Planning for the Restart of Clinical Research

Things to consider for restarting clinical research after COVID-19 closure.

The following are only some of the things that should be considered. This list is not intended to be exhaustive and study teams are encouraged to devote sufficient time to think through their processes to ensure the highest quality clinical research is being conducted within a safe environment for all parties.

Information regarding the resumption of non COVID-19 clinical research is discussed in a June 12 Announcement from the Vice Dean for Clinical Investigation. The policies for the restarting of research are provided by leadership. This information will also be added to this site when it is available. https://hub.jhu.edu/novel-coronavirus-information/jhu-2020-planning/

If you have recommendations that can be of use to your fellow researchers, please share them with

us. You can email Liz Martinez at liz@jhmi.edu with your suggestions.


JHU SOM Clinical Research Visit Guidelines during the COVID-19 Pandemic

The purpose of this document is to provide guidelines for clinical research visits during the COVID-19 pandemic in a manner that is coordinated across the enterprise, ensures research participant needs and safety, staff safety and well-being, and congruence with the JHU SOM mission. Clinical research teams must familiarize themselves with all relevant guidelines and workflows in the clinical locations where research participants will be seen. As the needs related to research restart will be dynamic, this document may be revised as needed. Study teams should check back regularly for updates.

https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information.html/JHUSOM_Clinical_Research_Visit_Guidelines.pdf

MyLearning Course: JHCP | Care Delivery in the COVID Pandemic
https://lms14.learnshare.com/l.aspx?Z=Pz3xdJcv4W%2bIKfDO2pFaJeK8QEf%2fwaHJdK%2bO5dQkuFI%3d&CID=89

Description:

This module will introduce and reinforce guidelines to assist in the ramping up of JHM ambulatory in-person visits.

At the end of this module, learners will be able to:

  • Identify Essential Protocols that must be maintained in all practices at all times
  • Demonstrate safe physical distancing practices
  • Utilize appropriate personal protective equipment (PPE) in clinical and non-clinical spaces
  • Identify procedures that are currently not permitted in the clinical setting
  • Maintain enhanced infection control measures in accordance with the JHM Hospital Epidemiology and Infection Control (HEIC) guidelines and recommended frequency
  • Recognize an unanticipated “Patient under investigation” (PUI) situation and implement workflows to minimize exposure to other patients and team members
  • Verbalize the purpose and importance of compliance with the COVID-19 Safety Auditor (CSA) role

MyLearning Course: JHHS | Infection Prevention in Clinical Areas during the COVID-19 Pandemic

PPE Recommendation during the COVID-19 Pandemic for Ambulatory Settings

Research procedures are expected to follow the PPE/safety recommendations for clinical procedures found here: https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_ppe_ambulatory_recommendations.pdf

Preparation to Open Ambulatory Spaces
The information below can be used to certify your clinics.
https://ictr.johnshopkins.edu/coronavirus/ambulatory-spaces/
Work Space
The institutional information has been added: https://ictr.johnshopkins.edu/coronavirus/researchrestart/.
Scroll to Process for Preparing Plans for Johns Hopkins University School of Medicine Principal Investigators who Supervise Staff Involved in Human Participant Research

Personal Protective Equipment (PPE)
For the foreseeable future, in person research interactions with participants (even COVID-19 negative) will require staff to obtain and wear PPE. All staff will be required to wear surgical masks and face shields and participants will wear a face mask. https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_asymptomatic_screening_precautions.pdf.

Research staff need to review the trainings on HEIC website to see how to don and doff (put on and take off) properly, and how to reuse equipment before replacement is needed. https://intranet.insidehopkinsmedicine.org/heic/_docs/jhm_p3_instructions_handout.pdf, https://www.youtube.com/watch?v=SLb-z-bInl0 and  https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_universal_masking.pdf

Teams should consider designating a single, or a few members (depending on their level of research activity) of their staff (rather than all) to be the only ones with patient/participant interaction to preserve PPE supplies. https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_conserving_ppe_specific_types.pdf

The cost of PPE will need to be added to research budgets.

When “allocation of PPE for research” information becomes available it will be posted here.

N95 Fit Test- This will take place in Halstead 303 Monday to Friday from 9:30 – 11:00 am and from 2:30 – 4:00 pm

HEIC Training for Return to Work: PPE Competency- Training provided by HEIC for clinical research staff that interact with research participants. This training will take 45 minutes and be offered June 15-19 in multiple sessions throughout the day. Twenty participants may register per session. Please register for the training at: https://www.signupgenius.com/go/4090e4ba9a922a4f85-return

PPE Ordering Information

JHH Central Stores Department- CSD, Meyer sub-basement- 410-955-8357.  To order, complete the JHH Requisition Order Form.

Item                                      Catalog#

Mask                                     257468
Mask w/Visor                        101086
N95 3M 1860 (small)            4743
N95 3M 1860 (regular)         4725
N95 3M 1870+ (one size)     174570
N95 3M 1870 (one size)*      75927
Face/Splash shield                no catalog number
Cleaning supplies:
Sani wipes-large                    121713
Sani extra-large                     121712

Communication with Participants

Information regarding participating in research visits during the COVID-19 pandemic will likely need to be provided to research participants. The current documents are found at the link below and may be updated as the situation evolves.
https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information.html/research_participant_covid19_risk_information_documents.html

The COVID-19 symptom screening phone questionnaires will be required prior to all in person visits (clinic or home). https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_phone_triage.pdf

There will likely be restrictions to where participants may park and enter/exit buildings. https://www.hopkinsmedicine.org/coronavirus/index.html#patient-visitor-alerts

Parking Map and Directions to Blalock 3 Adult CRU

Participants will need to wear face masks at their research visit. https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_asymptomatic_screening_precautions.pdf

Supplies
Review all expiration dates. Contact the sponsor to ensure sufficient supplies are on-hand. Assure supplies you normally obtain through university systems and/or your sponsors will be available.
Participants Reporting Symptoms
Follow guidelines of what to do if someone reports symptoms over the phone. https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_phone_triage.pdf or if a participant shows up to a research visit with a fever/other symptoms. https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_outpatient_guidelines.pdf
IRB

The IRB must approve all requests for study restart. You should check the IRB website for updates regarding submission instructions; they will be posted when the University determines restart may begin. Check the IRB COVID-19 response link below frequently for updates. https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information.html

 

Staffing Guidelines and Issues

The JHU Human Resources COVID-19 Webpage will have the most up to date information https://hr.jhu.edu/coronavirus/. Consider that some research staff may have been redeployed to work on COVID-19 research. Some staff may need to work from home. Some staff may encounter child care issues. Some staff may need time off due to COVID-19 exposure or illness.

Onsite Monitoring

Onsite study monitoring may not resume at the same time as research studies. Study teams need to consider the current rules for onsite Study Initiation Visits and Monitoring. https://ictr.johnshopkins.edu/coronavirus/jhu-covid-19-requirements-for-visits-by-external-monitors-and-site-initiation-visits/ https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information.html/covid19_faqs.html.

If onsite visits are allowed to occur, teams must follow visitor rules. https://www.hopkinsmedicine.org/coronavirus/visitor-guidelines.html

Updates to FDA guidance for FDA inspections. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-updates-surveillance-inspections-during-covid-19

Radiology & Other Clinical Departments

Access to testing in some areas may be limited for research evaluations. Scheduling procedures may be different (some departments have machines/instruments designated to COVID-19 positive patients only). Study teams should check with the departments that are accessed during the conduct of their research to monitor these changes.

New Roles and Responsibilities

Ensure any personnel assuming or taking on new roles and responsibilities have all the required documented training which may include myLearning, CITI and Sponsor sites. The Delegation of Duties Log should also be updated if applicable.

FDA and NIH Guidance Regarding Research during COVID-19

The FDA and NIH are providing guidance for research during the COVID-19 pandemic. Information can be found at https://ictr.johnshopkins.edu/coronavirus/guidance-documents-to-address-the-covid-19-pandemic/

Home Visits

Please check the Hub https://hub.jhu.edu/novel-coronavirus-information/jhu-2020-planning/ to determine when home visits for research purposes will be permitted. This decision will be made by leadership. Resources that review training, guidance, and recommendations for when home visits should be used (versus clinic visits) are currently being collected. PPE will still need to be worn in the home in the same manner as for an in clinic visit.

View a Sample Home Visit Protocol

Visits Conducted Remotely

Some study visits previously conducted in person may be modified to remote visits by phone or telemedicine. View the information and prepare for this modification. https://ictr.johnshopkins.edu/coronavirus/telemedicine/