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HOW TO:REPOSITORIES AND
REGISTRIESRESEARCH MATTERS
HRRP OFFICE
ANNOUNCEMENTS
MICROSOFT TEAMS LIVE EVENTS - HOUSEKEEPING
• If you have any questions, please type your question in the Q&A
• Slides will be sent after this session and video is immediately available by clicking on the link in the meeting
• Attendance certificates will be sent to those who logged in with a valid email address (signed in and joined through Teams)
• If you do not receive a certificate, email [email protected]
HRPP UPDATES
• Congratulations to Rhonda Oilepo – promoted to Assistant Vice President, Human Research Administration!!!
• Hend Nadim has been promoted to Sr. Regulatory Analyst (!!!) and will be supporting the Reliance/sIRB teams
• Erica Howard-Dunn will be supporting the Analyst Team
• Welcome to Jazsmine Armstrong to the IRB Team
• Farewell to Aluel Mayen and Allison Griffin
• 2 Regulatory Analyst positions are posted
• Regulatory Monitoring Analyst is also posted
• Please contact Rhonda or Josh if you have any questions about open positions!
CITI EDUCATION
• Email was sent to Listserv on 1/13/21 as a courtesy reminder that study teams need to monitor and ensure that CITI education remains up to date
• Policy went into effect 1/2018 with 3 year expiration
• Many research staff have training expiring within the next 3-6 months
• This is causing a disruption in HRPP reviews and slowing reviews down
• Please review the content of that email to identify ways to prevent training from expiring
eIRB UPDATES
NAME AND STUDY NUMBER FONT
• Content in upper right hand corner of eIRB has been changed back to white font for easier reading
QUESTIONS 6.15 AND 6.17
• Consolidated uploads of all patient facing documents into 6.15; 6.17 will be for all other study documents
• Old text:
• 6.15: Upload questionnaires (if applicable) (Form J, J1):
• 6.17: Upload other documents (e.g., patient diaries, case report forms, SBC approval, Laser Safety approval, etc.) [Form J, Form X (Laster Approval), Miscellaneous Forms]
• New text:
• 6.15: Upload questionnaires, patient diaries, case report forms (if applicable) (Form J, J1):
• 6.17: Upload other documents (e.g., SBC approval, Laser Safety approval, etc.) [Form X (Laser Approval), Miscellaneous Forms]
RELIANCE WORKFLOW UPDATES• Reliance studies workflow within the eIRB Parent Smartform has been changed
• Old – skip from Section 5 (Performance Sites) to Section 7 (Populations), Section 9 (Review Type), to Section 12 (Reliance)
• Studies answered questions about drugs, devices, radiation in Section 12
• New – complete Section 5, to Section 6 (Study information), to section 7…
• Reliance studies will now answer what type of study it is (intervention vs use of data – 6.3) and what study activities will be conducted (6.7), which allows reliance studies to initiate IBC review
• Simplifies design and reporting of IRB Smartform
• Reliance studies will also route to Section 24 (Data and Specimens) to allow capture of data/sample transfers
• Question 6.7 will be auto-completed for reliance studies which have completed the drug/device and/or radiation questions in Section 12
• Question 6.3 will need to be answered for all reliance studies when the next modification is submitted
HOW TO:REPOSITORIES AND REGISTRIES
OBJECTIVES
Define and Explain the difference between:
• Repository
• Registry
Define the Responsibilities of:
• The Investigator (also known as the Administrator)
• Address the Risks associated
• The IRB
REPOSITORY VS. DATA REGISTRY
Repository – A collection of biological specimens whose organizers receive, maintain, control access, permit use of, and often code information and specimens to the donor’s identity• Usually includes demographic and/or medical
information
Registry – A collection of information elements or databases whose organizers receive, maintain, control access, permit use of and often code information and specimens to the donor’s identity.
√ Both need to be submitted to the IRB for review when used for Research purposes√ Both require oversight by the Investigator or Manager and the IRB
RESEARCH DATABASES
• De-identified research databases may be maintained after the completion of a study (new Common Rule requires that this be disclosed in the consent)
• Additional questions may arise in the future that can use the same dataset.
• If there is an intent to set up a registry, then the informed consent document should include language for subjects to opt-in or opt-out of storage of their data for future research purposes
• This registry must be separately IRB approved (not as a sub-study to the protocol approved to enroll participants)
COMPONENTS OF A REPOSITORY
• Collectors of tissue samples
• IRB Review, Informed Consent, Submittal Agreement
• Storage and Data Management center
• IRB Review, Informed Consent
• The recipient Investigators
• Recipient Agreement
• Local Policies
*Human repositories may be combined with data management centers
EXAMPLES OF REGISTRIES AND REPOSITORIES
Registries can be Public or Private
• Centers for Disease Control & Prevention
• State Cancer Registries
• The US Census Data Bank
• The National Library of Medicine Hazardous Substances Data Bank (HSDB)
• The National Practitioner Data Bank
Repositories• The National Human Radiobiology Tissue
Repository
• The National Institute of General Medical Sciences (NIGMS)
• Human Genetic Cell Repository
• NIH Genotypes and Phenotypes (dbGaP)
• NIH Dash - (NICHD – National Institute of Child Health and Human Development) Data and Specimen Hub (DASH)
EXAMPLES OF NON-RESEARCH REPOSITORIES
Created and maintained for purposes unrelated to research:
• Health records intended for diagnosis, treatment, billing, marketing, and quality assurance/improvement
WHEN IS IRB APPROVAL NEEDED?
• IRB Approval and consent is needed if:
• There is planned collection of additional tissue beyond what is needed for the clinical procedure
• Discarded tissue is obtained with identifiable information for analysis
• Note: Secondary analysis of de-identified specimens does NOT require IRB review and approval. However, federally funded studies may need some documentation of an IRB determination.
INVESTIGATOR RESPONSIBILITIES
• IRB Submission
• Collection
• Consent
• Security and Confidentiality
• Maintenance, Access and Storage
• Distribution and Tracking
RISKS
• Security
• Inappropriate access to the information
• Confidentiality
• Subject no longer wants to be part of the registry
• Misuse of data
• Depends on terms of the agreement
BEST PRACTICES
• Describe how you will secure the data and confidentiality
• Appropriate data use agreement (DUA) Required when sharing data/specimens between different institutions
• Universities, government agencies, other non-profits, and for-profit companies
• Describe how you will maintain the registry/repository
• Describe the consent process
• Describe and develop a training plan for study personnel
• Describe the intent and process in full detail throughout your protocol
IRB RESPONSIBILITIES
• Adhere to Regulatory guidance found at:
• Office for the Protection of Human Subjects (OHRP)
• 45CFR46.102(d, f)‐ addresses identifiable private data and criteria for when research does not involve living subjects.
• Food and Drug Administration (FDA)
• 21CFR50, 21CFR56, 21CFR312, 21CFR812‐ addresses informed consent, IRB review, Investigational Drugs, Investigational Devices, Biological Products, exceptions and exemptions
• Health Insurance Portability and Accountability Act (HIPAA)
• 45CFR160 and 164‐ addresses when an authorization is required and when it is not required
• HRPP Policies and Procedures
*UTSW IRBs do NOT allow repositories housed at UTSW to piggyback or be included within another study (repositories are not meant or intended to close)
