Hanover Research

Hanover Research is closely monitoring developments surrounding the Coronavirus Disease 2019 (COVID-19) and how it has and may continue to impact the higher education and health research communities. For information, visit the web page Grant Alerts: COVID-19 & Health Research. If you have any questions, contact your grants manager or Charlotte Johnson, Director of Office of Sponsored Programs at charlotte_johnson@harvardpilgrim.org.

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National Institutes of Health (NIH)

NIH has published several notices regarding the funding status of current and future grants and contracts in the wake of COVID-19. The Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients ​page was published by NIH on 3/16/20 and includes all previous NIH communications regarding the coronavirus. It will be updated regularly. Below are the notices most relevant to DPM. If you have any questions, contact your grants manager or Charlotte Johnson, Director of Office of Sponsored Programs at charlotte_johnson@harvardpilgrim.org.

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• NOT-OD-20-091-UPDATE: NIH Late Application Policy Due to Public Health Emergency for United States for 2019 Novel Coronavirus (COVID-19) 

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• NOT-FD-20-019-FDA - Flexibilities Available to Applicants and Recipients of Federal Financial Assistance Affected by      COVID-19

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• NOT-OD-20-086 – Flexibilities Available to Applicants and Recipients of Federal Financial Assistance Affected by COVID-19

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• NOT-OD-20-087- Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19

 

• NOT-OD-20-083 - General Frequently Asked Questions (FAQs)Proposal Submission and Award Management Related to COVID-19

 

• NIH FAQs: COVID-19 Flexibilities for Applicants and Recipients - ​NIH Frequently Asked Questions  in response to inquiries on policies and programs affecting the grants processes.                     ​

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• Updated: NIH Message to Applicants and Recipients (video)

      This video provides an update for applicants and recipients of federal funding on flexibilities NIH has put in place to            support them and their research through the disruptions caused by COVID-19.​

 

 

Office for Human Research Protections (OHRP)

In response to questions from the research community, the Office for Human Research Protections (OHRP) is offering guidance on how the HHS human subjects protection regulations (45 CFR part 46) apply to actions taken by institutions and investigators in response to the COVID-19 outbreak. If you have any questions, contact Paula Tebeau, Senior Compliance Manager, IRB          at paula_tebeau@harvardpilgrim.org. 

• OHRP Guidance on COVID-19

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U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. If you have any questions, contact            Paula Tebeau, Senior Compliance Manager, IRB at paula_tebeau@harvardpilgrim.org.

• FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

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Verrill Dana

​The following alert from Verrill Dana provides an easy-to-read list of potential COVID-19 issues on human subjects research. For questions specific to IRB review, please contact Paula Tebeau, Senior Compliance Manager, IRB at paula_tebeau@harvardpilgrim.org.

• Verrill Dana: Responsible Research During the COVID-19 Pandemic 

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Additional Resources

• Harvard Pilgrim Health Care is monitoring the coronavirus (COVID-19) outbreak and what it means for our members and communities. 

• Centers for Disease Control and Prevention (CDC)

• Massachusetts Department of Public Health