Elon University will take all steps allowable by law to protect the privacy
of personal information.
(Indicate how privacy and confidentiality will be protected. How will records be secured? To whom will access
be limited? Will names be used, or will there be ID numbers only, and a linkage file? Is any sensitive
information being collected, and will it be treated differently?)
(If reviewed or sponsored by a manufacturer or government agency, include a statement that the manufacturer
or government agency may review all records. If the study involves products regulated by the Food and Drug
Administration (FDA), add a statement that the FDA may inspect the records.)
(Include the following if research is clinically relevant for these subjects. Delete for healthy volunteers.)
Because this study involves the treatment of a medical condition, a copy of this consent form will be
placed in your medical record. This will allow the doctors caring for you to obtain information
about what drugs or procedures you are receiving in the study and treat you appropriately, if you
have other health problems or needs during the study.
Will you be paid for participating?
You will receive (amount) for your participation in this study.
(Or, “You will not be paid for your participation in this study.” if that is the case.)
(If payment will be made, address how payments will be prorated in the event the subject withdraws, or is
withdrawn by the investigator, from the study prior to completion.)
Will it cost you anything to participate?
The costs of this research will be...
(e.g. “… billed to you and/or your insurance.” Or “… paid by the sponsor. There will be no costs to you
for participating.” Elaborate as necessary, to describe specific items or procedures that may/may not be
covered.)
What will happen if you are injured by this research?
In the event of personal injury resulting directly from the research procedures, financial
compensation cannot be provided by Elon University. All forms of medical diagnosis and treatment,
(or moderate exercise programs, participation in this activity, etc.) whether routine or experimental, involve
some risk of injury. In spite of all precautions, you might develop medical complications from
participating in this study. If such complications arise, the researchers will assist you in obtaining
appropriate medical treatment but Elon University does not provide financial assistance for medical
or other costs. You do not waive any liability rights for personal injury by signing this form.
(The above statement may be omitted if the study involves only minimal risk. "Minimal risk" means that the
risks of harm anticipated in the proposed research are not greater, considering both probability and
magnitude, than those encountered in daily life or during the performance of routine physical or psychological
examinations.)
vii
(For research not involving diagnosis or treatment, omit the sentence: "All forms of diagnosis and treatment,
whether routine or experimental, involve some risk of injury".
(If applicable, add a separate paragraph about any compensation for injury that will be provided by the
study sponsor.)
What if you want to stop before your part in the study is complete?
You can withdraw from this study at any time, without penalty. The investigators also have the right
to stop your participation at any time. This could be because you have had an unexpected reaction,
or have failed to follow instructions, or because the entire study has been stopped.
(Modify the above paragraph, if necessary, to fit the study. For students participating in a study for which
they were recruited during a class, make it clear that there will be no grade penalty should they choose to
withdraw from the study)
What if you have questions about this study?
You have the right to ask, and have answered, any questions you may have about this research. If
you have further questions, or if a research-related injury occurs, you should call (name and degree of
investigator) at (phone number).
What if you have questions about your rights as a subject?
This research has been reviewed and approved by the IRB at Elon University, North Carolina. If
you have any questions or concerns regarding your rights as a research subject, you may contact the
Chairman of the IRB (Dr. Mathew Gendle) at 336-278-6431 or [email protected].
----------------------------------------------------------------Subject’s Agreement:
I have read the information provided above. I voluntarily agree to participate in this study.
_________________________________________
Signature of Research Subject
Date
_________________________________________
Printed Name of Research Subject
_________________________________________
Signature of Person Obtaining Consent
_________________________________________
Printed Name of Person Obtaining Consent
viii
_________________
_________________
Date
APPENDIX C
IRB APPLICATION COVER PAGE
ix
Elon University
Application to Institutional Review Board (IRB)
Cover Page
Title of the Study/Project: ________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Name of Principal Investigator: _________________ Email:___________ Phone: ___________
Check Status of Principal Investigator:
____ Faculty
____ Student ____ Staff ____ Other
Address of Principal Investigator: _________________________________________
_____________________________________________________________________________
If the Principal Investigator is a student, provide the following information:
Dept: ________________________
Name, Campus box, & Phone # of Research Advisor: ___________________________
Email: _______________________________
Name(s) and phone number(s) of other investigator(s) __________________________________
__________________________________
__________________________________
__________________________________
Estimated beginning date of the study: ______________________________________________
Estimated completion date of the study: _____________________________________________
Research being conducted for:
____ thesis
____ research project
____ class project
____ professional paper
____ independent study
____ other
If this research is or may be supported by a grant or outside sponsor, list name(s) of sponsor(s):
_____________________________________________________________________________
Type of review expected:
______ Exempted (Provide the original and 1 electronic copy)
______ Expedited (Provide the original and 1 electronic copy)
______ Full (Provide the original, 7 copies, and 1 electronic copy)
Date Application Received by IRB: ______________________________________________
PLEASE NOTE: IRB APPLICATIONS SHOULD BE SUBMITTED TO THE CHAIR OF
THE IRB. Electronic copies should be submitted to the Chair via e-mail as .pdf or .doc files.
x