Additional Guidance on Update #2: Interim UCSF Policy on Human Subjects-Related Research Visits at San Francisco Campuses during COVID-19 Outbreak

 

March 11, 2020

*This message contains information regarding UCSF policy as well as an update from the NIH regarding the impact of COVID-19 on application submission and award management.*

Guidance to Researchers Regarding Determination of "Essential to the health and/or well-being" for human subject research visits during the COVID-19 outbreak.

The interim UCSF policy on human subject research visits at UCSF's San Francisco campuses during the COVID-19 outbreak requires determination of whether or not a research visit is "essential to the health and/or well-being of a participant.” The following examples are provided as a guide to help principal investigators, participants, and participant care providers determine suitability of in-person research visits. These determinations and the balance of potential benefits and harms will vary by study objectives, target patient population, and may change as the COVID-19 outbreak evolves. The following examples are not intended to be comprehensive of all study types.

For these study designs:

Is the specific research visit "essential to the health and/or well-being" of the participant, thus supporting in-person visits?

 

 

These visit types are LIKELY “essential”

(supports an in-person visit)

These visit types may or may not be “essential”

(Support for in-person visit will depend on specifics of the study)

These visit types are LIKELY not “essential” (does not support an in-person visit)

Randomized controlled efficacy trial (e.g., phase IIb or III) of a potential drug or device or other intervention

  • New enrollments
  • Follow ups

 

 

Post-approval trial (e.g., phase IV) of a therapeutic drug, device, or other intervention to assess tolerability and/or long-term benefit

  • Follow ups
  • New enrollments

 

Early phase (e.g., phase I or IIa) pharmacodynamic, safety, tolerability or feasibility trial a potential drug or device or other intervention

  • Follow ups
  • New enrollments

 

Non-randomized interventional trial of a drug, device, or other intervention requiring safety monitoring

  • Follow ups
  • New enrollments

 

Non-randomized interventional trial of a drug, device, or other intervention not requiring safety monitoring

 

  • New enrollments
  • Follow ups

 

Comparative effectiveness studies or other study types describing the natural history of disease or other clinical outcomes

 

  • Follow ups
  • New enrollments

Non-interventional qualitative study
 

 

 

  • New enrollments
  • Follow ups

Non-interventional study with collection of clinical data and/or biological specimens for future research

 

 

  • New enrollments
  • Follow ups

 


NOT-OD-20-082NIH LATE APPLICATION POLICY DUE TO PUBLIC HEALTH EMERGENCY FOR U.S. FOR 2019 NOVEL CORONAVIRUS (COVID-19)

SUMMARY:  NIH will consider accepting late applications on a case by case basis when delays occur because the applicant or recipient organization is officially closed or unable to submit grant applications due to the effects of COVID-19.

https://osr.ucsf.edu/nih-late-application-policy-due-public-health-emergency-us-2019-novel-coronavirus-covid-19


NOT-OD-20-083NIH GENERAL FREQUENTLY ASKED QUESTIONS (FAQs) FOR PROPOSAL SUBMISSION & AWARD MANAGEMENT RELATED TO COVID-19

SUMMARY: NIH has provided FAQs to address high-level questions that may arise related to COVID-19.

https://osr.ucsf.edu/general-frequently-asked-questions-faqs-proposal-submission-award-management-related-covid-19