Coronavirus: COVID-19 - Updates from the IRB

Human Research Protection Program

Institutional Review Board

RESUMPTION OF RESEARCH – June 1, 2021, revised September 1, 2021*

The State of Michigan has recently announced plans to move Michigan forward towards normalcy based on increased vaccination rates and recent CDC guidelines. In step, the University has announced measures to return to campus. In this context, the Office of the Vice-President for Research and the HRPP have established guidelines and processes for research involving human participants as we enter the next period of activity and mission re-engagement. 

This specific update provides information related to the resumption of research for studies classified as "without potential for direct benefit" and that are conducted at Wayne State University and/or in established health care facilities.

The current process for the review and approval of risk mitigation strategies for research with a potential direct benefit, as established through the Appendix N (pdf) mechanism, is now extended to include research classified as without a potential for direct benefit.

Effective June 1, 2021: In-person research without potential for direct benefit conducted at Wayne State University sites and/or established health care facilities will resume.

Effective July 1, 2021: In-person research without a potential for direct benefit to participants conducted at nonaffiliated WSU sites will resume. The study's mitigation plan must include the non-affiliated study sites' approval/letter of support to conduct in-person research activities.

*Effective September 1, 2021: All visitors to the WSU Campus are required to complete the WSU Guest Campus Screener on the day of the on-site visit and prior to arriving on campus. With the exception of research participants with prior approval to visit campus, all visitors to campus must be fully vaccinated. The vaccine mandate does not apply to non-WSU individuals who are visiting campus to participate in research.

For research participants completing the WSU Guest Campus Screener, the participant will select Yes in response to the question: Are you a participant in a WSU research study attending campus as part of that study?

 

Vaccination Requirements:

Researchers affiliated with any of WSU's affiliate institutions must follow their institutional vaccination requirements. It is important to be familiar with the COVID-19 policies for your study site.

Vaccination does not eliminate the requirement for strict adherence to COVID-19 risk mitigation procedures.

WSU Vaccine Policy:

As of August 31, 2021 WSU requires all WSU staff, students, faculty and visitors to be fully vaccinated before arriving on campus. Additional details about the WSU Vaccine Mandate is available on the WSU Vaccine Mandate Website.

https://wayne.edu/coronavirus/vaccine-mandate

Vaccines for Research Participants: 

Restricting access to human participant research based on an individual's vaccination status raises ethical concerns pertaining to the equitable selection of subjects which is a requirement of the Belmont Report described by the Ethical Principle of Justice. Therefore, investigators cannot include COVID-19 vaccination in their inclusion criteria for the enrollment of research participants.

Appendix N (pdf) is located in the Appendices section on the IRB Forms page: 

Instructions for submission to the IRB is also located on the IRB Forms page: https://research.wayne.edu/irb/forms-requirements-categories

HRPP-IRB Webinar Series:

The HRPP-IRB webinars are ongoing touch base opportunities to address your questions. The webinars take place on the last Tuesday of each month from 10:30am to 11:30am via Zoom.

To register for the webinar, please send an email to: WSUIRBInfo@wayne.edu

The link and instructions to access the webinar will be sent via email after registering for the session.

https://research.wayne.edu/irb/education

IRB Training Requests & IRB Questions:

IRBQuestions@wayne.edu

https://research.wayne.edu/irb/education.

 

HUMAN PARTICIPANT RESEARCH AND IN PERSON PARTICIPANT INTERACTIONS:

Key considerations - It is important to be mindful that research participants are volunteers who must be afforded all reasonable protections to mitigate risk while participating in research. Whenever possible, research should maintain remote study interventions/visits, as per IRB approval. All changes made to the research protocol and procedures to conduct study interventions/visits remotely must be submitted to the IRB in an amendment before those changes can be implemented.  

The Principal Investigator (PI) and the Department Chair should assess their capacity to resume human participant research that requires in-person contact and have established operational parameters for risk mitigation that are considered by the IRB in their review of Appendix N.   Such operational parameters may include, but are not limited to, masking, social distancing, vaccination of study personnel interacting with study participants, consideration of the duration of in-person contact with participants and staff, an established scheduling structure for coordinated participant visits and cleaning procedures between participant visits.

When clinical research is conducted in the clinic/hospital setting, please follow that site's COVID-19 precautionary standard operating procedures. For research conducted at a WSU research facility, refer to the university's guidance for on campus-activities and additional information on restarting WSU research operations:  https://research.wayne.edu/coronavirus/restartguidance

Steps to take before beginning/resuming in-person research interactions with participants:

  1. Review the research protocol to determine which study visits, interventions, or tests are essential to conduct in-person study visits so as to provide participant safety.
  2. Discuss options with the sponsor for alternatives to in-person study visits.
  3. Consider whether the in-person study visit could coincide with a standard of care visit.
  4. Develop comprehensive procedures to mitigate the risks of exposure to COVID-19.
  5. Develop a procedural checklist to ensure adherence to the mitigation procedures developed.
  6. Appendix N: Resumption of Clinical Research Plan and PI Attestation: Studies that do not take place in a clinical setting with standard COVID-19 operating procedures:
    1. Compete Appendix N
      1. New studies being submitted for initial IRB review and approval: Include Appendix N with initial IRB submission.
      2. Studies with current IRB approval: Complete Amendment application
        1. Full board studies: complete a full board amendment application
        2. Expedited and exempt studies: complete an expedited amendment application
    2. Submissions should include all materials used to communicate with participants prior to arriving to their in-person study visit.
        • The IRB has provided templates on our "Forms and Submission Requirements" website:
          • COVID-19 Oral scripts for telephone communications
          • COVID-19 Information Sheets to be given to participants
    3. Submit for IRB review

Note: Study visits that have been modified to virtual/phone/remote formats should continue to conduct those visits as per IRB approval

Appendix N: Resumption of Research Plan and PI Attestation:

In-person research activities require additional precautions at this time to protect both the participant and the research staff.

The IRB is responsible for considering the risks and benefits for participants engaged in research. The IRB evaluates whether risks to participants have been minimized, that the risks are reasonable in relation to anticipated benefits, and the importance of the knowledge that may be reasonably be expected to result (45 CFR 46.111). To meet this responsibility as research is resumed, the IRB requires the submission of Appendix N: Resumption of Clinical Research Plan and PI Attestation. Appendix N is designed to describe the plan to mitigate risks of in-person study visits.

Appendix N includes:

  • Participant Information including the expected number of in-person visits that will occur per participant and a description of any potential increased risks due to COVID-19 that may affect the study's participant population.
    • A COVID-19 Phone Script is required to be used when contacting the participant about resuming in-person study visits. The template is available on the IRB website.
    • A COVID-19 Participant Information sheet is required to be given to the participants. The template is available on the IRB website.
  • Procedures for Promoting Safety of the Physical Environment including the physical space in which the study visit will occur and how it will accommodate the COVID-19 precautionary measures, including social distancing. 
  • Procedures for Promoting Safety of Person to Person Interactions including pre-screening participants for COVID-19 symptoms, limiting the number of individuals present during the study visit, vaccinations, social distancing plan, personal protective equipment [PPE] for participants and research staff, handwashing, disinfecting, plans for assessing and responding to the participant's and research staff's health concerns.
  • Procedural Checklist to monitor adherence to the plan.
  • Principal Investigator Attestation to provide assurance that all risk mitigating steps will be followed.

Research activity coinciding with Standard of Care visit:

In instances where research activity coincides with a regularly scheduled standard of care visit(s) and would not add risk to the participant or research staff, the research activity may proceed regardless of whether the research provides a direct benefit.

Participant risk:  If the research activity coincides with the standard of care visit, the participants are already on-site, moving forward with the research activity would be acceptable since the participant's risk of exposure to COVID-19 is not increased. The research activity should be completed within a reasonable amount of time in relation to the standard of care visit.

Research staff risk:  If the research staff are already routinely reporting on-site, then moving forward with the research activity during a standard of care visit would be acceptable. If the research staff is reporting on-site ONLY for the research activity, ensure that risk mitigation plans are in place.


COVID-19 Research Advisory Committee

The Vice President for Research has announced the establishment of a committee that will provide initial screening of proposed COVID-19 research before the proposed research is submitted to the IRB. This committee's review is intended to maximize access to resources and enhance feasibility and merit. The committee will consider community impact and compliance with evolving state and federal guidance for assuring adequate protections to the community.

All proposed studies involving COVID-19 must be submitted to the advisory committee.

The advisory committee will provide an assessment and recommendation of the submission prior to IRB review. To view the complete memo from the Vice President of Research click here.

Objectives of the Advisory Committee:

  • Maximize access to resources
  • Enhance feasibility and merit
  • Assess community impact
  • Assess compliance with evolving state and federal guidance
  • Ensure all COVID-19 protocols include adequate protections to the community

Process:

 Email the following information to COVID19Research@wayne.edu

  • Brief summary of the proposal and protocol
  • P.I. name, contact information and affiliation
  • Informed consent (if applicable)
  • Confirmation of Department Chair approval

Following the committee's assessment of the proposed research, submitters will receive the committee's recommendation and input by email within two days. The protocol can be submitted to the IRB for review once the COVID-19 Research Advisory Committee's recommendations are received.

 

HRPP/IRB Operations - General Information

The Human Research Protection Program, IRB Administration and IRB Committees will continue to function remotely until further notice.

  • The IRB office is not accepting in-person visits or hard copy submissions.
  • Emails and phone lines are being routinely monitored per usual practice during business hours.
  • Priority is given to all inquiries, requests, applications and modifications related to COVID-19, and its impact on research.
  • Non-COVID-19 studies are now also being reviewed in the order they were received.

IRB Submissions

  • Research protocol submissions, including initial submissions, amendments, continuations, and closures continue to be accepted.
    • eProtocol electronic submissions continue per usual practice through the eProtocol web application.
    • Paper-based submissions should be emailed to eIRBManager@wayne.edu
      • Electronic signatures are accepted for paper-based submissions.
    • VA Full Board submissions should be emailed to M1 for Medical, B3 for Behavioral research to the following addresses: M1board@wayne.edu or B3Board@wayned.edu
    • External IRB requests should be emailed to the appropriate external IRB email address: relyirb@wayne.edu, wirb@wayne.edu, or cirb@wayne.edu as per usual practice.
  • Unanticipated Problem Reports should be emailed to eIRBManager@wayne.edu.
  • Single Time Emergency Use requests should be emailed to eIRBManager@wayne.edu
  • Single Time Expanded Access requests should be email to eIRBManager@wayne.edu
  • Continuation Requests/ Status Update Reports and Closure Reports:
    • Paper based submissions should be emailed to eIRBManager@wayne.edu
    • eProtocol electronic submissions should continue per usual practice through the eProtocol web application

Modifying Study Procedures

MODIFICATIONS TO THE IRB APPROVED PROTOCOL REQUIRES IRB APPROVAL

The amendment requires the appropriate amendment submission form, and:

  • Revised research protocol/proposal or addendum.
  • Consent forms- if modifications require changes to the informed consent
    • A waiver of documentation of informed consent will need to be requested if informed consent will be obtained verbally over the phone. This is only permitted for minimal risk research. An oral consent script must be included in the submission.
      • Information about waivers of consent and instructions for requesting a waiver of consent is available in our IRB On-Demand Training Library located on the IRB Education Website.
  • Any new materials or revised materials that will be provided to participants related to the research such as information pertaining to the COVID-19 epidemic and how to reduce risk of infection.
  • Appendix N: Resumption of Clinical Research Plan and PI Attestation.

If action is taken without IRB approval to eliminate an immediate risk to the participant, please report the action to the IRB, per IRB policy 13-01: Unanticipated Problems and Other Reportable Events. The PI should follow with an amendment to seek approval for participants not at immediate risk.

Please use the Unanticipated Problem and Event Reporting form: https://research.wayne.edu/irb/docs/unanticipated_problems_and_event_reporting_form_corrected_10_4_19.doc.

Participant Exposures to COVID-19 and IRB Reporting Responsibilities:

When an investigator becomes aware of a participant who may have been exposed to COVID-19, or has tested positive to COVID-19, an unanticipated problem report must be promptly submitted to the IRB following instructions provided above in the IRB Submissions section.

EXTERNAL IRB

Notify your External IRB of actions taken with the protocol as they relate to COVID-19 and WSU-imposed research restrictions. Be sure to comply with the External IRB's reporting, modifications, and other requirements.

The WSU External IRB review addresses local context issues. To meet this responsibility as clinical research is resume following the pandemic, the IRB will require the submission of Appendix N: Resumption of Clinical Research Plan and PI Attestation for protocols reviewed by an External IRB. Appendix N is designed to describe the plan to mitigate risks of in-person study visits.

  • For new research, include Appendix N with the initial submission.
  • For currently approved research, submit Appendix N with the External IRB modification from prior to conducting on-site visits.

Local Unanticipated Problems for studies with an External IRB:

 Local unanticipated problems that occur at the WSU site must be promptly reported to the IRB by completing the External IRB Modification and Event Reporting form and emailing to relyIRB@wayne.edu.

This process should be followed if an investigator becomes aware of a local participant who may have been exposed to COVID-19 or has tested positive to COVID-19.


Single Patient Expanded Access

The single time expanded access to novel therapies may be required during this time. The request for the single time expanded access will be processed as per IRB policy:

11-1 Research and expanded access involving investigational drugs

https://research.wayne.edu/irb/docs/11-01-research_and_expanded_access_involving_investigational_drugs_10_2019_1.docx

Please submit requests electronically only to eIRBManager@wayne.edu.      https://research.wayne.edu/irb/docs/expanded_access_submission_form_10_2019.doc

 


Single Time Emergency Use of a Test Article

The emergency use of a test article (drug, biologic or device) may be required during this time. The request for an emergency use of a test article (drug, biologic, or device) will be processed as per IRB policy:

11-3: Emergency Single Time Use of a Test Article.

https://research.wayne.edu/irb/docs/doc144_policy_11-03_emergency-single-time-use-of-test-article_11_2019.doc

Please submit requests electronically only to eIRBManager@wayne.edu.      https://research.wayne.edu/irb/04_2015_forms/single_time_use_04_2015.doc


COVID-19-Related Activities That May Not Be Research

The WSU IRB is ready to assist researchers and clinical care providers who are planning COVID-19-related activities that may intersect or overlap with public health authority activities and/or FDA emergency authorizations for diagnostics. In some cases, IRB approval will not be required. The WSU IRB can assess the circumstances, provide advice, and issue determination letters. Please contact IRBquestions@wayne.edu for more information.

Human Participant Research (HPR) Determination Tool

For information regarding activities that are not considered Human Participant Research, please view the HPR Guidance Tool (pdf) (4.2019 update).

Additional Guidance about the definition of human participant research and determining if a project requires IRB review is available in the IRB On-Demand Training Library located on the IRB's Education website.


ClinicalTrials.gov Registration Updates

Some studies registered at the federal site ClinicalTrials.gov are modifying their research procedures to include testing for SARS-CoV-2 and/or assessment of COVID-19 symptoms. The ClinicalTrials.gov information for the study should be updated to include these new procedures, if they are done for research purposes. If they are being added as public health surveillance activities in coordination with public health authorities, the registration information does not need to be modified. The federal requirement about modifications is that any research-related changes that are communicated to the subjects (past, ongoing, future) must be added to the study's ClinicalTrials.gov registration with 30 days after IRB approval of the modification.


Coronovirus – COVID-19 Information

CDC Prepare your practice for COVID 19

https://www.cdc.gov/coronavirus/2019-ncov/hcp/steps-to-prepare.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Fclinic-preparedness.html

OHRP Guidance on COVID-19

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-covid-19/index.html

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID 19 Public Health Emergency

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency

World Health Organization/Risk Communication/Health workers and administrators

https://www.who.int/teams/risk-communication/health-workers-and-administrators

State of Michigan – Coronavirus Information

https://www.michigan.gov/coronavirus/