Revisions to 45CFR46 (Common Rule) have been delayed for at least 6 months. (1/2018)
The revisions to 45CFR46 (Common Rule) that were to go into effect tomorrow, January 19, 2018 have been delayed for at least 6 months (July 19, 2018) and may possibly be further delayed. The announcement may be found at https://www.federalregister.gov/documents/2018/01/22/2018-00997/federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-for.
Changes Regarding Need for Application for Certificates of Confidentiality (CoC) if study is Federally funded (1/2018)
On September 7. 2017 the NIH published a new policy regarding applications for certificates of confidentiality. Under the new policy, as of October 1, 2017, Federally funded research no longer requires an application for a CoC and researchers will not receive an actual certificate. The CoC will be issued automatically to grants, cooperative agreements, contracts and intramural research funded wholly or in part by the Federal government that collects or uses identifiable, sensitive information. Compliance with the requirements of the law will become a term and condition of award. All research that was commenced or ongoing on or after December 13, 2016 and is within the scope of this policy is issued a Certificate through this policy. Additional information may be found at https://nexus.od.nih.gov/all/2017/09/07/nih-new-certificates-of-confidentiality-policy/.
New Risks of Gadolinium (9/2017)
The FDA and the Radiological Society of North America (RSNA) have provided new information regarding the risks of gadolinium, a contrast dye used during an MRI. Several preliminary studies have demonstrated the presence of residual gadolinium concentrations in the brains of patients with no history of kidney disease. The clinical significance of this observation is unknown at this time, but warrants attention.
The IRB-HSR has implemented new requirements for studies involving gadolinium contrast and is requiring modifications to existing studies in which subjects will have an MRI with gadolinium contrast in the future. For questions contact the IRB at 924-9634.
Virginia IRB Consortium Conference (9/2017)
The 2017 Virginia IRB Consortium Conference titled “Final Rule Dissected: Moving toward Implementation” will be held at Inova in northern Virginia on Friday October 6th. The conference will focus on changes to 45CFR46 Part A (Common Rule). To attend you must register: https://www.surveymonkey.com/r/VAIRBConsortium. Space is limited so you are encouraged to register soon.
NIH Policy on Single IRB Review (9/2017)
The NIH Policy requiring a single IRB to serve as the IRB of Record for all sites on an NIH funded multi-site trial has been postponed until January 25, 2018. (postponed from September 25, 2017 & May 25, 2017). This policy will go into effect for any Grant/Proposal submission to the NIH for a new grant/proposal or a competitive renewal of a grant/proposal submitted AFTER January 25, 2018. Multi-site studies within ongoing, non-competing awards will be expected to comply with the policy when a competing renewal application is submitted. This means that if additional subjects will be enrolled in the federally funded multi-site trial under the new funding, the IRB oversight of the study for all sites will need to be transferred to a single IRB of record.
UVA Reliance on a Non- UVA IRB: Single/Central IRB Review (9/2017)
UVA is willing to rely on a non-UVA IRB to serve as the IRB of Record as long as there is an existing reliance agreement in place between UVA and the proposed IRB of Record (Reviewing IRB). Additional information on this may be found on the IRB-HSR Website under Submissions/ Reliance on a non- UVA IRB.
ISPRO now InfoSec (9/2017)
ISPRO has changed its name to Information Security or InfoSec.
Registration Open 8-21-17 - Spaces Limited- Virginia IRB Consortium Conference
The Virginia IRB Consortium Conference will be hosted by Inova this year and held on Friday, October 6,, 2017 in northern Virginia. The topic will revolve around upcoming change to 45CFR46: the Common Rule. To register go to https://www.surveymonkey.com/r/VAIRBConsortium
NIH Single IRB Review Policy ( 3/2017)
The NIH Policy requiring a single IRB to serve as the IRB of Record for all sites on an NIH funded multi-site trial has again been postponed until January 2018 (postponed from May 25, 2017).
This policy will go into effect for any Grant/Proposal submission to the NIH for a new grant/proposal or a competitive renewal of a grant/proposal submitted AFTER January 2018. Multi-site studies within ongoing, non-competing awards will be expected to comply with the policy when a competing renewal application is submitted. This means that if additional subjects will be enrolled in the federally funded multi-site trial under the new funding, the IRB oversight of the study for all sites will need to be transferred to a single IRB of Record.
Links to several resources are found below:
Learning Shot: Single IRB Review for Multi-Site Studies
Final Common Rule
The long awaited revisions to the Common Rule will go into effect January 19, 2018. The date by which institutions must be in compliance with these revisions may be delayed. Stay tuned for additional information.
Virginia IRB Consortium Conference
Registration is now open for the 2016 Virginia IRB Consortium Conference which will be held at UVA on September 30th. This years’ conference will focus on single IRB review and other proposed rule changes. There is no fee to attend however registration is required; due September 16th.
Agenda and Registration Forms
New Website Page: Coming to UVa?
A new website page has been added to the IRB-HSR website especially for new faculty members coming to UVa. Please share with any new faculty in your department who will be involved in research.
Coming to UVA?
Updated Data Security Plan
The Data Security Plan template has been updated in Protocol Builder. We hope the revised template will alleviate some confusion with the questions in the template. In addition, the IRB staff has modified the process for ISPRO review. The pre-review process by the IRB-HSR staff will now determine if review by ISPRO is required. If required, the IRB-HSR staff will forward the protocol to ISPRO for review. A protocol may also now be put on the full board agenda if the ISPRO approval is pending.
A Second IRB-HSR Panel
A second IRB-HSR panel (IRB-HSR # 3) has been formed to handle review of full board continuations and submissions requiring rapid/emergency review. This will allow more review time for IRB-HSR # 1 to review new full board protocols. Information about the board may be found at FWA Information and membership lists are available at IRB-HSR Membership Lists. Please list both IRB-HSR#1 and IRB-HSR# 3 as a UVA IRB that may review the protocol.
Protocol Builder and IRB Online No Longer Compatible with Internet Explorer
Due to recent changes made by Internet Explorer documents created by Protocol Builder no longer save correctly as word docs. Documents are created correctly as word docs if using Firefox or Safari as your internet browser.
Protocol Builder /IRB Online behind NETBADGE
Protocol Builder and IRB Online are now behind Netbadge at https://www.irb.virginia.edu. Unless you log out access is valid for 8 hours. You no longer need a separate password from IRB Online. An eservices digital certificate and UVa Anywhere VPN is required to access IRB Online off grounds. Need help? Contact UVA Help Desk http://its.virginia.edu/helpdesk/ or ITS website http://its.virginia.edu.
A-Z Index replaces Research Guide
The IRB-HSR Research Guide has been replaced by an A-Z Index. The A-Z Index may be accessed from the main header at the top of the page on the IRB-HSR Website found at http://www.virginia.edu/vpr/irb/hsr/
Personnel Designation Reminder- The following personnel designations will receive emails regarding a protocol. A person does not need to be listed multiple times in any of these positions in order to receive the emails: Principal Investigator, Study Coordinator I, Study Coordinator II, IRB Coordinator, Department Contact (this person may not have access to subjects or their identifiable data)
ISPRO Protocol Templates and Review (Posted August 19 2015)
The Privacy Plan protocol templates will be discussed in a session sponsored by the SOM Clinical Trials Office on September 9th at 9 AM: Presenter: Tim Tolson Location: Jordon Hall G 1/G 2 . In addition, a Q&A Brown Bag session will be held on Thursday, September 24th at 1 PM Location: Jordon Hall Room 1-17 Presenter- Susie Hoffman
Virginia IRB Consortium Conference: Adapting to Evolving Research and Regulatory Environments (Posted August 19 2015)
The Virginia IRB Consortium Conference will be held at VCU in Richmond on Friday, October 16th. The conference is free to attend, however registration is required. CEU and Attendance Certificates will be granted. Registration deadline is August 31st. Additional Information and Registration Information
Enrolling Non- English Speaking Subjects (Posted August 19 2015)
If you are enrolling a non- English speaking subject into a protocol which has a written consent, you may not enroll the subject without the use of a Short Form. A Learning Shot on the process may be found on the IRB-HSR Website at Use of short forms for non-English speaking subjects
UVa VPN Required to Access IRB Online/ Protocol Builder if Off Grounds (Posted August 19 2015)
A UVa VPN is required to access IRB Online/ Protocol Builder if you are physically off grounds. Be aware that this is a UVa VPN which is different from a Health System VPN. If you are in need of a UVa VPN please contact ITS.
IRB-HSR Website Search Feature (Posted April 2015)
The IRB-HSR Website now comes with a “Search this Site” option- top left hand corner.
Coded and Non-engaged Applications (Posted April 2015)
The signatures in the agreements in the Coded and Non-engaged Applications have been eliminated. All signatures required on agreements/ contracts will be handled by the SOM Grants and Contracts Office/ OSP with the Material Transfer Agreement.
Sharing Identifiable Data outside of UVa for an Improvement Project? (Posted April 2015)
If you will be sharing identifiable data outside of UVa for an Improvement Project- you MUST submit The Determination of Human Subjects Research form to the IRB-HSR.
5 Year Updates (Posted April 2015)
If a protocol is Open to Enrollment and the 5 year update is not completed the IRB approval will expire. Five-year updates will now also be required for Database Protocols.
VPN Required to Access IRB Online/ Protocol Builder if Off Grounds (Posted April 2015)
For added security a VPN is now required to access IRB Online/ Protocol Builder if you are physically off grounds.
ISPRO Approval (Posted April 2015)
As we have found situations where the changes required by ISPRO have required alterations in the protocol the ISPRO approval will now be required at the time of the protocol submission for pre-review to the IRB.
Expiration Dates on Certificates of Confidentiality (Posted April 2015)If you have a protocol which has a Certificate of Confidentiality granted by the NIH, you should be aware that the Certificate has an expiration date. If an updated Certificate is not submitted the IRB approval will expire. If your protocol has an IND or IDE, the Certificate will expire with the IND or IDE.
Welcome Tara Gaucher to IRB-HSR Staff (posted November 2014)
Please join me in welcoming Tara Gaucher to the IRB-HSR Staff. Tara is responsible for continuations for the 2nd IRB meeting of the month and for protocol closures.
Improvement Project vs. Research (posted November 2014)
The IRB-HSR continues to update the guidance to clarify improvement projects from research. The Determination of Human Subjects Research Form was revised recently. If you are performing what you consider to be an Improvement Project, you are strongly encouraged to review this form before you begin your project to determine if the project requires IRB approval.
Department Closure Reports Available (posted November 2014)
The IRB-HSR is now able to provide Department Closure Reports. The report provides a listing of all protocols of PI’s from a department. The report includes IRB #, protocol title, PI Name, Closure date and sponsor name. You may find this helpful as you comply with the UVa Records Management requirements. To obtain a report send an email to Susie Hoffman at email@example.com. Please include department name.
2014 Virginia IRB Consortium Conference (posted September 2014)
The University of Virginia (UVA), Virginia Union University (VUU), and Public Responsibility in Medicine and Research (PRIM&R) are pleased to announce
"Lifting the Fog: Issues of Informed Consent, Data Protection and Oversight in QI/Institutional Assessments and Research".
The conference will be held on November 14, 2014 at Newcomb Hall, University of Virginia, Charlottesville. For additional information, see conference agenda. To register, submit the registration for by October 30.
Note on CME:
The University Of Virginia School Of Medicine is accredited by the ACCME to provide continuing medical education for physicians.
The University of Virginia School of Medicine designates this live activity for a maximum of 5.5 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Quality Improvement vs. Research (posted May 2014)
The IRB-HSR Guidance on QI vs Research has been updated. If the project falls in the gray zone between QI and Research, the team will be required to submit a Determination of Human Subjects Research Form
Submission of Large Documents on CD (posted May 2014)
The IRB-HSR strongly encourages the submission of all large documents on a CD. The documents on the CD must be in PDF format. Paper copies of these documents are no longer required. The CD must be attached to a Document Submission Form Complete instructions are found on the Document Submission Form
Submission of Documents for Receipt of Acknowledgment (posted May 2014)
If you are submitting hard copy documents to the IRB for Receipt of Acknowledgment, the IRB # must be written on each document. If you are submitting multiple documents at one time for Receipt of Acknowledgement, you must submit them with a completed Document Submission Form.
Revisions to IRB Application (posted May 2014)
Any modification to the IRB Application will require the change be made to the full document along with the use of tracked changes and updates to the version date. A signature on the Application Form from the PI will NOT be required UNLESS the modification is for a change in PI or a 5 year update.
Submission of Continuation Status Forms (posted May 2014)
You are strongly encouraged to send all requested continuation paperwork via email to firstname.lastname@example.org
The Continuation Status Report should NOT be submitted to the IRB before it is signed by the PI.
Without the signature, the continuation cannot be counted as received and will not be reviewed.
Legally Authorized Representative (posted May 2014)
Information on who may serve as a Legally Authorized Representative and provide Surrogate Consent for another person to participate in research has been added to the IRB-HSR website at http://www.virginia.edu/vpr/irb/hsr/surrogate_consent.html
Data Security and Approval from ISPRO (posted May 2014)
Any new protocol/5 year update will require review and approval from the UVa Office of Information Security, Policy & Records Office (ISPRO) prior to IRB submission if any of the following will be done in the protocol:
Save the Date (posted May 2014)
The 2014 Virginia IRB Consortium Conference entitled “What Constitutes Human Subject Research in the 21st Century?” will be held at UVa’s Newcomb Hall on Friday, November 14th. Stay tuned for registration information.
Consent Form Template Changes for Studies involving Banking (posted February 2014)
In response to changes in the HIPAA regulations, the IRB-HSR has modified the consent form templates. Two signature sections are no longer required for studies that involve both a main study and banking for future unspecified research. These changes have been incorporated into Protocol Builder.
Receipt Acknowledgments of Submitted Documents (posted February 2014)
If you are submitting ANY documents in addition to the UVa IRB protocol and consents you are required to complete the Document Submission Form.
Consent Form Issues (February 2013)
The IRB-HSR has modified its policy regarding consents in medical records. You are now required to send the signed consent form to medical records ONLY if the study involves research of a drug, device or biologic, or involves an intervention that might significantly affect the clinical care of the subject.
Privacy Plan Issues (February 2013)
The template for the Privacy plan found in the IRB-HSR protocol has been modified to allow the study team to FAX identifiable info to the sponsor under certain conditions-
FAXING outside of UVa is only allowed if the receiving fax machine is in a restricted-access location, the intended recipient is clearly indicated, and that recipient has been alerted to the pending transmission and is available to pick it up immediately. Also verify FAX numbers before faxing and use FAX cover sheet with a confidentiality statement.
Study Documents (February 2013)
Please note that adding, deleting or revising things like questionnaires, is considered a modification. The IRB-HSR cannot process them through a Receipt of Acknowledgement process.
AGENT FORM(April 2012)
The IRB-HSR has developed a process and forms to help you determine if you are working as an AGENT of UVa while performing research. If you are NOT working as an agent of UVa, you may not need approval from the UVa IRB-HSR. There are two common situations where you might not need IRB-HSR approval (see below) . For more information see the IRB-HSR Website at http://www.virginia.edu/vpr/irb/hsr/activities_examples.html
August 2011- LEAVING UVA?
If you are a researcher leaving UVa please be aware of requirements. Please take advantage of the Exit Checklist found under FORMS on our website at http://www.virginia.edu/provost/facultyexit.pdf
What Needs IRB Review?
New Learning Shot: The IRB-HSR has teamed up with Dr. Ron Turner, Assistant Dean for Research of the School of Medicine on a new Learning Shot entitled What Needs IRB Review. We hope you find it helpful in answering this sometimes difficult question.
Health System Device Approvals
No medical device (supplies, accessories, or equipment), whether purchased, contracted, donated, loaned or for trial, may be used in the UVa Health System without first being evaluated by the UVa Health System. The approval process is now being done by Clinical Engineering instead of the Office of Supply Chain Management. The submission form and the contact information have been updated on the New Medical Device Request form which can be found on the IRB-HSR Website under “FORMS”.
Continuation Review Dates
Have a question about when your protocol is due for continuation review? The next review date may be found by logging into IRB Online and clicking on IRB Schedule (Removed 05/30/09)
Did You Know A Protocol Violation is any unapproved deviation from the protocol, GCPs, or IRB policies whether or not it is intentional and whether or not it is under the control of the Investigator. (Removed 12/12/08)
Did You Know Unless approved by the IRB, study subjects must provide the study team with a SS# or TIN #(Tax ID Number) or they cannot be compensated for being in the study (cash or gift card).
They may enroll, but
may not be paid. (Removed 08/18/08)
Protocol Builder Assistance:
The staff of the IRB-HSR provides assistance with Protocol Builder at no charge. If you are using Protocol Builder and need assistance please contact Margaret Ball at email@example.com or 243-0639.
Last Modified: Wednesday, 12-Jul-2017 13:59:39 EDT