On-Site WVU Tissue or Data Repository Application
Office of Research Integrity and Compliance

Tissue or Data Repository Application

Principal Investigator: / Click here to enter text. / Email: / Click here to enter text. /
Co-Investigator(s): / Click here to enter text. / Email: / Click here to enter text. /
Co-Investigator(s): / Click here to enter text. / Email: / Click here to enter text. /
Contact Person(s): / Click here to enter text. / Email: / Click here to enter text. /
Sponsor (if applicable): / Click here to enter text. / Department: / Click here to enter text. /

Instructions

This form is intended to register a data or tissue repository for future use with the Office of Research Integrity and Compliance. Once this Application is approved, the form needs to be attached in the appropriate WVU IRB protocol. Conceptually, specimens are considered a medium for data and a data repository is the equivalent of a tissue or blood repository. Please send a copy of this application electronically to and include your Institutional Biosafety Committee approval.
Respond to each of the following sections that request information, even if to indicate “not applicable”. For questions please call the Office of Research Integrity and Compliance at 304-293-7073.

Application

General Information
Please indicate the type of application submitted: / ☐ Tissue Repository / ☐ Data Repository
  1. Describe the research purpose or the purpose of the tissue or data repository:

Click here to enter text. /
  1. Describe the data or specimens collected and/or retained in the tissue or data repository:

Click here to enter text. /
  1. What is the status of the data or specimen(s)?
/ Currently existing? ☐Yes ☐No / To be collected? ☐ Yes ☐ No
Please describe: Click here to enter text.
  1. Describe the source of your data and/or specimens:

Click here to enter text. /
  1. Explain the process for collecting and storing data or specimens:

Click here to enter text. /
  1. Where and how will the tissue or data be retained?

Click here to enter text. /
  1. What is the timeline for tissue or data collection once approved?
/ ☐ ______to ______
☐ ______toNo specific end date.
  1. What is the timeline for tissue or data retention once approved?
/ ☐ ______to ______
☐ ______toNo specific end date.
  1. List individuals with direct access to the tissue or data repository.

Click here to enter text. /
  1. If accessible to other researchers, how will the data or specimens be accessed? Please explain the process:

Click here to enter text. /
  1. Will identifiable protected health information (PHI) be disclosed (released) outside of WVU?
/ ☐ Yes ☐ No
If yes, please list to whom that PHI will be disclosed: / Click here to enter text. /
(Note: This release does not refer to publication (which should be released with no patient identifiable information); rather, is the PHI being collected for release to an entity outside of WVU(e.g. data analysis, archiving). See below for a listing of the 18 HIPAA Identifiers.
  1. Is there an internal tracking mechanism in place for the data or tissue repository?
/ ☐ Yes ☐ No
If so, please describe (e.g. If data has and end point, how will this be flagged for removal?) / Click here to enter text. /
  1. Please indicate which type of data or tissue you will collect. The definitions of the terms can be found below.

☐ De-Identified Health Information(Note: If using Statistical Waiver fill out justification section at end of this form).
☐ The de-identified data or tissue received has been coded or a link exists that can be traced to PHI (See Honest Broker).
☐ There is no link or code establish with the de-identified data or tissue.
☐ Limited Data Set
☐ The limited data set received has been coded or a link exists that can be traced to PHI.
☐ There is no link or code establish with the limited data set.
☐ Individually Identifiable Health Information
Statistical Review Waiver 45 CRF 164.514(b)(1)
Will a Statistical Review Waiver be requested with this tissue or data repository? / ☐ Yes ☐ No
If so, Please certify the following if a Statistical Review Waiver is requested:
  1. A person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable;
  2. Determines that the risk of re-identification of the data, alone or in combination with other reasonably available data, is very small; and
  3. Documents the methods and results of the analysis to justify the determination.

Printed Name of Statistical Reviewer: / Click here to enter text. / Signature: / Date:
Justification of analysis: / Click here to enter text. /
Re-Identification
A covered entity may assign a code or other means of record identification to allow information de-identified under this section to be re-identified by the covered entity, provided that:
  1. Derivation. The code or other means of record identification is not derived from or related to information about the individual and is not otherwise capable of being translated so as to identify the individual; and
  2. Security. The covered entity does not use or disclose the code or other means of record identification for any other purpose and does not disclose mechanism for re-identification.

Honest Broker
Definition - A neutral person or system that retains the pertinent source information of the individual’s tissue or data being used in the research. The honest broker replaces identifiers with a code, and releases only coded information to the researcher. The broker cannot be on the research team.
Will an honest broker be utilized as a part of this tissue or data repository? / ☐ Yes ☐ No
If so, please list the names of the individuals and their roles at WVU. / Click here to enter text. /
PI Verification
Please select the check boxes given below to verify the following:
☐ All individuals listed with direct access to the tissue or data repository have completed the appropriate Ethics Training course.
☐ All individuals listed with direct access to identifiable private information have completed the appropriate HIPAA training.
Chair Verification
☐ The scientific questions addressed for which this tissue or data repository will be used, have adequate merit to justify
experimentation involving human tissue or data.
☐ The PI understands that collection and future study will necessitate the submission of an IRB application.
Signatures
Printed Name / Signature / Date
Principal Investigator: / Click here to enter text. /
Department Chairperson: / Click here to enter text. /
IRB Chair or Vice Chair:
IRB Manager:
ORIC Director:

Definitions

De-Identified Data Set: HIPAA Safe Harbor 45 CFR 164.514(b)(2)(i)
In order to be considered "De-identified data" the data collected may not contain any of the following items or a qualified statistician must verify methods as outlined below to qualify for a Statistical Review Waiver:
  1. Name
  2. Phone Number
  3. Fax Number
  4. Health plan beneficiary numbers
  5. Certificate/license numbers
  6. Device Identifiers and serial numbers
  7. Internet Protocol (IP) address numbers
  8. Account Numbers
  9. Other identifying number, characteristic, or code
  10. Elements of dates (except year) directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older
/
  1. Geographic information smaller than state (i.e. zip code)
  2. Electronic Mail Address (Email)
  3. Social Security Number (SSN)
  4. Medical Record Number (MRN)
  5. Vehicle Identifiers and Serial Numbers (including license plate numbers)
  6. Web Universal Resource Locators (URLs)
  7. Biometric identifiers, including finger and voice prints
  8. Full Face photographic images and any comparable images

Note: The first 3 digits of a zip code can be retained if publicly available data from the Bureau of the Census indicates that the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people, and the initial 3 digits of a zip code of all such geographic units containing 20,000 or fewer people is changed to 000.
Limited Data Set:
The following identifiers must be removed to qualify as a limited data set:
  1. Name
  2. Phone Number
  3. Postal address (other than town or city, state, and zip code)
  4. Health plan beneficiary numbers
  5. Certificate/license numbers
  6. Device Identifiers and serial numbers
  7. Internet Protocol (IP) address numbers
  8. Account Numbers
  9. Fax Number
/
  1. Electronic Mail Address (Email)
  2. Social Security Number (SSN)
  3. Medical Record Number (MRN)
  4. Vehicle Identifiers and Serial Numbers (including license plate numbers)
  5. Web Universal Resource Locators (URLs)
  6. Biometric identifiers, including finger and voice prints
  7. Full Face photographic images and any comparable images
  8. Any other unique identifying number, characteristic, or code except as specifically permitted by HIPAA.

The health information that may remain in the information disclosed includes the following:
  1. Dates such as admission, discharge, service, DOB, DOD
  2. City, state, five digit or more zip code
  3. Ages in years, months or days or hours

Note: You are required to submit major revisions to this repository to the WVU IRB for review.