Coronavirus: COVID-19 - Updates from the IRB

Human Research Protection Program - Institutional Review Board

Updated guidance for human subjects research following the executive order from Governor Whitmer is provided below.

https://www.michigan.gov/whitmer/0,9309,7-387-90499_90705-522626--,00.html

State of Michigan Executive Order No. 2020-21

Temporary requirement to suspend activities that are not necessary to sustain or protect life.

Please continue to monitor this site regularly for updates.

UPDATES

Updated guidance for human subjects research following the executive order from Governor Whitmer is provided below. New updated guidelines are indicated below.

Governor's Executive Order 2020-21: Temporary requirement to suspend activities that are not necessary to sustain and protect life.

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

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

HUMAN PARTICIPANT RESEARCH THAT MAY CONTINUE:

  • CLINICAL RESEARCH

On-going clinical trials with a direct potential therapeutic benefit to participants may continue for enrolled participants.  As noted above, all research activities must be conducted in accordance with relevant state and local orders and CDC guidelines.

  • RESEARCH WITHOUT DIRECT PERSON to PERSON CONTACT

Research conducted remotely without direct person to person contact may continue as per the IRB approved protocol.

Research that may be safely modified so that there is not direct person to person contact may be able to resume once the modifications to the research are approved by the IRB.


Voluntary Hold by the Principal Investigators

Principal investigators are asked to voluntarily hold their clinical research if they can do so safely without risk to participants. Please see section: PI Initiated Voluntary Study Hold


New Clinical Research Submissions

New clinical research protocol submissions, with the exception of research directly related to COVID-19, requires the concurrence of the Vice President for Research.


New Enrollment in Active Clinical Trials

New enrollment in currently approved clinical research is prohibited.

An exception may be considered for compelling medical reasons. For instance, an existing clinical trial is the best medical option for a patient, the investigational product is not available outside of the trial, and the trial procedures may be safely implemented in a manner to minimize risks related to exposures for both the participant, the investigators and staff. Authorization should be provided by the departmental chair.


HRPP and IRB Remain Operational

The Human Research Protection Program, IRB Administration and IRB Committees are operational.

  • At this time, the IRB office is not accepting in-person visits or hard copy submissions.
  • The IRB Administration is working remotely to manage all IRB related processes and procedures. 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.

CHANGES IMPLEMENTED SUBSEQUENT TO EXECUTIVE ORDER No.2020-21

IRB OPERATIONS:

  • New COVID-19 clinical research submissions will be given priority.
  • New clinical research submissions that are conducted for direct benefit of participants, with the exception of research directly related to COVID-19, requires the concurrence of the Vice-President for Research.
  • Amendments related to study procedural changes impacted by COVID-19 will be given priority review.
  • Unanticipated Problem reports related to COVID-19 will be given priority review.
  • New minimal risk research (expedited & exempt) not related to COVID-19 will not be processed at this time. This action will be re-assessed once the shelter-in-place order has been lifted and resources allow.
  • Currently pending minimal risk research that is not related to COVID-19 will not be processed at this time. This action will be re-assessed once the shelter-in-place order has been lifted and resources allow

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

Participant Visits and Safety Monitoring

Research visits which cannot be performed remotely but are essential to sustain or protect life may be performed in person, with the following additional guidance:

  • For research conducted within WSU affiliate hospitals or clinics, investigators and key personnel should follow the COVID-19 guidance and precautionary measures in place for that facility and the screening procedures described below.
  • Research visits that cannot be performed remotely and do not provide an immediate benefit to a participant's health and/or well-being should be postponed until further notice.

Currently, the determination of whether or not a research visit is necessary to sustain or protect life of a participant is determined by the principal investigator of the research study, the participant, and the participant's care provider, and should be informed by current federal, state, and local orders and public health guidance regarding the COVID-19 outbreak.

  • Participants should be provided with information regarding the current COVID-19 epidemic and how best to reduce their risk of infection. This information may be provided in multiple forms suited to the type of contact, including a website link, a telephone script and an in-person handout. If possible, this information should be shared before the research visit. 
  • All research participants should be screened for fever, cough and flu-like symptoms, including current season flu history and flu vaccine history, by research staff prior to the research visit. Screening should be repeated by research staff at the arrival before being cleared to participate in an in-person research visit.
  • If a participant has fever or symptoms of respiratory illness, they should not come to WSU or WSU-affiliate clinics for a research visit but should contact their healthcare provider for next steps.
  • Screening procedures required by healthcare systems do not require an amendment to the IRB unless that screening data is going to be used for research.

Enrollment of new participants to a clinical trial or other human participant research is prohibited. An exception may be considered for compelling medical reasons. For instance, an existing clinical trial is the best medical option for a patient, the investigational product is not available outside of the trial, and the trial procedures may be safely implemented in a manner to minimize risks related to exposures for both the participant, the investigators and staff.

The PI should temporarily pause the research or the appropriate subset of research activities when staff, protective equipment, or other required equipment is not available to continue the research safely.

As healthcare facilities restrict access to non-essential personnel or divert personnel and equipment to other activities, it is important that PI's stay informed of the impact that these restrictions or diversions may have on their research. If these restrictions will impact the ability to continue the research and changes to the protocol are necessary, the IRB must be notified.


Integrative Biosciences Center - IBio

Since research conducted at IBio does not currently involve emergency care or clinical/therapeutic care, the IBio site will not be open to on-site visits by participants until further notice.


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.

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 NOTIFICATION

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.


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

COVID-19 EXPANDED ACCESS INFORMATION:

REMDESIVIR

Gilead is currently in the process of transitioning the provision of emergency access to remdesivir from individual compassionate use requests to expanded access programs. This approach will both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients. These programs are currently under rapid development in conjunction with national regulatory authorities worldwide.

While emergency use is still an available option under the regulations, FDA has updated their requirements so that single-patient expanded access (EA) can be approved by the IRB Chair (or another Chair-designated IRB member with appropriate expertise) instead of the convened IRB.  


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

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