COVID-19 Information and Human Subjects Research

NEW as of 6/16/20, The Office of the Vice President for Research and the Human Subjects Office are providing updated ramp up guidance related to human subjects-related research visits.

As research activities gradually resume on campus, the health and safety of research participants, study teams, faculty and staff must remain a priority. Please be aware that the situation is fluid and we may encounter setbacks as we endeavor to slowly move toward more normal research operation.  With that in mind, in-person research study visits may begin to resume outside of clinical care settings under the following conditions:

  • Research may resume in university buildings and off-campus locations and facilities (schools, nursing homes, etc.) as they are brought online, following the health and safety guidelines in place at each location.
  • Situation-specific research ramp-up plans for activities involving human subjects must be approved by the respective associate dean for research or their designee.
  • Associate deans for research will have specific instructions for research ramp up plans and implementation schedule.
    • A sample Research Ramp-up checklist and Research Ramp-up plan can be found on the VPR COVID Ramp Up Website, under the top-center box called Resources.

A complete summary of the conditions outlining what is expected of researchers as they ramp up human subjects related study activities can be found on the OVPR Research Ramp Up Update webpage.  

The Human Subjects Office (HSO) has also provided information on human subjects ramp up recommendations  addressing the most common questions raised by researchers when determining how to ramp up research related activities.   

 

Recent Updates to FDA Guidance on COVID-19 research

As of 6/3/20, the FDA has added content ot the question and answer appendix in the guidance titled "Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency" and released information on an FDA eConsent tool called the FDA MyStudies app.  The updated guidance on the conduct of clinical trials of medical products during COVID-19 public health emergency includes:

  • Part 11 compliance for electronic systems that are used to generate electronic signatures on clinical trial records
  • Protocol deviations
  • General considerations for study sponsors

The FDA has also provided a FDA eConsent tool called "MyStudies" app to investigators as a free platform to obtain informed consent securely from patients for eligible clinical trials when face to face interactions may not be practical due to the COVID-19 public health emergency.  This app is available in the Apple App and Google Play Stores and is referred to as "COVID MyStudies."  Additional information on how to work with the FDA to set this up can be found on the FDA Website under "COVID MyStudies Application App" webpage.

As of 6/2/20, the FDA has issued guidance titled "Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators."  The updated guidance includes:

  • establishing procedures for single IRB member review in response to physician waiver requests for exemption from full IRB review
  • factors to consider when assessing benefits and risks for patient's treated under expanded access

Guidance provided during the COVID-19 Public Health Emergency

As of 5/11/20, The Vice President for Research issues guidance allowing clinical human subjects research to resume under limited conditions
Effective May 11, The Vice President for Research issued a memo indicating research study visits coincident with a clinical care appointment in UI Hospitals and Clinics and other clinical settings may resume with the following conditions:

  • Applies only to research study visits occurring in UI Hospitals & Clinics and other clinical settings where there is an already scheduled patient visit(s)
  • Participation in study must not increase the risk that the participant may be exposed to COVID-19.
  • Study teams must work with the health care system or clinic on appropriate scheduling of the research component of the visit; study activities must not overburden clinics.
  • Patients may be uncomfortable returning to the health care setting.  If that occurs, study team members must be respectful and should be prepared to modify study visit activities with input from the subject, sponsor, and Institutional Review Board.

All the UI, UI Hospitals & Clinics and state/local public health guidelines must be followed during conduct of the research. Appropriate PPE must be available for study teams before the work begins, following the guidance in place at the location where the research is performed. Study teams may be required to supply their own PPE. In addition, virtual consenting and monitoring processes should be followed whenever possible.

As of 4/16/20  The FDA Updates the Q&A Appendix in the Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency 
The FDA has added content to the Q&A Appendix in the Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency  The updated guidance includes new content on the following:

  • conducting remote clinical reported and performance outcome assessments
  • remote site monitoring
  • investigational product administration by a local health care provider who is not a sub investigator
  • updated information about obtaining informed consent from a patient who is unable to travel to the clinical trial site due to COVID-19 illness or where electronic informed consent is not available.
  • other sponsor related updates

As of 3/30/20  FDA Issues Updated Guidance on Clinical Trial Conduct During the COVID-19 Pandemic 
On March 18, 2020, FDA issued “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.  On March 27, 2020, FDA amended the guidance to include an appendix to further explain those general considerations by providing answers to questions about conducting clinical trials that the Agency has received during the COVID-19 pandemic.  

As of 3/18/20 FDA Issues Guidance on Clinical Trial Conduct During the COVID-19 Pandemic
The following FDA Guidance has been released regarding the conduct of clinical trials of Medical Products during the COVID-19 Pandemic.  The guidance contains recommendations for how to continue existing IRB approved research under the FDA purview, when necessary, to minimize or eliminate immediate hazards or to protect the life and well being of research participants.  The Human Subjects Office strongly encourages the study teams to consider the implications of reduced staffing, clinical\UIHC resources, and availability of study related materials (i.e. PPE, investigational product, etc) during this time and implement study measures consistent with the FDA regulatory guidance.  New human subjects research detracting from hospital resources that may need to be directed to clinical care should be avoided.        

As of 3/18/20 Iowa City VA Research conducted with VA ORD funds and the COVID-19 Pandemic 
The VA ORD (Office of Research and Development) has issued the following communication regarding ORD funded research during the COVID-19 pandemic. ORD is placing an administrative hold on all non-critical, in-person, ORD-funded human research subject interactions.  Please review the VA ORD FAQs for what to do if your study is impacted by this.  In addition, ORD-funded Principal Investigators who find that they are unable to continue with their research during this time due to increased clinical demands should contact their ORD funding service for guidance at their earliest opportunity in accordance with the COVID-19 Administrative Hold Frequently Asked Questions.  If you contact VA ORD regarding your study, please include Mark Yorek and Kari Points on your e-mail (also include Bonnie Bootsmiller for HSR&D and Lori White for Vision Center).  

As of 3/16/20 Vice President for Research Issues a Statement on Research Slowdowns 
The Vice President for Research has also issued the following guidance earlier today regarding research activity rampdowns.  FAQs and other resources for research involving human subjects, animal subjects, costs charged to sponsored projects, and more is available on our COVID-19 Information for Researchers webpage. 

Other COVID-19 Related Resources