Spring 2018
Issue 53
Update - Single IRB for NIH Proposed Research
We have received a handful of inquiries from UVM researchers regarding reliance on Western IRB. The IRB has written letters of support for grants, provided the Western IRB fee schedule and Western IRB contacts for those researchers who were interested in developing a budget. More information about Western IRB can be found online (opens in a new window).
RPO is actively working with UVM researchers and other IRBs to set up multiple agreements to rely on external IRBs for NIH funded research. The projects range from a record review to a clinical trial. We are learning alongside most other institutions as to best practices. We have developed a step-by-step process which is located in our IRB Policies and Procedures Manual online, Section 13.3 Procedures for Relying on External IRB for NIH Research (opens in a new window). If you have been approached to rely on an external IRB, read this material first, then contact our office for assistance. We will walk you through the process.
Update - Common Rule Delay Status
On January 18, 2018, hours before the Common Rule effective date, we had received notice from our regulators that an Interim Final Rule had been approved, delaying the implementation of the final revisions to the Common Rule until July, 19, 2018. A Notice of Proposed Rule Making (NPRM) issued by our regulators on April 20th (opens in a new window) proposes further delaying these revisions to the Common Rule for another six months, making the new general effective date January 21, 2019. This new proposal is undergoing a 30-day comment period.
We will continue to keep you updated regarding the effective date as information becomes available.
Reminder - UVM Researcher Credentialing for FY19
We are taking this opportunity to remind you about the UVM Researcher Credentialing Policy. This policy is in place to ensure that research staff will have the appropriate orientation, competency, and oversight before participating in research activities and is a regulatory requirement.
Please communicate with your UVM research faculty and staff that their current UVM Medical Center ID research badges expired on June 30, 2018.
Information regarding the research credentialing process is on the Office of Clinical Trials Research website, Credentialing Process (opens in a new window).
New Process - Not Research Determination Self-Service Tool
During the analysis of IRB data that is being converted to the new UVM Connect module for IRB, it was noted that our IRB analysts have made approximately 400 “not research” determinations over the last few years. Only a small number of those projects did not meet the “not research” criteria and thus required additional IRB review. This means that researchers are appropriately applying the regulations in relation to the definition of “not research” the majority of the time. Given this information, the Committee has decided that the IRB office no longer needs to make those determinations.
To assist researchers with their own determinations, the Committee has developed a self-service tool for "not research" determinations (opens in a new window). The tool consists of the same questions taken from our “not research” form and indicates when the project falls out of the “not research” category thus requiring additional IRB review. There will be no documentation of the determination in the IRB office, therefore the tool provides an option for you to print the determination for your records as shown below.
You may contact your IRB Research Analyst (opens in a new window) for assistance.
Policy Update - Surrogate Consent for Research (Legally Authorized Representatives)
The Committee convened a subset of members in the fall to review and assess the legally authorized representative policy. We included constituents from UVMMC as we needed to reference hospital policies that were in place for surrogate consent for clinical care. We are pleased to announce that the team of members have successfully rewritten the policy and it is now available in our IRB Policies and Procedures Manual online, Section 9.2 Surrogate Consent for Research - Legally Authorized Representatives (opens in a new window).
The policy includes clearer guidance for researchers regarding capacity to consent of the individual and the criteria by which surrogate consent can be obtained. There are also now templates available for use to document that capacity was assessed, that an appropriate surrogate was consented as well as the relationship to the subject. Templates can be found in the Consent and HIPAA Guidance section of our website (opens in a new window). We have decided on a common signature line template for surrogates and will provide that template as applicable to the research.
If you have any questions regarding this process, contact your IRB Research Analyst (opens in a new window).
Helpful Tips - CITI Training Certifications
The RPO office is receiving multiple calls requesting that we provide a printed certificate for individual CITI training completions for key personnel. We created the Tutorial Completions page (opens in a new window) to allow for easy identification of required training completion dates. If you need/require printed certificates of completion, you must obtain them by going into the CITI Program, or if you are a PI and wish to have certificates for all of your key personnel, you must obtain those individually from your key personnel. Administrative staff in our office do not have the authority to obtain those for you.
Follow the instructions below to obtain a certificate.
Step 1: Log Into CITI by visiting the CITI Program Training page (opens in a new window) and click on "Main Menu/My Courses".
Step 2: Click to view or Copy the link to share the certificate of completion.
Step 3: Review the certificate of completion and save for future reference.
Update – UVMClick for IRB
UVMClick –We started with a kick-off meeting with Huron on February 28th and here we are already three months into the implementation process. Staff from Huron have been on site meeting with local project management, IT staff, RPO and IRB staff, as well as many individual constituents across UVM and UVMMC.
Our project plan includes steps to prepare migration of data, import of people profiles, departments, sponsors as well as the development of new smart forms, new business process, and training.
We have successfully completed one of several data integrations, meaning we are on the right track. Several RPO and SPA staff attended a national Huron meeting where important connections were made with Huron staff as well as other institutions such as Memorial Sloane Kettering, UCLA, and University of Washington discussing their process and experiences with the product. The feedback we received was positive. Lessons learned by others while implementing such a large module is to expect the unexpected, be flexible and communicate, communicate, communicate.
Noted System Functionality that will Reduce Burden
- UVMClick will use the power of on-line SmartForms, eliminating majority of word documents.
- SmartForms offer powerful branching logic where based upon answers to questions directs the user to complete only the next set of applicable questions.
- There is help text throughout all SmartForms.
- Use of the SmartForm provides opportunity for greater accuracy, quicker data entry and overall turn-around time on reviews and approvals.
- UVMClick allows researchers to assign a proxy to complete this work similar to our current system.
- UVMClick provides an immediate visual ability to check the whereabouts of your protocol as it moves through various states.
- UVMClick has functionality referred to as Ancillary Review. Currently, some research protocols require various institutional reviews that are not specific to the IRB, which requires that the researcher provide the protocol materials to multiple people. For example, UVMMC Billing Analysis and Contract Review and Negotiation are examples of required institutional reviews. With the Ancillary Review function, the protocol will be submitted one time to the IRB and the materials will be forwarded to the Ancillary Reviewer based on questions on the SMART form.
Next Steps and Where We Need Help
UVMClick is being rolled out by module starting with the IRB as shown in the timeline below.
We have created all of our SmartForms and will be testing those and producing process documents over the next few months. Any research coordinators interested in getting in front of the curve, by assisting with our review and testing, please contact Lynn.Tracy@uvm.edu, Project Manager.