October 12, 2020
Research During COVID
The IRB continues to receive COVID related protocols and COVID related amendments to ongoing protocols. We encourage researchers and staff to continue safe practices. The July 6, 2020 notices distributed to Larner College of Medicine faculty and non-Larner College of Medicine faculty regarding resumption of in-person human subjects research included the requirements and safe practices. These notices may be found in the Committees on Human Research Newsletter dated July 9.
Resumption of IRB Quality Assurance Visits
The office had suspended in-person site visits in March but will be scheduling those again within the next couple of months. We have developed a process for these site visits, approved by ̽̽ Environmental Health and Safety.
For the protection of our IRB and research staff, we will use the following procedures while conducting our visits.
RPO staff will:
- have completed the ̽̽ Health Check-In Tool prior to conducting the inspection
- have completed the ̽̽ Return to Work Training
- wear masks at all times
- will conduct the exit interview with the PI/staff respecting the social distancing protocol
We request that researchers:
- wear masks when in the presence of RPO staff
- be prepared to greet staff at the scheduled time
- have regulatory and subject binders/folders ready
- reduce the number of key personnel within the area to allow for required social distancing
Regulatory Updates/Clarifications
For those you who submit record reviews, the new Exempt 4(iii) category “The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under and 164, subparts A and E (HIPAA), for the purposes of “health care operations” or “research” as those terms are defined at or for “public health activities and purposes” as described under ()” requires a waiver of HIPAA not a waiver of the informed consent under the Common Rule. The Common Rule Signatories have expressed a view deeming HIPAA protections, when combined with adequate privacy and security measures, to be substantially equivalent to the protections under the Common Rule. To reduce burden, applications for consent waivers are no longer necessary.
If you are applying for Exempt 4(iii) you are no longer required to apply for a waiver of consent, a request for waiver of HIPAA Authorization is sufficient.
Educational Opportunities
IRB Drop-In Hours
Staff continue to work from home. Please feel free to reach out to your analyst for assistance using the Who’s My Research Analyst tool found at the bottom of the IRB main page.
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There are openings for the November “Fundamentals in the Conduct of Clinical Research” training series (the first of the four class series begins on 11/03/2020). This is one of the components of the new mandatory research staff training announced by the Larner College of Medicine on 08/18/2020. Register .
October Research Professionals Network Workshop Series
Topic: (preregistration registration required)
Date: Wed Oct. 21, 2020, 3:00 p.m. to 4:15 p.m. via Zoom Meeting
IRB Policies and Procedures Update and Form/Template Changes
Manual
New Sections
8.7 Sustainable Agriculture Research and Education (SARE) Grant Projects
8.8 Department of Defense (DOD) Supported Research Projects
8.9 Exception from Informed Consent for Emergency Research
9.9 Obtaining Electronic Consent
10.5 Family Educational Rights and Privacy Act (FERPA)
Substantial Revisions
9.0 Consent
22.0 Humanitarian Use Device (HUD) Designation and Humanitarian Device Exemptions (HDE)
Minor clarifying revisions were also made to multiple other sections of the manual. All modified sections will have a revision date.
Forms
The following exemption forms were revised slightly to reduce redundancy and better align with the 2018 Common Rule regulations.
Exemption 2 – Surveys, Interviews, Educational Tests, or Observation
Exemption 3 – Benign Behavioral Interventions
Exemption 4 – Secondary Research
The Preparatory to Research and Attestation for Decedent Research forms were updated to reflect a new contact person from ̽̽MC for questions and submissions.
News from The Office of Clinical Trials Research
The Office of Clinical Trials Research has added some new features and resources to our Commons Site under the following site pages:
A REDCap COVID screening template for remote electronic screening of research participants is now available as a ZIP file to be uploaded to existing REDCap projects to assist with screening requirements
A Clinicaltrials.gov Determination Tool is now available to assist Researchers in determining if their study is required to be registered on ClinicalTrials.gov
There is a new “How to” section on this page with information on how to, request Epic access for outside study monitors, how to include a signed consent form into a patient's Epic medical record, and how to securely send sensitive research information electronically
We hope for this to be a collaborative process and welcome your feedback on existing resources, as well as suggestions for the development of new research materials and offerings.
Thank you for the hard work you do every day to bring high quality research to our community and beyond.