WVU Research Office Communication

    COVID-19 Research Office Communication

May 8, 2020 - Memo from Sally Hodder re: Additional Recommendations for HSC Clinical Research

March 18, 2020 Memo from Gretchen McMasters regarding Submissions to the IRB

March 13, 2020 Initial Memo from D. Fred King re: COVID-19 Impact

March 18, 2020

From:              Gretchen McMasters, Director, WVU Office of Human Research Protections

Re:                   Submissions to WVU IRB Still Being Accepted

At present, the WVU IRB continues to review, and approve, submissions for all;human subject research studies university-wide. If you have questions related to WVU IRB submissions, you can find our contact information and a link to request assistance at  HELP LINK.

Clinical Trials:

Please be advised that additional recommendations from Health Sciences Center regarding study commencement and enrollment may apply to your clinical trials. If you have questions regarding the HSC memo dated March 17, 2020, please contact Shelley Welch, Co-Director, Clinical Trials Center of Excellence at  shelley.welch@hsc.wvu.edu or at 304.293.7348.

Non-Clinical Trials:

While IRB submissions are being reviewed and approved, no new or existing in-person data collection at any location is currently allowed unless you have a written waiver from Fred King, Vice President for Research.

Thank you,

Gretchen

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March 13. 2020

On behalf of Dr. Fred King, please see the memo below regarding the coronavirus and recommendations for human subject research. If you have specific questions regarding IRB submissions, please contact WVU OHRP for more information. Thank you.

DATE:                    March 13, 2020 

TO:                        Principal Investigators, Study Coordinators and Research Community 

FROM:                  Fred King, PhD, Vice President of Research and Institutional Official 

SUBJECT:           Evolving COVID-19 Outbreak and Human Subjects Research at WVU  

As we grapple with the COVID-19 coronavirus outbreak, we strongly recommend investigators decrease the likelihood they put themselves, members of their study teams, or study participants at risk of infection. Below are suggested guidelines with respect to data collection for biomedical and social & behavioral studies—as applicable.

Establish Formal Plans: Investigators should develop concrete and actionable plans that limit risk to study participants and study staff.  Specific plans should be made for the following:

·       Continuing or halting data collection.

·        Regularly communicating with sponsors, participants, caregivers, and the study team.

·        Cross training staff to ensure coverage. 

·        Ensuring access to study medication and medical care for participants.

Revisit Data Collection Procedures:  Review circumstances under which collection should be modified or halted, either temporarily or permanently. Suggestions include the following:

Research staff with COVID symptoms (fever, cough, shortness of breath) should not report to work.

• Prior to study visits, screen participants for  flu-like symptoms, contact with persons either exposed or diagnosed with COVID-19, recent travel.
• Check study sites; ensure there are no identified cases of COVID-19 there; verify no one has been quarantined.
• Implement alternatives to face-to-face study visits for those with symptoms; consider alternatives to face-to-face visits for those who traveled out of the area over the past two weeks.
• Decrease protocol-mandated, face-to-face study visits to facilities and/or replace with home visits/telemedicine.
• Allow blood draws at remote or commercial laboratories.
• Ship investigational products directly to research participants, when feasible.
• Avoid/minimize group collection of data (e.g., focus groups, whole group interventions).
• Move face-to-face data collections (e.g., interviews, in-person surveys) to Zoom, phone or online.
• Follow recommended guidelines for reducing exposure and, when in doubt, pause study activities.
• Determine if it is necessary to halt research activities and if so, pause recruitment until the situation changes.

Full Board/Expedited Amendments/Continuing Reviews:  

Submit study changes (e.g., to alter the mode of data collection, protect participants/study personnel, etc.) by adding “COVID” as the first word to the study title in WVU+kc. Using “COVID” will flag submissions for faster review. If an investigator needs to make a change to research plans in order to       eliminate apparent immediate hazards  to participants,  changes can be made and then reported to the sponsor and to the IRB within 5 days . Examples   include mitigation of potential exposure or a need to provide medically necessary care (including study drug) to participants in isolation or quarantine because of exposure. Consider submitting a continuing review in lieu of an amendment.

The WVU IRB encourages sponsors and investigators to take steps to eliminate additional risks to participants and personnel.

At present, the WVU IRB will continue to review and approve submissions that require Full Board review. However, research teams that have not initiated research activities should ensure doing so will not jeopardize members of the research team or participants. In addition, should the COVID-19 landscape change significantly, it may be necessary to restrict or pause human subjects research activities in the interest of individuals and public health. 

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