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February 14, 2020

Changes to Committee Leadership/RPO Staff

Renee Stapleton, MD, PhD has been appointed Associate Chair of the Medical Sciences Committee.  Dr. Stapleton is a pulmonologist and critical care medicine physician as well as a successful researcher.  She has been a member of the IRB for 4 years.  Congratulations, Renee, on this new appointment!

Welcome new RPO research analyst – Jen Dulin, DVM, MS. 

Educational Opportunities

Principal Investigator Responsibilities in Research – Bag Lunch

David Kaminsky, M.D., Pulmonary and Critical Care Physician

February 19, 2020 12:00 – 1:00 pm HSRF 300

Additional ����̽̽ Consent Process and Documentation Training – online training module

This is an updated ����̽̽ slide deck on the Who, What, When, Why, and How to carry out the informed consent process.  This is important additional training for all research team members who have been delegated the task of obtaining and documenting informed consent.  A mini-quiz will record your completion at the end.

IRB Drop-In Hours

IRB Research Review Analysts continue to hold drop-in hours every Monday from 1:00 to 3:00 in 213 Waterman.  Please feel free to bring your questions about protocols or Click.  We are here to help.

Request for Exceptions to IRB Policy/Procedures

As you are aware, the IRB has a set of policies and procedures for the conduct of research at ����̽̽/����̽̽MC.  Having a set of procedures is a regulatory requirement.  These procedures are referenced by ����̽̽/����̽̽MC researchers and research staff, FDA inspectors, OHRP representatives, and other external IRBs that we rely upon for protocol review.  They are also a very important tool for the IRB Analysts and Committee members to reference while conducting their reviews.

Policies and procedures included within the manual have been vetted through a Policy & Procedure Subcommittee consisting of IRB Committee Members and IRB Analysts.  The vetting process, when necessary, pulls in specific stakeholders across both ����̽̽ and ����̽̽MC.  Both new procedures as well as any substantive revisions to current procedures are approved for distribution through this mechanism. 

We realize that not every issue is black and white.  If a researcher finds that a particular procedure or policy does not appear to apply to their specific situation, an exception from that requirement may be formally requested.  This provides a mechanism for review as well as document the departure from our internal policies and procedures.

IRB Policies and Procedures Quarterly Update and Template Changes

The majority of changes to the manual are related to the final 2018 Common rule compliance date of January 20, 2020.  If you have any questions, please do not hesitate to contact irb@uvm.edu.

Sections

5.0     Eligibility to Perform Research at ����̽̽/����̽̽MC (changed title to be more representative of section content, previously Investigator Responsibilities)

9.1     Consenting Children (clarified parental permission requirements)

9.1.1  Children Reaching Legal Age of Consent While Enrolled in a Study (updated procedures and form)

13.0   Cooperative Research (updated for January 20, 2020 Cooperative Research clause)

13.3   Procedures for Relying on External IRB for Federally Funded Research (updated to include all federally funded research as require by the January 20, 2020 Cooperative Research clause of the 2018 Common Rule)

13.7   Non-Collaborative Review and ����̽̽ IRB New

26.     Human Subject Quality Assurance Review (previously Human Subjects Research Monitoring Program)

31.     2018 Common Rule Transition (describes how the IRB transitioned protocols to the 2018 Common Rule)

Templates

Consent for Continued Participation in a Research Study after Age of Majority

Children who have been enrolled in a research study with their parent’s permission (and possibly their assent) must re-consent to continued participation at the time they turn 18 years of age.   The consent template has been revised to include the full HIPAA language.  See section 9.1.1 above for more details about the require process to re-consent these subjects.

News From The Office of Clinical Trials Research

Research Account Process Changes after EPIC “Go Live”: 

The ����̽̽ Medical Center Eletronic Medical Record (EPIC) update on 11/09/2019 necessitated changes to the ����̽̽ Medical Center research billing accounts, previously known as 96 accounts.  Information regarding these changes and if and how to can be found on the OCTR Commons Site.

IRB Quality Assurance Reviews

For the past 18 months, in an effort to be proactive in assuring that our institution is compliant with local and federal research requirements, The Larner College of Medicine (LCOM), in conjunction with the ����̽̽ Research Protections Office, has instituted a Clinical Trial Quality Assurance (QA) Monitoring Program of more than minimal risk protocols being conducted within LCOM. 

Beginning in March, RPO will begin their quality assurance program as described in the IRB Policies and Procedures, section 26: Human Subject Quality Assurance Review.  Initially the focus will be on those protocols that no longer have continuing review and those protocols for which we cede review to an external IRB.  These reviews should be viewed as a collaborative effort to ensure the safety and rights of our research participants.  IRB staff will work with the research teams to identify gaps, educate and correct any insufficient items.

����̽̽Click-IRB Tips

1.  Deleting Attachments - Please never delete IRB reviewed or approved versions of documents unless you are directed to do so by your IRB analyst. When you delete items we lose history of review.  The maintenance of IRB records is a regulatory requirement.  You may delete documents during pre-submission, but that is the only time. 

2.  Revising Attachments - If you want to REVISE a previously uploaded document, click the UPDATE button, not the +Add button.  Please use track changes in Word to identify your changes (do not use highlighting).  Also please make sure that you update the documents and their associated file names with the new revised date so that you and the IRB can manage your document versions effectively.

3.  Adding Attachments (New Documents)

If the document is new, for example a new addendum to consent, you must use the +Add button as that would be a new document not a revised document. 

 

 

4.  Investigational Drug Brochure (IDB) submissions must include;

·   a summary of changes;

·   a version number and date on the document; and

·   a statement about whether the IDB changes result in an increase in risk to subjects.

5.  Key Personnel – The personnel listed on a protocol are not necessarily the same personnel listed on a Delegation of Authority log.  For instance, pharmacists or radiologists are not required to be on the IRB key personnel roster but may be need to be listed on the Delegation Log per the sponsor.

6.  Key Personnel – One of the roles available for key personnel is “External Collaborator”.  ����̽̽ defines an External Collaborator as an individual who is collaborating on a specific protocol, but is not an employee of either ����̽̽ or ����̽̽MC.  If the individual has any type of appointment with ����̽̽/����̽̽MC they should not be given this role.  The distinction is important for determining training requirements and any necessary agreements.

7.  Approved Documents – The IRB stamps both the approved consent forms and the final approved protocol version.  The IRB stamped versions of these documents can be found in the right side column under the Documents tab under “Final”.  The IRB approved stamped copy of the consent and the protocol should be filed in your regulataory binder. 

 

Regulatory Updates

The NIH generated additional guidance on the NIH policy on the Use of a Single Institutional Review Board for Multi-Site Research on January 22, 2020.  Previously the policy for use of a single IRB did not apply to career development (K) and fellowship (F) awards.  This notice indicates a change to include this requirement for those types of awards effective January 20, 2020.  The application instructions have been modified to address this. 

See notice here .

InfoEd Human Subjects Module

Access to the old InfoEd human subjects module will be discontinued with the termination of our InfoEd subscription in June of this year.  At that time, current users, including IRB staff, will no longer have access to this tool for reference.   

All existing documents from the InfoEd system (approved protocols within the last 6 years) have been transferred to ����̽̽Click-IRB.  These documents may be found on the individual protocol record under “Historical Documents” which is on the left side of the work space page towards the bottom.