HSPP- October, November, December, 2020- Newsletter
Accessing and Signing-off Submissions in iRIS
In order for a member of the study team to be notified that there is an IRB submission that requires the study team member’s sign-off, there must be a valid e-mail address associated with the study member’s account in iRIS. Therefore, it is important to verify the validity of email addresses when selecting the members of a study team. For UConn Health faculty, staff, students and residents, iRIS is linked to the LDAP active directory at UConn Health; so if a user does not have an e-mail in that directory there will likely be problems notifying them of the required sign-off task in iRIS. In addition to verifying addresses by using the active directory; at the time of adding study team members to the form in iRIS there should be an email address listed next to the team member’s name in iRIS. Lack of a valid e-mail address prevents the submission from being routed to the study team member for sign-off and from being submitted to the IRB for review and approval.
To avoid these problems, the person creating the study form in iRIS should follow the steps described in pages 7 and 8 of the iRIS user manual entitled “Basics for Creating a New Study Submission- Manual 1.” The manual is available in the help section within iRIS.
FAQ about Facilitated Review – Reliance on External IRB
Q: What changes do I have to report to the UConn Health IRB when my study has been approved by an external IRB?
A: When the UConn Health IRB has elected to rely on an external IRB, the external IRB is referred to as the IRB of Record. Per the IRB Reliance Agreement in place, with one exception, only the IRB of Record for your study is responsible for all reviews of your study, inclusive of continuing reviews, requests for study modifications or amendments, and for reviews of non-compliance and unanticipated problems.
The one exception is that changes to UConn Health study personnel must still be processed through the UConn Health IRB by submitting a request for modification form through the iRIS system.
OHRP Determination of Exception to the Single IRB Review Requirements for Certain HHS-Conducted or – Supported Cooperative Research Activities Subject to the 2018 Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
To ensure that institutions conducting cooperative research are able to take advantage of the most appropriate IRB review structure, the Office for Human Research Protections (OHRP) in the Office of the Assistant Secretary for Health of the Department of Health and Human Services has determined that, for studies that are conducted or supported by HHS and subject to the 2018 Requirements, and for purposes of 45 CFR 46.114(b) (2)(ii), an exception to the requirement to use a single IRB is appropriate for the following category:
Cooperative research:
- that is ongoing or initially reviewed by the IRB during the Coronavirus Disease 2019 (COVID-19) public health emergency, as declared by the Secretary of Health and Human Services here.
- where reliance on a single IRB would not be practical; and
- for which the HHS division supporting or conducting the research approves of the use of this exception.
This exception applies for the duration of the HHS-conducted or supported research.
OHRP has made this exception determination due to concerns regarding the application of the single IRB requirement to cooperative research subject to the 2018 Requirements when this research is initially reviewed or ongoing during the COVID-19 public health emergency. The COVID-19 public health emergency has created unprecedented burdens and disruption to the research enterprise, while at the same time requiring urgent research responses that necessitate flexible approaches to oversight in order to provide vital information and to allow other research to continue where possible. This exception represents an effort to prioritize the health and safety of both research subjects and investigators, and provides flexibility to institutions in seeking IRB review due to the unique challenges created by the COVID-19 outbreak.
The exception includes some scenarios for which OHRP anticipates it may not be practical to rely on use of a single IRB for multi-site, cooperative research trials during the ongoing COVID-19 pandemic. This exception determination can be accessed here.
OHRP’s November 2019 Determination of Exception and related background information can be accessed here.
NIH Policy on Registration/Results Posting Of Basic Experimental Studies with Humans (BESH)
NIH’s clinical trial definition includes prospective basic science studies involving human participants. Basic Experimental Studies with Humans (BESH) use an intervention to understand fundamental aspects of a phenomenon without specific application towards processes or products in mind. NIH published case studies with examples of BESH (cases 9, 14, 40 & 41).
NIH funded clinical trials, including BESH, are required to register and post results in ClinicalTrials.gov.
On December 7, 2020, the Acting Director of ClinicalTrials.gov, presented the results of the National Library of Medicine analysis of challenges and considerations for registration and results information reporting of BESH in ClinicalTrials.gov. The recording of this webinar is available at https://videocast.nih.gov/watch=40141
For more information about ClinicalTrials.gov, including assistance with registration, please contact Research Compliance Monitor, Ellen Ciesielski at eciesielski@uchc.edu.
Recent Articles Published by Central IRBs
ADVARRA IRB:
Beginner’s Guide to Investigator-Initiated Trials This article describes the basic concepts an investigator must understand about “investigator initiated clinical trials” and how they fit into the clinical research landscape.
Western IRB (WCG):
Virtual Clinical Trials: Best Practices in moving Toward a Patient-Centric Research Model
This article defines virtual clinical trials, describes the potential benefits/risks of this new paradigm, and best practices for maintaining regulatory and Institutional Review Board (IRB) compliance.