Human Subjects Research during the COVID-19 Outbreak
Ascension Wisconsin has implemented specific policies and procedures for the conduct of human subject research during the COVID-19 pandemic.
This information is being provided by the Ascension Wisconsin Research Institute (AWRI) for research PIs, staff, and administrators. AWRI leadership will continue to evaluate, revise and communicate this guidance as appropriate. Direct any questions or concerns to Dr. Douglas Reding, Chief Academic Officer at Douglas.Reding@ascension.org or at 414-465-3709.
As of July 1st, clinical research activities have resumed, including the following:
- Reactivating all clinical studies that had been halted.
- Allowing remote monitoring by study sponsor/CROs.
- Scheduling on site procedures and tests for study participants.
The following additional precautions and restrictions remain in place:
- Appropriate PPE should still be worn in accordance with the requirements of your local hospital or clinics.
- Remote visits (e.g., by phone, Zoom, Webex, etc.), are still acceptable when appropriate.
- For in person visits, all research participants should be screened for fever, cough and flu-like symptoms by work site or hospital staff prior to the research visit, with repeat screening by research staff at the time of any additional in-person visits.
- Subjects who appear to be infected should be tested for either the presence of antibody or virus and referred accordingly.
- Research staff who are working from home should adhere to the current Institutional Guidance on Remote Work, unless required to be onsite to directly support the conduct of research as specified above.
- On-site monitoring by study sponsors/CROs should be delayed until research staff are able to resume normal on-site staffing, as designated by the current Institutional Guidance on Remote Work.
Ascension Wisconsin Participation in COVID-19 Vaccine Trials and Clinical Research Staff Support
- Temporary Policy Update (v. 6/8/2020)
- Temporary Policy: Human Subjects Research at Ascension Wisconsin during the COVID-19 Outbreak and FAQs (v. 5/4/2020)
- Temporary Policy: Human Subjects Research at Ascension Wisconsin during the COVID-19 Outbreak and FAQs (v. 3/16/2020)
FDA Approves emergency use authorization (EUA) for convalescent plasma for the treatment of COVID-19
On August 23, 2020, the U.S. FDA announced that it issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients..
On 9/2/2020 the FDA issued Investigational COVID-19 Convalescent Plasma Guidance for Industry. This guidance outlines the EUA process, and notes that the FDA intends to exercise enforcement discretion with respect to the IND requirements for a period of 90 days following the issuance of this guidance document. This time allows blood establishments to develop the necessary procedures to manufacture COVID-19 convalescent plasma under the conditions of the EUA. This enforcement discretion policy only applies to convalescent plasma that is not collected and administered as described in the guidance. After 12/1/2020 investigational convalescent plasma can only be administered under an IND
What that means for providers:
- Now until 12/1/2020: Providers can request and use investigational convalescent plasma to treat hospitalized COVID patients without an IND.
Patients must be informed that they will receive an investigational product. Patients and Parents/Caregivers should be provided the Investigational Use Fact Sheet, in addition to standard local clinical/blood bank contents
- After 12/1/2020: Plasma must be used under the EUA or an IND (research study, emergency use, etc)
Patients must be provided the FDA Fact Sheet for Patients and Parents/Caregivers, in addition to standard local clinical/blood bank contents
- No IRB review is required for clinical use (IRB review is needed for clinical trial, Emergency IND, Expanded Access)
- All plasma needs to be from registered blood establishments from eligible donors and required labeling, as outlined in the guidance.
- For additional information, please consult the FDA fact sheet for health care providers.
Additional guidance on how to request and obtain convalescent plasma for the treatment of COVID-19 will be provided through Ascension Transfusion Services and local blood center partners.
Mayo Clinic Expanded Access Program Closes
Requirements for current EAP sites include the following:
- New patient enrollment in the Mayo Clinic EAP is not authorized after August 28, 2020.
- Order of convalescent plasma under the Mayo Clinic EAP is not authorized after August 31, 2020.
- Participating sites are required to complete data follow-up forms for all patients enrolled in the Mayo Clinic Expanded Access Program (EAP).
Visit the Mayo EAP website for additional information.