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 has not been finalized. The policies for the restarting of research will be provided by leadership. This information will 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.

Work Space

If work space does not allow for at least 6 feet between employees, then rotating shifts, days or times may need to be established. Final institutional guidance will be added here once the link is available.

Ambulatory cleaning schedule MUST be followed for any area that is seeing research participants. https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_frequently_touched_surfaces_checklist.pdf and https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_product_chart_east_baltimore.pdf

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.

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

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/

Staff Symptom Checks

System wide symptom checks of all employees will occur at the university level. Staff must self-check before reporting to work. The Health Safety and Environment website will be updated regularly regarding the status of self-checks and steps for employees to take in the event of positive symptom checks. https://www.hopkinsmedicine.org/hse/

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/