Committees on Human Research
June 2011 Special Notice - FAHC Billing Compliance
December 1, 2010 - CHANGES TO THE HUMAN SUBJECTS IN RESEARCH TRAINING MODULE
Along with the InfoEd implementation, we are updating our Human Subjects Tutorial registration process. The current software that supports the registration data is being retired so we will be moving the registration portion of the training into “Limesurvey”, a survey software tool supported by UVM ETS.
Everyone taking the tutorial as of 12/3/10 will be required to register their completion using a UVM NetID and password. If you know both your UVM NetID and password you are all set and can complete this requirement.
If you do not know whether you have a UVM NetID and password, try the following:
1. Check the UVM directory at http://www.uvm.edu/directory/. Search for your name, scroll to the bottom of the directory card to find your NetID. (ex. dsilver, kfay) If your name does not come up on the directory, skip to #4 below.
2. If you have the UVM NetID but don’t know your password, you must reset your password. Go to https://account.uvm.edu/cgi-bin/accounts/reset-password to accomplish this.
3. Once you have both, you may complete your training requirement.
4. If you are clear that you do not have a UVM NetID, you must complete the following "Request for UVM NetID for Required Training" form and forward in a sealed envelope to the Research Protections Office at 213 Waterman Bldg., 85 South Prospect Street, Burlington, VT 05405. RPO will forward to you a UVM NetID at which time you will be able to set your password and complete your training requirement.
If you have any questions, please contact the office at email@example.com.
April 16, 2010 **IMPORTANT IMMEDIATE FEE POLICY CHANGE**
Effective immediately, the IRB will reinstitute the practice of holding the documentation of initial IRB approval until the review fee has been paid by the sponsor. On July 1, 2009, the IRB began releasing documentation of IRB approval before payment was received and this has created a serious delay in sponsor payment to Fletcher Allen. This process change required by FAHC is intended to correct this delay.
We regret any inconvenience that this change
may cause. Please see the
policy for more details and answers to FAQs on this policy.
Revision to IRB Policy Related to Multi-Institutional Studies under UVM/FAHC Leadership
The Committee is seeing increasing numbers of protocols in which
a UVM/FAHC researcher has taken on the responsibility of the “Operations or
Coordinating Center” in multi-institutional clinical trials. In these cases,
the UVM/FAHC researcher is ultimately responsible for the conduct of trials
at all participating sites. This requires that the UVM/FAHC researcher have
processes and oversight mechanisms to ensure proper study management. We have
revised Section 13 of our research manual to assist researchers in knowing what
their responsibilities are in this situation. Please refer to the full policy
to obtain details.
A new federal law, call the Genetic Information Nondiscrimination Act (GINA), makes it illegal for health insurance companies, group health plans, and most employers to discriminate based on a person’s genetic information. It prohibits health insurers or health plan administrators from requesting or requiring genetic information of an individual or an individual’s family members, or using such information for hiring, firing, or promotion decisions, and for any decisions regarding terms of employment. Given that GINA has implications regarding the actual or perceived risks of genetic research and an individual's willingness to participate in such research, OHRP Guidance has indicated that investigators and IRBs should be aware of the protections provided by GINA as well as the limitations in the law's scope and effect. See Research Manual Section 8.B.1. for additional information and new requirements.
IRB Fee Changes to Industry Sponsored
Research Effective July 1, 2009
Two major IRB fee changes will be implemented on July 1, 2009.
First, after review of the current IRB fee schedule for industry-sponsored research, the IRB review fees will increase as follows:
Initial Review: $2000 to $2500 per review
Continuing Review Fee: $1000 to $1500 per review
These are very challenging economic times. It has been two years since we have adjusted our fee schedule, and like most enterprises, our costs have been rising. Although is a national trend towards charging incremental IRB fees for additional IRB services, such as the review of each amendment, consent form change, advertisement, final report, serious adverse event, and Drug/Device Brochure Update, we believe that by raising the current review fees our expenses for all of these services will be covered and that payment of our current simple fee structure will be less burdensome for all involved than processing invoices for each of these individual services.
The Office of Clinical Trials Research (OCTR) will include this fee increase in contracts that are currently under negotiation. For previously approved contracts, PIs should contact OCTR to assist in any renegotiation that is required. This change in the fee schedule will apply to all new industry-sponsored protocols to be reviewed after July 1, 2009 and all ongoing trials that will undergo continuing review by the IRB after July 1, 2009.
The second major change is that FAHC will be
taking over the IRB fee invoicing function through their Financial Edge accounting
software. The IRB fees will be paid from the researchers'
clinical trial accounts at the time the sponsor is invoiced. Protocol approvals
will no longer be withheld pending receipt of sponsors’ payment of these fees.
October 30, 2008
October 24, 2008
Changes to Training Grant Internal Review Process (September 2008)
In the past, the RPO Committees (IACUC, IBC, IRBs) have given a single certification of approval for institutional training grants that were awarded to UVM through a process we called “administrative review.” This process was based on the requirement of certain federal sponsor for a single certification that all the individual research protocols named in the institutional training grant application had been reviewed and approved by the appropriate committee. Over the years, we have found that this certification is no longer required.
The research that trainees are involved in changes over the life of a project and any approval is only a “snapshot” in time. What is important to the funding agency is the institution provides assurance that all projects that a trainee will work on have been appropriately reviewed and approved. This assurance does not need to be in the form of a single IRB or IACUC certification of approval.
Because this administrative review activity is no longer necessary we are phasing out single protocols associated with institutional training grants. We will notify individual investigators that they will no longer be required to complete and submit continuing review paperwork and the files will be closed.
Principal investigators of training grants, however, are still required to provide the funding agency with a list of the projects and approval dates that trainees are working on with their annual progress report. The Research Protections Office can assist you with obtaining protocol approval information if you submit a list of protocols with the following information:
Committee File Number (CHRMS/CHRBS,IACUC, IBC), Principal Investigator
Name, and Protocol Title
Please call (656-5040) or email (firstname.lastname@example.org) the Research Protections
Office if you have any questions about this change.
CLINICAL TRIALS REGISTRATION: WHAT YOU NEED TO KNOW! (January 2008)
There are two different clinical trial registry mandates:
1) International Committee of Medical Journal Editors (ICMJE)
- Required as a condition for publication of trial results
- Clinical research studies must be entered in a public registry before any subject enrollment
- See definition of clinical trial in the link below
- Enacted as law with penalties
- See link below for types of trials requiring registration and timing of registration
- Types of trials have recently expanded and number of data elements increased
Where should a clinical trial be registered? Who is responsible? What is the process for registering a clinical trial? Who do I call if I have questions?
All of the questions listed
above are answered in the document entitled: Clinical
Trials Registration Information (scroll through the update instructions)
Continued Approval Policy: (Approved 10/17/07)
In order to resolve the issue of indefinitely reviewing and reapproving protocols annually for which work has not ever been started and wasting valuable staff and reviewer time, the IRB voted to approve the following policy:
If the work on a research protocol has not yet begun after a three-year period, the protocol will be closed. A new protocol must be submitted for review at the point in time when activity is anticipated to begin. Exceptions may be made if the funding period exceeds three years and the protocol is not scheduled to begin until after that time period. You must indicate that that is the case on your continuing review form.
This policy does not apply to protocols that have been and plan to remain open to accrual but have just not had any enrollment to date, such as many of the oncology group protocols that are approved for rare tumors. For that situation, the category (active - work in progress) should be checked on the continuing review form.
The majority of protocols
that we have been reviewing and reapproving for many successive years actually
never get started. If the work was to begin many years after submission, the
original forms and protocol would likely be outdated and it would be beneficial
for the protection of human subjects to give the project a new review.
RPO COMMITTEES AND INFOED PROPOSAL NUMBERS OR THE CHALLENGE OF MATCHING GRANTS TO PROTOCOLS
Funding agencies generally require review of the specific research procedures outlined in the grant application by the applicable RPO review committee(s). Each protocol submitted to the RPO for review must be linked to the corresponding grant application. This is a requirement for all of the RPO Committees (the IRBs, IACUC and IBC).
A new protocol must be submitted for Committee review and approval for every new funding proposal and every competitive renewal submission.
Pre-award services (PAS) will not release your funds until they have documentation from the applicable Committee that the protocol corresponding to the specific grant application, has received the appropriate clearances from RPO. The task of matching grants to protocols over the years has been extremely difficult because it was done manually and, unfortunately, the system has been less than perfect.
Now, with the implementation of Infoed, the electronic proposal and protocol management system, we are now able to link the protocol to the grant electronically and both PAS and RPO will have access to the corresponding materials. However, in order to link correctly we need your assistance in making the initial identification.
Each of our Committees have revised their protocol submission forms to include a field for the Infoed Proposal Number. We have been piloting this field on the Biosafety Committee forms for six months and have found that a majority of protocols are received with inaccurate or incomplete information. Inaccuracies typically include a proposal number for a proposal in which the project period has already ended or for a project that was never funded.
We wanted to take this opportunity to remind you of this requirement and to assist you in becoming familiar with this very important number. Below is a copy of routing form with the Infoed Proposal ID Number circled. This is the required number for all initial and continuing review forms.
Going forward, we will not be able to enter protocols submitted to the RPO committees into the Infoed management system without the correct information, and review of the protocols may be delayed.
It is critical that you identify the correct grant application and indicate the Infoed Proposal Number from the routing form that corresponds to the protocol you are submitting. If there is any uncertainty, please contact a staff member from either PAS or the RPO to assist you in determining the appropriate Infoed proposal number. Ultimately, this will make the entire process much smoother for everyone.
08/07 - New Adverse Event and Unanticipated Problems Policy
On July 12, 2007 our new Adverse Event and Unanticipated Problems Policy was put into effect. Section 9.B of the Manual for Human Subjects Research and the safety reporting forms on our website have been revised. Additionally, a powerpoint presentation has been created and is available on our website for further training on this topic.
The IRB will no longer accept submissions on old forms effective August 13,
Contact our office with any questions regarding what events or safety information needs to be reported.
5/08/07 - Change in Fee Policy
Please note that the University of Vermont/FAHC IRB has increased its continuing review fee from $500 to $1,000 for industry-sponsored trials. This increased fee applies to all protocols undergoing continuing reviews on or after July 1, 2007. Please see fee policy.
If this change results in the need for a contract renegotiation, please contact:
Office of Clinical Trials Research
1 South Prospect Street, Arnold 3431B
Burlington, VT 05401
Ph (802)-656-9097 Fax (802)-656-4074
08/06 - New Version of Instructor's Assurance
There is a new version of the faculty form to be completed for all exempt student projects that will be assigned as part of a course's requirement. This is available from the "Forms" page of this web-site and must be submitted and certified prior to the beginning of the course projects.
1/06 - Change in Fee Policy
Effective January 1, 2006 all industry-sponsored clinical trials will be invoiced a continuing review fee. This fee will be invoiced each time a trial receives a continuing review for the duration of the project. An invoice for $500 will be generated and sent along with the continuing review request form. This fee applies to full or expedited categories of continuing review and is expected at the time the PI submits the continuing review form for review.
This fee does not replace the current initial $2,000 review fee. This additional continuing review fee will help to meet our expenses for ongoing oversight of protocols. The volume of materials submitted for industry sponsored protocols has doubled if not tripled over the last few years. This fee structure is now standard for the majority of similar peer institutions.
OCTR began negotiating these fees with sponsors for those clinical trial agreements received in the last few months. They will also renegotiate those agreements that have been previously signed off.
Our fee policy is in the process of being updated and will be posted in our
research manual soon.
3/05 - IRB Policy Regarding Investigator Financial Interest
A subcommittee of the IRB has been meeting over the last few months to review current conflict of interest policy, federal guidance, other comparable institutional policies and accreditation standards. A draft policy was brought forward to the Committees in February which was approved.
This investigator financial interest policy is a first step in the direction to meet regulatory guidelines and accreditation standards as they relate to conflicts of interest in human subject research. Future policies will address and manage conflicts of interest at the institutional level and IRB member level. Please review the new policy.
6/22/04 - IRB, IACUC and IBC have Moved!
New Contact Information & New Office Name
The IRB has moved into new space with the IACUC and IBC in Colchester.
The IRB, IACUC, and IBC, will now be operating under the umbrella name “Research Protections Office” or "RPO" (these functions remain within the Office of Sponsored Programs (OSP)). All inquiries to any of the research committees should be routed to the new RPO main number.
CONTACT INFO CHANGES:
|RPO Telephone Number:||(802) 656-5040|
|RPO Fax:||(802) 656-5041|
|RPO Interoffice Address (UVM/FAHC):||245 South Park - Suite 900|
|U.S. Mail / Walk-In Address:||
245 South Park Dr.,
RESEARCH PROTECTIONS OFFICE - COMMITTEES
- Institutional Review Boards (IRBs)
- Committee on Human Research for Behavioral Sciences (CHRBS)
- Committee on Human Research for Medical Sciences (CHRMS)
- Institutional Animal Care and Use Committee (IACUC)
- Institutional Biosafety Committee (IBC)
RESEARCH PROTECTIONS OFFICE STAFF
|RPO Lead Administrator||Nancy Stalnaker|
|Committees on Human Research (IRB) staff||Donna Silver, Nancy Heller, Gale Weld & Megan Holthoff|
|IACUC staff||Penni Cross|
|IBC staff||Penni Cross|
|RPO general staff||Kay Fay, Georgia Siegchrist & Michael Olavarri|
6/7/04 - The IRB is moving!!!!!
At long last, the IRB has obtained additional space and will be relocating off-campus! This move includes only the administrative staff for the review boards (the Committees on Human Research, the Animal Care and Use Committee and the Institutional Biosafety Committee). This move does not include the grant administration function of Sponsored Programs, which will remain in 231 Rowell and 340 Waterman.
The IRB will be moving to 245 South Park in Colchester (where Continuing Education used to be located and next door to the Colchester Research Facility). Our tentative move date is June 23rd! As you can imagine, we have a huge volume of paperwork to keep track of during this move. We are asking your patience and to assist us by prioritizing your requests, and by holding off on submission of lower priority items until after the move whenever possible.
After the move, we will continue accepting protocols in the Rowell Office and
plan to have daily courier service. As details are finalized, we will keep you
posted. We are looking forward to being able to provide even better service
after the transition.
1) Who, exactly, is moving?
|Committees on Human Research staff||Donna Silver, Nancy Heller, Gale Weld & Megan Holthoff|
|IACUC staff||Penni Cross|
|IBC staff||Penni Cross|
|RPO general staff||Kay Fay & Michael Olavarri|
|RPO Administrator||Nancy Stalnaker|
2) Who is NOT MOVING?
|OSP Grant Administration @ Rowell||Beverly Blakeney, Dayna LeDuc, Lora Campagna & Dennis Herron|
3) How will this affect me?
Except for a change in our address and phone number, it probably won't. Interoffice mail will still be delivered to us in the same reliable manner. We will have a daily courier from Rowell 231 to the Colchester office for any hand-delivered documents.
AS SOON AS WE HAVE THE EXACT INTEROFFICE ADDRESS AS WELL AS OUR NEW PHONE NUMBER, IT WILL BE POSTED TO OUR WEBSITE.
The Medical Sciences IRB (CHRMS) will be temporarily limiting the number of protocols placed on the agenda for full committee review due to an extremely heavy workload. We are in the process of planning for an additional Medical Sciences IRB and in the interim, the Committee believes this is essential in order to ensure full compliance with all of the federal regulations and guidance protecting human participants in research.
Protocols will be added to the Committee’s meeting agenda on a first-come, first-served basis and the limit will be determined based upon the complexity of the protocols and the number of Committee reviewers available for each meeting. In order to promote fairness, departments and/or units with multiple submissions will be asked to prioritize them and the lower ranked protocols may need to be deferred to the next meeting if space is not available on the meeting agenda. Those protocols not included on an agenda will be placed next in line for the subsequent meeting.
Also effective immediately, in order for protocols to be added to the agenda, the submission must be complete, including the correct number of copies of all applicable requirements, e.g., Investigational Drug Brochure, HIPAA authorization forms, or waiver/alteration of consent requests. The earlier we receive a submission, the earlier any deficiencies can be identified and communicated back to the researcher, so they can be quickly rectified allowing the protocol to be placed on the next available agenda.
Last modified July 11 2011 08:30 AM