What platforms can I use for remote research visits?
For research purposes you may use WebEx or Zoom to conduct audio or video sessions with participants. You should not record these sessions without prior approval, should not use the chat functions for research purposes, and no PHI should be recorded within the chat window. Additional security measures for using Zoom are described here. More information is available in the Remote Research Guidelines.
If your protocol requires you to record audio or video, please submit a request to DOCR here. They will review and provide you instructions on how to proceed.
Some general guidelines:
- A clear statement should be made at the beginning of the call that it is being recorded. Several states including CA require that all parties be made aware if a call or meeting is being recorded. Secure informed/affirmative consent from the student prior to the conversation.
- Establish strict access controls to the recordings.
- Patients need to verify their identity at the beginning of the session by showing government-issued photo ID.
I need to contact research participants by phone. What are my options?
There are several options for phone contact with research participants, as described in the Remote Research Guidelines. If you wish to have a video component to the call, you can use Zoom or WebEx. If all you need is audio, you can use Jabber. When you install the Jabber app on your personal phone you can initiate Jabber outgoing calls with your work number using your personal mobile device. More information about using Jabber can be found at the OIT site here.
If I am a clinician, conducting telehealth visits using the Maestro Care Citrix telehealth integration, can I also use this platform for research visits with the same patient?
Yes. A. clinician using the platform to provide health care visits for their patient may include their research visits to minimize technical disruptions for the patient. The Maestro Care integrated telehealth platform is experiencing high volumes of use right now, and it is important to consider the burden to the system and use other platforms when possible to leave this platform available for clinical needs. If you are a clinician we ask you to consider both the workflow for your patients/participants as well as the system burden when selecting how to conduct research-only assessments.
Do I need to request Telehealth charges to be added to my study calendar?
The Maestro Care integrated Telehealth platform should only be used either for clinical care or as part of the standard workflow for a clinician conducting a research visit. If your current calendar includes an “Office Visit” procedure, it should not be necessary to revise the calendar. DOCR and PRMO are updating the codes tied to the “Office Visit” procedure to include Telehealth charges. This means that Telehealth charges will be routed in the same direction as charges for in-person office visits on your study. Please be sure to link study-related Telehealth encounters to the timeline, just as you would for a normal office visit.
If your study plans to use Telehealth and your calendar does not currently include office visit charges, please email DOCR-Startup@dm.duke.edu for assistance.
If I am required to work from home, what documents can I take with me?
You may only transmit paper PHI for remote work so long as it is the minimum amount of PHI necessary to perform your job and so long as you follow Duke policies and procedures regarding our obligations to adopt reasonable safeguards to protect PHI.
Where possible, transport PHI in a locked container. Lockbox is preferred over a locking back because bags may be more susceptible to tampering. See below for some examples:
Vaultz Locking Chest Mobile (with wheels & handle)
Can we change our consent process to eConsent?
Yes. Per the communication from the DUHS IRB, moving your informed consent document to be electronic is considered a platform change and does not require an amendment; however, you must internally track these deviations in the event that an accounting is required at a later time.
If your study does not currently use eConsent, you can build one quickly in REDCap. DOCR has updated the directions on how to set-up eConsent, which you can find here. The electronic version of your consent should match the approved paper version, however you should add the suggested language around email communication to that document.
If you are considering using eConsent for a study subject to FDA oversight you must consult with DOCR, as there are additional system requirements. There may be costs associate with transitioning to eConsent for FDA studies.
If you have questions or need assistance setting up your eConsent please email the DOCR Data Team at firstname.lastname@example.org and they will arrange a time for a consult with you.
If I switch from a paper consent to a telephone consent, do I need to submit an IRB amendment?
No, this change in consent platform does not need to be submitted as an IRB amendment. This change is covered und the Duke Health IRB policy entitled COVID-19 and Research at Duke released on March 11th 2020. The DUHS IRB does not need to be notified of, or approve, platform change deviations from the IRB-approved protocol due to COVID-19 at this time; however, please internally track these deviations in the event that an accounting is required at a later time.
What is an acceptable method to obtain the participant’s signature on the IRB Personal Data Disclosure form when a visit occurs over the telephone or virtually?
For telephone and virtual visits, the study team staff may check the telephone visit box and write N/A in the subject signature line. Document the details of the visit on the Personal Data Disclosure Form.
If study team members are working remotely, without access to a fax machine or copier/scanner, what is an acceptable method for signing and transmitting the IRB Personal Data Disclosure forms to the designated Approver?
Study team member signature
- For study team staff that have access to electronic signatures through Adobe software, the use of electronic signature is acceptable.
- For study team staff that do not have access to electronic signatures, staff may type their name and date using word processing software.
Transmission of the form to the department-designated person for processing, this may also be the ClinCard Approver (no changes to current policy)
- The study team may forward the IRB Personal Data Disclosure Form, within an encrypted, secure email, to the designated person for uploading to the Duke Protected Directory. Once completed and uploaded, the study team should immediately delete the attached IRB Personal Data Disclosure form from the email. There are two ways to send an encrypted secure email:
- Type (secure) or [send secure] at the beginning of the subject line to encrypt the message
- For users with Outlook 2010 or Outlook Web Access, click the Sensitive Electronic Information button or select this option from the menu.
- Type (secure) or [send secure] at the beginning of the subject line to encrypt the message
We have studies that require monitoring: How do we alter our monitoring plan to allow for remote monitoring?
Duke School of Medicine has issued a new External Monitoring Policy, which indicates the suspension of all in-person monitoring visits and scheduled meetings until June 30 2020, at which point the policy will be re-assessed. This is effective immediately. If there is an urgent need to maintain an in-person visit, please contact Susanna Naggie for approval (email@example.com).
Requests for remote monitor access to Maestro Care will follow the standard process as described in the Monitor/Auditor Access to Maestro Care policy. Please review the remote monitoring policy (steps 5 to 9), the access will be for a limited time. Monitors will gain access through the Duke MedLink application. To apply for monitor access, the study team will submit a request to Health Information Management (HIM) using the online REDCap system. Both the contract and Duke MedLink Site Access Agreement must be fully executed. A REDCap survey will need to be completed for each monitor visit request as we currently do for in-person visits. Once the remote access has been approved and a Medlink account has been created, the user ID and password will be sent to the CRC/ CRNC in separate emails. **These emails should not be forwarded or copied.**
Information you will need to provide in the email to ORC when you submit Med Link Access Agreement:
SPS Number or IRB Number
Sponsor and contact
IMPORTANT: On the first day of the remote monitoring session, the CRC or CRNC will video conference with the monitor to visually confirm the monitor’s identification via WebEx. The Duke MedLink ID and password must be provided verbally to the monitor during the initial electronic contact. The Research Auditor/Monitor would only have remote access to the participant’s medical record using Duke MedLink. If the research staff has never met the monitor before, they should ask to see a regional state-issued driver's license or identity card.
At this time, study participants do NOT need to be reconsented, and the IRB does not need to be amended for protocol or consent form changes. Please keep track of any changes to your currently approved protocol during this time. This process differs somewhat from the policy, so please contact Maria Manson at firstname.lastname@example.org in DOCR so she can assist you with agreement processing with ORC and your sponsor and assist with submission request to HIM.