welcome may 2010 sponsored projects information network
TRANSCRIPT
WelcomeMay 2010
SPONSORED PROJECTS INFORMATION NETWORK
SPIN Meeting Agenda
IRB Research Repository Compliance ProgramSusan Burner Bankowski, MS, JD
Chair, OHSU IRB and Director, OHSU Research Ethics Program
New Facilities & Administrative (F&A) Rate AgreementSteven Cofield, Cost Analyst Supervisor, Central
Financial Services (CFS)
Research Grants & Contracts (RGC) Hot TopicsDeb Golden-Eppelein, Director, RGC
SPIN Meeting Agenda
National Institute of Health (NIH) UpdateDeb Golden-Eppelein, Director, RGC
InfoEd UpdateKellie Guentert, Assistant Director, RGC
RGC New WebsiteKellie Guentert, Assistant Director, RGC
IRB Research Repository Compliance Program
Susan Burner Bankowski, MS, JD
Chair, OHSU IRB
Director, OHSU Research Ethics Program
Applicability of the Policy
This policy applies to human subject research repositories established by OHSU investigators for the purpose of storing data and/or specimens for future research purposes.
This policy does not apply to data/specimens that are collected and stored as part of routine clinical care or hospital procedures, for example, blood banks, pathology, surveillance, or quality assurance. However it does apply to data/specimens from these sources that are then stored for future research.
Approval Requirements
A human specimen/data repository may be categorized in one of three ways:Non-human subjects repositories (NHS)Exempt RepositoriesNon-Exempt Repositories
All research repositories, except those qualifying as non-human subjects research, require review and approval by the IRB.
Non-Human Subjects Research Repository
Non-Human Subjects Research – this is an activity that doesn’t meet the definition of human subject or research. Research projects that are originally deemed non-
human subjects (NHS) research and converted to a repository are considered NHS repositories.
Data/specimens that are de-identified as part of the original research protocol will likely be deemed NHS repositories.
A request for determination should be sought to have the IRB confirm the NHS status.
Exempt Repositories
Exempt Repositories – these meet the regulatory definition of being exempt from the full requirement of IRB oversight.
For repositories that are exempt, continuing oversight by the IRB is limited to annual renewals.
Repositories will NOT be found to be exempt if the data/specimens retain any identifier or link that would permit anyone to identify, directly or indirectly, the person whose data/specimens are stored.
Non-Exempt Repositories
The operation of any non-exempt research repository requires standard continued oversight by the IRB.
Creating a repository specific protocol will be required for the review.
The IRB will review and approve the repository protocol specifying the conditions under which data and specimens may be accepted into the repositories, how they will be securely stored, and the procedures under which they will be shared in order to ensure that adequate measures are employed to protect the privacy of subjects, maintain the confidentiality of the data and the integrity of specimens.
The Basics of a Repository
Repository activities involve three components:
1) the collection of materials,
2) the repository storage and data management
and
3) the use by recipient investigators.
Collection
Data & Specimens to be Included:DescriptionSourcesAcquisition processConsent & Authorization (or waiver)Conditions for Acceptance – Submittal AgreementConfirmation of local IRB approval
Maintenance
Security and confidentialityDescription how and where data/specimens will be
storedDescription of how the privacy of subjects and the
confidentiality of data will be protected, including if a Certificate of Confidentiality will be obtained.
Access to the data/specimens Description of who will have access to the
data/specimensDescription of what the requirements are for accessIndication of who is designated as the Guardian
Security and Confidentiality
Coding. A method to code the data/specimens, including a process to protect/maintain the key to the code and limit access to the key. The coding system must be adequate to reduce the possibility of re-identification.
Control of access to the data/specimens - access to the un-coded data/specimens must be restricted to a limited number of repository staff. Accountability for controlling and monitoring access must be provided.
Security and Confidentiality [2]
Usage requirements - A complete description of the process for requesting and releasing data must be included.
Methods for certification that the releases are not contrary to any previously imposed limits, via law, previous consent, genetic opt out, or other applicable limits.
Ensuring that material transfer agreements are used when necessary for the transfer of biological materials
Release
Description of Mechanisms release of data/specimens.
A statement that separate IRB approval/determination will be required for each specific human subject research activity that uses identifiable data/specimens from the repository.
Methods for securing Usage Agreements from recipient investigators.
Release [2]
Usage requirements - A complete description of the process for requesting and releasing data must be included.
Methods for certification that the release are not contrary to any previously imposed limits, via law, previous consent, genetic opt out, or other applicable limits.
Ensuring that material transfer agreements are used when necessary for the transfer of biological materials
Submitting for IRB Approval
The electronic IRB (eIRB) will contain a specific application for the creation of new research repositories.
Any existing study that is completed but has collected data and/or specimens for future research purposes may choose to convert the study to a repository via a modification or continuing review application.
It is recommended that a request for determination be sought from the OHSU IRB whenever there is a question of IRB oversight requirements.
Conversion of a Study Protocol to a Repository
For currently approved IRB protocols, including those not only with a specific research study, but also a research database/repository to store data/specimens for future studies:Once the research study and subsequent data
analysis are complete, the repository protocol can be separated into a repository specific IRB submission and the original research study submission can then be terminated.
This can be done at continuing review or via a modification
Modifications & Continuing Reviews
Modifications must be submitted only for changes to the protocol, not for every data/material exchange. If you are accepting data/material that is beyond what is described in the scope of the study or wishing to release beyond the scope, the modification must be submitted for review.
Releases requiring a waiver of consent & authorization require review by an IRB.
Continuing reviews must include a summary of data exchanges for the past year.
Terminating a Repository
When there is no intent to continue to operate a repository for future research or if the data/specimens are being transferred to another repository, the repository should be terminated via a modification in the eIRB.
The termination request must include the disposition of the data and samples, including details on transfer, donation or destruction of specimens or data in a secure way.
When applicable, a description of any communications with research participants regarding disposition of data and samples should be submitted for approval.
IRB Research Repository Compliance Program
Effective date 6/1/2010Year-long compliance initiative ends 5/31/2011Repository Information Page
http://www.ohsu.edu/xd/research/about/integrity/irb/repository-policy.cfm
More details & Updates are in development – Keep checking back.
Questions
New F&A Rate Agreement
Steven Cofield
Cost Analyst Supervisor, CFS
New F&A Rate Agreement
Activity FY10 FY11 FY12 FY13
Organized Research 54.0 54.0 54.0 54.0
Other Sponsored Activity
33.5 32.0 32.0 32.0
Sponsored Instruction 40.0 40.0 40.0 40.0
ONPRC – Core Grant 28.0 28.0 28.0 28.0
ONPRC – Federal Research
75.0 75.0 75.0 75.0
ONPRC – Non-Federal Research
91.0 91.0 91.0 91.0
Note: The off-campus rate remains at 26% for all activities.
Key Concepts
New F&A Rates are effective immediately
RGC/SPA to work with departments and/or agencies if any F&A adjustments are required.
F&A Rate AgreementCFS Website, Forms & Policies, F&A CostsBreakdown of F&A rates by component
http://www.ohsu.edu/xd/about/services/financial-services/forms/upload/farateagreemt.pdf
Questions?
Pre-Award Activities, excluding Industry
Deb Golden-Eppelein, Director of Research Grant and Contracts (503-494-4853)
Industry Sponsored Research
Arundeep Pradhan, AVP for Technology Transfer and Business Development (503-494-8200)
Industry Sponsored Clinical Trials
Darlene Kitterman, Director, Investigator Support and Integration Services (503-494-6263)
Post-Award Activities James Trotter, Director of Sponsored Research Administration (503-494-3211)
All other general questions can be directed to Steven Cofield in Central Financial Services at 503-494-1287
RGC Hot Topics
Deb Golden-EppeleinDirector, RGC
RGC Hot Topics
Subaward Request Form UpdateAdded First Year and Continuing Subaward
checkboxesCarry-forward of funds will automatically be
Restricted unless otherwise indicated on the form http://www.ohsu.edu/research/rda/forms.shtml
Reminder – RGC closed 6/24 and 6/25 during NIH Regional Seminar. Please plan accordingly!
NIH Update
Deb Golden-EppeleinDirector, RGC
NIH Update
Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section (VAS) in NIH Contract Proposals (NOT-OD-10-049)http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-049.html
Reminder: NIH/AHRQ/NIOSH/FDA Return to a Two-day Error Correction Window for Grant Applications Effective May 8, 2010 (NOT-OD-10-088)http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-088.html
NIH Update
NIH Expands Provisions of the Streamlined Noncompeting Award Process (eSNAP) and Requires Electronic Submission of SNAPs Beginning August 1, 2010 (NOT-OD-10-093)http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-093.html
Enhancing Peer Review: Clarification of Resubmission Policy and Determination of New Application Status
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-080.html
NIH Update
Amendment NIH Policy on Submission of Late Grant Application Materials Prior to Initial Peer Review http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-070.html
InfoEd Update
Kellie GuentertAssistant Director, RGC
InfoEd Upgrade
InfoEd Upgrade has been postponed. We expect to upgrade in August 2010, in time for the October submissions.
Continue to use Adobe forms for your submissions until we upgrade.
RGC Website Update
Kellie GuentertAssistant Director, RGC
RGC Website Update
RGC Website has been updated in new format!
http://www.ohsu.edu/xd/research/administration/research-grants-contracts/
Helpful Hints:bottom left of every page has “Quick Links” – you can
always find the link to the Forms theresome pages have a box on the right side -“Other
Helpful Links” or “Useful Links” or “Important Information”
RGC Website Update
Many thanks to Katie Wilkes, Amanda Horton and Rachel Dresbeck in RDA for creating our new site!
Have trouble finding something on the new site? Until June 1, please email Katie Wilkes
([email protected]) in RDA for assistanceAfter June 1, please contact your GCA.
The next SPIN meeting will be:
June 17, 2010
at 9:30am
in UHS 8B-60
Mark your calendar!