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Human Subjects

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 – permissions for human subjects activities may change on a day-to-day, or week-to-week basis, based on the current county/city/state or federal outlook. Ensure that you and your research team closely monitor emails from the Vice President for Research and Technology Transfer, your Associate Dean for Research, and the DOR COVID-19 website.

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, repeated shaking with chills, muscle pain, headache, sore throat, loss of taste or smell, diarrhea, feeling feverish or a measured temperature greater than or equal to 100.0 degrees Fahrenheit, or known close contact with a person who is lab-confirmed to have COVID-19.
    • 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.
This information does not need to be maintained as part of the research record unless the data will be analyzed as part of the research; if data will be utilized, a modification to the protocol is required.

  • 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).
    • Research conducted in settings providing paid clinical health care services.
    • Other research conducted on campus if six feet of distancing between the subject and research team members can be maintained at all times. This will eliminate some research where close contact is required until UH proceeds to the next phase of re-opening.

  • External institution policy prevails for research conducted in external clinics and other established institutional settings (e.g., schools, prisons).

  • Research in non-institutional/community settings (e.g. homeless shelters or on the streets, famers’ markets or community social/church gatherings) is not permissible at this time.

Approvable Online Platforms

There are significant security concerns associated with information sharing through the available collaboration tools. We require that you use only UH officially licensed applications, not trial versions or personal licenses to make sure that the appropriate security controls can be implemented and that there are UH-accessible logs for the sessions. The following platforms can be approved by the IRB for online interviews that do not require HIPAA or other healthcare privacy compliance:
  • 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.

IMPORTANT - In consideration of in-person limitations: for studies where subjects could be adversely affected by missing research visits (i.e. in cases where missing a study-related intervention or research-related treatment may cause additional harm), a plan to mitigate the risk and/or provide information to subjects must be submitted to the IRB as a modification within ICON. Please also provide notification to CPHS@central.uh.edu to ensure that the modification is given top priority. Submit this plan as soon as possible for IRB review.

For these studies, the IRB office will follow up with the PI/study team following the public health emergency to assess actual risk having occurred to participants and to ensure mandatory reporting as necessary. Principal investigators will be responsible for reporting individual subject deviations to sponsoring agencies per award requirements.

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.