FOR IRB USE ONLY Protocol
Number: IRB-
Human Subject Institutional Review Board Proposal Form
Activity Title:
PRINCIPAL INVESTIGATOR ASSURANCE
I agree to use procedures with respect to safeguarding human subjects involved in this research that conforms
to the TSU policy and DHHS and FDA regulations. Except when necessary to eliminate apparent immediate
hazard to the human subject, if significant changes in the investigative procedures involving human subjects are
called for during the research program covered by this application, I shall seek prior approval for such changes
from the Institutional Review Board (IRB), and I shall agree to follow the advice of the IRB. I further agree to
report immediately to the IRB any unanticipated complications or untoward incidents with respect to human
subjects.
Type Principal Investigator Name
Signature
Date
DEPARTMENTAL CHAIRMAN ASSURANCE
I understand that responsibility for assessing the quality of research must be shared by both the department and
the IRB. My signature as Department Chairman certifies that the proposed research has been reviewed for the
proper use of human subjects. This review encompassed experimental design, scientific merit and accuracy of
the proposed research.
Type Dept. Chair Name
Signature
APPROVED:
Signature, IRB Chairperson
Date
Date
1
FOR IRB USE ONLY
Protocol Number: IRB-
Human Subject Institutional Review Board Proposal Form
Instructions: Check all appropriate boxes, answer all questions completely, include attachments, and obtain appropriate
signatures.
WARNING: If you wish to SAVE the text you
insert on this form- SAVE this form to your
computer BEFORE inserting test.
REQUIRED ON ALL APPLICATIONS, CONTRACT PROPOSALS, REQUESTS FOR SUPPORT OF SPONSORED ACTIVITIES,
AND ON PROTOCOLS SUBIMITTED TO THE INSTITUTIONAL REVIEWBOARD
1. Activity Title:
2. Contact Information
2.1. Principal Investigator (PI)
Name
UIN/UID
Univ. Email
Univ. Phone No.
Department/Division
Affiliation:
__ TSU Faculty
Highest Degree Earned: __ Doctoral
__ TSU Staff
__ Master’s
__ TSU Research Associate
__ Bachelor’s
2.2 Complete Section below if Proposal is for a Thesis or Dissertation:
Student
UIN/UID
Univ. Email
Univ. Phone No.
Department/Division
Affiliation:
__ TSU Faculty
__ TSU Staff
__ TSU Graduate Student
Highest Degree Earned: __ Doctoral
__ Master’s
__ Bachelor’s
3. Location of Activity
Institution
Building
Room
4. Funding Agency
Name
Number
“For all sponsored research activities, Texas Education Code 51.954 and 51.955 require full and conspicuous
disclosure of the research sponsor in any oral or written communication intend for public release.”
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Institutional Review Board (IRB)
Box # T-0015
(254) 968-1647
5. Each Responsible Investigator (List Principal Investigator First)
1. Last Name
First Name
MI
Highest Degree Earned
Signature, Principal Investigator
2. Last Name
First Name
MI
Signature
3. Last Name
First Name
MI
MI
Signature
5. Last Name
Signature
First Name
MI
Title
Department
Highest Degree Earned
Date
Title
Department
Highest Degree Earned
Date
Title
Department
Highest Degree Earned
Date
First Name
Department
Highest Degree Earned
Date
Signature
4. Last Name
Date
Title
Title
Department
UIN/UID
Attach CITI & COI
UIN/UID
Attach CITI & COI
UIN/UID
Attach CITI & COI
UIN/UID
Attach CITI & COI
UIN/UID
Attach CITI & COI
1. Cooperating Facilities: Will data, subjects, equipment, personnel, supplies be used at or obtained from
an organization outside of Tarleton State University?
Facility Name
Address
Sponsor
Phone Number
**Cooperating Facilities Letter MUST be attached for review
2. Does this activity require or involve the following? (Answer All)
A. Additional space, not presently available in the department, alterations
and/or renovations
If “YES” Please check all that apply: ___ department ___ Alternations ___ renovations
B. Subcontracting or direction outside Tarleton State University?
C. Faculty Salary?
__ YES
__ NO
__ YES
__ YES
__ NO
__ NO
__ YES
__ YES
__ YES
__ YES
__ NO
__ NO
__ NO
__ NO
If “YES,”check one: ___ new positions ___ support of current positions.
D. Generation of potential direct monetary profit to the institution?
E. Restrictions on publication of results?
F. Activities which involve the community and “social action”?
G. Will anyone other than the investigator(s) obtain informed consent?
If “YES” this person MUST be listed on page 2 as an investigator.
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Institutional Review Board (IRB)
Box # T-0015
(254) 968-1647
3. Does this activity involve the use of human subjects?
__ YES
__ NO
If “YES” indicate the appropriate action:
__ This activity has not been previously approved for use of human subjects.
__ This activity was approved for use of human subjects on _______________________.
4. A.1. Does this research proposal involve only the collection or study of existing data, documents,
records, pathological specimens, or diagnostic specimens?
__ YES
__ NO
A.2. If “YES,” are the sources publicly available, or will the information be recorded by the
investigator(s) in such a manner that subjects cannot be identified directly or through identifiers linked
to the subjects? If so, this study may qualify as exempt research or for an expedited review procedure.
__ YES
__ NO
B. Will this activity/research be restrictive to a survey?
__ YES
__ NO
If you answered “YES” to either 4 A1, 4 A2, or 4 B skip to #7.
Does your research involves the use of drugs and/or devices, recumbent DNA, hazardous materials, or any
form of radiation on human subjects?
__ YES
__ NO
If "YES", please complete #5 and #6.
If "NO", please skip to #7.
5. Does this activity require or involve the following? (Answer All)
A. Does this research involve the use of drugs and/or devices, recumbent DNA, or hazardous
__ YES
__ NO
materials?
If “YES” check all that apply: ___ drugs ___ devices ___ recumbent DNA ___ hazardous materials
B. Condition or disease to be studied _________________________________________________
C. The amount, if any, charged for an investigational drug/device $___________. If subjects will be
charged, state why sale does not constitute commercialization: __________________________
D. Is there a conflict of interest between the investigator and the sponsor of the drug/device or
procedures to be studies, e.g. ownership in company?
__ YES
__ NO
__ N/A
E. Will placebos be used?
__ YES
__ NO
__ N/A
F. Will the investigator(s) be directly involved in diagnostic and treatment procedures for subjects?
__ YES
__ NO
__ N/A
__________________________________________________________________________________________
4
Institutional Review Board (IRB)
Box # T-0015
(254) 968-1647
6. Use of Radioactivity in Human Subjects:
Is any form of radiation used in this study?
__ YES
A. If “YES” indicate type used:
__ X-Ray
__ Isotopes
B. Are studies done
__ in vivo
__ in vitro
C. Are studies done for
__ therapeutic __ experimental
__ NO
__ Pharmaceuticals
The purpose? ___________________________________________________________
D. Has the Radiation Safety Committee approval been received for this project?
__ YES
__ NO
E. If “YES” give date of approval: ____________________________________
Check off response and complete the blanks for each of the following which, in your opinion, best describes
the research.
7. Risk Category
8. Request Category of IRB Review
9. Benefit Category
__ Minimal Risk
__ More than a Minimal Risk
__ Exempt
__ Expedited
__ Full Board Review
Benefit to Others:
__ YES
__ NO
Benefit to Subjects:
__ YES
__ NO
If “YES” please explain how...
10. Subject Population: Indicate whether the following groups are targeted in your subject population.
Reviewers must be able to assess risk for vulnerable populations even if these populations are not
targeted.
5
Institutional Review Board (IRB)
Box # T-0015
(254) 968-1647
A. ___ Normal Subject (non-patient volunteers)
B. ___ Minors (less than age 18)
C. ___ Fetuses:
___ Nonviable
___ Viable
D. ___ Pregnant Subjects
E. ___ LGBT
F. ___ Economically Disadvantaged
G. ___ Prisoner
H. ___ Intellectually disabled or impaired
I. ___ Age (over 65)
J. ___ Students
K. ___ Minorities-Specific:
_____________________
L. ___ Inpatients-as experimental subjects
M. ___ Inpatients-as control subjects
N. ___ Outpatients-as experimental subjects
O. ___ Outpatients-as control subjects
P. ___ Non-English speaking subjects- Native language
Are you targeting any specific population listed above?
If “YES” please explain why…
__ YES
11. Additional Information
A. Sex of subjects
B. Age Range
C. Will subjects be randomized?
D. Type of study
E. Estimated number of participants involved
F. Estimated duration of study
G. Duration of each subject’s participation
H. Will subjects be paid to participate?
I.
State type and amount of incentive to be offered
J.
Will incentive be prorated for subjects who withdraw from
participation?
K. Estimated additional cost of subjects that may result from
participation:
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___ Male
___ Female
___ Both
_____________________
___ Yes
___ No
___ Qualitative
___ Quantitative
___ Experimental subjects
___ Control subjects
_____________________
_____________________
___ Yes
___ No
_____________________
___ N/A
___ Yes
___ No
___ N/A
$_____________________
___ N/A
__ NO
Institutional Review Board (IRB)
Box # T-0015
(254) 968-1647
I.
What research question(s) does this study seek to address? (Briefly explain the purpose of your study)
II.
Background (Give a brief description of background information)
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Institutional Review Board (IRB)
Box # T-0015
(254) 968-1647
III.
Concise Summary of Project
A. Please Identify your human subjects (based on question 11)
B. How will you recruit your subjects (i.e., flyers, email, etc.)? Attach recruiting document
C. Criteria for Inclusion of Subjects
D. Criteria for Exclusion of Subjects
E. What type of research material will be used in your study (i.e. survey, exam/test, blood
sample, etc.)? Please Attach
F. Detailed description of your project, please include; how will you interact with your subjects,
how will consent/assent be obtained, how will data be collected, analyzed, and reported
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Institutional Review Board (IRB)
Box # T-0015
(254) 968-1647
IV.
Potential Risks & Special Precautions to Protect Subjects
A. Will the result be reported in aggregate form without identifiable information included?
__ YES
__ NO
B. Will the results be presented so as to avoid the subjects being identified directly through identifying
links?
__ YES
__ NO
C. Will you be requesting the IRB waiver documentation of informed consent (only applies if the
consent form will be the only link between your subjects and the research)?
__ YES
__ NO
D. Give details of potential risks and special precautions mitigating these risks.
V.
Potential Benefits of your Research
VI.
Risk/Benefit Assessment (explain how the potential benefits outweigh the risks)
9
Institutional Review Board (IRB)
Box # T-0015
(254) 968-1647
Subject Consent to Participate in Research
*Note: This is a generic consent form available for your use. If you choose to use another consent form,
please make sure it contains the required elements (see “Informed Consent” on website under IRB
Proposal Tools)
Title of Study:
Sponsor:
1.
2.
3.
4.
Investigators:
Office Phone #:
Night & Weekend Phone #:
You are being asked to participate in a research study. Persons who participate in research are entitled to
certain rights. These rights include but are not limited to the subject’s rights to:
1. Be informed of the nature and purpose of the research;
2. Be given an explanation of the procedures to be followed in the research, and any drug or device to be
utilized;
3. Be given a description of any attendant discomforts and risks reasonable to be expected;
4. Be given a disclosure of any benefits to the subject reasonable to be expected, if applicable;
5. Be given a disclosure of any appropriate alternatives, drugs, or devices that might be advantageous to
the subject, their relative risks and benefits;
6. Be informed of the alternatives of medical treatment, if any, available to the subject during or after the
experiment if complications arise;
7. Be given an opportunity to ask any questions concerning the research and the procedures involved;
8. Be instructed that consent to participate in the research may be withdrawn at any time, and
the subject may discontinue participation without prejudice;
9. Be given a copy of the signed and dated consent form; and
10. Be given the opportunity to decide to consent or not to consent to participate in research
without the intervention of any element of force, fraud, deceit, duress, coercion, or undue
influence on the subject’s decision.
10
Institutional Review Board (IRB)
Box # T-0015
(254) 968-1647
Title of Study:
You have the right to privacy. All information that is obtained in connection with this study that can be identified
with you will remain confidential within the limits of State Law. Information gained from this study that can be
identified with you will be released only to the investigators, and if appropriate, to your physician and the
sponsors of the study. For studies regulated by the Food and Drug Administration (FDA), there is a possibility
that the FDA may inspect your records. The results of this study may be published in scientific journals without
identifying you by name.
In addition, members and staff of the Institutional Review Board may review the records of your participation in
this study and you may be contacted by a representative of the Board for information about your experience
with this study. If you wish, you may refuse to answer any questions the Board may ask of you. We also would
like for you to understand that your record may be selected at random (as by drawing straws) for examination
by the Board to insure that this research project in being conducted properly.
We will make every effort at preventing physical injury that could result from this research. Compensation for
physical injuries incurred as a result of participating in the research is not available. The investigators are
prepared to advise you about medical treatment in case of adverse effects of these procedures, which you
should report to them promptly. Phone numbers where the investigators may be reached are listed in the
heading of this form.
If you have questions about the research or about your rights as a subject, we want you to ask us. If you have
questions later, or if you wish to report a research-related injury (in addition to notifying the investigator), you
may call the Chairman of the Institutional Review Board during office hours at (254)968-9463.
Participation in this research study is entirely voluntary. Refusal to participate will involve no penalty or loss of
benefits to which you are otherwise entitled. If you decide to participate, you are free to withdraw your consent
and discontinue participation at any time without affecting your status (as a patient, student, employee, etc.), or
the medical care that you will receive.
Any significant new findings developed during the course of the research, which may relate to your willingness
to continue participation in this study will be provided to you.
YOU WILL BE GIVEN A COPY OF THIS CONSENT FORM TO KEEP
11
Institutional Review Board (IRB)
Box # T-0015
(254) 968-1647
Title of Study:
Please briefly fill out each box below.
Purpose
What you will be
asked to do if you
participate in this
study. (Choose
one)
Possible Risk and
Discomforts
__ If you participate in the study you will be asked to:
__ No experimental procedures are involved in this study.
Possible Benefits
Alternatives to
Participation
12
Institutional Review Board (IRB)
Box # T-0015
(254) 968-1647
Title of Study:
YOU ARE MAKING A DECISION WHETHER OR NOT TO PARTICIPATE IN THIS STUDY. YOU SHOULD NOT SIGN
UNTIL YOU UNDERSTAND ALL THE INFORMATION PRESENTED IN THE PREVIOUS PAGES AND UNTIL ALL YOUR
QUESTIONS ABOUT THE RESEARCH HAVE BEEN ANSWERED TO YOUR SATISFACTION. YOUR SIGNATURE
INDICATES THAT YOU HAVE DECIDED TO PARTICIPATE HAVING READ (OR BEEN READ) THE INFORMATION
PROVIDED ABOVE.
Signature of Participant/Subject
Age
Date
Signature of Legally Responsible
Representative
Time
Signature of Witness
Typed/Printed Name of Witness
Signature of Investigator
Subject’s Name (typed or printed):
Hospital Number (if applicable):
Mailing Address:
Phone Number:
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