Research with Human Subjects

The Research Integrity and Oversight (RIO) office is fast-tracking new COVID-19 related IRB protocols, as well as modifications to utilize remote procedures in your currently approved research. We realize it is important to ensure that this work proceeds in as timely a manner as possible.

The IRB submission process through ICON remains the same for all submissions. If you are planning to submit a COVID-19-related protocol that is time-sensitive, please also send an email to Kirstin Holzschuh (kmholzsc@central.uh.edu) with a copy to Danielle Griffin (dgriffi5@central.uh.edu). We will “fast track” these items in that:

• We will place those meeting exempt or expedited regulatory criteria at the top of the priority list in order to provide the fastest turnaround time possible.
  
  
• If full board review is required, we will assess on a case-by-case basis with appropriate justification if we can convene an off-cycle quorum of one of our full committees for faster turnaround.

In the current phase of reopening of the campus for research, only limited human subject research activities are permitted. The details below are mirrored on the Reopening Research page, which also includes additional requirements for research in general and for working in shared spaces. We ask you to familiarize yourself with all requirements prior to commencing research.

Important Considerations

When considering the items below, pleased keep in mind that human subjects are volunteers, and should not be on campus if they are uncomfortable or are required to comply with county or city mandates. In addition,

• We cannot always be aware of those in higher-risk groups for COVID-19.
  
  
• UH, and the IRB, must continue to consider risk/benefit ratio for subjects participating in research.
  
  
• Only limited, lower-risk human subjects activities are currently allowed. Remote interactions should continue to be used whenever possible, to control the spread of the virus.
  
  
• When activities are conducted in person, additional precautions to protect both research team members AND subjects apply.

Minimum Requirements

During this phase, social distancing must be maintained. If procedures require less than 6 ft of distance from subjects, they cannot be conducted at this time, except in clinics providing paid health care services.

• A verbal pre-screen is required for all subjects prior to coming on campus. Ensure that the subject:
  
  • has not received a diagnosis of COVID-19 in the past fourteen days.
  • does not exhibit any of the COVID-19 symptoms:
    • Cough
    • Shortness of breath or difficulty breathing
    • Chills
    • Fatigue
    • Repeated shaking with chills
    • Muscle or body aches
    • Headache
    • Sore throat
    • New loss of taste or smell
    • Congestion or runny nose
    • Nausea or vomiting
    • Diarrhea
    • Feeling feverish or a measured temperature greater than or equal to 100.0 degrees Fahrenheit, or
  • to the best of their knowledge, has not come in close contact with a person who is lab-confirmed to have COVID-19 prior to coming on campus for research-related activities.

• Do not invite subjects in known high-risk groups to campus at this stage:
  • Adults > 65
  • Minors
  • Research requiring the following as inclusion criteria (from CDC website):
    • Asthma
    • Chronic kidney disease being treated with dialysis
    • Chronic lung disease
    • Diabetes
    • Hemoglobin Disorders
    • Immunocompromised
    • Liver disease
    • People aged 65 years and older
    • People in nursing homes or long-term care facilities
    • Serious heart conditions
    • Severe obesity

• Strict adherence to safety precautions is crucial:
  • Schedule appointments to not overlap with those of other subjects
  • Thoroughly sanitize research area and equipment between subjects
  • Frequently sanitize hands during visits
  • All subjects and research personnel must wear masks, provided by the lab. Subjects should be given the option to wear gloves.
  • Research personnel interacting with subjects must wear gloves and remove them properly between subjects
  • For individual contact tracing purposes, maintain a list of all subjects who come to the lab and who interacted with them
  • Required sanitization, verbal COVID-19 screening, use of personal protective equipment, and other safety precautions do not have to be added to the IRB protocol.

Research by Category

• The following research procedures may continue:
  • Online interviews, surveys, and focus groups Note: See DOR/IT guidance for online platforms in next section.
  • IRB protocols switching to online methodologies, once a modification has been submitted and approved (IRB office priority for quick turnaround).

• With Harris County’s Threat Levels, the type of in-person human subjects research that is allowed, depends on the threat level. Further guidance on assessment and considerations for minimizing risks are on the COVID-19 Human Subjects page, and we ask you to consult this page prior to commencing human subjects research.

  Threat Level 1 (current threat level)

  • On campus, in settings that do not provide paid clinical health care services: The only research procedures that can be conducted are those that can be done while maintaining at least 6 ft distance at all times.
    
    
  • On or off campus, in settings that do provide paid clinical health care services: All approved research procedures may be conducted in these settings, following established clinical policies and procedures (in particular, sanitization procedures and PPE utilized for COVID-19 in the specific clinical field).
    
    
  • Off campus in other established institutional settings (e.g., schools, prisons): The only research procedures that can be conducted are those that can be done while maintaining at least 6 ft distance at all times. In addition to UH requirements, additional precautions set forth by the external institution apply.
    
    
  • Off campus in non-institutional/community settings (e.g., homeless shelters or on the streets, farmers markets, or community social/church gatherings): No human subject research is allowed at this time.

  Threat Level 2

  • On campus, in settings that do not provide paid clinical health care services: The only research procedures that can be conducted are those that can be done while maintaining at least 6 ft distance at all times. Policies and procedures are currently under development to allow for less than 6 feet distance.
    
    
  • On or off campus, in settings that do provide paid clinical health care services: All approved research procedures may be conducted in these settings, following established clinical policies and procedures (in particular, sanitization procedures and PPE utilized for COVID-19 in the specific clinical field).
    
    
  • Off campus in other established institutional settings (e.g., schools, prisons): The only research procedures that can be conducted are those that can be done while maintaining at least 6 ft distance at all times. In addition to UH requirements, additional precautions set forth by the external institution apply. Policies and procedures are currently under development to allow for less than 6 feet distance.
    
    
  • Off campus in non-institutional/community settings (e.g., homeless shelters or on the streets, farmers markets, or community social/church gatherings): No human subject research is allowed at this time.

   Threat Level 3 or 4

  • Guidelines are under development.

Assessment and Considerations for Minimizing Risks

• Students and staff must give their explicit consent to participate in any human subjects research in their role as researcher. They may choose to participate in research where no human subjects are present but decline participation when human subjects are present.
• Students and staff should not be placed in high-risk environments defined as
  • Subjects are positive or unknown status for COVID-19 infections
  • Prolonged duration exposures (> 1 hour)
  • Near proximity (< 6 ft.) without PPE
  • High-risk procedures (e.g., significant to severe aerosolization risks, cough, sneeze, etc.)
• Consider the following questions to reduce risk:
  • Can the study be performed remotely?
  • Consider the type of contact between subjects and research staff, in particular, proximity requirements and duration.
  • Is personal protective equipment (PPE) required? If yes, who is responsible for providing it?
  • If the study is conducted off campus, consider the following additional questions:
    • Does the location where the procedure will be conducted have a COVID-19 protocol, policy and/or procedure in place to ensure the health and safety protection of students, employees, and subjects?
    • What are the policies at the off-campus location if someone at the site (student, employee, or subject) develops symptoms or tests positive for COVID-19 within two weeks of the in-person interaction?
  • Using the above considerations, assess risk and determine if the environment seems appropriate for students and research staff.

Approvable Online Platforms

• Microsoft Teams using the UH license. This is the preferred collaboration tool.  Tips are available here.
  
  
• Microsoft Skype for Business (SFB) using the UH license.  Tips are available here.
  
  
• Zoom using the UH license.  Information on how to obtain a UH license can be found here. Tips are available here.

The University is currently working on a Zoom license for online interviews that require HIPAA compliance. Researchers should contact Ruth Shapiro (Office of General Counsel; rshapiro@uh.edu) directly to learn more about this.

Research and Reporting COVID-19

• No state or county reporting is required if a subject self-discloses that he/she has had a lab-confirmed case of COVID-19.
  
  
• IF, however, you have a new or updated IRB protocol that requires the testing of human subjects for research purposes with an FDA-approved COVID-19 test, both positive and negative cases must be reported to state and local health authorities. This must be addressed in the consent form.
  
  
• Contact tracing – the best way to document which individuals had contact with specific HS is to make a note in the research file; this may be accessed later if needed. Do not maintain subject names outside confidential UH locations(i.e. a list kept at home).

Protocol Modifications

• Submit a modification to the protocol in ICON for IRB review if 1) research will be adapted to collect data in other formats not involving face-to-face contact to promote continuity of research, and/or 2) if COVID-19 screening data will be maintained and used for research purposes. Please note that modifications must receive approval prior to implementation. For this reason, we suggest not making other changes to the protocol at this time.

Award-Specific Guidance

• If staff need to contact human subjects from home, inexpensive cell phones used solely for the purpose of the grant might be a defensible charge to the grant. The PI/department authorizing the charges would need to oversee the purchases and use of the phones to ensure that they were used exclusively for the project; if used for multiple projects, cost allocations must reflect relative usage. Documentation should be retained in the department's grant file. In addition, the department may want to consider alternative technologies that allow users to shield their personal number when using their own cell phones for business purposes. 
  
  
• Funding agencies have processes in place for no-cost extensions and are being lenient due to COVID-19 and institutional restrictions. Contact your program officer.