Human Subjects Research during the COVID-19 Outbreak
Ascension Wisconsin will be decreasing support for recruitment and enrollment resources in non‐COVID‐19 clinical trials that are FDA regulated and/or managed through the Clinical
Research Department for a 6‐8‐week period beginning at the activation of the COVID vaccine study.
Read the Updated 6/25/2020 memo from Dr. Reding for details: Enrollment Suspension in Non‐COVID‐19 Clinical Trials
Direct any questions or concerns to Dr. Douglas Reding, Chief Academic Officer at Douglas.Reding@ascension.org or at 414-465-3709.
For all studies that are neither managed through Clinical Research nor FDA regulated, activities may continue following the previous guidance, see below for additional details.
Effective March 17, Ascension Wisconsin is implementing specific policies and procedures for the conduct of human subject research. These policies and procedures are planned to remain in effect until June 30th. Beginning on Monday July 1, we will resume normal clinical research activities. This will include the following:
- Reactivating all clinical studies that had been halted.
- Allowing study sponsors and monitors to come on-site as needed after September 8th.
- Scheduling on site procedures and tests for study participants.
- 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 Institutional Guidance and continue to work from home until September 8th, unless required to be onsite to directly support the conduct of research as specified above.
For more information see:
- 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)
AWRI leadership will continue reviewing and updating this guidance as needed. Direct any questions or concerns to Dr. Douglas Reding, Chief Academic Officer at Douglas.Reding@ascension.org or at 414-465-3709. This information is being provided by the Ascension Wisconsin Research Institute for research PIs, staff, and administrators and will be revised as appropriate based on new information and circulated to the Ascension Wisconsin research community.
Ascension Wisconsin is participating in the Expanded Access Program (EAP) to Convalescent Plasma for the Treatment of Patients With COVID-19 through the Mayo Clinic.
Working collaboratively with industry, academic and government partners, Mayo Clinic will serve as the lead institution and IRB for the program registering participating providers and potential patients who may benefit from and qualify for this investigational treatment.
References and Contact Information
- For more information about the EAP program and process, review the Mayo Clinic EAP website (www.uscovidplasma.org) or contact them at firstname.lastname@example.org.
- The Ascension Wisconsin IRB/Regulatory contact is Jackie Kirchen (email@example.com; 414-915-3229).
- There are Physician leads available to provide guidance and assistance for physicians through Ascension Wisconsin.
Ascension Wisconsin Physicians Instructions to Request Convalescent Plasma
1. Review all of the information on the Mayo Clinic EAP website
The Mayo Clinic website, at: www.uscovidplasma.org, is updated frequently and is the one place physicians will need to refer to for information, registration and reporting.The site includes the protocol, eligibility criteria, consent forms, and clear instructions for sites and physicians to request participation, register patients, and record results.
The workflow on the EAP website outlines the process, but physicians should be familiar with the eligibility criteria and EAP protocol, which includes a study checklist for participation.
2. Complete the Physician Registration Form
Any physician who wants to request plasma for a patient must complete the PI registration form on the EAP website. The physician registration form requires selection of a facility. The facility needs to be registered, before a physician can register. Physicians need to register only at one site, even if they are treating patients at multiple facilities.
Ascension Wisconsin has begun to register sites. DO NOT register your facility directly. If your site is not registered, email the Director of Research Integrity and Protection: firstname.lastname@example.org to request the site be registered.
Please note, your site will not be activated until plasma is available. Sites with current plasma supply will be eligible for activation once the Physician/PI Registration and Patient Enrollment Forms are completed.
3. Obtain consent and register the patient
Informed consent must be obtained from the patient or their Legally Authorized Representative/ surrogate. Informed consent documents approved from the Mayo Clinic IRB are available on the EAP website.
Informed consent is available in English, Spanish, Arabic. For other languages, it is acceptable for clinicians to have someone verbally translate the information to the patient, then document that process in the medical record. The consent must be included in the patient medical record per local process.
After obtaining consent, the physician must register the patient on the EAP website.
4. Work with the Mayo Clinic and Ascension Transfusion services to obtain plasma
After the medical facility, patient and physician are registered, the online tool will create a patient identification number to match with plasma. Mayo Clinic will contact you to fill out short regulatory documents for you and your patient.
At Ascension Wisconsin Southeast Region Hospitals Versiti will provide convalescent plasma as supply permits. Transfusion Services will submit orders to Versiti.
Submit the following to your facility Transfusion Services:
- Place an order for ABO Typing and 1 unit of plasma following normal ordering processes
- Provide the Versiti Request Form to Transfusion Service
- Unit is approximately 200 mL- labeled Convalescent Plasma.
- Order one unit per patient per Mayo Protocol)
- IND and IRB approval Forms (Obtained from Mayo Clinic)
- FDA approved eIND or IRB approved blanket IND
- IRB approval statement
Versiti will coordinate with Ascension Wisconsin’s Transfusion Services department to provide plasma. Products will be distributed as requests are received. There may be times when a product is not available. Orders will be filled as soon as possible. Transfusion Services may call to confirm if order is still needed.
Transfusion Services is exploring the ability to obtain plasma from other sources as well. Updates will be provided on this site. If you are requesting plasma at another site, work with your local transfusion services department.
5. Provide Mayo Clinic required follow up data
The treating physician is required by federal regulation to provide updates to the IRB (Mayo Clinic). Reports must be made at the following times, through the EAP website.
- 4-hour report with (1) unit number and (2) patient medical record number. This report must be completed even if the transfusion is not given, including the CoVID-19 Convalescent Donor Pre-Screening reason why it was not given.
- 7-day report form
- 30-day report form, if patient remains hospitalized.
Other information to be collected retrospectively will include patient demographics, acute care facility resource utilization (such as total length of stay, days in ICU, days intubated and survival to discharge from an acute care facility).
6. Notify the Ascension Wisconsin IRB after each use
Within 30 days of each use, send an email to the Ascension Wisconsin IRB at IRB@ascension.org:
1. Treating Physician Name:
3. Date patient treated:
4. Was consent obtained using the Mayo Clinic consent form, and the form added to the patient’s medical record? (Yes/No)
5. Was all required reporting to Mayo Clinic completed as applicable (4 hour, 7 day, 30 day); reports may be attached, but are not required? (Yes/No)
6. Provide a brief description of the use/outcome:
Information for Donors
If you are an Ascension Physician and have a patient that you would like to identify and refer to Versiti Blood Center of Wisconsin, please review the following: instructions, referral , donor pre-screen and donation FAQ forms.
If you have a patient who tested positive for COVID-19 and has since tested negative, they may be eligible to donate plasma. If they would like to consider donating they can find more information about donation locations and the donation process at Versiti Blood Center of Wisconsin or the American Red Cross.