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Conducting Clinical Research During COVID-19

Useful content for conducting IN PERSON and REMOTE clinical research during the COVID-19 pandemic.

As researchers navigate conducting their research  during the COVID-19 pandemic many changes to the conduct of studies are taking place. The ICTR has gathered resources to assist you in conducting research remotely and how research visits are handled in person during the pandemic.

The following are only some of the things that should be considered before conducting clinical research during the ongoing COVID-19 pandemic. 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.

Study teams should check back regularly for updates and when there are changes in the pandemic.

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 during the pandemic will be dynamic, this document may be revised as needed.

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

Researchers should familiarize themselves with the information on the IRB website.  Check the link below frequently for update and faq’s.

https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information/index.html

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.

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.pdfhttps://www.youtube.com/watch?v=SLb-z-bInl0

https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_universal_masking.pdf

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

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

PPE can be obtained from JHH Central Stores Department

JHH-Requisition-Form.pdf

Study teams need to consider the current rules for onsite Study Initiation Visits and Monitoring.

When onsite visits occur, teams must follow visitor rules.

https://www.hopkinsmedicine.org/coronavirus/visitor- guidelines.html

Remote Research Monitoring: You can explore information regarding remote research monitoring which allows for study monitors to review study documentation from an offsite location:

https://www.hopkinsmedicine.org/CareLink/research-study-monitoring.html

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.

Please check the following webpage regularly for information on the operational status of the Clinical Research Units: https://ictr.johnshopkins.edu/service/study-conduct/clinical-research-units/

Home visits may be considered in lieu of inhouse visits for conduct research when appropriate and feasible.

View a Sample Home Visit Protocol

Communication regarding participating in on site research visits during the COVID-19 pandemic will need to be provided to research participants. The information can be found at the following links. Note the links may be updated as conditions evolve!

Participants need to receive the COVID risk form prior to in person visits for research:

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

Updated Information targeted at patient/participant visitors to the institution is found here and may be helpful to your participants https://www.hopkinsmedicine.org/coronavirus/for-johns-hopkins-patients.html

Follow these guidelines of what to do if someone reports symptoms over the phone.

https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_phone_triage.pdf

Follow these guidelines if a participant shows up to a research visit with a fever or other symptoms.

https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_outpatient_guidelines.pdf

Considerations for Conducting Research Remotely during the Pandemic

Method

 

InformationCostAudienceContact to Learn More at JH
MyChart Recruitment ServiceUses the Hopkins electronic medical records (EHR) Epic to create computable phenotyping around research study inclusion criteria.  A research invitation is then sent out to the potential participant through the MyChart patient portal.$$$Diagnosis Specific

MyChart Recruitment Service

Cassie Lewis-Land
Clewis4@jh.edu

Social Media Recruitment Ads and PostUse IRB approved recruitment ads on social media platforms.

$-$$

variable

Can be targeted to for age, region, interest

RIU Social Media Service

Cassie Lewis-Land
Clewis4@jh.edu

Digital Signage at JHH campusesUtilize the flat panel screens around campus to advertise research opportunities$$General Public visitor, faculty, staff and patients

Digital Signage (plasma screens)

Steve Seebode  sseebod1@jhmi.edu

 

Google AdsUse IRB approved advertisement on google

$-$$$

variable

General public, uses pay per click to website

Recruitment Innovation Unit

Cassie Lewis-Land
Clewis4@jh.edu

Online Recruitment RegistriesResearchmatch a national registry free for JHU researchers to recruit fromFreeMatches general public with research interest

https://www.researchmatch.org/

Hopkins Liaison

Cassie Lewis-Land
Clewis4@jh.edu

 

Clinical Trials at Johns HopkinsList your JH IRB approved studyFreeGeneral Public

https://trials.johnshopkins.edu/

 

Researchers may consider conducting the consent process via a remote process to decrease face to face time during the pandemic.

Information on remote consent can be found in Section B items 1-4 on the below IRB FAQ webpage.

https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information/resuming_research_faq.html

DocuSign is a 21 CFR Part 11 compliant electronic signature tool that can be used to enable remote signatures on research consent forms. JH has contracted to use this tool to document informed consent. Details about using DocuSign can be found here:

https://ictr.johnshopkins.edu/service/informatics/docusign/ and https://cscop.jhmi.edu/confluence/pages/viewpage.action?spaceKey=DOCUSIGN&title=DocuSign

Below is a video presentation covering remote consent best practices:

https://web.microsoftstream.com/video/c9160455-a7d2-43e0-8678-2abe774cc43c

In order to minimize the need for research-only in-person visits, telemedicine visits may be substituted for in person clinical trial visits or portions of clinical trial visits where determined to be appropriate and where determined by the investigator not to increase the participants risks. Details regarding this option can be found in Section B items 5 on the below IRB FAQ webpage.

https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information/resuming_research_faq.html

JH telemedicine site https://intranet.insidehopkinsmedicine.org/telemedicine/

Contact the Office of Telemedicine at 410-955-0664 or JHM_Telemedicine@jhu.edu

Research teams may consider shipping study materials or study drugs to participants.

Consult with the Investigational Drug Service at your site for details regarding drug shipment.

The IDS Standard Operating Procedure for Shipment of drugs is below for reference.

https://hpo.johnshopkins.edu/doc/fetch.cfm/T64kDgqP

Investigational Drug Service Guidance for COVID-19 Pandemic https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information/IDS_guidance_COVID19_pandemic.pdf

**Study Sponsor and IRB need to approve the shipment of drugs/study materials**