Announcements Archive
IRB-HSR Archive Announcement Documents
August 15, 2022
ResearchMatch: Recruitment made easier! ResearchMatch is a free and secure tool that researchers use to invite Volunteers to take part in their health research studies. Please see the iTHRIV portal and ResearchMatch to learn more about it!
July 1, 2021
HRPP Re-accreditation
UVA was granted re-accreditation of our human research protection program (HRPP) during the June, 2021 AAHRPP Council Meeting. Many thanks to all of those involved in human subject research at UVA and for all you do to protect those who participate in our research! This re-accreditation is in effect for 5 years.
Studies with Age of Majority Consent Addendum
If a study enrolls minors, who will turn 18 while participating in the study, it is important for study team members to remember to obtain consent from the subject who is now an adult unless the IRB-HSR has granted a waiver of consent in this situation.
Therefore, if a study has an Age of Majority Consent Addendum form in the active documents in IRB Pro, the study team must obtain consent from the emerging adult subject.
If consent is not obtained, the study team may not collect new information regarding the subject either through a review of medical records or an interaction with the subject. To do so would be conducting research without consent.
UVA Health and Human Subject Research
UVA Health made an announcement on July 1, 2021, that UVA Health has fully acquired the Novant UVA Health hospitals at Culpeper, Haymarket and Prince William. These hospitals were added to the UVA FWA on July 1, 2021, and the UVA IRB-HSR will serve as the IRB of Record for research conducted at these hospitals. The IRB-HSR will also serve as the HIPAA Privacy Board for research conducted in these hospitals.
Email Forwarding
- Automatic emails from IRB Pro are sent to the following individuals via their @virginia.edu email address: PI, SCI, SCII, IRB Coordinator, Department Contact.
- Emails from IRB Pro are sent automatically ONLY to @virginia.edu email addresses.
- If you only check email in your @hscmail.mcc.virginia.edu mailbox, you MUST forward the email from your @virginia.edu email address to your @hscmail.mcc.virginia.edu email address.
- To forward your email follow instructions found on the Information Technology Services website at https://in.virginia.edu/emailforwarding
Expedited or Full Board Review
Information is available on the IRB-HSR website which provides examples of study procedures to help you determine if a new study meets the criteria for expedited or full board review. If you are unsure of the review type you are encouraged to review this information.
Risk Assessment Tool- Expedited vs Full Board Review
A link to this document has also been added to the Submission Type Table under the Expedited column and in Protocol Builder under the question regarding Expedited review.
NIH Changes to Certificate of Confidentiality Effective Dates
The NIH has made a change in the effective date of a certificate of confidentiality (C of C) for studies that are not funded by the NIH. Data collected during the study are only:
“covered by the Certificate beginning on the later of the approval date of this Certificate or the commencement of the project, until the collection or use of identifiable, sensitive information concludes. The new language is included on Certificates issued on or after January 12, 2021.”
Therefore, for studies that require a C of C, that are not funded by the NIH, the IRB will not open the study to enrollment until the C of C is approved. For submissions sent to the NIH, the turnaround time is less than a week. You are advised to submit the C of C application when you submit the study to the IRB for pre-review.
Updated UVA Gene Transfer Policy
The School of Medicine has updated the Gene Transfer Policy. It is available at https://med.virginia.edu/policies/policy-on-human-gene-transfer-research/
You are strongly encouraged to review this document if you are planning to start a study involving gene transfer.
New Consent Language required for Studies Involving Treatment or Vaccine for COVID -19
Additional language is now inserted into consent form templates for studies involving treatment or vaccine for COVID 19. The section is included in the “What if you are hurt” section.
(January 13, 2021)
HIRE Standard Radiation Language
The HIRE committee has reviewed its standard radiation language and has determined that it is applicable for adults only. They will be working to develop additional standard radiation language that may be used with minors. Existing studies that may have used the standard radiation language in consent forms that enrolled minors are not required to be re-reviewed.
HIRE has also added standard radiation language for additional procedures. The current information will now be located only on the HIRE website. You may find a link to this information from the IRB-HSR website at Resources/ A-Z Index/Radiation Safety Standard Consent Language.
In addition, the HIRE questions in Protocol Builder have been updated to make sure that all applicable studies are sent to the HIRE committee for their review.
CITI TRAINING VERIFICATION
The VPR/IRB offices have now provided a new way for study teams to check the CITI training for study team members. This process should be used prior to submitting a new study for pre-review to the IRB-HSR to confirm all personnel have current CITI training.
Information is available on the IRB-HSR website under Education/ CITI Training/ How can you determine if others have completed required CITI training? found at https://research.virginia.edu/human-research-protection-program/hrpp-citi-training
Clinical Research Connect (CR Connect) Support Staff
Please be aware that you should contact the CRConnect support staff if you need help with CRConnect including determining if a study has been submitted to the IRB for pre-review. The CRConnect staff are able to identify what steps may be holding up the submission and assist study teams in moving the submission forward. IRB-HSR staff do not have access to this information.
CRConnect staff are available at CRConnectSupport@hscmail.mcc.virginia.edu.
Templates and Instructions
It is critical that study teams do not delete instructions or template sections from documents created in Protocol Builder (e.g. application, protocol, consents). This information is needed by IRB staff not only for the pre-review of a new study but also at the time of a modification review for revisions to applications and protocols. The pre-review completion will be delayed, as IRB staff have to spend time re-inserting deleted items.
New Study Submissions for Expedited and Full Board Studies Required via Clinical Research Connect
(July, 2020)
Effective July 1, 2020, all new studies requiring expedited or full board review MUST be submitted using Clinical Research Connect (CRConnect). If you have questions regarding the use of CRConnect please contact CRConnect Support within the SOM Clinical Research Office at CRConnectSupport@hscmail.mcc.virginia.edu.
Data Security Plan Modifications (July, 2020)
With the updates to Clinical Research Connect (CR Connect) that went live on February 26, 2020, study teams are now able to submit revisions to the Data Security Plan (DSP) created in CR Connect using tracked changes. The DSP with tracked changes may be submitted to the IRB-HSR when modifications are needed.
In addition, with this update the IRB-HSR staff will now perform pre-review and send the protocol to InfoSec if their review is required. The protocol will not be forwarded to InfoSec by CR Connect based on how the study team answered the security questions in Protocol Builder.
NIH Guidance Regarding Single IRB Review (July, 2020)
PER PRESS RELEASE FROM COGR:
The NIH released NOT-OD-20-058 Additional Guidance on the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.
The Notice reminds grantees that the Revised Common Rule is now in effect as of January 20, 2020. As a result, NIH K and F awards, which were previously exempt under the NIH Single IRB policy, are now covered under the Common Rule.
NIH also reminds awardees that exceptions granted under their sIRB Policy are only in effect until the next competing award.
If you are submitting a grant for a new or competitive renewal to the NIH and the study will be done at more than one site within the US, the study is required to be overseen by a single IRB. For additional information on the single IRB process see the IRB-HSR Website under Submissions.
Reliance on the IRB-HSR to serve as the Single IRB (sIRB) of Record
Reliance on a Non UVA IRB to serve as the Single IRB (sIRB) of Record
Access to Health Information for Research Purposes (July, 2020)
As a reminder, only individuals who are approved as a volunteer within the School of Medicine or who have an appointment (faculty or employee) (paid or unpaid) within the UVA HIPAA covered entity may access identifiable health information for research purposes before a subject has signed a research consent /HIPAA authorization. Appointments are usual approved for a one year period, at which point a new appointment is needed to continue to work on health related research.
The UVA HIPAA Covered Entity includes the following areas:
UVA Health including the School of Medicine & the School of Nursing, the Sheila C. Johnson Center, the Exercise and Sports Injury Laboratory and the Exercise Physiology Core Laboratory and University Physicians Group (UPG).
Identifiable health info may also be shared with the following areas without tracking the disclosure as agreements are in place to protect the information:
- VP Office of Research
- Nutrition Services (Morrison’s)
- UVA Center for Survey Research
By default, faculty and staff of the following areas are not employees under the UVA HIPAA Covered entity:
- School of Engineering and Applied Sciences
- School of Arts and Sciences
The implications of this is that these individuals may not review medical records to identify potential subjects or obtain consent for health related research.
With the implementation of IRB Pro on October 22, 2019, the IRB-HSR will no longer be adding a receipt acknowledgement stamp to documents submitted to the IRB-HSR.
Study teams should name the document in the file name and in the Document Submission form, if used, in a manner that they will be able to identify the document contents from a receipt event in IRB Online (e.g. 12345 Batch AE Submission; version date: 10-22-19) . Study teams should print the Event Listing from IRB Online to demonstrate to study monitors that documents have been submitted to the IRB-HSR.
If requested, study team members may also show monitors the actual document in IRB Pro. A link to a Standing Letter on this topic may be found on the IRB-HSR Website under Resources/ Standing Letters.
IRB Pro: New IRB-HSR Electronic Storage System
In October, 2019 the IRB-HSR will be implementing IRB Pro, our new electronic storage system which will serve as a storage portal for all study related documents. Study teams will still continue to submit study related documents to the IRB-HSR via the email contacts. Hard copy documents will no longer be submitted to the IRB-HSR or provided to study team members for any approval/determination completed on or after October 22nd.
Orientation sessions for IRB Pro will be provided to study team members in Pinn Hall Auditorium on the following dates/times:
- September 30th- Monday 3:00-4:00
- October 4th- Friday 8:30-9:30.
A Learning Shot will also be developed regarding IRB Pro and will be posted on the IRB-HSR Website under the Education tab.
Virginia IRB Consortium Conference:
"Data Management, Data Sharing and the IRB in the Era of the Revised Common Rule".
The Virginia IRB Consortium Conference will be held on Friday, September 27th in Norfolk, Virginia at Eastern Virginia Medical School.
This year's event will have keynote speakers on the topic of data management and sharing. There will also be afternoon sessions regarding Virginia Regulations and use of a legally authorized representative; the revised Common Rule (federal regulations); using Single IRBs and setting up Reliance Agreements.
Registration is free but you must register by the deadline of Friday, September 13, 2019 in order to attend. Click here for Event and Hotel information.
Questions? Contact Alyson Savage at Savageam@evms.edu.
IRB-HSR Website
UVA HRPP and the IRB-HSR websites will be undergoing formatting changes due to technical constraints and to conform to the UVA Brand Guidelines. An updated Learning Shot on the IRB-HSR website will be posted to ease the transition.
IRB Online/ Protocol Builder Down Time
IRB Online and Protocol Builder will not be available for use all day September 27th. Please plan accordingly.
Human Subject Research Protection Training Certificates- (May, 2019)
As of July 1, 2019 the IRB will only provide human subject research protection training certifications for new study approvals and at the time of continuation review for studies requiring review by the full board. No certifications will be provided for expedited studies at the time of continuation review.
Approval Stamps to be Eliminated from Consent Forms (May, 2019)
As of July 1, 2019 the IRB will no longer be adding an approval stamp including the approval and expiration dates to consent forms. Study teams should verify with IRB Online to make sure they are always using the most current approved version date of a consent form. A standing letter addresses this issue and may be shared with sponsors if needed.
Elimination of 5-Year Updates- Full Board Studies (May, 2019)
The IRB-HSR has eliminated the requirement for 5 year updates for studies requiring full board review. If major changes occur, studies affected by the change will be identified and study teams contacted to make required updates.
New UVA Health System Guidance Document: Research in Patient Care Settings (May, 2019)
The UVA Health System has developed a new guidance document titled Research in Patient Care Settings. Anyone involve in research in patient care settings is strongly encouraged to review the guidance. It may be found on the IRB-HSR website under Special Issues. http://www.virginia.edu/vpr/irb/HSR_docs/Forms/Guideline_Research_in_Patient_Care_Settings.pdf
Data Security: Texting and Use of Vendor Services for Handling Communication (May, 2019)
The IRB-HSR has received recent updates from Information Security. These updates have been made to the Data Security Plan and Privacy Plan of IRB applications.
Submission of Documents for Receipt Acknowledgement (May, 2019)
Please note that any document submitted to the IRB-HSR for a Receipt of Acknowledgement must be submitted in electronic format. Hard copies will not be accepted.
Pregnant Partner Consent (May, 2019)
The IRB-HSR is no longer requiring the submission of the Pregnant Partner Consent at the time of initial approval of a study. If the partner of a subject becomes pregnant and the sponsor wishes to obtain information regarding the newborn a Pregnant Partner Consent Addendum (template on IRB-HSR website under FORMS should be submitted with a modification to the IRB-HSR.
Required Posting of Consents from Clinical Trials
The 2018 Common Rule requires posting a consent form for any study regulated under the 2018 Common Rule that meets the definition of a clinical trial. OHRP has launched a webpage with information on the revised Common Rule�s clinical trial informed consent form posting requirement (45 CFR 46.116(h). https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/index.html. Contact the School of Medicine Clinical Trials Office if you have questions regarding posting consent forms.
Common Rule Revisions-Consent Expiration Dates (1/21/19)
Most revisions in the revised Common Rule (45CFR46) become effective January 21, 2019. All consent forms, with a new study approved by an expedited review procedure under the 2018 Common Rule, will no longer include an expiration date as these studies do not require a continuation review. In place of the Continuation Status Report study teams will receive an IRB Update Form. This form must be completed and returned to the IRB, however an IRB continuation assurance form and a new stamped consent form will not be provided. Accordingly, any modification made to a consent form for a study that was originally approved by an expedited review procedure and regulated under the 2018 Common Rule will also not have an expiration date.
Common Rule Revisions-Grant Proposal Reviews with Studies Regulated by Pre 2018 Common Rule (1/21/19)
Only new grants that are funding studies regulated by the pre-2018 Common Rule require review by the IRB-HSR. To determine if a study is regulated by the pre-2018 Common Rule see "Search IRB-HSR Protocols" from the IRB-HSR Website and look for "Regulated by Common Rule Version".
If a study is regulated by the pre-2018 Common Rule (previous rule) go to the Grant Submission Process at http://www.virginia.edu/vpr/irb/hsr/submit_grant.html for steps to follow to submit the Grant Application to the IRB-HSR. If all studies to be funded by the grant are/will be regulated by the 2018 Common Rule (new rule), no grant application to the IRB-HSR is required. Any new study submitted to the IRB-HSR after January 21, 2019 will be regulated by the 2018 Common Rule (new rule).
Common Rule Revisions-Grant Proposal Reviews with Studies Regulated by 2018 Common Rule (1/21/19)
If a study is regulated by the 2018 Common Rule (new rule) no submission of the Grant Proposal to the IRB-HSR is required. OSP or the SOM Office of Grants and Contracts will provide the Human Subject Research Certification training form.
UVA Receives Accreditation of our Human Research Protection Program: June 20, 2018
UVa received notification on June 19, 2018 from AAHRPP (American Association for the Accreditation of Human Research Protection Programs) that UVA has been granted full accreditation.
Revisions to the Common Rule (45CFR46): January 19, 2019
DHHS announced on June 18, 2018 that the implementation of the revisions to the Common Rule (45CFR46) will be delayed again until January 19, 2018. The IRB-HSR will be sharing information in the future on steps to comply with the revisions to the new rule as the implementation date draws closer.
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
NIH Policy on the Use of a Single IRB for Multi-Site Research
NIH Single IRB Policy FAQs for Extramural Community
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.
- Major changes include:
- Elimination of review of Grants/ Proposals by the IRB
- Elimination of continuation reviews for all expedited studies and for full board studies that have moved to analysis of data or accessing follow-up clinical data as part of clinical care. An annual update from study team regarding active /closed status will be required to enable the IRB to continue to provide Human Subject Research Protection Training Certificates.
- Review of medical records and collection of identifiable information will be transitioned from the requirement of expedited review to that of �limited� exempt review. A Data Security Plan will be required.
- Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. IRB-HSR consent form templates will be updated to include this requirement.
- A copy of an IRB approved consent form for clinical trials conducted or supported by a Common Rule department or agency will be posted by the awardee or agency in a publicly available federal repository.
- A single IRB of Record will be required for any federally funded multi-site clinical trial.
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 Forms Reminder: DO NOT delete any questions/ information found on IRB forms ( Status Forms) . If a question is not applicable to your study simply answer NA. Deleting questions/sections only extends the review time for IRB staff.
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.
http://www.virginia.edu/vpr/irb/HSR_docs/Forms/Determination_of_Human_Subjects_Research.doc
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 srh@virginia.edu. 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.
The University of Virginia School of Medicine awards a maximum of 5.5 hours of participation (equivalent to AMA PRA Category 1 Credit(s)TM) to each non-physician participant who successfully completes this educational activity. The University of Virginia School of Medicine retains a record of participants for six years. Educational transcripts may be obtained at www.cmevillage.com (click on Transcripts and follow the instructions).
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 irbhsrcontinuation@virginia.edu
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:
- Collecting data via a single use device (e.g. smart phone app, tablet, laptop)
- Collecting data via web based format (e.g. online consent, online surveys, online CRF’s)
- Storing identifiable health information or other highly sensitive data (e.g. SS#) on a server NOT managed by Health Systems Computing Services (HS/CS) or Information Technology Services (ITS)
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.
(Removed 04/01/2015)
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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.
(Removed 05/09/2014)
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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
(Removed 02/22/2013)
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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.
http://www.virginia.edu/vpr/irb/learningshots/RT%20SOM%20Oct09/player.html
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”.
(Removed 01/05/12)
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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)
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Copies
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)
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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)
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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 mnw2h@virginia.edu or 243-0639.
(Removed 01/29/08)