Important Clarification Regarding Verbal Consent on Informed Consent Forms

March 18, 2020

March 18, 2020


IMPORTANT CLARIFICATION REGARDING VERBAL CONSENT ON INFORMED CONSENT FORMS


To all staff participating in human subject research at DF/HCC:


The policy announcement below that was distributed this morning addressed using a verbal process instead of a written signature in certain administrative and clinical settings. This policy does NOT currently apply to Informed Consent Forms signed for research purposes. If your research study requires a signed Informed Consent Form, at this time you should continue to obtain a written signature on the research Informed Consent Form.


Investigators and study teams must follow their institutional policy that is in place at this time regarding the types of studies that remain open to recruitment. 


As a reminder, researchers must continue to follow DF/HCC policy CON-100 when conducting the informed consent process. Any changes to the plan for consenting or notifying subjects of new information must be submitted as an Amendment and receive IRB approval.

If you have any questions about this announcement, please email OHRS@dfci.harvard.edu.

From: Broadcast PHS <PHSBROADCAST@PARTNERS.ORG>
Date: Wednesday, March 18, 2020 at 7:07 AM
Subject: Coronavirus Update: Patient Consent and Visitor Policies, Employee Resources, Virtual Care

 

Dear Colleagues:


Below are some important updates for today including changes to patient consent and visitor policies, EAP resources employees can take advantage of during the COVID-19 pandemic and an update on Virtual Care. We appreciate everyone’s continued efforts as we manage through this situation.


PPE Supplies and Conservation
Since the beginning of the COVID-19 outbreak, we have been reminding employees that we need to work together to conserve our Personal Protective Equipment (PPE) so that we can maintain supply levels and protect our patients and our colleagues. At this point, we have appropriate supplies on hand, but we are very concerned about the shortages we are facing and following the conservation strategies we have put in place is more important than ever. As a reminder:

  • Masks, gowns, gloves and respirators should only be used to support patient care and under no circumstances should be taken for personal use
  • It is critically important to follow appropriate guidelines for the extended use/reuse of our N95 respirators, surgical and procedural masks and eye protection supplies. These policies are consistent with federal guidelines.

We are actively monitoring this situation and are managing our supply chain as closely as possible and working with suppliers and vendors to make sure we do, in fact, have the needed PPE for all. The safety of our employees is our priority, and we are relying on everyone to work together.


Employee Resources for Coping with COVID-19
The unprecedented circumstances surrounding the emergence of COVID-19 have created a great deal of stress and uncertainty for all of us, for our patients, our fellow health care workers and the community at large. As resources for addressing these issues proliferate, it can be confusing to find, evaluate or sort through all the available information. Below is a set of resources that the Partners Employee Assistance Program (EAP) has created as well as a new guide from the Mass General Department of Psychiatry. Please use these resources to cope with the everyday stresses and concerns that we are all feeling:


Policy Update: Verbal Consents in Lieu of Patient Signatures
An important method to avoid infection transmission is to avoid the sharing of pens (including electronic) and pencils among patients and staff. One of the most common scenarios for this practice is obtaining patient signatures on written informed consents and on numerous administrative forms during registration (e.g., non-emergent visits, emergency department, observations, ambulatory, etc.) and during patient care activities in all clinical settings (e.g., hospital, ambulatory, post-acute, home care). During this emergency response period, documented verbal consent in lieu of patient signature should be obtained as outlined below:

  • Registration and other administrative activities – staff to fully inform the patient of what they are consenting to (or hand the patient paper, point to sign, etc.) and document consent was verbally received. This would apply to the general consent to treatment, financial consent and acknowledgment of Notice of Privacy Practices and other administrative forms.
  • Clinical settings – the clinician completes the consent discussion, seeks verbal consent from the patient and signs the Informed Consent Form, at the patient’s direction, where the patient would otherwise have signed the form. This process would also apply to discharge paperwork and other forms completed and signed by the patient during the course of care.

New Visitor Policies
To protect our patients, staff and communities, we are implementing further changes to our visitor policies. Beginning today, Wednesday, March 18, 2020, we will no longer allow routine visitors/patient attendants into our facilities for the foreseeable future. We understand how important family and friends are to patient care, so there will be exceptions made at each of our hospitals. As a reminder, all visitors must be over 18 years of age. Any visitors will also be encouraged to remain six feet from patients at all times and wash or sanitize their hands before visiting a patient room.


Virtual Care Update
We know providers are eager to start replacing in-person visits with video-enabled virtual visits, and many vendors are offering their services to meet this need (Facetime, Skype, Zoom, etc.). We continue to aim to deliver secure video tools across the system over next few weeks through our Virtual Care platform. However, we understand that providers and patients will not have immediate access, so we are asking that in the meantime, providers please use the phone when possible, and only use retail video tools if absolutely necessary. Learn how to conduct telephone virtual visits.


For Clinicians: Latest Updates to COVID-19 Testing Criteria
Infection control experts have been collaborating with colleagues across the Partners system to continually evaluate and update our COVID-19 testing criteria based on our testing capacity:

  • Testing is limited to patients who are symptomatic and who fall into one of the categories identified in this testing criteria document.
  • We expect these criteria will continue to evolve as our clinical need and testing capacity change.
  • Please stay tuned to your work email for the latest updates.

Thank you for your continued support. If you have questions, please reach out to your manager or visit Partners Pulse.


Gregg Meyer, MD
Chief Clinical Officer

Partners HealthCare


Paul Biddinger, MD
Medical Director, Emergency Preparedness

Partners HealthCare