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 7, 2021 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 email@example.com with your suggestions.
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.
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
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
Scroll to Process for Preparing Plans for Johns Hopkins University School of Medicine Principal Investigators who Supervise Staff Involved in Human Participant Research
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
JHH Central Stores Department- CSD, Meyer sub-basement- 410-955-8357. To order, complete the JHH Requisition Order Form.
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
Sani wipes-large 121713
Sani extra-large 121712
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.
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
Participants will need to wear face masks at their research visit. https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_asymptomatic_screening_precautions.pdf
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
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 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
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.
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.
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/
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.
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/