Protocol & consent

Reference or download the documents below. Informed consent is available in English, Spanish and Arabic. For other languages ─ as this is a national pandemic and an expanded access protocol ─ it is acceptable for clinicians to have someone verbally translate the information to the patient, then document that process in the medical record. Contact our office with any questions: uscovidplasma@mayo.edu

R Scott Wright, M.D.

Senior Chair and Medical Director, Mayo Clinic Institutional Review Board

Director, Mayo Clinic Human Research Protection Program

Photo of R Scott Wright, M.D.

Download Protocol & Consent Documents (PDF’s):

Informed consent options

There are 3 options for obtaining informed consent and they should be applied in the following order.

  1. Option 1

    Most preferred

    Obtain written informed consent from the patient.

  2. Option 2

    Use a LAR/Authorized Representative to sign the informed consent document if the patient is not able to provide consent because of an impairment or being unable to communicate (i.e., on a ventilator and sedated).

  3. Option 3

    Use only when option 1 or option 2 are NOT feasible

    You may utilize an exception for informed consent in an emergency (21 CFR 50.23) which allows you to discuss the participation with a second physician who concurs with your recommendation of enrolling the patient in the Expanded Access Program (EAP). The second physician must put a note in the patient's medical record indicating their concurrence of the patient participating in the EAP. You are also responsible for informing the patient or the LAR, as time progresses, of the patient's enrollment in the study and answer their questions. Patients may elect to withdraw from the study but their data will remain in the databank and you are required to fill out the 4 hour infusion, 7 day and 30 day forms for safety evaluation.

What if I cannot get into the room to consent the patient?

We understand that it may be too difficult or challenging to obtain written informed consent in person, especially if the patient is critically ill and not able to provide consent. If the treating physician/PI is unable to be physically in the room with the patient at the time of written informed consent, they or their designee trained to get informed consent can speak with the patient via a telemedicine or telephone device, and ask the patient to sign the consent form. The patient or his/her family member or health care worker can photograph the consent form and email it with signature to the physician/PI.

What if the LAR/Legal representative is not at the hospital?

If the LAR/designee is unable to be physically in the room with the patient at the time of written informed consent, the Physician/PI or their designee trained to get informed consent can speak with the LAR via a telemedicine or telephone device, and ask them to sign the consent form. They can photograph the consent form and email it with signature to the physician/PI.

Are there alternatives to obtaining written consent from patients?

We understand it may be too difficult or challenging to obtain written informed consent in person due to risk of contamination.

While written consent from the patient is most preferred, you may choose to use one of the following options if this is not feasible:

  1. If the treating physician/PI is unable to be physically in the room with the patient at the time of written informed consent, they or their designee trained to get clinical consent can speak with the patient via a telemedicine or telephone device, and ask the patient to sign the consent form. The patient or his/her family member or health care worker can photograph the consent form and email it with signature to the physician/PI.
  2. A bedside registered nurse (RN), who is gowned in personal protective equipment, may watch the patient sign the consent form.

    A) The form can then be photographed and a digital image transmitted to regulatory staff.

    B) Or, the consent form can be put in a plastic bag and sealed. The bag can remain with the patient at the bedside. The form that the MD and witness sign can be entered into the study record with an attestation that the patient signed a separate consent form that was sealed and left with the patient but not stored to reduce risk of COVID-19 transmission.

  3. Use of witness attestation as outlined in the recent (revised 7/2/2020) FDA guidance (“FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (see questions 10, 11 and 12).
  4. You can move to digitally based consent processes using a tablet. The patient can sign the consent form on a tablet and an electronic copy can be uploaded to your research office.

How can I reach the Mayo Clinic IRB with questions?

Email: uscovidplasma@mayo.edu