HRPP Newsletter

November 24, 2020

Tier 0 Research Restart

MSU has been phasing in human research that has the potential for in-person interactions with participants using different Tiers of criteria. A matrix of the tiers of research is available at: https://hrpp.msu.edu/COVID-19/covid-tiers.html

Approval of a Human Research Plan for a Safe Return form is required for any potential in-person interactions with research participants conducted by MSU individuals (e.g. faculty, staff, students, agents), including all studies in Tier 0.

Tier 0 included research where ongoing in-person interactions with participants may have been permitted under minimum basic operations:

  • Clinical trial activity, which if discontinued, would negatively impact the patient’s care, OR
  • Research related to COVID-19, particularly if they have a timeline for deployment that could address the crisis, OR
  • Exceptions approved by MSU Office of Regulatory Affairs (ORA)

As a reminder if your study met the criteria for Tier 0 and in-person interactions were permitted to continue, a Human Research Plan for a Safe Return form must be submitted if not done so already. For Tier 0 studies, the Human Research Plan for a Safe Return form must be submitted to the Office of Regulatory Affairs ASAP.

If you have any questions, please contact Judy McMillan at mcmill12@msu.edu.

Compliance Office Remote Monitoring

During the COVID 19 pandemic the Compliance office has replaced on-site monitoring with remote monitoring and will conduct routine remote site visits for all full board initial applications that have enrolled subjects and a sample of ongoing expedited projects. Remote monitoring will be completed in 2 steps. Step 1: a standard remote monitoring form is sent to the PI and study coordinator via email to complete. Step 2: the HRPP Compliance Analyst will schedule a Zoom session with the PI and any study team members who wish to join. Prior to the meeting, the HRPP Compliance Analyst will provide any additional questions that we will ask at the remote monitoring visit.  

The Compliance office has also implemented Investigator self-audits for projects where there is no contact with subjects and researchers are not obtaining a signed consent form.

Post-approval monitoring serves to educate researchers and to ensure that research is conducted in accordance with federal, state and local regulations, university policies, and ethical standards. For more information, please visit sections 5-2-B Compliance Office and 8-10 Research Site Visits of the Human Research Protection Program (HRPP) Manual.

If you have any questions, please contact Judy McMillan at mcmill12@msu.edu.

To learn more, visit MSU HRPP Manual Section 8-10.

Changes to GCP Training

Because Good Clinical Practice (GCP) training requires completion of refresher training, the set-up of GCP training is being modified in the Ability training system. If you wish to complete the initial GCP training through Ability you will be required to register for and complete all 8 courses, instead of registering for a single track. You can also still complete both initial and refresher GCP courses with either a focus on FDA or social science through CITI, and you can still submit completion of equivalent GCP training to the Compliance office. Because of these changes, the integration between Ability and Click for GCP training will be removed; researchers should instead access Ability or CITI directly to view GCP training information. For NIH sponsored Clinical Trials the Compliance office will track all GCP training for all project personnel listed in Click. However, it is the responsibility of the PI to ensure all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials complete required training in GCP, including refreshers.

If you have any questions, please contact Judy McMillan at mcmill12@msu.edu.

Biomedical IRB Chair Changes

After many years of dedicated service, Dr. Ashir Kumar has retired as the Biomedical and Health Institutional Review Board (BIRB) chair. The MSU Human Research Protection Program (HRPP) appreciates the expertise and leadership that Dr. Kumar has provided to the IRB and the HRPP. We are pleased to announce Dr. Paul Quinlan as the new BIRB chair.

To learn more visit the MSU HRPP News Announcement BIRB Chair Changes.

HRPP and IRB Operations

The HRPP office is fully functional and we expect this to continue as we work remotely. All HRPP staff can work from home and the Institutional Review Boards (IRBs) will continue to perform reviews. HRPP office hours are Monday through Friday, 8:00am to 5:00pm and we will be responding to all phone calls and emails. 

Updates will be provided if there are changes that impacts HRPP operations.