12/14/20 UIHC In Person Human Subjects Research Allowed to Resume
In-person research visits occurring in UI Hospitals and Clinics facilities may resume beginning Monday, December 14, 2020, given the following conditions:
- Appropriate research personnel and PPE are readily available to ensure subject safety.
- The study team continues to minimize COVID related risks by following the Guidelines for In-Person Research Study Visits copied below.
- The study team continues to follow research plans approved by their associate deans for research and all institutional, state, and local public health guidance.
- Research teams retain plans to ramp down in the event of a COVID resurgence.
Units providing research support such as the Clinical Research Unit (CRU) may be short staffed because of clinical reassignments so we ask for your patience as the resumption of research activities may not occur immediately in these areas. The following guiding principles should be applied to all research conducted by UI researchers:
- Health and safety of research participants and study teams remain the priority
- Research study visits should continue to occur remotely whenever possible
- All UI, UIHC and state/local public health guidelines must be followed
- PPE must be available for a study before work begins. Study teams should adhere to the PPE guidance in place at the location where the research is performed.
- Appropriate research personnel must be available to ensure subject safety.
- COVID-19 Research will continue to be prioritized, but care must be taken not to overburden subjects or put them at unnecessary risk.
- Health care systems, schools and other off-campus agencies/facilities must not be overburdened with research requests. The study teams must work closely with these entities to ensure that the research teams abide by all policies in place at each facility.
- Virtual consenting and monitoring processes should be followed whenever possible. The HSO has provided researcher guidance for Alternatives to an In Person Consent process. This guidance can be found on the Educational Tools page of the HSO website.
Please refer to the OVPR Responding to COVID-19 guidance for additional information. In addition, University of Iowa researchers should follow all institutional requirements as posted on the Campus Coronavirus Updates and guidance documents posted at The Loop. Please address questions to the Office of the Vice President for Research at 319-335-2119 or email@example.com, the Human Subjects Office firstname.lastname@example.org or 319-335-6564. The Human Subjects Office (HSO) has also provided information on human subjects ramp up\down recommendations addressing the most common questions raised by researchers when determining how to ramp up research related activities.
Guidelines for In-Person Research Study Visits
For study visits that will be conducted in person, study teams should contact participants within 24 hours prior to the visit:
- Staff should verbally confirm that the participant is well and explain the screening procedures, if any.
- For research occurring on campus or in institutional settings, screening procedures in place at the relevant location will be followed.
- The participant and any participating caregiver must be informed that they will be required to wear a mask throughout the visit (except when removal of the mask/covering is necessary for the research procedure), and whether the mask will be provided by the study team. Individuals at higher risk for serious illness from COVID-19 may also be asked to wear a face shield.
- Participants should be advised to wash their hands before and after entering the research space. Hand sanitizer should be available if a restroom isn’t nearby.
Research teams should also have procedures to ensure:
- Participants should be asked to report a COVID positive diagnosis to the research team within 14 days from a research visit.
- Research participants should be advised not to bring guests to the visit. Children and adults who require assistance may be accompanied by one caregiver. If a caregiver is present, the caregiver should also be screened.
- Throughout the study visit, including during the screening process, research personnel should follow physical distancing guidelines (i.e., 6 feet of physical distancing), except as necessary to complete required procedures.
- Research related activities should be conducted by a minimum number of necessary people, with time limitations and minimal personnel density.
- Researchers should eliminate traditional waiting and common seating areas and utilize non-traditional alternatives, e.g., call ahead registration, waiting in car until called, moving participant directly to research room, etc.
- Ensure adequate supplies to minimize sharing of high-touch material to the extent possible. Discourage sharing of items that are difficult to clean or disinfect.
- Establish a cleaning procedure between research participants.
11/17/20 Effective Immediately: Pause called in UIHC non essential in-person human subjects research
Because of Monday’s (11/16/20) proclamation by Iowa Gov. Kim Reynolds and the need to reassign clinically trained research staff to clinical responsibilities, in-person research visits in UI Hospitals & Clinics facilities that are not essential to a participant's health and/or well-being should be postponed until further notice. Examples of research that may continue include:
- Visits that are coincident with standard of care medical appointments (individuals will be allowed to move from their standard of care clinic location to other on-site locations if needed, e.g. the Clinical Research Unit)
- COVID-19 treatment, identification, or vaccine research
- Visits that are critical for safety follow up or for receipt of life-saving therapies
- Enrollment of new patients on a clinical trial or other human subject-related research may occur if: 1) participation in the research is essential to a participant's health and/or well-being, as determined as above; or 2) the enrollment and participant interactions and interventions can be conducted remotely; and 3) appropriate research personnel are readily available to ensure subject safety
- IRB-approved study activities that do not involve direct subject contact (e.g., chart review, Qualtrics surveys, and remote interviews) or research that has transitioned in-person visits to virtual visits (e.g. interviews, surveys, questionnaires)
This guidance does not apply to IRB-approved, in-person subject visits occurring outside of UIHC facilities. Researchers should continue to follow their research plans approved by their associate deans for research and follow all institutional, state, and local public health guidance. Please refer to the OVPR Responding to COVID-19 guidance for additional information. In addition, University of Iowa researchers should follow all institutional requirements as posted on the Campus Coronavirus Updates and guidance documents posted at The Loop. Please address questions to the Office of the Vice President for Research at 319-335-2119 or email@example.com, the Human Subjects Office firstname.lastname@example.org or 319-335-6564, or visit the HSO website at hso.research.uiowa.edu.
The Human Subjects Office (HSO) has also provided information on human subjects ramp up\down recommendations addressing the most common questions raised by researchers when determining how to ramp up research related activities.
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.
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
Prior 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
- University of Iowa Coronavirus Information
- The Loop - University of Iowa Hospitals and Clinics (UIHC) FAQs for patients, clinical care, COVID updates.
- NIH Notice containing COVID updates for grant related purposes
- CDC COVID related updates
- Iowa Department of Public Health (IDPH) COVID related updates