RPO Office Staffing News
A new RPO baby! Ryann Guayasamin, IRB Analyst, had a baby girl in early June. She will be returning to work after her maternity leave in late August.
Gale Weld, IRB Analyst, is retiring September 1st after working in our office for 18 years. Gale has assisted many researchers throughout the years and has counseled countless number of students with their class research projects. We will miss Gale’s expertise on human subject regulations and wish her a happy and relaxing retirement.
Single IRB Update
Since the NIH and subsequent Common Rule requirement for use of Single IRBs in collaborative, federally funded research, the ̽̽ IRB has ceded review to the National Cancer Institute Central IRB 147 times for Adult and Pediatric Cooperative Group Studies. We have also deferred review to an additional 29 institutions/commercial IRBs. Two ̽̽ researchers have utilized the Western IRB as lead investigators on their grants.
The mandates from both NIH and OHRP to utilize single IRB are applicable only to non-exempt research projects. Projects that are deemed exempt do not require ongoing IRB review. To set up a reliance agreement for reliance on another institution is more work then the ̽̽ IRB conducting the exemption determination. Therefore, we do not rely on another IRB, nor do we act as a single IRB for any exempt projects. We have updated our IRB Policies and Procedures to clearly outline this requirement so that you may reference to other institutions.
The IRB has created a PowerPoint presentation titled “WHAT YOU NEED TO KNOW ABOUT SINGLE IRB.” The slides are a good overview summarizing the federal requirement for using a single IRB and reviewing ̽̽’s reliance request process. You may review the presentation here.
IRB Policies and Procedures Update
This is the quarterly summary update of the IRB Policy and Procedure document. The following sections have been altered with minor changes, unless otherwise noted.
1.1 Introduction to the Boards, the Principles, and their Authority(updated governing principles)
1.5 IRB Jurisdiction (new)
2.0 Coordination with Other Compliance Committees (updated with additional potential ancillary reviews)
8.1.3 Plans for Recruitment/Screening/Retention (added social media information) under development
13.0 Cooperative Research (Single IRB) (single IRB does not apply to exempt projects)
13.9 Collaborative Research Between ̽̽ and the State (new)
13.10 Collaborations with Community Partners (new)
20.4 Controlled Substances Used in Research (new)
21.0 Investigational Devices (added clarifying information about level of device risks) under development
Educational Opportunities
The April 30th IRB on-line presentation, “WHICH PROJECTS DO AND DO NOT REQUIRE IRB REVIEW?” A brief overview of the types of projects which require IRB oversight can be accessed here.
The June 1st IRB on-line presentation of, “The History and Regulations Involving Prisoners in Research.” A slide deck outlining why prisoners need special protections and the federal regulations governing the IRB oversight of this vulnerable population can be found here.
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Reminder: Mandatory Research STAFF Training Fundamentals in the Conduct of Clinical Research Training Program
In light of the unprecedentedly difficult year, we have had with the pandemic and cyberattack, we are extending the mandatory research staff training deadline from August to the end of 2021.
This free comprehensive fundamental clinical research training was created to ensure essential knowledge for staff involved in clinical research at LCOM/̽̽ HN. Comparable trainings would cost hundreds of dollars from an outside source and would not be adapted to LCOM/̽̽ HN processes and policies. We hope you appreciate the value this course is bringing to Researchers and their staff, and that the time investment will elevate the quality and compliance of clinical research at our institutions.
We are asking that researchers be flexible and to prioritize participation in this training with your research staff.
We are offering the following trainings* through the end of the year. Please use this link for more information and to .
August 2021 Sessions (Location:TBD)
Tuesday, Aug 03, 2021, 2:00-4:30pm
Tuesday, Aug 10, 2021, 2:00-4:30pm
Tuesday, Aug 17, 2021, 2:00-4:30pm
Tuesday, Aug 24, 2021, 2:00-4:30p
September 2021 Sessions (Location:TBD)
Wednesday, Sep 08, 2021, 9:00-11:30am
Wednesday, Sep 15, 2021, 9:00-11:30am
Wednesday, Sep 22, 2021, 9:00-11:30am
Wednesday, Sep 29, 2021, 9:00-11:30am
October 2021 Sessions (Location:TBD)
Thursday, Oct 07, 2021, 2:00-4:30pm
Thursday, Oct 14, 2021, 2:00-4:30pm
Thursday, Oct 21, 2021, 2:00-4:30pm
Thursday, Oct 28, 2021, 2:00-4:30pm
November 2021 Sessions (Location:TBD)
Tuesday, Nov 02, 2021, 2:00-4:30pm
Thursday, Nov 04, 2021, 2:00-4:30pm
Tuesday, Nov 09, 2021, 2:00-4:30pm
Thursday, Nov 11, 2021, 2:00-4:30pm
*We reserve the right to cancel trainings if less than 5 people register for a session. Who needs to take this training?
The Larner College of Medicine, in conjunction with The Office of Clinical Trials Research, is requiring that all research staff engaged in at LCOM and/or the ̽̽ Health Network complete LCOM Research Professionals Training, Fundamentals in the Conduct of Clinical Research Training Program. This requirement applies to all research staff who are involved in the conduct of research involving human subjects, irrespective of funding source supporting the research activity (which includes, but is not limited to; Research Coordinators, Research Nurses, Research Health Care Professionals and Regulatory Staff, or individuals fulfilling these roles).
At this time, our focus is on the research staff and while we have had some investigators participate in this training, we will be launching our investigator training later this year. More information about investigator will be forthcoming as we prepare for its roll-out.
̽̽MC Corner
From the Office of Clinical Trials Research
Reminder:
We are taking this opportunity to remind you about the . This policy is in place to ensure that ̽̽ research faculty and staff will have the appropriate orientation, competency, and oversight before participating in research activities at ̽̽MC.
Please communicate with your ̽̽ research faculty and staff that their current ̽̽MC research ID badges expire on June 30, 2021.
For the purposes of this policy, clinical research activities include all research projects within ̽̽MC that involve direct patient interaction, retrieving blood or tissue, or health record data for review. Overall, if ̽̽ research personnel are involved in clinical research at ̽̽MC (even if this does not include subject contact) then they are required to be credentialed.
Failure to comply with this renewal process by June 30, 2021 will result in denied ̽̽MC IT access, and ̽̽ research faculty and staff will not be allowed to participate in ̽̽MC research activities until they have successfully fulfilled the credentialing requirements.
If you have any questions, please call the Office of Clinical Trials 656-8990. Your prompt attention to this renewal process is greatly appreciated.
̽̽Click Updates
As of this week, you will be required to sign into the ̽̽Click system with your ̽̽NetID and password. This would be the same credentials you use to get into My̽̽ or Peoplesoft. This extra protection was felt to be necessary by the ̽̽ Technology Team.