Guidelines for IRB protocol descriptions for studies that
order tissue from TIES
This document is intended for the use of research teams that are submitting an IRB
protocol for a study that uses TIES to order tissue from the Health Sciences Tissue
Bank. The document lists the questions in the OSIRIS application that pertain to the use
of data from human subjects, and provides sample answers that accurately reflect the
nature of the data that is available from TIES. (OSIRIS is available at
https://www.osiris.pitt.edu/osiris/)
Questions from OSIRIS are shown in Bolded text, and example responses are shown
below them in italics. Selections from drop-down lists are identified with red asterisks
(*). We use double angle brackets (for example << information>>) to denote projectspecific information that the investigator must insert research-specific information.
Additional instructions are in this format.
IMPORTANT NOTES:
(1) The responses listed here are valid only for studies that will use only deidentified data from TIES. If your study involves obtaining de-identified data from
other sources or obtaining identified data from any source including TIES, these
responses are not appropriate and should not be included in your IRB
submission.
(2) Researchers who wish to obtain aggregate data preparatory to research, or
record-level data (but no tissue) do not need to obtain or provide an IRB protocol.
Aggregate data is available with a Preliminary User account, which may be
obtained at https://cdssecure.upmc.com/ties/PrelimReq.cfm No individual-level
information will be obtainable if you are a “Preliminary User” in TIES. Record-level
data is available with a Research Study (Data) account, which may be obtained at
https://cdssecure.upmc.com/ties/DataReq.cfm
OSIRIS Triage Section
T1.0 Select the type of application
* New Research Study
T2.0 Is the proposed research study limited to the inclusion of deceased individuals?
* no
T2.1 Are any research activities being conducted at the VA Pittsburgh Healthcare
System or with VA funds?
* no
T3.0 What is the anticipated risk to the research participants?
* Minimal Risk
T3.1 Why do you feel that all aspects of this research study, including screening and
follow-up, involve no more than minimal risk to the research subjects?
* There will be no human subjects. This study is based on de-identified preexisting data
extracted from TIES, a database of de-identified surgical pathology reports. At no point will
the researchers have the option to view identified data.
T4.0 Does the proposed research study qualify for “exempt” IRB review status or for
a "no human subject research" determination ?
* yes
E1.0 Which category applies to your proposed research study?
* Research with biological specimens
E2.0 Upload the exempt category form(s)
Fill out the exempt form for activities that do not involve human subjects that is available for
download at http://www.irb.pitt.edu/exempt/ . See the end of this document for an example
of an exempt research category form.
OSIRIS Cover Sheet Section
CS2.1 Research Protocol Abstract:
<<Describe background and significance as appropriate, and include text like the
following, modifying it as appropriate to reflect the nature of your study>>
* METHODS: Collection of de-identified data will be through TIES, a database of over 2 million
surgical pathology reports from the UPMC hospitals. Cases of <<disease, finding, or other
criteria>> will be extracted from the database.” <<Describe what you will do with the
cases; for example, “The number of cases of each specific form of <disease> will be tallied
and sorted by the demographic information (age, sex, race).” Etc>>
CS3.0 – CS14.2
Fill in appropriately.
CS15.0 Indicate the sites (i.e., institutions or facilities) where research interventions
or interactions will be performed and/or private information will be obtained:
Select only the site where you are located – for example, the University of Pittsburgh. Do not
select all of the hospitals that are represented in the TIES database.
CS15.1-CS15.2
CS16.0 Special Research Subject Populations: Check the categories that apply to this
research
study.
*None
OSIRIS Section 2 – Research Design and Methods
2.14 Will protected health information from a UPMC/Pitt HIPAA covered entity be
obtained for research purposes or will research data be placed in the UPMC/Pitt
medical record?
*No
2.14.1 Will protected health information from a non-UPMC/Pitt HIPAA covered entity
be obtained for research purposes or will research data be placed in the nonUPMC/Pitt medical record?
*No
OSIRIS Section 6 – Costs and Payments
6.2 Will subjects be compensated in any way for their participation in this research
study?
*No
OSIRIS Section 7 - Qualifications of Investigators and Source(s) of
Research Study
Answer this section appropriately
EXEMPT RESEARCH CATEGORY FORM
Below is an excerpt from the IRB Form that describes studies that do not involve human
subjects research. The sample below includes only those questions that are relevant to
the use of de-identified data in your study. The complete form contains additional
information. You must download the form from the IRB website
(www.irb.pitt.edu/exempt/), complete it with answers to all of the questions, and upload it
with your OSIRIS submission.
NOTE: The responses listed here are valid only for studies that will use only deidentified data from TIES. If your study involves obtaining de-identified data from
other sources or obtaining identified data from any source including TIES, these
responses are not appropriate and should not be included in your IRB
submission.
Study Title:
Answer each of the following questions:
1. Will any information from this project be submitted to the FDA or held for
inspection by the FDA? No
Yes
If Yes, STOP and contact the IRB at
askirb@pitt.edu.
2. Are the data or specimens being studied in this project obtained in a systematic
manner?
No
Yes
3. Is the intent of this data collection to contribute to ‘generalizable knowledge’ –
that is the findings are applicable to sites outside the University of Pittsburgh /
UPMC?
No
Yes
a. If No, and if this project is being conducted at a UPMC facility, has it been
submitted to the UPMC QA/QI committee? No
Yes
Note: If you are submitting this project to the UPMC QA/QI committee, or a similar
review committee, you need not complete this form.
4. Will the planned activity involve intervention or interaction with living persons
(human subjects)? No
Yes
5. Will the planned activity involve accessing (i.e., looking at or reviewing)
identifiable private information?
No
Yes
6. Are the data coded in such that a link exists that could allow the data to be reidentified?
No
Yes
If Yes, is there a written agreement that prohibits the PI and the research staff
access to the link? No
Yes
7. Are all records currently available for study? No
Yes
;
If No, over what time period will they be collected, from what source, and who will
collect them?
1. Study Design and Methods:
b. How will the project be conducted?
Collection of de-identified data will be through TIES, a database of over 2 million
surgical pathology reports from the UPMC hospitals. <<Briefly describe the criteria
you will use for selecting cases from TIES; for example, age, diagnosis>>
2. Types of information to be studied:
a. What data will be accessed?
The TIES database consists of over 2 million surgical pathology reports from the
UPMC hospitals. We will use TIES to obtain cases which contain <<describe the
criteria for selecting cases from TIES>>. The data will contain none of the HIPAA
“safe harbor” identifiers. The data will contain the patient’s age, sex, and race; the
year of diagnosis, and the specimen site (that is, anatomic site of the disease or
finding).
b. Describe PI’s right to access this data:
The PI will have approval to access TIES through the Health Sciences Tissue Bank
(HSTB).
c. How and where were data collected originally (if applicable)?
The database consists of over 2 million surgical pathology reports from the UPMC
hospitals.