Resumption of Research

Guidance for Resumption of Research 4/7/2022

The SMU IRB, in response to the reduced COVID-19 risk assessments produced by the CDC and Dallas County, recently voted to move to Phase 4 of the resumption of research. This means that most in-person research with human subjects may be conducted without COVID-19 precautions.

However, the COVID-19 pandemic is not over, and risks to participants still exist: some locations continue to experience elevated transmission rates, and some populations remain at higher risk. It is at the discretion of the Principal Investigator to determine if these location- and participant-specific risks necessitate continued COVID-19 precautions. The CDC offers guidance about county-specific COVID-19 risks and groups at increased risk for severe illness. Research conducted internationally may also require COVID-19 precautions. If you are unsure if your protocol needs additional precautions, please contact Research Compliance to discuss your unique research situation.

  • If your IRB-approved research protocol never resumed during the pandemic, you may resume normal in-person research interactions without notifying the IRB, taking into consideration location- and participant-specific risks as appropriate.
  • If you changed all research procedures exclusively to remote formats, you may begin or resume normal in-person research interactions, taking into consideration location- and participant-specific risks as appropriate. Please notify the IRB of your intention to do so by emailing Research Compliance.
  • If your research protocol was approved by the IRB for remote interactions only, and you would like to begin in-person interactions, file an amendment in the Mentor IRB Management System detailing the new in-person procedures, taking into consideration location- and participant-specific risks as appropriate.
  • If your IRB-approved research was permitted to resume in-person interactions with COVID-19 precautions, you may remove those precautions and resume normal in-person research interactions, taking into consideration location- and participant-specific risks as appropriate. Please notify the IRB of your intention to do so by emailing Research Compliance.

The SMU IRB will continue to monitor the COVID-19 situation and make changes as needed to protect researchers and research participants. If you have any questions, please contact Heather McClary at hpowell@smu.edu or 214-768-2030.

The main purpose of the IRB at Southern Methodist University (SMU) is to assure appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research process. The recent SARS-CoV-2 virus (COVID-19) affects the safety and welfare of the human subjects participating in research affiliated with SMU. However, we also recognize the importance of research to the SMU community and are committed to finding ways to safely conduct human subject research at SMU with appropriate COVID-19 safeguards in place. The IRB Committee will continue to monitor the situation closely and reinstate more research as the risks for human subjects can be mitigated.

The IRB is implementing a phased reopening of human subjects research at SMU, where research protocols are categorized according to the risks to which they could expose participants and the potential benefit they provide (see Categories of Human Subjects Research and When to Resume), especially research directly relating to COVID-19, including its impact on communities. Where possible, data-driven criteria have been given for phased resumption of research protocols. However, given the unknown effects of state-wide relaxation of restrictions and unexpected contact from large gatherings (such as protests), these data-driven models may be rapidly evolving.

Portions of this web page reflect the guidelines posted by the human subjects division at the University of Washington, which halted all human subjects research in response to the pandemic. The criteria have been largely manipulated to serve the purposes of SMU. The University of Washington guidance can be viewed here (accessed last on June 1, 2020).

 

How to use this information: View each category, in order, and ascertain which category of human subjects research your protocol falls into. Once you have determined the category of your research protocol, follow the stated guidelines on whether to resume research or keep your project suspended. At this time, if you wish to continue your research protocol, it is required to revise any portion of your research protocol that (1) can be performed remotely or (2) can be safely eliminated to reduce exposure. If changes to the protocol are necessary, these MUST BE APPROVED by the IRB before any research starts. Amendment requests can be submitted in the Mentor IRB Management System. Please contact Research Compliance if you have any questions.

CATEGORY 1: Are there ANY in-person interactions in your research protocol?

  • YES, my protocol includes use of in-person interactions: Look at Category 1.5.
  • NO, there are no in-person interactions: Resume/begin your research following the approved protocol. There is no need to look at the other categories.

CATEGORY 1.5: Can ALL of your in-person interactions be eliminated?

  • NO, my research requires in-person interactions: Look at Category 2.
  • YES, my protocol(s) could be modified to eliminate in-person interactions: Submit an amendment request in the Mentor IRB Management System describing the procedures for removing in-person interactions for approval by the IRB. Once APPROVED you may resume/begin your research following the new approved protocols. Please view guidance for amending protocols in section "Revising Protocols to Remove In-Person Procedures" below.

CATEGORY 2: Is your research protocol approved for direct COVID-focused research?

Examples: Studies looking at diagnosis, treatment, interventions, or other directly-related activities, including some social-behavioral research that primarily investigate the impact of COVID on certain populations.

CATEGORY 3: Is your research considered essential for the health, clinical care, or well-being of participants?

This Category is comprised of protocols with high potential for direct health benefit to research participants due to life-saving or life-sustaining interventions or treatment.

CATEGORY 4: Is your research protocol considered a Clinical Trial?

“Clinical trials” are defined by the World Health Organization as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc.”

CATEGORY 5: All Other Research

The phases of allowable research are described below. The stipulations outlined in Phase 4 below are currently in place. The IRB may opt to revert to earlier phases in response to the evolving COVID-19 situation.

Phase 1 (Enacted April 30, 2020): All in-person interactions are suspended per IRB recommendations previously emailed. Only Category 1 research is allowed.

Phase 2 (Enacted June 30, 2020; re-enacted December 2, 2020): In addition to allowing Category 1 research, Categories 2-4 research may be approved on a case-by-case basis. These research protocols represent a direct benefit to the participant that outweighs the risk of exposure to COVID-19.

Phase 3 (Enacted October 23, 2020; revoked December 2, 2020; re-enacted 4/7/2021): In addition to the procedures for Categories 1-4, some procedures in Category 5 will be allowed, but must be approved by the SMU IRB. Researchers that can keep procedures remote are encouraged to continue to do so. In this phase, allowable research will expand to in-person procedures for which the protocol adopts ALL of the procedures listed in Revising Procedures to (Re-)Introduce In-Person Procedures below.

Participants that are NOT allowed to be recruited for in-person research interactions in Phase 3 unless participants and research personnel are fully vaccinated include: vulnerable populations such as elderly individuals and individuals with serious underlying health conditions, including high blood pressure, chronic lung disease, diabetes, obesity, asthma, and those whose immune system is compromised such as by chemotherapy for cancer and other conditions requiring such therapy.

Phase 4 (Enacted 4/7/2022): Human subjects research resumes for all research protocols. Researchers that can keep procedures remote are encouraged to continue to do so. Additional safety procedures may still be necessary depending on the location of the research and the medical vulnerability of the subjects.

Research involving in-person interactions may not begin or resume until final approval is granted by the IRB. Follow the steps below to request permission to begin or resume in-person research interactions.

  1. Create and describe sufficient protections for participants and researchers.
  2. Affirm the following in writing:
    • If the IRB determines that in-person research interactions are no longer safe, researchers must cease in-person research interactions immediately upon notification.
    • If utilizing the SONA subject pool, sufficient research alternatives and / or remote research opportunities are available to students.
    • Researchers will submit an Adverse Event Report if any issues related to COVID-19 are encountered while conducting the research.
    • Researchers agree to more frequent post-approval monitoring procedures.
  3. Request permission to begin or resume in-person interactions by completing the previous steps and submitting an amendment request via the Mentor IRB Management System.

New 4/7/2022: The IRB opted to enter Phase 4 of the Resumption of Research. As a result, the parameters detailed above are only required for research involving in-person interactions in certain contexts, including in geographic locations where the risk of COVID-19 is high and research with medically vulnerable populations.

New 3/2/2022: Researchers are no longer required to customize and implement a separate COVID-19 Consent Addendum or record all research interactions for contact tracing purposes. The other Phase 3 requirements (listed above) remain in place.

New 12/2/2021: COVID-specific CITI training (COVID-19: Back to Campus and Remote Contact Tracing) is no longer required for researchers wishing to begin or resume in-person research interactions.

New 11/4/2021: Protocols that involve several disparate research sites and reliance agreements can be complicated, especially during the COVID-19 pandemic. Please remember that COVID infection and vaccination rates differ geographically, so you may need to implement different COVID-19 protection procedures at different research sites.

New 7/1/2021: The IRB will now consider requests to resume in-person research interactions that take into account the vaccination status of researchers and participants. If all persons involved with in-person research interactions are fully vaccinated, the researchers may employ reduced COVID-19 precautions (e.g., no face masks). This option should only be used if members of the research team who will interact in-person with research participants voluntarily disclose their vaccination status. If researcher team members and / or participants opt not to receive the vaccination or disclose their vaccination status, researchers may still request permission to begin or resume in-person research interactions with appropriate COVID-19 protections. See the flow chart below for guidance. Please review the SMU COVID-19 Protocol Addendum for Research Involving Human Subjects Vaccination Status template and contact ResearchCompliance@smu.edu if you are interested in pursuing this option.

 

flowchart

 

It may be appropriate for an existing research protocol to eliminate in-person interactions to reduce risk of exposure to COVID-19. Procedures may include moving consent documents and written forms to online surveys or revising in-person interviews to be online via video conferencing. Amendment requests can be submitted in the Mentor IRB Management System.

Investigators revising protocols should consider the following:

Anonymization

Protocols that require participants to be anonymous (not just confidential, but where the identity of the subject cannot be determined by a reasonable person). Should consider the privacy measures used by their online survey provider. Many online survey forms track users based on their IP, cookies, emails, etc. The following links may be helpful for investigators choosing which survey provider to use.

Confidentiality of Forms and Video (Including HIPAA and FERPA Regulations)

Protocols that require collected data to be confidential will need to review the privacy policy of their chosen video conferencing and survey provider. For surveys, Qualtrics or SurveyMonkey are recommended as these provide dual encryption standards required by the University.

For video conferencing, protocols should consider the privacy policy of their video conferencing provider. They should also consider the confidentiality of the participants. For instance, a telephone call (not over the internet) is typically secure from third parties eavesdropping on the conversation, but may log that a call was made on the participant’s personal device—which might increase risk for certain protocols. Moreover, if using audiovisual recording software, be sure to include that these will be used in the consent form. If video recording is not needed, please include a statement in the protocol and consent that the recording function of the program will be disabled. No video conference can be recorded without justification and approval from the IRB.

Additionally, compliance with HIPAA or FERPA requires that no third party may eavesdrop on the conversation. This is only guaranteed for video conferencing services that are end-to-end encrypted. End-to-end encryption is different than video conferencing that is “encrypted.” In order to be end-to-end encrypted, the communication channel must never decrypt the audio or video until it reaches the devices of participants in the call. Please note that Zoom, Skype, WebEx, and other video conferencing software are NOT end-to-end encrypted. Some services can be upgraded to use end-to-end encryption, such as skype business. Apple FaceTime and iMessage ARE end-to-end encrypted. However, Apple FaceTime will also typically leave a log on the participant’s personal device that the call has occurred (which may or may not increase risk in your protocol).

Some research involving in-person interactions may be permitted to resume (see Categories and Phases above). In that case, the researcher must demonstrate that the research will be conducted in accordance with the IRB Requirements for Safely Conducting Research During COVID-19.