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IRB-HSR > Announcements Archive

 

 

 

 

 

 

Announcements Archive

Consent Form Issues (February 2013)
The consent form template has been modified.    You are no longer required to provide the subject with a copy of the signed consent.  The subject must receive either a signed or unsigned copy. 

(Removed 04/09/2013)

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NEW REQUIREMENTS FOR CERTAIN MULTISITE TRIALS (August 2012)

If your protocol meets the following criteria, the IRB-HSR now requires review by the SOM CTO and a common protocol to be used by all sites.

  • Requires Full Board Review
  • Investigator Initiated
  • Multisite

 

REGISTER NOW:  Virginia IRB Consortium Conference ( August 2012)
The 6th Annual Virginia IRB Consortium Conference will be held at UVa at Newcomb Hall on Friday, October  12th .  To Register see:    http://www.virginia.edu/vpr/irb/hsr/va-irb.html

 

NEW IRB-HSR ROUTING FORM. ( April 2012)
In order to enhance communication, the IRB-HSR has revised the Routing Form.  PLEASE use the new form to ensure your submission gets to the right person. 
Link to revised form:  Routing Form

 

UVA 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

 

If you have questions, or would like to suggest a future topic or different meeting times, please contact me at jmg5b@virginia.edu.

(Removed 02/22/2013) ___________________________________________________________________

November 2011- Grant Review Process

Grants will now be reviewed by expedited review.  They will no longer need to go to the full board.  Therefore, you do not have to meet full board submission deadlines.  The forms have also changed.   Submission will be done with electronic copies only- no hard copies required.  Please see the IRB-HSR Website for detailed information and links to the appropriate forms.  http://www.virginia.edu/vpr/irb/hsr/submit_grant.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

Major Changes Completed to Protocol Builder!

  • The IRB-HSR Protocol Builder program was modified on February 4, 2011.
  • If you had started answering the questions in Protocol Builder prior to February 3rd but had not yet downloaded your templates, you will have to answer a few additional questions in Protocol Builder before being allowed to download your templates.
  • The program has been modified to NOT require a UVa IRB Protocol if there is already an existing protocol- such as a Sponsor's Protocol or Investigator Initiated Protocol.  An IRB Application will be required in place of a UVa IRB Protocol. 
  • For those protocols without an existing protocol- the UVa IRB Protocol template has also been modified to more closely resemble an industry sponsored protocol.
  • The applicable changes for modifications have also been posted. For additional information see the revised Modification Request Form under FORMS on the IRB-HSR Website.
  • An IRB Chat Hour on the new changes will be held in February. Please register if you plan to attend. If you work with Sponsor initiated studies we STRONGLY encourage you to attend this Chat Hour. 2/16/11 -Biostats conference room, Division of Biostats and Epi, Old Med School, 12-1 pm. 2/25/11-Morton 4th floor Conference Room, 8:30-9:30 am

Decrease in Number of Hard Copies Required

  • The IRB-HSR has DECREASED the number of hard copies needed for new full board protocols from the Original plus 6 copies to the Original plus 3 copies. 

(Removed on 08/08/2012)
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Education Updates

  • The dates and topics for the IRB-HSR Chat Hours have been determined for Feb-March of 2011.  See In Person Education page of IRB-HSR website for details.  Registration is required.  One nursing contact hour will be provided for each session.  
  • The next class of IRB 101 has been scheduled for February 23, 2011-Morton 4th floor Conference Room, 8:30 am-12 noon.  See In Person Education page of IRB-HSR website for details. To register, please contact jmg5b@virginia.edu.

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

New Website Information:  Examples of Activities that Require IRB Review
Several new examples of items that do not need IRB review, including the use of data from Public Data Sets have been added to the IRB-HSR Website.
See the website for additional information.
http://www.virginia.edu/vpr/irb/hsr/activities_examples.html

Specimen and Data Banks
HIPAA regulations require IRB approval for maintaining clinical information (outside of the official Medical Record) in a database if data from the database will be used for research purposes. 
An additional IRB protocol approval will be needed when you are actually ready to remove data and perform analysis. 
This process is also true for any specimens kept outside of clinical labs/ pathology that will be used for future research. 
If you have questions regarding the need for IRB approval, please contact the IRB office. 

IRB-HSR Chat Hours
The IRB-HSR will start hosting monthly IRB Chat Hours beginning this month.  
Each IRB-HSR Chat Hour is a one-hour education session focused on a specific clinical research topic. The hour begins with a presentation on the topic, followed by a discussion.

Each month features a different topic. Each month’s topic will be offered at two sessions, one in the hospital and the other in the 4th floor conference room, IRB-HSR Offices (located at One Morton Drive, on Route 29 N (next to Bodo’s Bagels) in Charlottesville). One nursing contact hour will be provided per session.
See the schedule at the end of this announcement:

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”.

Review Turn Around Time for Modification
The IRB-HSR has been inundated with modifications.  We have had to increase our turn around time from “up to 5 business days” to “up to 10 business days”.  Please keep this in mind as you are scheduling your submission.

(Removed 01/05/12)
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  •  Major changes coming to Protocol Builder:  Effective February 1st new templates will be posted into Protocol Builder.   

  • The order of the IRB-HSR protocol template sections has been modified to more closely resemble a sponsor's type protocol.  New template also includes a Table of Contents.

  • An IRB-HSR Protocol will NO LONGER be required if there is an "another protocol" to be used for this study.  An IRB-Protocol Application will take the place of the IRB protocol in these cases.

  • The IRB-HSR has DECREASED the number of hard copies needed for new full board protocols from the Original plus 6 copies to the Original plus 3 copies. 

  • The dates and topics for the IRB-HSR Chat Hours have been determined for Feb-March of 2011.  See In Person Education page of IRB-HSR website for details.  Registration is required.  One nursing contact hour will be provided for each session.  

  • The next class of IRB 101 has been scheduled for February 23, 2011-Morton 4th floor Conference Room, 8:30 am-12 noon.  See In Person Education page of IRB-HSR website for details. To register, please contact jmg5b@virginia.edu.

    (Removed 02/04/11) ___________________________________________________________

    IRB-HSR 101 Class Dates

    Additional dates for the IRB-HSR 101:" A short course for Study Coordinators and Sub-Investigators of Clinical Research have been set for 8:30- 12:00 AM on  
    March 8, 2010 l 8:30 to 12 Noon
    April 28, 2010 l 8:30 to 12 Noon
    If interested in attending please contact Jean Gaare Eby at jmg5b@virginia.edu
    (Removed 1/21/11)
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Upcoming Seminar
GENOMIC BIOBANKS:ETHICAL & LEGAL ISSUES

A seminar with Stanford University Law Professor Hank Greely
Friday, March 5, 2010  9:00-10:30
Jordan Conference Center Rms G1 & G2
Coffee & pastries will be available at 8:30 outside these rooms

Speaker/Seminar Leader: Hank Greely is Deane F. and Kate Edelman Johnson
Professor of Law at Stanford University, where he also directs the Center for Law and the Biosciences, chairs the Steering Committee of the Center for Biomedical Ethics, and directs its Program in Neuroethics. An expert on the legal, ethical, and social issues surrounding health law and the biosciences, Professor Greely specializes in the implications of new biomedical technologies, especially those related to neuroscience, genetics, and stem cell research, and frequently advises governmental and non-governmental bodies on these and other topics.

Sponsors:
•Institute for Practical Ethics and Public Life
•Department of Public Health Sciences
•Center for Biomedical Ethics and Humanities
•Research Ethics Advisory Group
•Institutional Review Board for Health Sciences
Research
(Removed 1/21/11)
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IRB-HSR Chat Hour Offerings
Summer/Fall 2010 Offerings (registration required):
 
July
Dates/Locations:
7/21-Health Sciences Library Rooms 1335-1337, 12-1 pm
7/30-Morton 4th floor Conference Room, 8:30-9:30 am

Topic:
Enrolling subjects with cognitive impairment/ surrogate assent
Led by Jean Gaare Eby, ScD, IRB Educator and Susie Hoffman, RN, BSN, CIP, IRB-HSR Director

August
Dates/Locations:
8/12-Public Health Sciences Classroom A, 3rd floor, West Complex, 12-1 pm
8/20-Morton 4th floor Conference Room, 8:30-9:30 am

Topic:
Modifications
Led by Theresa Altherr, IRB Compliance Coordinator

September
Dates/Locations:
9/13-Morton 4th floor Conference Room, 8:30-9:30 am
9/22-Public Health Sciences Classroom A, 3rd floor, West Complex, 12-1 pm

Topic:
Continuations
Led by Gretchen Watkins, IRB Compliance Coordinator

October
Dates/Locations:
10/6-Public Health Sciences Classroom A, 3rd floor, West Complex, 12-1 pm
10/14-Morton 4th floor Conference Room, 8:30-9:30 am

Topic:
PAM Program Overview
Led by Jane Lehmbeck, RN, BSN, CCRC, CIP Post Approval Compliance Monitor and Karen N. Parks, BSN, RN, CCRP, CIP Post Approval Compliance Monitor

November
Dates/Locations:
11/5-Morton 4th floor Conference Room, 8:30-9:30 am
11/12-Public Health Sciences Classroom A, 3rd floor, West Complex, 12-1 pm

Topic:
Data Use Agreements, IRB Authorization Agreements, Material Transfer Agreements- which one do I use when?
Led by Susie Hoffman, RN, BSN, CIP, IRB-HSR Director
 
December
Dates/Locations:
12/8-Public Health Sciences Classroom A, 3rd floor, West Complex, 12-1 pm
12/15-Morton 4th floor Conference Room, 8:30-9:30 am

Topic:
IRB Online
Led by Jean Gaare Eby, ScD, IRB Educator and Karen Mimms, RN, IRB-HSR Associate Director

(Removed 1/21/11)
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Education
Several new learning shots have been posted to the website.

See Inperson Education page for next inperson training class dates.
(Removed 05/30/09)
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Modification Update
Please remember that modifications requiring a change to the protocol and/or consent now require a pre-review.  Do not submit hard copies of your modification documents until you have received notification that your pre-review is complete.

Certain changes to a protocol will affect the templates you should use for the protocol and or consent.  For this reason- the full templates are now found on the website.  CAUTION:  These templates should ONLY be used for modifications to protocols already approved by the IRB.  A researcher must use Protocol Builder to write a new protocol or to complete the 5 year update.
(Removed 05/30/09)
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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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New IRB-HSR Chair
Effective August 1, 2009, Dr. Richard D. Stevenson will become the new chair of the IRB-HSR.  Dr. Stevenson is a professor in the Department of Pediatrics. He has been a member of the IRB-HSR for the last 6 years.  Please join us in welcoming him into his new position as chair.  We would also like to take this opportunity to thank Dr. Karen Schwenzer, who has chaired the IRB-HSR for the last 6 years, in addition to having been a member for a total of 12 years.  Her contributions to the IRB-HSR will have a positive impact on this board for years to come. (Removed from Main Page on 03/09/10)

Copies
The IRB-HSR office has been swamped with requests for copies.  We are currently receiving about 30-40 a week.  Unfortunately, when we spend much of our time making copies, there is little time left to review your submissions.  We need to ask that you either check with other people on the study team to find the copies you need or call the IRB office at 243-7039 or 924-5152 to make an appointment to come over and make the copies you need. (Removed from Main Page on 03/09/10)

CITI Online Training to be down
The online CITI training will be down for servicing the first week of August. If a new member of your study team needs to complete CITI training in the near future, we recommend they complete the training prior to August 1st. (Removed from Main Page on 03/09/10)

New Guidance on Aggregate Review
The IRB-HSR has added new information to our website regarding an explanation on how to carry out an aggregate review of your study data.  This information is required to complete the continuation status form.  The new information may be found at
http://www.virginia.edu/vpr/irb/hsr/continuations.html#aggreview
(Removed from Main Page on 03/09/10)

New Learning Shots
Two additional learning shots have been developed and are now posted.

IRB-Online describes the wealth of information that is available to the study team regarding their protocols in IRB Online. http://www.virginia.edu/vpr/irb/learningshots/IRBonline_Jun09/player.html

Writing a Clinical Research Protocol provides important information to consider when developing a research project and writing the protocol. 
http://www.virginia.edu/vpr/irb/learningshots/Writing_protocol_June09/player.html
(Removed from Main Page on 03/09/10)

IRB-HSR 101 Class Dates
Additional dates for the IRB-HSR 101:" A short course for Study Coordinators and Sub-Investigators of Clinical Research have been set for 8:30- 12:00 AM on  
-Monday, September 21st
-Wednesday, October 28th
If interested in attending please contact Jean Gaare Eby at jmg5b@virginia.edu
(Removed from Main Page on 03/09/10)

Protocol Builder Update
Several new questions have been added to Protocol Builder  regarding Waiver of Consent and Waiver of Documentation of Consent.  New questions were added in order to make sure the correct templates are being inserted into the protocol for all the different possible combinations of no consent, verbal consent and written consent involved in the consenting process. Additional guidance has also been developed to help you answer the new questions.  PLEASE review the guidance found in Protocol Builder before answering the new questions(Removed from Main Page on 03/09/10)

Auxiliary Documents Required for Submission
In the past the IRB-HSR has allowed certain items like the New Medical Device Form or the Radiation Safety Committee Approval to be submitted after the Agenda Submission Deadline.  As the process for these items has been improved, the IRB-HSR has found that in some cases, the outstanding item is the ONLY thing preventing the full board from approving a protocol.  Therefore, the Protocol Cover Sheet now states that these items will be required at the time of the agenda deadline submission along with the protocol. (Removed from Main Page on 03/09/10)

Need Any Clips? 
The IRB-HSR has a large box full of all different sizes of black clips.
FREE- First Come- First Serve-
Contact Florence Thoms at fgt@virginia.edu if interested.
(Removed from Main Page on 03/09/10)
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IRB-HSR Chat Hour Offerings
Winter/Spring 2010 Offerings (registration required):

February Dates/Locations:
2/22-Public Health Sciences Classroom A, 3rd floor, West Complex, 12-1 pm
2/24-Morton 4th floor Conference Room, 8:30-9:30 am

Topic: Safety Reporting: Adverse Events, Protocol Violations, and Unanticipated Problems
Led by Karen Mimms, RN, IRB-HSR Associate Director

March Dates/Locations:
3/22-Public Health Sciences Classroom A, 3rd floor, West Complex, 12-1 pm
3/31-Morton 4th floor Conference Room, 8:30-9:30 am

Topic:
Sponsored Trials and IRB-HSR Review Fees Led by Corky Miller, Business Manager, Office of the Vice-President for Research
Recruitment, Advertising, and HIPAA Led by Jean Gaare Eby, ScD, IRB Educator

April Dates/Locations:
4/12-Public Health Sciences Classroom A, 3rd floor, West Complex, 12-1 pm
4/29-Morton 4th floor Conference Room, 8:30-9:30 am

Topic:
HIPAA: Terminology & Writing a Privacy Plan Led by Jean Gaare Eby, ScD, IRB Educator

May Dates/Locations:
5/3-Public Health Sciences Classroom A, 3rd floor, West Complex, 12-1 pm
5/13-Morton 4th floor Conference Room, 8:30-9:30 am

Topic:
Protocol Builder: Genetics Questions
Led by Susie Hoffman, RN, BSN, CIP, IRB-HSR Director
(Removed from Main Page on 07/23/10)
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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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! Decrease in Number of Copies Needed to SIX! The IRB-HSR is now sharing many documents with IRB members electronically. Therefore the number of copies needed from the research team is decreasing. The number of hard copies needed for protocol and grant submissions has decreased from 23 to 6. (Removed from Main Page on 8/6/08.)

! Modifications and Continuation Status Reports: Modifications may no longer be submitted with a continuation status report. Modifications must be submitted separately. The only exception to this is a change in personnel. Please see the modification process page for additional information on how to submit a modification. (Removed from Main Page on 8/6/08.)

! Investigator Agreements: The IRB-HSR now requires the signed Investigator Agreement to be submitted to the IRB with the initial submission. If there is a problem in obtaining signatures from the Department Chair prior to the submission deadline the IRB staff will work with the study team on a case by case basis to obtain the signatures. (Removed from Main Page on 8/6/08.)

! Caution: Keep in mind that any data or documents, such as your research data, protocols or consents stored on the C-drive of your computer will not be backed up unless you do it yourself. For this reason the IRB does not advise files be stored on the C-drive. (Removed from Main Page on 8/6/08.)

The pre-review process has been so helpful that the IRB-HSR is requiring the same process for Expedited Studies. Please see the new instruction in Protocol Builder for assistance.

HSR Full Board Pre-Review Deadlines: The IRB-HSR is now accepting pre-review applications on a continuous basis and the pre-review is no longer subject to deadlines.  Please note that all protocols must be pre-reviewed before they can be included in a full board meeting. Allow for at least 7 business days for the pre-review process.  Please see HSR protocol submission for more information. (Removed from IRB Homepage 1/11/08)

IRB Coordinator Designation: Individuals other than IRB Coordinators hired by the IRB may now be designated as the IRB coordinator in Protocol Builder.  This person will receive emails regarding the protocol along with the PI, Study Coordinators and Department Contact.  (8/06) (Removed from IRB Homepage 1/11/08)
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The IRB-HSR has a brand new SOP on Violations and Protocol Enrollment Exceptions. Read the new SOP (Removed from IRB Homepage 1/11/08)
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Notice Regarding IRB-HSR Protocol Builder Program:
The IRB-HSR is currently in the process of making improvements to protocol builder. These improvements may affect you only if

  1. you are in the process of answering the questions and have not yet downloaded your protocol and consent form templates or
  2. if you need to go back and change answers to questions and re-create the templates.

Prior to creating your templates click on "Check Progress." 
You may receive a message of "Sequence Incomplete" next to "Questions."
If this happens please take the following steps to remedy this situation:

  1. Click on Questions. 
  2. Start with question # 1 and go through the questions consecutively - answering each question in order. 
  3. If the question is already answered - all you need to do is hit the enter button and go onto the next question. 
  4. This process will reset the program and allow you to print the templates when you click on Create Forms.

This process should take you no longer than 5 minutes to complete.  We apologize for the inconvenience. Unfortunately, there is no other way to make these upgrades.  Thank you for your attention to this issue. (01/11/08)
(Removed 01/29/08)
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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)
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Notice Regarding IRB-HSR Protocol Builder Program:
The IRB-HSR is currently in the process of making improvements to protocol builder. If you are having trouble creating your templates please review.

Changes to Modification Process

The IRB-HSR is happy to announce changes to the modification process.  Several things such as personnel changes (other than PI), minimal changes in # of subjects, and most change of status may now be done electronically.

In addition, any type of modification made to the protocol and consent form must be submitted initially electronically for pre-review.  As with pre-review for other submissions we have found that this actually saves many steps back and forth with hard copies. 

The new process is now posted on the IRB Website under "Maintaining a Protocol.  The   revised forms are now posted under "Forms".  Please throw away any copies of outdated modification forms you may have saved on your PC or in hard copy.
http://www.virginia.edu/vprgs/irb/hsr_maintain_modification.html

Studies Involving Drugs, Biologics and Devices
The IRB-HSR has added more information to the website regarding FDA information and IRB processes for studies involving drugs, biologics or devices. Please see http://www.virginia.edu/vprgs/irb/hsr_polproc.html

New "learning shot" presentations available online
Three new voiced-over presentations have been added to the IRB's website.  The new presentations cover the process for modifying an approved protocol, use of consent "short forms" for non-English speaking research participants, and how HIPAA can impact the research recruitment and advertising process. These talks can be viewed at http://www.virginia.edu/vprgs/irb/education_online.html

Studies Involving Gene Transfer
The School of Medicine has updated their Gene Transfer Policy.  It is now posted on the IRB-HSR website http://www.virginia.edu/vprgs/irb/HSR_docs/Forms/Gene_Transfer_1-25-08.pdf
(Removed 04/04/08)
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