Human Subjects Research Ramp Up\Down Recommendations

  1. Human Subjects Office(HSO)\IRB Operations
  2. Guidance Regarding Human Subjects Research During the COVID-19 Pandemic
  3. Tools Available to Conduct Remote or Virtual Research Related Activities
  4. Data Security When Conduct Research Related Activities Virtually or Outside UI Physical Space

Human Subjects Office(HSO)\IRB Operations

HSO\IRB Operations

The staff in the Human Subjects Office and the University of Iowa IRBs are conducting business as normal.  The HSO\IRB will continue to conduct all activities in a virtual manner.  The HSO office remains closed to in person meetings. For assistance email irb@uiowa.edu, call (319)335-6564 or visit the HSO website. Information from the Vice President for Research on COVID-19-Related Guidance for Ramping Up\Down Research has moved to a new URL.  For up to date information, please visit the HSO and the VPR COVID-19 specific webpages frequently.

HSO\IRB Educational Opportunities

While HSO remains open and ready to assist campus, we will not be holding in person HawkIRB trainings, IRB Office Hours, or IRB presentations until further notice. 

  • Virtual Office Hours will be held beginning on June 3, 2020 using Zoom. 
  • Virtual HawkIRB training sessions are also offered beginning in June 2020. 
  • Virtual study monitoring has been scheduled to begin the second week in June.
     

Information on the current IRB Educational Offerings can be found on the Education and Training page of the HSO Website.

Guidance Regarding Human Subjects Research During the COVID-19 Pandemic

 11/17/20 Pause called in UIHC on Non-essential In-Person Human Subjects Research

 To address the pause, researchers should submit a Receipt of New Information Reportable Event Form (REF) reflecting when the pause begins. The REF can be updated once the research resumes.  The IRB is not requiring a modification to the IRB application simply because research ramps down.  A modification to the research application would be required if there are any changes, additions, or removal of any IRB approved research related activities.  

Stage 3 guidance regarding research ramp up activities

Effective Tuesday, June 16, 2020 the Office of the Vice President for Research has issued guidance for how to implement stage 3 of research ramp up.  In person research study visits may 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.

  • Study teams should consider Potential Sources of COVID-19 Related Risks for Research Participants while preparing ramp-up plans.

  • Researchers will follow the Guidelines for All Research Study Teams, Guidelines for In Person Research Study Visits and the Guidelines for Maintaining Healthy Research Environments as well as additional direction provided by their department, college or study location.

  • Care must be taken not to overburden newly opened facilities.

  • Study teams must work with each participating facility/agency to develop a study plan that incorporates updated safety and operational requirements. For previously approved studies, the teams may be required to update operational plans.

  • Appropriate PPE must be available before for both researchers and research participants prior to when the research work begins, following the guidance in place at the location where the research is performed.

  • UI and state/local public health guidelines must be followed when interacting with research participants. Research study visits as should continue to be conducted remotely as much as possible. In addition, virtual consenting and monitoring processes, if available, should be followed. As a note, be sure to check The Loop for the most up to date information regarding clinical visits.

Stage 1 & 2 guidance regarding research ramp down\up activities

On Monday, May 11, 2020, the Office of the Vice President for Research issued an update implementing stage 2 in the research ramp up which includes research study visits coincident with clinical care only at the UIHC may resume with the following conditions:

  • 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.  Research occurring outside the UIHC must follow the March 16, 2020 guidance and conduct all research visits virtually. Research involving vulnerable populations or individuals with underlying health conditions should include special precautions when possible (CDC guidelines)

Prioritization of research occurring at the UI\UIHC

Research Deans, and DEOs, in conjunction with Faculty Advisors and the Graduate College (when there is a student PI), should coordinate with research teams to ensure research ramp up plans are consistent with departmental expectations. This analysis should include both existing and new research submissions. If questions arise, the IRB will rely on these same individuals to identify research priorities.

Submitting modifications to the IRB to alter research related activities

For research ramping up, PIs and research teams should consider the conduct of their individual study(ies) and what individual ramp up plans may be necessary.  The ramp up plans should not only consider procedural based activities but also ongoing safety of research subjects and the research staff conducting the research.  Modifications to the IRB should not occur until after the Associate Research Dean has approved the applicable research ramp up plans.  If the research ramp up plans differ from what is IRB approved, a modification will be necessary.  In general, institution required activities such as employee or research subject COVID-19 symptom checks, use of PPE, research space sanitizing\cleaning would not need to also be approved by the IRB.  The IRB reserves the right to request a copy of the ramp up plan and approval if questions arise.  Examples of activities that would require IRB approval, include but are not limited to:

  • Changes to the research related interventions or study activities
  • Information provided directly to or used as a script to subjects
  • Specimen or sample collection

Instructions are available on how to submit modifications to project approved by the UI IRBs on the HSO Website. If you have any questions about whether a virtual option is possible or approvable (especially for consent), contact the IRB at irb@uiowa.edu.

COVID-19 screening requirements for human subjects research

The UI IRB requires all research studies implement COVID-19 symptom screening if in person study visits must occur for both subjects and research team members.  Research requiring subjects to enter UI Hospitals & Clinics (UIHC) continue to be required to complete screening for all subjects that enter the University of Iowa Hospitals and Clinics.  This screening is occurring upon entrance to the UIHC.  More information can be found at https://uihc.org/hospital-visitor-screenings-and-restrictions-place-safety.  UIHC and non UIHC patients can call 1-319-384-9010 if they are experiencing symptoms.  For UIHC patients, they may also schedule a video visit via MyChart.

Enrolled subjects uncomfortable coming onsite to the UI\UIHC for a scheduled research visit

Subjects may miss study visits for a variety of reasons.  If this occurs, identify if missing a study visit would put the subject at additional risk.  If applicable, notify the study sponsor.  If necessary, reschedule the visit as soon as possible.  Consider whether the study visit can be safely conducted in an alternate location or whether or not the schedule of study related events can be altered.  This should be reported to the IRB as a reportable event form (noncompliance-protocol deviation).   

Handling single patient emergency use scenarios

The procedures for a single patient emergency use of an investigational drug or device remains unchanged during this time.  The policy for Emergency Use of an Investigational Drug or Device is in Section 9.D.vi of the UI Investigator’s Guide.  Contact the IRB office in the event an emergency use scenario arises.  (FDA Guidelines)

Research conducted with children in a research lab

Researchers should continue to prioritize the health and safety of project personnel, collaborators, students, and human subjects when deciding how to move forward with research activities.  Research involving vulnerable populations or individuals with underlying health conditions should include special precautions when possible (CDC guidelines).  The June 15, 2020 memo from the Vice President for Research has allowed research falling under Stage 3 to resume. 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 it is possible there could be setbacks as we slowly move toward more normal research operations.     

Research with focus groups or a large number of participants

Researchers should prioritize the health and safety of project personnel, collaborators, students, and human subjects when deciding how to move forward with research activities.  Research involving vulnerable populations or individuals with underlying health conditions should include special precautions when possible (CDC guidelines).  General guidelines for social distancing may preclude research related activities including a large number of participants gathering in one location.  CDC, state, and local guidelines should continue to be followed to ensure appropriate social distancing measures.

Research offering extra credit or using a student subject pool (e.g. Sona)

Ultimately this is a decision that should be made by the Principal Investigator.  This decision should be consistent with the June 15, 2020 guidance issued from the OVPR office.  Researchers should prioritize the health and safety of project personnel, collaborators, students, and human subjects when deciding how to move forward with research activities.  Research involving vulnerable populations or individuals with underlying health conditions should include special precautions when possible. (CDC guidelines)

Research conducted in a nursing home

Researchers are requested to check with the specific nursing home or skilled care facility to determine whether or not they are allowing visitors.  Researchers should prioritize the health and safety of project personnel, collaborators, students, and human subjects when deciding how to move forward with research activities.  Research involving vulnerable populations or individuals with underlying health conditions should include special precautions when possible.  (CDC Guidelines)

Research occurring in a school district

Researchers are requested to check with the school district prior to the conduct of any research related activities to ensure they are still allowing visitors or remain open. (https://educateiowa.gov/article/2020/06/03/covid-19-guidance-and-information)

Human Subjects Research conducted at an International location

The UI IRBs will continue to review all human subjects research submissions as staffing levels permit.  IRB approval of human subjects research proposing to conduct activities at an international location should not be construed as approval to override University of Iowa or CDC\WHO guidelines on travel.  Researchers must comply with institutional requirements as documented on the University of Iowa Campus Coronavirus Updates website and the latest guidelines issued by the Centers for Disease Control and Prevention (CDC),  the World Health Organization (WHO), and the Iowa Department of Public Health (IDPH). The Department of State also has information on current Travel Advisories.

Sponsor study monitoring requirements for human subjects research

The UIHC is allowing limited visitors and vendors in the facility.  The study team should contact the monitor and explain the process for gaining entry to the hospital with particular attention to the fact that they will be required to wear a face shield at all times when in public spaces.  Virtual monitoring of ongoing studies procedures is the preferred method to offer to a study sponsor.  However if the study sponsor requires an in person site initiation visit, the following must occur:   

  • Study team must contact the study monitor to inform them if they have COVID symptoms, they must reschedule.  COVID-19 symptom screening will occur at the door when entering the UIHC. 
  • Study teams will need to provide the monitors with directions to the appropriate hospital entrances 
  • The study team should request the study monitor arive with a face shield.  A face shield must be worn in all UIHC public spaces.  
  • Prior to arrival, the study team should then send the following information to the screening/main information desk teams: (Lyndsey-mascher@uiowa.edu, jill-furgason@uiowa.edu, and robin-hennes@uiowa.edu)
  • Vendor\Study Monitor name
  • Date of arrival
  • Department Administrator
  • Department Contact (may or may not be the same as the administrator)
  • Department Contact’s Phone number
  • The study monitor should show up to an entrance that supports visitor screening (Main Entrance – off the Skyway only due to construction, Fountain Lobby Entrance, SFCH 1st floor, 1st floor PFP or 2nd floor PFP Skyway from Ramp 4).
  • If study monitor shows up without a face shield, the process is to call that contact/contact name to have the department work with the monitor to obtain one or turn them away as this is a requirement for all vendors entering the UIHC.

The ICTS offers the opportunity for study teams to set up virtual monitoring with the sponsor\monitor.  For more information, please contact Kim Sprenger (Kimberly-sprenger@uiowa.edu, 319-353-8862).        

Tools Available to Conduct Remote or Virtual Research Related Activities

eConsent (Use of Electronic Consent) options available at the UI

Federal regulatory guidance must be followed if an eConsent (electronic informed consent) tool is used in the conduct of human subjects research.  Limited tools are available at the UI as an eConsent Tool.  REDCap is available as eConsent tools to conduct non-FDA regulated research.  Contact the ICTS for more information on REDCap.   Qualtrics could also be used in limited instances as an eConsent tool.  Any eConsent tool used as part of a human subjects research project must be approved by the IRB of record prior to use.  Contact the Human Subjects Office via email irb@uiowa.edu or call (319)335-6564 for assistance.  

Virtual options for conducting human subjects research visits  (e.g. interview, surveys, questionnaires, etc.)

There are several video conferencing options available from the UI ITS that the UI IRBs would find acceptable for conducting virtual research visits.  The HSO\IRB strongly recommends using an UI ITS supported video conferencing solution.  If you use a tool not endorsed by the UI ITS, the IRB will require you to discuss the tool with UI ITS Research Computing to ensure appropriate security and confidentiality measures are in place prior to submission to the HSO\IRB.  A technology or IT security plan may be required.     

Data Security When Conduct Research Related Activities Virtually or Outside UI Physical Space

Remote Access Set up

Principal Investigators\Research Teams should continue to maintain appropriate data security and confidentiality measures to conduct research related activities at an alternate location.  UI ITS recommends the study team ensure remote access to study files is set up for work at an alternate location (e.g. data entry, transcription, data or statistical analysis, coding data, etc.) Appropriate IT security and confidentiality measures consistent with UI ITS policies (e.g. encryption, use of VPN, use of OneDrive, etc.) would be required. 

PI\research teams should also consider grant or contractual obligations related to data security, storage, and confidentiality measures prior to allowing research team members to work from a location outside of the University of Iowa campus.  Check with the Division of Sponsored Programs or UI ITS if you have questions regarding if these obligations apply to your research.  Any changes must be approved in advance by the IRB as a modification to the study. Additional information regarding best practices for data security can be found on the Educational Tools page of the HSO Website.  If you have any questions about whether a remote option is possible or approvable (especially for consent), contact the IRB at irb@uiowa.edu.

IT best practices and security requirements for continuing to conduct my research from home

The HSO\IRB recommends applying the security and IT best practices outlined by the UI ITS for any research efforts continuing from a remote location.  The first step is to ensure the UI ITS standards for working remotely are in place.  UI ITS has also outlined the “Top 10 Security Considerations When Working From Home” to help to protect University of Iowa research data when working from home.       

IT related information available when using Zoom to conduct virtual research visits

The HSO\IRB recommends below UI ITS recommendations for IT safety, security, best practices for the use of Zoom for research purposes.  

Storing human subjects research data in a secure manner

The Human Subjects Office (HSO) has a Data Security Educational Tool outlining best practices for data security protections involving human subjects research.  The HSO\IRB require all data be stored in a UI ITS managed service like OneDrive, RDSS, or the departmental shared drive. (see the full list of research data storage options)  These best practices can be applied for all human subjects research regardless of the method or mode of data collection.  The UI ITS also offers a data classification guide for storing and sharing UI data.

Audio\Video recording best practices for virtual research visits

Researchers conducting audio and video recordings via Zoom or Skype should immediately be transferred to a UI-managed storage service (UI OneDrive, RDSS, H:Drive, for example) at the conclusion of the research visit. Once securely stored, the audio and\or video recording should be deleted from the recording device. Cell phones cannot be used for any recording functions – phone conversations, Zoom, or Skype sessions.

Investigators seeking only audio recordings should take care not to obtain video recordings via Zoom or Skype. Investigators should ask Zoom participants to disable their cameras before recording sessions begin; this will allow the PI to capture only audio content. Both Zoom and Skype applications have the capability of automatically storing local recordings to UI-managed storage drives if the drive is first mapped to the computer and the application settings are updated.  In order to set this up correctly, please refer to UI ITS Security and Privacy Tips for Zoom.  Contact UI ITS with questions. Once securely stored, the recording must be deleted from the recording device.

If phone interviews are used, the research team member should engage the phone’s speaker phone tool. Conversations may be recorded using a separate recording device (such as a hand-held digital recorder or a secure recording application on a laptop or desktop computer). Please contact the IT department to determine what recording applications are acceptable.