Coronavirus: COVID-19 - Updates from the IRB

Human Research Protection Program

Institutional Review Board

UPDATES FOR NEXT PHASE OF ACTIVITIES INVOLVING CLINICAL RESEARCH

In response to the COVID-19 pandemic in Michigan, the Governor issued a series of Executive Orders to guide the state through phases of response to the public health emergency. The executive orders included stay home orders, limiting in-person activities and additional steps to protect the health of all. https://www.michigan.gov/whitmer/0,9309,7-387-90499_90705---,00.html

This process involved stay at home orders, limiting in-person activities and many other steps taken to protect the health of all. 

During this period, the HRPP and IRB have remained fully operational on a remote basis as indicated in the regular updates provided for researchers through routine updates to this website, and frequent communications with the research community through listserv announcements, established meetings and guidance sessions.

The Governor has recently approved the restart of multiple sectors of the economy and institutional activities that were previously paused.  This includes the resumption of limited and defined on campus research activities in accordance with the required elements encompassed in the "Principles and Guidelines for a Phased Ramp-Up of On-site, Laboratory-based Research Activities" developed and posted May 11, 2020 with specific action items from the Office of the Vice President for Research, and the parameters defined by the Michigan Governor's Executive Order 2020-90 – "Resumption of laboratory research activities" on May 15, 2020.

In this context, we have established guidelines and processes for research involving human participants as we enter the next period of activity and mission reengagement. 

This specific update provides information related to the resumption of clinical research.

Only research which will provide a potential direct benefit to the participant may be resumed with in-person visits at this time. Direct benefit means that the participant is expected to receive benefits immediately themselves from participation in the clinical/research trial. This is not intended to mean indirect benefit that arises from participation such as a free physical exam, or long term benefits to society.

In-person research activity during a public health crisis requires additional precautions to protect both the participant and the research staff. We have established a specific application appendix, Appendix N, to capture information related to the precautions to be taken to protect participants and the research staff and the direct benefit that may result from in-person research activities. Appendix N is located in the Appendices section on the IRB Forms page: https://research.wayne.edu/irb/forms-requirements-categories.

Appendix N: Resumption of In-Person Clinical Research (new)

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. Only research that will provide a potential direct benefit to the participant may be resumed with in-person visits at this time.

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. In planning for the gradual resumption of research, precautions such as screening, physical distancing, availability of appropriate PPE, increased disinfecting precautions and other modifications is necessary. These precautions are described in the CDC guidelines and the State of Michigan Executive Order No. 114.

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: Information on restarting WSU research operations:  https://research.wayne.edu/coronavirus/restartguidance.

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 and a direct benefit.

Discuss options with the sponsor for alternatives to in-person study visits. Consider whether the in-person study visit could coincide with a standard of care visit. Study visits modified to virtual/phone/remote formats should continue to conduct those visits as per IRB approval.

Appendix N: Resumption of Clinical 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. To meet this responsibility as clinical research is resumed, the IRB will require 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.

  • For new research, include Appendix N with the initial submission.
  • For currently approved research, submit Appendix N as an amendment prior to conducting on-site visits.

Appendix N: Resumption of In-Person Clinical Research (new)

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, 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.

 


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

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.
  • 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.

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 descrip the plan to mitigate risks of in-personn 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.

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).


PI Initiated Voluntary Study Hold

Principal Investigators are asked to voluntarily hold their clinical research if they can do so safely without risk to participants. 

  • Please consult with the IRB: IRBquestions@wayne.edu
  • Key actions for voluntary hold:
    • PARTICIPANT:
      • Safe withdrawal of participants from the research
      • Notification to participants about the study
      • Follow up with the participants for their safety
      • Arrangements for care of participants outside the research
    • NOTIFICATIONS:
      • IRB must be notified by submitting an amendment
      • FDA must be notified if the PI is the Sponsor of an IND or IDE
      • Sponsor must be notified for Sponsored trials

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 Get Your Clinic Ready for Coronavirus Disease 2019 (COVID-19)

https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinic-preparedness.html

CDC Corononavirus 2019 Guidance: Reopening Guidance for Cleaning and Disinfecting Public Spaces, Workplaces, Businesses, Schools, and Homes

https://www.cdc.gov/coronavirus/2019-ncov/community/reopen-guidance.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 Pandemic

https://www.fda.gov/media/136238/download

World Health Organization: CORONAVIRUS DISEASE (COVID-19) OUTBREAK: RIGHTS, ROLES AND RESPONSIBILITIES OF HEALTH WORKERS, INCLUDING KEY CONSIDERATIONS FOR OCCUPATIONAL SAFETY AND HEALTH

https://www.who.int/docs/default-source/coronaviruse/who-rights-roles-respon-hw-covid-19.pdf?sfvrsn=bcabd401_0

Centers for Disease Control

https://www.cdc.gov/coronavirus/2019-ncov/index.html

Centers for Disease Control: STEPS HEALTHCARE FACILITIES CAN TAKE NOW TO PREPARE FOR CORONAVIRUS DISEASE 2019 (COVID-19)

https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/steps-to-prepare.html

State of Michigan - Coronavirus

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

Wayne County – Coronavirus

https://www.waynecounty.com/departments/hhvs/wellness/novel-coronavirus-information.aspx

NIH Resource to Analyze COVID-19 Literature: The COVID-19 Portfolio Tool

https://icite.od.nih.gov/covid19/search/