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Human Subjects

On May 18, 2021, Texas Governor Abbott issued Executive Order No. GA-36 prohibiting governmental agencies and officials from mandating face coverings in response to the COVID-19 pandemic. Therefore, UH no longer mandates face coverings, and no UH employee can require that another person wear a face covering, unless the IRB approved study protocol specifically requires it.

Research with Human Subjects

In the current phase of reopening the campus for research, all categories of human research activities are now permitted. Social distancing and sanitization protocols remain in effect.

Faculty, staff, students, and research volunteers cannot be required to wear a face covering, unless specifically required by the IRB approved study protocol, nor can they be asked whether or not they have been vaccinated.

The previously signed Investigator/Research Personnel Agreements have been replaced by the guidelines below, effective May 18th.

The novel coronavirus continues to infect others through close contact, and new variants continue to appear. Carefully review the guidelines below and consider vaccination to protect yourself, our research teams, and volunteers.

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 Transition and Reopening website.


What Has Changed?

  • All IRB-approved human subjects activities are now permitted.

  • A signed Investigator/Research Personnel Agreement is no longer required for each study being started or restarted.

  • Subjects must sign an updated handout, reflecting the Executive Order. The use of the previous handout should be discontinued, and both new subjects and those who signed the previous COVID handout should be provided with and sign the updated one. Keep this document in the subject’s research file along with the signed informed consent document; provide the subject copies of both documents.

  • Contact tracing information needs to be maintained.

Should you have questions regarding the recommendations or recent changes, please reach out to Kirstin Holzschuh, Executive Director, Research Integrity and Oversight (RIO) at kmholzsc@central.uh.edu, with a copy to cphs@central.uh.edu.


Important Considerations

When considering the items below, keep in mind that human subjects are volunteers, and should not be on campus if they are uncomfortable. In addition, please take the following into consideration:

  • A human subject may belong to a higher-risk group for COVID-19 without the investigator necessarily being aware of it.

  • It is advised that remote interactions and/or those able to be conducted at a distance of more than six feet continue be used whenever possible to control the spread of the virus. 

  • When research procedures are conducted at locations other than on the UH campus (e.g. schools, churches, medical facilities, homeless shelters, prisons) with a more stringent set of guidelines, the requirements of the external entity must be followed.

    When activities are conducted in person, the additional precautions listed on this page may help protect both research team members AND research subjects.

Guidelines

Guidelines for most studies are below. In addition, enhanced guidelines exist for College of Optometry studies and Health and Human Performance Exercise studies:

  • Guidelines for College of Optometry protocols may be found here.

  • Guidelines for Health and Human Performance (HHP) Exercise Science studies may be found here. (These guidelines may also be useful for other research activities that elicit forceful respirations, such as those that involve singing or shouting.)

Prior to Subject Arrival:

  • Subjects/potential subjects must be verbally screened for COVID-19 symptoms or known COVID-19 exposure, using the Health Self-Screening criteria and Exposure Assessment questions on the Visitors page within 24 hours of coming to campus. If any questions are answered with “yes,” and the symptom is not related to a pre-existing medical condition, they may not come to campus.

  • Discuss details about how the visit will be conducted, including additional information related to any protective measures that may be utilized to prevent the spread of COVID-19. Inform the subjects that face coverings are recommended but not required, and that research personnel also have this choice.

  • When the subject is a minor, ideally only one accompanying adult will be present. If screened, both the child and the caregiver must pass all screenings. If the subject is not a minor, an accompanying person is not recommended unless the subject requires a caregiver for transportation or care.

Day of Visit:

  • Each subject (and accompanying adult in the case of a minor or research participant requiring assistance) must be met and screened prior to gaining building access and entry to the lab. This screening includes:

    • Ensure the subject meets the Health Self-Screening criteria and Exposure Assessment questions on the Visitors page. If the subject/potential subject exhibits any of the listed symptoms and those are not related to a pre-existing medical condition, the subject should be asked to leave. 

    • Time of entry, duration of visit, confirmation of screening, and contact information for potential contact tracing should be entered into the contact tracing log that will be kept for two weeks prior to being destroyed.

  • All research personnel must pass the same daily screening, and the number of research personnel in the lab/testing space should be limited to as few as necessary to conduct the required procedures. Non-study personnel should not enter the area.

  • Schedule appointments that do not overlap with those of other subjects and keep participants 6 feet or more apart in waiting areas. Allow sufficient time between subjects in the research space to clean applicable surfaces with an EPA-approved cleaner, for the fully required contact time designated by that cleaning agent (see below).

  • Research staff, subject, and accompanying adult (if applicable) must wash their hands with soap and water for 20 seconds or use hand sanitizer before and after each appointment, including when first entering the research area. Frequent hand washing or hand sanitizer use should occur throughout the visit.

  • The subject must be provided with and sign the updated subject handout, in addition to the consent form for the study. Ensure the subject receives a copy and that the signed copy is retained in the subject’s research file. If the subject is not comfortable with the COVID precautions listed, they may reschedule or choose to withdraw from the study.

  • To reduce the chance for viral transmission, more than 6 ft of distance must be maintained between individuals whenever possible throughout the visit. When study procedures or the use of equipment requires the subject and examiner to be within 6 feet of each other, the examiner may sit off to the side to avoid face-to-face contact whenever possible.

  • If the participant chooses to mask and the research calls for the participant to not wear a mask for a particular component essential to the research question, this will be reviewed explicitly with the participant. There are two conditions under which this would occur:

    • When the research calls for the collection of facial data (via camera or other equipment) or other orofacial activities (e.g., eating/drinking) the participant may be alone in a closed room prior to and including the time of demasking, and the participant can re-mask prior to any researcher entering the room.

    • When the research calls for the collection of physical data (e.g., saliva via cheek swab), demasking may occur only for the minimum amount of time necessary (e.g., seconds).

  • When the study involves the collection of biological samples (i.e., blood, tears), study personnel should follow standard biosafety procedures. Gloves may also be worn by study personnel for any direct contact with human subjects. If gloves are used, CDC guidelines for removing gloves should be followed.

  • All equipment and surfaces must be thoroughly cleaned after each subject with a disinfectant that meets CDC and EPA guidelines with disinfectant-specific contact times as follows:

    • Applicable surfaces include, at a minimum: keyboards, chairs, instrumentation, touchpoints, and any items that come in contact with the patient or investigator/study personnel.

    • If disinfectant is used, research data collection sessions should be scheduled to allow sufficient time for proper cleaning and disinfection of the area and equipment between subjects.

    • To make sure disinfectant is effective, follow all disinfectant-specific instructions, including ensuring the item/surface is left wet with disinfectant for the required contact time.

    • These cleaning standards are recommended for any space or research lab in which human subjects are seen.

    • Single-use or disposable supplies (e.g., pens) are encouraged when possible. In the event that sensitive equipment cannot be cleaned, appropriate protective equipment may be applied to the equipment (such as a disposable/cleanable cover) or to the participant (gloves or finger cots). If used, subjects will be guided in following the CDC guidelines for removing gloves.

  • Use of portable HEPA air purification/filtration devices (e.g. H13) for each data collection room is recommended as a secondary precaution against COVID-19 transmission in rooms with limited ventilation capabilities. For more information on how to find the appropriate size HEPA unit for your space, please see https://www.mdanderson.org/cancerwise/can-air-purifiers-protect-you-from-coronavirus-covid-19.h00-159385101.html.

  • The guidelines above serve as a minimum recommended standard. Given unique requirements for different research protocols and differing subject pools that may include populations more vulnerable to COVID-19, each PI may evaluate how to most effectively perform safe and responsible research beyond the requirements listed above, with the caveat that neither subjects nor research team members may be mandated to wear face coverings.

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. Zoom for health is also available for online interviews or sessions requiring HIPAA compliance. To register for Zoom for health or to obtain further information, Researchers should contact software@uh.edu

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 at UH had contact with specific subjects 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. 

  • If a protocol modification was previously submitted to add a less physical method of collecting data, and the previous method is still part of the approved protocol, the research team may choose to revert back to the original method. If the original method was deleted, it will need to be added back to the protocol via the submission of a modification prior to use.

  • Please note that modifications must receive approval prior to implementation.