Remote & Virtual Trials

April 9, 2020 - Message to Researchers (PDF)

IRB website

What is eConsent?

Electronic consent is a platform for consenting research participants using a computer-based consent versus the traditional paper documentation.
MUSC’s IRB has vetted three eConsent platforms: REDCap, Doxy.Me, and the FDA’s COVID MyStudies Application.

1. REDCap eConsent provides a framework to obtain and record informed consent. It can be utilized for in-person or remote consenting.  

Update 7/29/20: Efforts are underway to develop a 21 CFR Part 11 validated eConsent process utilizing MUSC’s eConsent REDCap template. Details to follow over the next few months.

REDCap Toolkit (PDF) 

2. The MUSC Biomedical Informatics Center has a telehealth platform called Doxy.me that is also available for use by MUSC researchers for eConsent. To receive information regarding the use of the Doxy.me system for electronic consent, please submit a Telehealth Research Services SPARCRequest or email Jihad Obeid or visit the FAQ’s available here.

A). Documents cannot be uploaded to Doxy.me directly by the research team or system administrators – instead they are reformatted and manually coded for use exactly as approved by the presiding IRB. Please expect at least 1-week of development and testing time between submitting your SPARC request and document availability on musc.doxy.me. A fee of $100/hour for federally funded and $140/hour for privately funded research will be charged for this development time. There is no ongoing cost associated with teleconsent or Doxy.me use.

B). MUHA has implemented a MyQuest course which all new Doxy.me users must complete – though it is geared towards clinical users, it is required for research users as well. It is a self-directed online course which should take no more than 30-minutes to complete.
Additional documentation and reference materials on using Doxy.me can be found here. Note: This material is targeted towards clinical users but may be of interest to research users as well.” 

Doxy.me (PDF) 

3. The IRB and Information Solutions recently vetted the use of the FDA’s COVID MyStudies Application, which is a free platform to obtain informed consent securely from patients when face-to-face contact is not possible or practical due to COVID-19 control measures. The agency is providing this resource after hearing that investigators were having difficulties obtaining informed consent for clinical trials when patients were in isolation rooms in health care facilities or could not travel to outpatient clinics. Due to the demands of COVID related activities, the FDA is prioritizing the requests for those that have open trials where informed consent in person is not possible for open PIND/IND (COVID/Non-COVID related).

The COVID MyStudies app storage environment is HIPAA compliant, and is considered Part 11 Compliant for eSignatures. View more information and how to request initial set up.

Please note, MyStudies staff will have access to a name and email address for troubleshooting purposes only but is not involved in research; therefore, a BAA does not need to be established prior to utilizing this resource.

Please visit MUSC’s IRB website for more information regarding the use of electronic consent for studies conducted under their purview.

Guidance for Processing an eIRB Amendment to Utilize eConsent Platforms

Study teams who are interested in using eConsent should review the steps below to learn more about how to process an amendment in eIRB.

1. Carefully review the MUSC IRB’s Policy Section 6.1 - Informed Consent to Participate in Research Policy and Procedures and Electronic Consent Guidance (DOCX) located on the MUSC IRB Forms & Guidance Website to determine if electronic consent is appropriate for a specific study. Information about electronic consent, how and when it can be obtained, general amendment processing information, where to access the MUSC eConsent Templates and much more is outlined in this guidance document. FDA regulated studies will need to determine Sponsor Part 11 Compliant requirements as they relate to electronic signatures and eConsent. Currently the two MUSC approved eConsent platform systems are not certified for Part 11 Compliance.
2. If it’s determined that eConsent is an appropriate tool to use for your project, you’ll need to process an amendment in eIRB. Per the IRB’s Electronic Consent Guidance Document, the following items need to be considered when drafting an amendment to use eConsent:
   a. The researcher should provide a detailed description of the circumstances in which electronic consent will be used and a description of the electronic consent process (how, what, when). Ensure this information is reflected within the eIRB application itself and the protocol document. Explain how the subject’s signature will be obtained. Also, explain the process for providing the participant with a signed copy of the informed consent must be outlined. The researcher will need to describe the backup plan to consent subjects if the electronic consent is not available at the time of the consent process. The researcher will also need to submit the version of the electronic consent document to be used.
   b. There is a specific Smartform in the eIRB system where researchers provide information about the informed consent process. The title of this Smartform is “Consent Process.” In this Smartform, Section 5.0 is where electronic consent is verified, and 6.0 is the where the researcher will detail the electronic consent process that will be used.
   When appropriate, the use of electronic consent should also be described in the protocol.
   c. The REDCap template for creating an eConsent database is available from the Template List on the “New Project” page within REDCap. The template is called MUSC eConsent Project Template. It includes Standard Operating Procedures (SOP) for the customization and use of the database.
   d. Doxy.me eConsent templates are developed via MUSC’s Telehealth Research Services. You will need to submit a Telehealth Research Services SPARCRequest.
3. Both regulatory and REDCap assistance are available if needed via the SCTR SUCCESS Center by submitting a SPARCRequest and requesting the appropriate consultation(s).

What technology options do I have for video conferencing or video chatting to conduct study visits with my participants?

Per the MUSC COVID-19 PM Message - October 21, 2020, MUSC has a variety of HIPAA-compliant tools that can be utilized and are in place for video conferencing. Please review this communication to obtain the list of MUSC-approved systems, as well as information on who to contact should you require the use of a non-approved application such as Apple Face Time.

To conduct visits remotely, an amendment to the IRB is required. Please refer to the MUSC IRB Message to Researchers: COVID-19 (March 25, 2020). In the IRB application, investigators should broadly describe a process for conducting the visit and how documentation of the visit will occur. Investigators should consider their study population when implementing remote visits including access to the internet (or lack thereof), technology capabilities, and possible data usage costs, etc.

If a study typically uses paper source documents, it is important to consider if HIPAA compliance can be maintained when completing source remotely, or if alternative methods of source documentation should be considered.

Source documentation for any assessments or procedures completed remotely should be completed and stored in a secure and HIPAA-compliant manner at all times. If paper source documentation must be created and temporarily stored outside of the MUSC campus, the source documentation may be labeled only with the subject ID and/or initials. The source documentation may not contain any identifiable subject information.  

Study teams may consider alternatives to paper sources as well. Before implementing any changes in source documentation, the study team should consult with the study sponsor. Study teams should also ensure that any method of source documentation or storage that will be used is consistent with the IRB-approved protocol and application.

Examples of compliant ways to complete and store source documents electronically include:

• Creating editable electronic document versions (e.g. fillable PDFs, Word documents, etc.) for assessments and source docs that can be completed and stored within Box. If using this option, it is important to determine what methods of electronic signature the sponsor will accept. Study teams who wish to share electronic source documents maintained in Box with external monitors should review information and instructions under the ‘Remote Monitoring’ tab.
• Documenting research procedures and assessments within a research note in the electronic health record (Epic). This is allowable as long as the study’s IRB-approved informed consent document does not specifically say that information about study participation will NOT be placed in the subject’s medical record (this would usually be stated in the “Medical Record” portion of the ICF). It is recommended that remote research visits be documented as a “Telephone Encounter” within Epic. The EPIC Tip Sheet (PDF) provides instructions on how to create a Telephone Encounter and associate it with your research study.
  
  Additional solutions are available for study teams wishing to use Epic as electronic source, but these solutions must be developed on a study-specific level. Study teams interested in learning more about these solutions should contact the Epic Research team: https://horseshoe.musc.edu/research/ocr/epic-research

To remotely obtain redacted Radiological Scans for research, contact Broderick Green with medical records to establish a Life Image Account. You will receive instructions and be required to test your account access with a redacted scan prior to downloading an actual research scan. After successfully testing account access, when a redacted copy of a radiological procedure is needed, the study team will be required to submit a study specific medical records redaction request along with a completed IIT form including the study Udak to Broderick Green and Nancy Faulk.

Participant Remuneration for Remote Trials (PDF)

Updated 3/1/2022

In line with the updated University COVID-19 Directives issued on 2/28/2022 by the Provost's office, the COVID-19 protocols for research have also been updated. Research visitors may return to campus; including research participants, clinical research monitors, research collaborators and trainees and vendors. Permission is not required prior to their visit.

Testing of visitors for SARS-CoV-2 prior to entering campus is not required. However, all visitors should self-monitor and get tested if symptoms arise (headache, cough, sinus congestion, body aches, sore throat, chills and fever; other symptoms may include runny nose, shortness of breath, diarrhea, nausea, abdominal pain or sudden loss of taste or smell). If such symptoms are present, they should not enter the campus.

Resources are available to support the remote review of source documents including the following:

External Affiliate NetID: The "External Affiliate NetID" process is available for non-MUSC research staff (i.e. community partners, off-campus staff, or research monitors) who, for study purposes, require an MUSC NetID to access the eIRB, CITI Training, REDCap, and/or SPARCRequest systems. This is a 2-step process that MUST be completed by an MUSC employee acting as the sponsor. A non-MUSC researcher cannot submit a request for themselves. Instructions, resources, and FAQs for requesting an External Affiliate NetID can be found here.

EPIC EMR: If source documentation is maintained in EPIC, remote access may be granted to monitors. The MUSC policy for Electronic Medical Record Access for Research Monitors includes instructions on how to request remote monitor access. For additional info on how EPIC may be used for source documentation, please review information in the Use of Source Documentation tab.

Box: Source documents may be shared with external monitors via Box. The external user must have an existing Box account, or a free account can be created: https://account.box.com/signup/n/personal#eljn2
If protected health information (PHI) or sensitive information (e.g., Social Security numbers, financial information, etc.) will be shared, the study team must first request 2Factor Authentication for the external user’s Box account.

To request 2Factor Authentication: Contact the IS Service Desk at (843) 792-9700 and request 2FA be implemented for the user. You must be able to provide the email address associated with the user’s Box account. To help direct your request, let the service desk staff know that the request should be routed to the Non-Clinical Applications Team.

Guidance for Using Box for Remote Monitoring:

• Box owners may give an external user access to a Box folder by selecting “Share this Folder” and entering the email address associated with that user’s Box account in the “Invite People” text box.
• Box owners may select the permission level to be granted to the external used by clicking the blue hyperlink underneath the “Invite People” text box. The default permission level is “Editor.” However, it is recommended that external monitors be given the “Previewer”, which allows the user to view, but not download files.
• Access should only be granted access to study files that are required for monitoring purposes. This may require creating a separate Box folder that contains only the files required for monitoring. For example, a department may have a Box folder that contains subfolders for each study. The external monitor must only be granted access to the specific study folder, not the department folder. Additionally, if the study-specific folder contains information that is not required to be monitored (e.g. – subject W9 forms, etc.) a separate folder should be created to house only those documents required for a monitoring visit.
• Box owners are responsible for ensuring that an external monitor’s access is promptly removed once a monitoring session is completed.

Guidance for external users on accessing MUSC Box files:

• When an MUSC Box file is shared with you, a link to the file will be sent to the email address associated with your Box account.
• When you click the link, you will be taken to a login screen where you should click on the link that says, “Not a part of Medical University of South Carolina?”.
• You will then log in with the email address and password associated with your Box account.
• Please note that the external affiliate NetID cannot be used to access Box.

Video applications: MUSC-approved, HIPAA compliant video applications may also be used to share source documents containing PHI with external monitors. If a video application is used to record a monitoring session meeting where PHI is viewed/discussed, the video must be stored in the same manner as other PHI. View a complete list of approved video applications.

Secure Email: Source documents containing PHI may be shared with external monitors via encrypted email. For instructions on how to send an encrypted email, please refer to the “External Communications” portion of the Secure Email instructions. 

eReg: This is an electronic Regulatory Management System that allows organizations to centrally store essential protocol documents, staff credentials, and organizational regulatory tracking documents. eReg does is not used to store source documents or PHI but may be used to share regulatory files with external monitors. Find information about eReg on the Horseshoe. 

Remote monitoring of Investigational Drug Services will be available via the Vestigo system during COVID-19 emergency operations.

If your Sponsor needs an official, signed copy of the mandate concerning study monitor visits, email the SCTR SUCCESS Center.

Enterprise wide solutions to address Part 11 Compliance and electronic signatures are currently being explored. For FDA regulated studies, research teams should consult with their Sponsors regarding acceptable forms of electronic signatures during COVID-19.

Update 7/29/20
Efforts are underway to develop a 21 CFR Part 11 validated eConsent process utilizing MUSC’s eConsent REDCap template. Details to follow over the next few months.

Study teams should communicate to Sponsors MUSC’s response to COVID-19 and the impact on clinical research operations. The Sponsor Communication Letter template can be used to notify Sponsors.

It is also recommended that a Study Specific Continuity of Care Plan be developed by the research team and shared (and approved) appropriately with Study Sponsors before implementation. The IRB must also be notified via an amendment of any changes to the study in response to COVID-19. Continuity of Care Plans should address the following: methods to protect participants and research staff, IP, laboratory, imaging, study assessments, method of remote visits, and tracking and documenting remote visits.

In developing a Continuity of Care Plan, potential questions to sponsors may include the following:

Investigational Product

• For IP that cannot be administered by the subject or subject’s caregiver (e.g. an infusion or injection typically administered by a nurse), are there alternatives available to having the subject present at the hospital, such as home health? If so, will the sponsor establish home health agreements or will this be a site responsibility?
• For IP that is administered by the subject or caregiver (e.g. an oral medication, topical cream or self-administered injection) will the sponsor allow for shipment? If so:
• What are the shipping requirements for IP to maintain stability?
• Will the sponsor provide supplies required to ship IP (e.g. shipper,
  shipping label, temperature monitoring device, sharps container) or will the sponsor reimburse the site for the cost of these supplies?
• Are additional patient instructions or documentation required related to the handling or use of the shipped IP? If so, will these be provided by the sponsor?

Specimen Collection

• Can certain labs be skipped if not needed for patient safety? (e.g. research only (PK) samples stored for future research)
• For labs that must be completed for subject safety:
• Is it possible to send the lab collection kits to participants’ homes to have them drawn at local labs close to their homes? (Labs would then be picked up by a courier and transported to MUHA for processing)
• Can safety labs normally performed at a central lab be moved to a local lab?
  Can urine pregnancy tests be shipped to a subject’s home and performed by the subject? Is a change in the kit required for home use?
• Is a blood self-collection kit (such as Mitra) an option?
• If blood and/or urine samples are required for laboratory tests, what options are available if the subject is unable to be seen in-person at the study site?

Study Visits and Documentation

• What study assessments are suggested to occur remotely? How should these assessments be administered (by phone, teleconference, mobile app, etc.)What study assessments can be delayed? Or skipped? How long can they be delayed?

For participant reported outcome (PRO) assessments usually completed on paper by the subject:

• Can the assessment be completed verbally by phone? If so, does the subject need a copy of the assessment to review visually while answering questions verbally?
• If assessment cannot be completed verbally, what options can be used to provide a copy of the assessment to the subject for remote completion? Can assessment be emailed to subject or must a hard copy be mailed? Once completed, can the subject email a copy of the completed version to the site, or must the assessment be mailed back?

For PRO assessments completed electronically by the subject:

• Is there a way for the subject to access the electronic assessments while not at the study site? If not, can the assessment be completed via Epic MyChart, mobile apps, phone or by providing a copy (via mail or email) to the subject for completion?

For physician assessments:

• Can assessments be completed via telehealth platforms, phone or other audio/video methods?

Anthropometrics:

• Are there any measurements which would be acceptable for the participant/caregiver to provide themselves if they have equipment at home? (e.g. weight, temperature, blood pressure)?
• If urine pregnancy testing is required, can the test be mailed to or otherwise provided to the subject to complete at home?

Medication adherence:

• Should the subject be asked to mail back any unused medication so that adherence can be assessed? Or can the subject just report any unused medication via phone (or other communication method) and save medication be returned at a later date.

Study teams should notify study participants regarding MUSC's response to COVID-19 and the impact it may have on their research participation. In situations where study visits cannot be conducted remotely and must be done in person on MUSC's main campus it is important to communicate any changes to MUSC's current operations that may impact their visit (e.g. parking, entry, visitor restrictions). The Participant Communication template can be used and modified accordingly.

Per MUSC's IRB, the templated letter does not need to be IRB approved, however, if you amend the templated letter to include study-specific information you will need to confirm with the IRB whether approval would be required before sending to the study participant. 

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

Review a technical assistance report focused on Methods for Remote Clinical Trials, included in the list of resources available at MUSC's Telehealth Center of Excellence webpage.

a. Investigators should be aware of new research review processes for enrollment of new study subjects and conducting in-person study visits during the COVID-19 pandemic. Information related to this process can be found on the MUSC Horseshoe. 

b. ResearchMatch.org: A free and secure online recruitment tool. Guidance is offered, including registering as a researcher, IRB approval of appropriate recruitment material, and accessing the volunteer registry to identify and contact potential study volunteers. Submit a SPARCRequest for a ResearchMatch consultation.

Updated 12/21/2020

c). SCresearch.org can be utilized for Investigators who wish to use a free online recruitment tool. Ensure that you have chosen this option in your IRB application and have chosen to have your lay friendly study description included on the site.

D). The Harvard Catalyst Guide, “The Use of Social Media in Recruitment to Research” is a useful resource providing a good overview of considerations for research and recruitment in the internet realm.

View active COVID-19 Clinical Trials

Contact MUSC's Office of Clinical Research with any Telehealth billing questions.

843-792-7900
musc-ocr@musc.edu