NIH Policy Regarding Use of Single IRBs
As of January 25, 2018, NIH policy requires that all NIH multi-site clinical trials use a single IRB of record. The Office of the Vice President for Research (OVPR) in conjunction with the Senior Associate Dean of the College of Medicine has determined that the UVM Human Research Protection Program is not appropriately staffed at this time to take on the role of lead IRB. Therefore, UVM researchers who are developing NIH proposals of this type and wish UVM to be the IRB of record should plan to use Western IRB (WIRB) which is a commercial IRB. Proposals should include the use of WIRB as the IRB of record for the multi-site research activities and budgets must be developed to include the expense for the use of this commercial IRB. Further information regarding use of WIRB will be forthcoming. In the interim, please contact UVM IRB for guidance.
The Institution will continue to consider a scenario where the UVM IRB would act as the IRB of record for NIH funded multi-site research.
Currently, UVM will only cede review to another IRB for NIH funded multi-site clinical trials in order to comply with the NIH Single IRB mandate. Please see our Single IRB FAQs for more information on ceding review to an external IRB. More information will be forthcoming on processes to allow UVM IRB to cede review by the January deadline. See single IRB resource page for additional information and FAQs.
New Form - Research Data Management and Security Plan
A common human subjects risk across every research protocol is a potential to breach confidential information. In each consent, we strive to address the protections of a participant’s data, however we have struggled with ensuring that the processes are in place to really protect the data. With the advent of electronic data, it is no longer a question of “did you lock the research file cabinet.”
Many researchers are not aware of the various types of methods required to protect human subjects research data. The Committee in conjunction with a member from COMIS has developed a supplemental form (and cheat sheet) that will now be required at time of initial protocol review. The form will educate and elicit from the PI the methods he/she intends to use to protect the research data. The form is currently undergoing beta testing by a handful of investigators. We will plan to roll out this new requirement once our testing is complete, all affected forms are revised and our web site updated. This supplemental form will be required for all new full and expedited level protocols going forward as well for any protocols where the IRB requires a clearer plan be in place to protect data.
New CITI Courses Added
UVM has added two more courses to our supplemental training options. For those research protocols where prisoners are targeted subjects of the research, key personnel must complete the “Research Involving Prisoners.”
We have also added a new option for behavioral researchers to meet their NIH requirement to complete good clinical practice training by completing the “Social and Behavioral Research Best Practices for Clinical Research.”
Certificates of Confidentiality
Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016 and is within the scope of this Policy is deemed to be issued a Certificate through this Policy and is therefore required to protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act. This Policy will be included in the NIH Grants Policy statement as a standard term and condition of award effective October 1, 2017 for new and non-competing awards. Institutions and their investigators are responsible for determining whether research they conduct is subject to this Policy and therefore issued a Certificate. Certificates issued in this manner will not be issued as a separate document.
Previously, NIH provided these protections through the issuance of Certificates only upon receipt and approval of an application. However, in order to comply with the requirement in subsection 301(d) of the Public Health Service Act to minimize the burden to researchers, streamline the process, and reduce the time it takes to comply with the requirements associated with applying for a Certificate, NIH will now provide Certificates automatically to any NIH-funded recipients conducting research applicable to this Policy.
UVM Researcher Credentialing Reminder for FY18
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.
The deadline for UVM research faculty and staff to credential was June 30, 2017. Individuals who have not completed their credentialing will be receiving an email reminder to finish their renewal and failure to complete this process will have their access to UVM Medical Center patients, data and facilities revoked.
Information regarding the research credentialing process is on the Office of Clinical Trials Research website, Credentialing Process. For questions regarding the UVM Researcher Credentialing process please contact the Office of Clinical Trials 656-8990 or firstname.lastname@example.org.
Good Clinical Practice Updates
Effective July 1, 2017, all investigators and staff engaged in Human Subject’s research at UVM and the UVM Medical Center that fits the definition of a Clinical Trial will be required to complete Good Clinical Practice (GCP) training. Please see the Notice to Researchers dated 6/8/17. Additional information regarding GCP training, access to CITI training and FAQ’s can be found on the IRB website here.
Our Social and Behavioral researchers now have an approved GCP Module available to them, entitled Social and Behavioral Research Best Practices for Clinical Research. Social and Behavioral Researchers conducting clinical trials can now use this module to fulfill their GCP training requirements. Social and Behavioral Researchers who have already completed the other GCP courses can utilize the Social and Behavioral module at the time of their GCP training renewal.
Human Gene Transfer
“Human Gene Transfer” or “HGT” is used to describe research involving the transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into human subjects. It is also sometimes referred to as “Gene Therapy.”
Review and approval of a gene transfer protocol is complex and requires review by multiple Committees and hospital service lines, therefore RPO has developed a step-by-step guide for submission of a human gene transfer protocol at UVM/UVMMC.
Everything seems to be going well with protocol submissions through InfoEd. We would like to take the opportunity to bring a few items forward for you to consider as you are submitting your materials.
1. Please try to be consistent with your document naming conventions as indicated below:
“name of document mm-dd-yy”
2. Please do not upload different types of submissions under one submission. For instance, if you need to submit an amendment and an update to key personnel, this would be considered two separate submissions, one amendment and one key personnel. You cannot submit under the same submission as the reviews for each are different. You will be contacted to resubmit separately.
NIH Definition of a Clinical Trial
In 2016, NIH launched a multi-faceted effort to enhance its stewardship over clinical trials. The goal of this effort is to encourage advances in the design, conduct, and oversight of clinical trials while elevating the entire biomedical research enterprise to a new level of transparency and accountability. The NIH definition of a clinical trial was revised in 2014 in anticipation of these stewardship reforms to ensure a clear and responsive definition of a clinical trial. Learn more about why NIH has made changes to improve clinical trial stewardship.
Change to IRB Fee Policy
The fee policy has been updated to clearly reflect which type of sponsor’s may be invoiced for IRB fees.
The University’s Institutional Review Boards (IRBs) charge fees for initial and annual continuing review for all University of Vermont (UVM) and University of Vermont Medical Center (UVMMC) studies. Charging sponsors for their share of the costs associated with the IRB review process allows the IRB to continue to provide the level of service required by our faculty.
Fees will be applied to protocols sponsored by industry, pharmaceutical companies, other for profit entities, as well as non-profit entities where such fees are not prohibited, such as foundations which accept contributions from industry/pharmaceutical sponsors. Fees will also be incurred for review of protocols for organizations unaffiliated with UVM or UVMMC.
Fees will not be applied to protocols with federal or federal flow through, non-profit where fees are prohibited, or departmentally-funded studies. The fee schedule is reviewed each year by the IRB and is subject to change.
RPO Websites Moving to Drupal
Drupal is an open source platform used and supported by the UVM Web Team. The features include a new information architecture, improved navigation and functionality, and responsiveness to mobile devices. It is also easier for the lay person to maintain. The pages will appear very different, however all the same information is there. We hope you like the changes.