Memorandum To: WHSC Clinical Research Principal Investigators and Staff
From: Jeffrey Lennox MD, Associate Dean for Research SOM
Bryce Gartland MD, Hospital Group President, EHC
Ira Horowitz, MD, Physician Group President, EHC
Re: Change in the status of onsite clinical research at EHC Facilities
Note that this memo applies to clinical research being conducted in EHC facilities.
We wanted to provide you with an update regarding access to EHC facilities in support of our continued academic mission. While we do not anticipate returning to pre-Covid-19 levels of research engagement within our EHC facilities at this point, we are taking the following steps to improve access of clinical research teams to our care facilities:
- Effective immediately, interventional and observational research teams may perform research related visits and procedures that involve patients who are being seen in the facility for clinical care,or for whom a research intervention is part of their clinical care. To continue to prioritize campus safety, we will maintain the policy of not inviting participants to come to the facility solely to participate in research, other than for follow-up of appointments that are necessary to adhere to requirements of the protocol. We continue to strongly encourage all researchers to fully utilize telehealth/telephonic visits to the fullest extent in support of our research enterprise.
- Study monitors that must perform site initiation or study monitoring visits may now be allowed in the facilities on a preapproved basis. To obtain approval, we ask that you please notify the executive team of the facility. When accessing a facility, all monitors must follow the same practices in place for vendors. Specifically, they must wear an ID, pass temperature and symptom screening upon entrance, comply with all PPE protocols including 100% compliance with masking at all times with supply of their own PPE as per the current standard of the facility, be escorted through the facility by a member of the research team, and limit their presence to only those areas necessary for study purposes.
- Principal Investigators must continue to limit the number of team members on campus to only those who are essential to perform the research visit and tasks that may not be conducted remotely. For device protocols, this includes vendors who work for the manufacturer or clinical research organization.
- Strict adherence to EHC requirements for PPE use and social distancing must be maintained by each member of the team.
- Study participants will be requested to follow the EHC patient and visitor policies at the time of their scheduled appointment. Study personnel should inform the participants of this current policy.