Institutional Privacy Board
UPR Medical Sciences Campus
Application for Research using Individually Identifiable
Protected Health Information
IMPORTANT NOTICE: Complete this application in all its parts. Do not leave any
question unanswered. Cross-references with another document will not be accepted.
Before submitting this application to the Office for Research Affairs, please verify that it
has all the required signatures.
You should attach the following documents to this application, if applicable
1.
2.
3.
4.
5.
Research Proposal
Authorization document in English and Spanish.
A letter from the performance site establishing a cooperation agreement
and their responsibilities toward this project.
Copy of the HIPAA required training certificate for all personnel, including
faculty advisors.
Include original and two copies of all the documents
ADMINISTRATIVE INFORMATION
Protocol Number
(To be assigned by the Compliance Office)
Project Title
Principal Investigator
School
Department
Office Num.
Telephone
Mailing Address
E-mail
Fax
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Is any of the IPB (Institutional Privacy Board) member part of
this project?
If Yes, indicate
FUNDING SOURCES
Federal Agency
(Specify Agency)
Private Funds
(Specify)
Institutional Funds
(Specify Program)
Not Funded
PERFORMANCE SITES
Medical Sciences Campus
University District Hospital
Pediatric Hospital
University Hospital at Carolina
Other
(Specify)
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Yes
No
LAY SUMMARY
Summarize (in no more than 400 words) the proposed research using non-technical language that can
be understood by members whose primary concerns are nonscientific. The information must include:
 A brief statement of the purpose, background, significance
 Research design and methodology
 A brief specific description of the procedure(s) involving the individuals
Potential risks to participant’s rights
DESCRIPTION OF DATABASE/S OR RECORD DATA EXTRACTION,
AND RECORDING
SOURCE OF DATA:
(i.e. research participants, medical records, database etc.) It database/s or records are going to be used:
describe, in a meaningful fashion, the nature and location of the database/s or records to be used in the
research
METHOD OF DATA COLLECTION:
(i.e. interviews, questionnaire, data chart extraction)
Attach a printed copy of the datasheet you are going to use to record the extracted data The method of
extraction of data from the database/s or records; whether the data extracted are recorded (on paper or
electronic medium) with individually identifiable protected health information that permit the potential
association of recorded elements with identifiable individuals; and nature of the identifiers.
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USE AND RECORDING OF EXTRACTED DATA WITH IDENTIFIERS:
If the extracted data is going to be recorded with identifiers, justify this with reference to the research
protocol and justify any other use of the identifiers.
IDENTIFIERS
JUSTIFY
Name
All geographic subdivisions smaller than a
State, including street address, city,
country,
precinct, zip code, and their equivalent
geocodes
All elements of dates (except year)
Telephone number
Fax number
Electronic mail addresses
Social Security Number
Medical record number
Health plan beneficiary numbers
Account numbers
Certificate/license number
Vehicle identifiers and serial numbers,
including license plate numbers
Devise identifiers and serial number
Web Universal Resource Locators (URLs)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and
voice prints
Full face photographic images and any
comparable images
Any other unique identifying number,
characteristic, or code, except as permitted
None of the above will be used
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DESCRIBE THE INDIRECT IDENTIFIERS USED
(e.g. unique study identifier, encrypted/coded identifier, etc.)
Describe how the link between the indirect identifier and subject is going to be maintained securely and
separately from the extracted data.
LOCATION OF EXTRACTED AND RECORDED DATA
Describe where the medium containing the recorded data used for analysis/evaluation is going to be kept,
and enumerate the measures used to secure it from unauthorized access.
SHARE OF EXTRACTED DATA WITH RESEARCH COLLABORATOR
If you are going to send extracted data electronically or any other media to collaborators, describe the
necessity for inclusion of direct identifiers. If you are sending direct identifiers, please include the general
security measures you intend to employ.
LINKAGE OF EXTRACTED DATA TO OTHER DATABASES
Provide details concerning these databases and the mechanism of linkage.
STATUS OF THE EXTRACTED DATA AFTER COMPLETION OF THE RESEARCH
Describe what you are going to do with the extracted data after completion of the project .
WAIVER
If you wish to request a waiver or alteration of the requirement of the Authorization, please answer each
one of the following statement, as it is pertinent to your research proposal.
Yes
No
The research involves more than minimal risk to participants.
Yes
No
The waiver or alteration will adversely affect the rights and welfare of subjects
No waiver requested
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INVESTIGATOR’S ASSURANCE
I certify that the information provided in this application is complete and correct.
I understand that as Principal Investigator, I have ultimate responsibility for the protection of the rights of
the participants, use and disclosure of the individual’s protected health information, conduct of the study,
and the ethical performance of the project.
I agree to comply with all University of Puerto Rico Medical Sciences Campus policies and procedures, as
well as with all applicable federal and state laws regarding the protection of participants’ rights in research,
including, but not limited to the following”



The project will be performed according to the UPR MSC IPB certified protocol
No changes will be made in the protocol or authorization form until approved by the UPR MSC IPB
A valid authorization will be obtained from human participants, if applicable
I will complete the required educational program on ethical principles and regulatory requirements.
I further certify that the proposed research is not currently underway and will not begin until all required
approvals have been obtained.
Principal Investigator (Printed Name)
Date
Principal Investigator’s Signature _______________________________
STUDENT’S FACULTY ADVISOR’S ASSURANCE STATEMENT
Required for Students and Residents
This is to certify that I have reviewed this research protocol and I attest to the scientific merit of this study
and the competency of the investigator(s) to conduct the project.
Faculty Advisor (Printed Name)
Date
Faculty Advisor’s Signature _____________________________
Form Approved as of August 24, 2005
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