Guidelines for IRB protocol descriptions for studies that use data 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 locate clinical cases that are relevant to the research. 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 examples 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 project-specific 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 de-identified 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 ONLY aggregate data preparatory to research do not need to obtain or provide an IRB protocol. They may obtain a “preliminary researcher” credential at https://secure.opi.upmc.edu/caties/prelimreq.cfm No individual-level information will be obtainable if you have are a “Preliminary Researcher” in TIES.

OSIRIS Triage Section

T1.0 Does your proposed project constitute a “research1.” study, a “quality assurance2.”

project, or “innovative practice3.” procedure?

* Research study

T2.0 Is the proposed research study limited to the inclusion of deceased individuals?

* no

T3.0 What is the anticipated risk of the proposed research study as it pertains to the involved

research participants?

* Minimal Risk

T3.1 Why do you feel that this research study involves 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

T4.1 Which category applies to your proposed research study?

* Research with biological specimens

T4.2 Exempt Research Category Form:

Fill out the exempt form that is available for download on the page. See the end of this document for an example of an exempt research category form. provide this document again through the TIES Researcher Account Request 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 approximately 1,000,000 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>

CS2.2 – CS14

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 for the purpose of this research study:

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.

CS16.0 Special Research Subject Populations: Check the categories that apply to this research

study.

*None

OSIRIS Section 2 – Research Design and Methods

2.11 What is the total duration of the subject's participation in this research study?

* Fill in duration below (e.g., x months):

No human subjects

2.13 Does this research study involve the analysis of de-identified private (e.g., medical record) information collected using an "honest broker" system/process?

* yes

2.13.1 Identify (i.e., by department or other affiliation) the honest broker system/process that will be used for this research study.

* Identify honest broker system/process:

Department of Biomedical Informatics, Center for Pathology Quality and Health Care Research, the Health Sciences Tissue Bank (HSTB), Clinical Outcomes and Cancer Registry

OR

Any other Honest Broker service if Honest Broker has access to TIES.

2.13.2 Specify the IRB approval number for the honest broker system/process that will be used for this research study.

* Specify IRB approval number:

IRB # HB015

2.13.3 Identify the specific individual who will provide the respective honest broker services.

* Identify the specific individual:

Specify the TIES honest broker that you will be working with. This may be any University of Pittsburgh Honest Broker, who currently has access to TIES.

Alternatively, if you do not have a pre-existing Honest Broker with access to TIES, or if you will be requesting de-identified human tissue through the Health Sciences Tissue Bank, then specify the following individual:

Michelle Bisceglia

Manager, Health Sciences Tissue Bank

University of Pittsburgh

UPMC Shadyside

Department of Pathology WG04.8

5230 Centre Ave.

Pittsburgh, PA 15232

Phone: 412.623.1042

Page: 412.263.8051

OSIRIS Section 3 - Human Subjects

3.1 Indicate the age range of the subject population to be enrolled into this research study.

* No Human Subjects

3.2 Indicate the gender of the subject population to be enrolled into this research study:

* Both males and females

Provide justification for single gender, as appropriate:

3.3 Will any racial or ethnic subgroups be specifically excluded from participation in this

research study?

* no

Identify subgroup(s) and provide justification, if answer is Yes:

3.4 Will all individuals being recruited to participate in this research study be able to read and comprehend English?

* no

If your answer is No, identify the languages that will be understood by the potential research subjects.

No human subjects

3.5 Participation of Children: Will children (i.e., age < 18 years) be included in this research

study?

* no

If No, provide a justification for excluding children:

No human subjects. The source of the Surgical Pathology Reports that comprise the data for this project is CoPath, which does not include data from Children's Hospital.

3.10 What is the total number of subjects (i.e., all disease or condition sub-groups) that will be enrolled to undergo experimental interventions at this site (i.e., under the direction of the principal investigator listed on this application)?

* 0

3.11 Identify below, each of the disease- or condition-specific subgroups (e.g., normal, healthy volunteers; disease or condition A; disease or condition B; etc.) that will be enrolled into this research study. Specify, for each disease- or condition-specific subgroup, 1) how many subjects will be enrolled (i.e., to undergo the experimental intervention(s)) at this site; and 2) how many subjects, based on your estimate, will be required to undergo screening procedures, if applicable, in order to meet the projected enrollment at this site.

* Provide subgroup information:

Subgroup name or description: <disease, age range, or other criteria used to select reports in TIES

Number to undergo experimental intervention: 0

Number to be screened: 0

3.12 Provide a statistical justification for the total number of subjects to be enrolled into this research study at the multicenter sites or this site.

* Addressed Below

No human subjects.

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 (http://www.irb.pitt.edu/Exempt/default.htm), 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 de-identified 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.

IRB COVER SHEET:

Request for a determination that planned activity does not involve human subjects research

Where will study take place? University of Pittsburgh ; UPMC Oakland Campus ; CHP ; Magee ; Other UPMC Hospitals (specify): ; Other (specify): – U.S. ; foreign . *Is documentation attached authorizing conduct of research at non-Pitt/UPMC site? No Yes
·  Are the data or specimens studied as part of this project obtained in a systematic manner? No Yes
·  Is the intent of this data collection to contribute to ‘generalizable knowledge’ – that is to disseminate the knowledge obtained to others outside the University of Pittsburgh / UPMC? No Yes
·  Will the study involve intervention or interaction with living persons (i.e., human subjects)? No Yes
·  Will the study involve accessing identifiable private information? No Yes
·  Will the investigator receive data or specimens with identifiable private information? No Yes
·  Are the data or specimens coded in such that a link exists that could allow the data to be re-identified? No Yes . If ‘yes.’ Is there a written agreement that prohibits the PI and the research staff access to the link? No Yes
Are all samples currently available for study? No Yes ; If no, over what time period will these samples be collected, from what source, and who will collect the sample? Note: If prospective collection occurs, to qualify for an exemption under §46.102f [no human subject], no member of the research team can interact with the subject providing the specimen, and no identifiable private information can be recorded and linked to specimen.

IRB Protocol

3. Study Design and Methods

(a) How will the study be conducted?

Collection of de-identified data will be through TIES, a database of 1,700,000 surgical pathology reports from the UPMC hospitals. <Briefly describe the criteria you will use for selecting cases from TIES; for example, age, diagnosis>

4. Types of specimens (tissue, blood, bodily fluids) or other information to be studied:

(a)  What samples or data will be accessed?

The TIES database consists of 1,700,000 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 these specimens or data.

The PI will have approval from the TIES PI, Dr. Rebecca Crowley, to use the database for this study. This approval is contingent upon IRB approval of the study.

(c)  How and where were specimens or data collected originally (if applicable)?

The database consists of 1,700,000 surgical pathology reports from the UPMC hospitals.