Research Integrity Department IRB Updates for Researchers on COVID-19
Guidance to Researchers
Best practices for research conduct and IRB operations amidst the COVID-19 pandemic are evolving daily. The McLaren Research Integrity Office’s main priority during this time, and as always, is the safety of our research subjects, the safety of our researchers and staff, and the continued compliance with human subjects protection regulations.
As we find ourselves in the extraordinary circumstance of a global pandemic, it may be necessary to urgently modify some or all of your ongoing research study protocols and procedures. Please refer to the Interim HRPP Policy on Human Subject Research During COVID-19 Pandemic.
COVID-19 Research Guidance FAQs
Is the IRB office still open and functioning?
Yes. The IRB office is open during business hours, as usual, on Mondays – Fridays from 8:00 a.m. – 4:30 p.m. Department staff are working remotely from home and are responding to emails and eProtocol submissions. Contact the IRB via hrpp@mclaren.org
How should I manage remote communications or data collection with subjects?
Privacy and confidentiality provisions remain critically important at all times, even when working remotely. Please note, collection, transmission, or access to private identifiable data or protected health information must comply with MHC and other policies for security of research data.
Do not store private identifiable information or protected health information on unsecure devices in order to work remotely. Use McLaren-approved cloud services and VPN access while working at home instead of storing data directly on personal devices.
If making copies of physical research records or data (paper consent forms, case report forms, questionnaires/surveys, etc.), secure all paper locally following HIPAA principles and return to the IRB-approved location as soon as is practical.
For more information, please contact our Privacy Officer by calling the MHC Compliance Line: 1-866-642-2667.
What should I do to prepare for study subjects being removed from active protocols due to COVID-19 infection?
Review each clinical trial protocol for drug reductions or holds due to serious adverse events or for other reasons. Subjects who are diagnosed with COVID-19 will likely be removed from study treatment by the sponsor or investigator. Treatment schedule modifications or removal from the study for subjects who are in quarantine should be discussed with the sponsor. Items should be reported consistent with the MHC IRB reporting policies or those of the IRB of record.
Will the IRB continue to accept and review Modification, Continuing Review, Protocol Violation/Exception Report, SAE Report, New, Final Report, and Unanticipated Problem Report form submissions?
Yes. The IRB will continue to review these form submissions. Forms will be approved with the expectation that ongoing research is compliant with applicable restrictions and accommodations for reducing exposure to COVID-19. Researchers are still expected to submit Continuing Review submissions during this public health emergency.
Do I need to re-consent subjects on changes to protect from COVID-19?
In most cases, new information regarding changes to protect from COVID-19 may be provided via a letter or other form of communication. Subjects must be provided with significant new findings that develop during the research which may relate to their willingness to continue participation. However, re-consent is not necessary unless the changes to the research are such that the original consent is no longer valid.
What should I do to ensure that subjects in clinical trials remaining open have an adequate supply of study drug?
For clinical trials with investigational drugs, devices and biologics, please confirm with the sponsor that the supply is not at risk.
What about monitoring/auditing by internal programs (e.g., QA checks)?
All monitoring visits, site initiation visits, site qualification visits, etc. have been cancelled immediately and until the threat of COVID-19 has subsided, unless necessary for the safety and/or efficacy of the study treatment. To the extent possible, these visits should occur remotely.
What guidance does the FDA provide for clinical trials during the COVID-19 pandemic?
The FDA outlines considerations to help sponsors assure the safety of study participants, maintain compliance with good clinical practice, and minimize risks to study integrity. Considerations include sponsors evaluating alternative methods for assessments, like phone contacts or virtual visits, and offering additional safety monitoring for those study participants who may no longer have access to investigational product or the investigational site, among others.
In addition, the FDA provides the following website for relevant updates that you may wish to regularly monitor:
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
Does the FDA require sites to track and report changes that were made without IRB approval to minimize hazards from COVID-19?
Yes. Changes to protect the life and well-being of research subjects (e.g., to limit exposure to COVID-19) may be made without IRB approval, but FDA-regulated studies require such changes to be reported afterwards. Investigators should submit an aggregate account of changes implemented without prior IRB approval on one Protocol Violation/Exception Report form.
The FDA has advised sponsors to collect a list including contingency measures taken, the subjects affected by study number, and the impact on safety or efficacy results, if applicable. Check with the study sponsor on reporting requirements.
Do I need to take any action on ClinicalTrials.gov?
Yes. Clinical trials that have paused recruitment due to COVID-19 should update their study status on ClinicalTrials.gov record to “active, not recruiting” within 30 days. For questions regarding ClinicalTrials.gov, please contact Jill George at Jill.George@mclaren.org
What about the NIH?
The NIH has issued formal guidance on clinical trials and other human subjects research activities. However, at this time, the guidance is broad and geared mainly at administrative and funding issues.
Guidance can be found on the NIH web page for Natural Disasters:
https://grants.nih.gov/policy/natural-disasters.htm
Federal Resources
We encourage you to stay up-to-date on MHC’s policies and guidance regarding COVID-19 by availing yourself of the following resources:
State of Michigan Orders