Fillable Form A: I understand my institutions policies concerning

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Form A: I understand my institutions policies concerning

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vNov2020
Form A
HUMAN USE RESEARCH
SIGNATURE ASSURANCE SHEET
Study Title:
Principal Investigator’s Assurance Statement:
I understand my institution’s policies concerning research involving human subjects and the IRB’s policies for protection of
human subjects. I will:
protect the rights, safety and welfare of the subjects involved in this research
ensure research is conducted in an ethical manner and in accordance with all laws, regulations, or policies
applicable to the protection for human research subjects and requirements and determinations of the IRB
personally conduct or oversee those who conduct this research
supervise study personnel to whom tasks are delegated. Ensure that study personnel: 1) are qualified by training
and experience and licensure to perform study-related tasks that have been delegated to them; 2) have an
adequate understanding of the research; and 3) follow the IRB-approved protocol, including the recruitment and
consent procedures described in the protocol summary
ensure that study subjects are provided with: 1) reasonable medical care for any adverse events, including clinically
significant laboratory values, related to the research; 2) a qualified contact to answer questions or provide care
during the conduct of the research; and 3) the study plan is followed, such as inclusion/exclusion criteria, safety
assessments, safety monitoring and reporting of unanticipated problems, and procedures to protect privacy of
subjects and confidentiality of identifiable data, in order to minimize risks to subjects
obtain, document, and maintain records of informed consent from each subject or when approved by the IRB the
subject’s legally authorized representative using the consent document(s) approved by the IRB
conduct the research in accordance with the protocol approved by the IRB
initiate changes in the research, including the approved consent form(s), only after IRB approval, except where
necessary to eliminate apparent immediate hazards to subjects
report promptly to the IRB and to the subjects, any significant findings or new information that becomes known in
the course of the research that might change the risk of or justification for the research or may otherwise affect the
willingness of subjects to participate or to continue to participate in the research
report promptly to the IRB, any unanticipated problems involving risks to subjects or others in research
operate within the parameters that have been defined in the authorization portion of the consent regarding
Protected Health Information (PHI)
comply with all applicable FDA regulations, including the Good Clinical Practices Guidelines, and fulfill all
investigator responsibilities (or investigator-sponsor responsibilities, where appropriate), including those described
at 21 CFR 312 & 812
control drugs, biological products, and devices used for research purposes
submit a progress report for continuing review prior to expiration of IRB approval in accordance with UTHSCSA
Policy;
halt all research activities should IRB approval lapse, until the IRB re-approves the research or until special
permission is obtained from the IRB to continue previously enrolled subjects if determined to be in their best
interests to do so
promptly submit a final report when the research has been completed or is being closed out prior to completion
maintain adequate and accurate research records in accordance with institutional and, when applicable, the
sponsor or FDA requirements
vNov2020
FORM A
SIGNATURE ASSURANCE SHEET
Completion of Section 1, Section 2, & Section 3 is REQUIRED. Complete Section 4 if PI is in an academic program.
Section 1
Study Title:
Method of Submission
Print, obtain signatures, then scan and submit an electronic (PDF) file of this signed form
When final digital signature is applied, lock the document & submit this Adobe Acrobat
version.
Section 2: Principal Investigator’s Assurance Statement: I understand my institution’s policies concerning research
involving human subjects. I understand the IRB’s policies for protection of human subjects. I have read and understand my
institution’s policy on conflict of interest or commitment. I understand it is my responsibility to ensure that others engaged in this
research report any potential conflicts of interest or commitment.
P.I. SIGNATURE: →_____________________________________________________________ DATE:________________
P.I. NAME (typed): ___________________________________________________________________
>> If there is a Co-P.I., a justification for sharing the PI responsibilities must be attached to the proposal & s/he must sign below:
Co-P.I. SIGNATURE: →_____________________________________________________________ DATE: ________________
Co-P.I. NAME (typed): ________________________________________________________________
Section 3: Department Chairperson’s/Division Chief’s (or equivalent) Assurance Statement: This is to certify that I
have reviewed this research protocol and that I attest: to the soundness of the design and its ability to answer the research questions;
to the competency of the investigator(s) to conduct the project; and to the presence of sufficient resources required for the research
and for protecting research participants’ safety. Due to concerns of a potential conflict of interest, if the Department Chair is the
PI, this section will need to be signed by a deputy chair/division chief or equivalent.
I confirm that the principal investigator is either: (choose one)
☐ An employee or agent of this institution (the Chair’s/Division Chief’s institution) OR
☐ Not an employee/agent of this institution (the Chair’s/Division Chief’s institution) and I support extending the institutional
assurance to this investigator ( submit a signed IIA [Individual Investigator Agreement])
The Chair’s/Division Chief’s Institution is:
☐ UTHSA; ☐ STVHCS; ☐ University Health; ☐ CSRHC; ☐ TBRI; ☐ SWRI; ☐ Other:
Chair/Division Chief SIGNATURE: __________________________________________________ DATE: ____________________
Chair/Division Chief Name (typed): ____________________________________________________________________________
Chair/Division Chief email (if not UTHSA): _____________________________________________________________________
Section 4: Academic Program Information Complete the following if the PI is in an academic program:
- Specify PI’s academic program (e.g. resident) ___________________________________ and Date Academic Program Ends:_____________________
(The protocol’s expiration date will be based on this date.)
- And include the signature of the PI’s Faculty Advisor (or Mentor):
Faculty Advisor’s Assurance Statement: I have reviewed this protocol and attest to its scientific merit and the competency of
the PI. I will provide guidance as appropriate.
Advisor SIGNATURE: ___________________________________________________ DATE: ________________________
Advisor Name (typed): ___________________________________________________________
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Form A: I understand my institutions policies concerning

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Completed 3 November 2021

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