Human Subjects and Clinical Research

May 19, 2020: The Vice Dean for Clinical Research released this memo indicating initial plans for phased resumption of clinical research activities:

Guiding Principles:

• Maintaining recommended social distancing  
• Masking and hand hygiene practices in the workplace  
• Symptom monitoring  
• Teleworking for staff and remote research visits for participants whenever possible  
• Minimizing the number of staff doing in-person activities  
• Minimizing the amount of time spent in the presence of others including participants

Phased Resumption of Clinical Research Activities:

• Phase 1 - June 1 Externally funded, Tier 2 in-person study activities that occur on Duke Health premises and can occur concomitantly with clinical care visit; continue current virtual/remote activities   
• Phase 2 - June 15 Externally funded, Tier 3 in-person study activities that occur on Duke Health premises and can occur concomitantly with clinical care visit; continue current virtual/remote activities  
• Phase 3 –
  • Phase 3A – August 3rd Remaining studies that occur on Duke premises in locations that are opened for clinical research and that do not require remote staff to be approved for on-site work may resume.  Plans must be submitted to CRU leadership for communication and clearance across SOM offices. CRUs will be able to approve some of these studies, others will need approval from VD Naggie and other offices.  
  • Phase 3B—September 1st: Based on the careful monitoring of our metrics including COVID case numbers, Phase 3B will be slowly re-opened beginning September 1, 2020. This includes all research happening off Duke premises, in community settings, or in participant homes with the exception of ongoing Tier 1 and 2 studies. Phase 3B plans must be submitted via the ReturntoResearch@duke.edu email, reviewed, and approved by Vice Dean Naggie prior to resuming research activities in these settings. Detailed communications are being regularly shared with CRUs. Please contact them for additional information.

Additional details can be found in the Clinical Research Social Distancing and Infection Prevention Guidelines document. Guidelines specific to planning for community-based research can be found in the Off-premises Social Distancing and Infection Prevention Guidelines. Both guidelines have been incorporated into this online training, which is required for all personnel prior to resuming in-person research.

**Please review the “Return to Research tab” for updates on the phase return of in-person research activity beginning June 1, 2020.

On Monday, March 16, the Duke School of Medicine Clinical Research Administration initiated the Essential Clinical Research Study Policy. At that time, all in-person clinical research study activities for Tier 3, non-essential, studies were temporarily suspended until further notice.  While other clinical research activities that can be done virtually or remotely are able to continue, participant in-person visits are not allowed.

**As of March 23: all in-person enrollment for Tier 2 essential studies have been temporarily suspended until further notice. In addition, we ask research teams to continue converting study activities to virtual or remote/tele visits as much as possible.  Please also prepare contingency planning in the case all in-person follow-up study activities are suspended for Tier 2 Essential Studies.** 

**As of April 13, laboratory building access has been restricted to personnel who have been identified as requiring access for essential research duties. Anyone requesting access to a laboratory building must submit the Lab Access Request Form for departmental approval.

**As of June 1, 2020, gradual phasing in of in-person research activity has begun.  All studies must be approved prior to resuming in-person activities Approvals must include approvals for personnel, study activities, and the use of research locations.  Plans must be submitted to your CRU, which will work with the Schools of Medicine and Nursing to secure approvals and prepare personnel and spaces. This process takes time and personnel may not return to in-person work until all steps are complete and all aspects have been approved.

Please review the IRB Policy titled “COVID-19 and Research at Duke” released on March 11, 2020, for further guidance on changes to research activities related to COVID-19.

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What do I do if I have an idea for a COVID-19 study? 

A COVID-19 study start-up checklist can be found here.

Duke requests that you submit all COVID-19 research studies, ideas, and proposal plans via the brief myRESEARCHhome survey. This helps track Duke’s response to COVID-19 and will get you quickly connected with the COVID-19 Leadership Task Force and additional resources you need to get your research going or your proposal submitted.  If you need help finding collaborators, contact the myRESEARCHnavigators team at myresearchnavigators@duke.edu . For assistance in planning operational aspects of your study, contact DOCR Outreach through docr-studyplanning@dm.duke.edu, and include your Clinical Research Unit leadership.

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What defines an essential study?  An essential study is any study utilizing drugs, biologics, or devices that holds the prospect of direct benefit to the participant. Furthermore, any study involving therapeutic radiation would be considered essential. We have asked PI and CRUs to assess studies meeting this definition to identify those they believe must continue with in-person study activities due to the health and well-being of the participant. All other studies would be considered non-essential.

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What defines a Tier 1 Essential Clinical Research Study? Tier 1 = High Potential Direct Benefit to Research Participants 

All clinical research protocols involving COVID-19 or clinical research protocols in which there is a high potential benefit for an individual’s survival or when alternative treatments are severely limited and there is a potentially serious or immediate harm for an individual without participation in the protocol. For example: 

• Clinical research protocols involving treatments for acute, life-threatening health conditions (e.g., some treatment trials for cancers). 

• Clinical research protocols where stopping the intervention (e.g., some investigational drugs or vaccines or preventative drug regimens) could be harmful.

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What defines a Tier 2 Essential Clinical Research Study?  Tier 2= Moderate Potential Direct Benefit to Research Participants 

Clinical research protocols that provide moderate potential benefit for an individual’s health or well-being over time, which, if unavailable, may pose a long-term risk to the research participant. For example: 

• Clinical research protocols evaluating treatments for chronic conditions (e.g., asthma, hypertension, depression, diabetes, HIV, fatty liver disease, etc.). 

• Clinical research protocols involving assessment of the safety or efficacy of an intervention in which, if stopped, the potential societal benefit of the science would be significantly and adversely impacted, for example where a research assessment (blood collection or imaging study) is only valuable if collected at a very specific time. This must be measured against the risk to participants, including the risk of exposure of COVID-19.

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What defines a Tier 3 (non-essential) clinical research study?  Non-essential studies are primarily observational or behavioral studies, surveys, focus groups, retrospective studies, archival data/sample-based research studies. Non-essential studies may also be interventional studies that are not viewed as so critical to the health and well-being of the participant that it is worth the risk to the research staff and Duke Health community. If a PI or CRU believes a non-essential study needs to continue with in-person study activities, they will need to request this permission from Susanna Naggie and Adrian Hernandez. We must balance the benefit to participants with risk to our research staff and the Duke Health community. 

Studies approved by the IRB as exempt do not meet the definition of an essential research study and must suspend any in-person activities. The PI should consider whether the activity can continue virtually or remotely, as well as other requirements described in this FAQ when deciding how to manage the study during this time.

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If my study is Tier 3 (non-essential), do I need to suspend my study?  Not necessarily.  Any remote (not on DUHS or Duke premises) research activities that do not require in-person visits can continue for any study. Furthermore, we encourage PIs and study teams to use virtual study visits whenever possible. Duke has made several accommodations to make this easier (see Going Remote Section). Only research activities that must be conducted in-person for non-essential studies must be suspended to minimize the risk of exposure to COVID-19 for participants, staff, and the Duke Health community.

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If my study is a Tier 2 essential study, do I need to suspend enrollment?  For studies that require in-person interaction, enrollment must be suspended at this time.  However, in-person follow-up visits may continue for Tier 2 essential studies as well as any research activities that can be done remotely. If all study activities can be done remotely (e.g. virtual consent and study visits), then you do not have to suspend enrollment.  Remote/virtual activities do not introduce risk of exposure to COVID-19 for either the participant or the study staff and may continue for any study.

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I run a biobanking study in which our staff interact with a lot of patients. Is such a study considered essential?   A biobanking study would not be considered an essential study (see above). On Monday, March 16, the Duke School of Medicine Clinical Research Administration initiated the Essential Clinical Research Study Policy. At that time, all in-person clinical research study activities for non-essential studies have been temporarily suspended until further notice.  While other clinical research activities that can be done virtually or remotely will be able to continue, participant in-person visits will not be allowed.  

If your biobanking study uses only regular clinic visits and clinic providers, you may submit a request to keep your study open.  Such requests are submitted in writing to Dr. Susanna Naggie and will be decided on a case-by-case basis, dependent on the evolving nature of Duke’s response to the COVID-19 outbreak. 

Am I responsible for screening research participants for COVID-19?  Yes. Whoever first encounters a patient will do the screening (front desk staff when applicable, or study staff). Research staff will have access to the Travel Screening Job Aid in Maestro Care for Duke patients (directions accessible here), and a paper version is available here for research participants who are not DUHS patients or when the Travel Screening Job Aid is not easily accessible via Maestro Care. These will be updated as needed. For Duke patients, the use of Maestro Care to screen patients is encouraged so that the screen results are recorded and, when applicable, the high-risk travel is documented and a flag created.  

**Starting Monday, March 16, for all essential studies with continued in-person research visits, participants should be called in advance for over the phone pre-screening. If a participant screens positive for symptoms or a high-risk contact or travel, the research visit should be deferred and the participant should be instructed to call their PCP office or local health department. If the participant screens negative, they should be instructed to call the research team immediately if they develop symptoms before the in-person research visit the next day.** 

If the contact with the participant will only be remote/virtual, and there will be no person-person contact with the participant, screening is not required.

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I do community-based research. What about screening for visits that are not on Duke premises?  For all approved studies with in-person research visits, participants should be called in advance for over the phone pre-screening. If a participant screens positive for symptoms or a high-risk contact or travel, the research visit should be deferred and the participant should be instructed to call their PCP office or local health department. If the participant screens negative, they should be instructed to call the research team immediately if they develop symptoms before the in-person research visit the next day. 

If the contact with the participant will only be remote/virtual, and there will be no person-person contact with the participant, screening is not required.

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Where do I get the paper version of the Travel Screening Job Aid to use for non-DUHS  patients?   A paper version of the Travel Screening Job Aid will is accessible here. 

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What do I do if a participant who is a Duke Health Patient screens positive?   If a research participant screens positive and they are a Duke Health patient on Duke Health premises, they should be immediately placed in a surgical mask and placed in an isolation room. Please immediately page/call Duke Infection Prevention for guidance on the next steps:  

• For Duke University Hospital, please page 919-970-9721  
• For Duke Regional Hospital, please page 919-470-4636 #7171  
• For Duke Raleigh Hospital, please page 919-206-3311  
• For Duke Primary Care and Urgent Care, please call 919-896-2428  
• For Private Diagnostic Clinics, please call 919-451-8828 

Do not send the participant to the Emergency Department, Urgent Care or their primary care provider unless instructed to do so by Infection Prevention. When a participant screens positive, one should stop managing them as a research participant and think of them as a patient. There should be a research-to-clinical care transition plan, and research activities should be deferred.    

All research staff members still conducting in-person research visits should pre-screen all research participants by phone. If a participant screens positive for symptoms or a high-risk contact or travel, the research visit should be deferred and the participant should be instructed to call their PCP office or local health department. If the participant screens negative, they should be instructed to call the research team immediately if they develop symptoms before the in-person research visit the next day. If a research participant shows up for a visit and screens positive, despite phone pre-screening, call Duke Primary Care and Urgent Care hotline at 919-896-2428 OR call the Duke Hospital Incident Command Center at 919-684-2222 (this will be operated daily from 7 am-5 pm), and the research visit should be deferred.

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What do I do if a participant who is not a Duke Health Patient screens positive?  All research participants should be pre-screened by phone (see “am I responsible for screening research participants” above) and research visits should be deferred if a participant screens positive. When participant screens positive, one should stop managing them as a research participant and think of them as a patient. There should be a research-to-clinical care transition plan and research activities should be deferred.    

If participant screens positive at scheduling or during a pre-visit call, the participant should be instructed to call their PCP office or local health department.  If they screen positive upon arrival, they should be given a face mask, isolated, and instructed to call their PCP office or local health department. In either case, the research visit should be deferred. Provide the participants with a listing of local testing sites and health departments (e.g., Durham County Public Health). If this is a home visit and the participant screens positive on arrival the research staff should not enter the home and should provide instructions for seeking care/testing by phone.

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What if a participant who screens positive refuses to wear a mask?  They will need to leave the premises and the study visit must be deferred. Please inform them of their obligation to self-isolate for the next 14 days. Please instruct them to call their PCP office or their local health department.

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What if a participant who screens positive refuses to stay while triage and management planning is ongoing?  The staff member should ensure they leave with a mask on and inform them of their obligation to self-isolate. Please instruct them to call their PCP office or their local health department.

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My study involves anesthesia, and Duke is currently requiring most patients to undergo COVID-19 testing prior to anesthesia.  Does this need to be added to my study calendar or order set?  How will the charges for this testing be handled? In this scenario, it is not necessary to add COVID-19 testing to your calendar or order set.  The charge reviewers in PRMO and DOCR are being instructed to route these charges in the same direction as the procedure requiring anesthesia itself.  So, if your study is paying for the procedure and associated anesthesia, the COVID-19 test will also be billed to the study.  If the procedure and anesthesia are being billed to insurance, the COVID-19 test will be billed to insurance.  As always, you should make sure that the encounter in which this testing is done is linked to the timeline in Maestro Care.  Please contact DOCR-Startup@dm.duke.edu if you have any questions about this.

What can I do to prepare?  Connect with your CRU and divisional leadership to verify your specific plans for triaging and managing study participants. Familiarize yourself with the triage and management plan on the COVID-19 resource page. Put relevant infection prevention phone numbers into your phone now so you will have them when and if you need them. 

• For Duke University Hospital, please page 919-970-9721 

• For Duke Regional Hospital, please page 919-470-4636 #7171 

• For Duke Raleigh Hospital, please page 919-206-3311 

• For Duke Primary Care and Urgent Care, please call 919-896-2428 

• For Private Diagnostic Clinics, please call 919-451-8828 

• Durham County Health Department, please call 919-560-7600 

• NC Department of Public Health Communicable Disease Branch 24/7 Hotline, please call 919-733-3419 

• Duke Hospital Incident Command Center at 919-684-2222

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I am sick, how do I record my time off? If you are sick, please follow EOHW guidelines.  Additional information on recording your sick time can be found here [link to Kyle’s page].

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I can’t access the research building where I need to work. As of April 13, laboratory building access has been restricted to personnel who have been identified as requiring access for essential research duties. Any clinical research personnel needing access to a laboratory building must indicate this need when submitting their Clinical Research Spaces and Access Survey (often referred to as “density survey”) as part of their on-site approval process. Key card access and approval will be managed through this process. Already approved personnel who need access to a new location can send their request to docr.help@dm.duke.edu for processing.

**Anyone who will be entering the hospital or clinic spaces must first enter through the main hospital or clinic entrance to be screened and may not enter clinical spaces through CARL or any other access point for the first time that day.**

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I have study staff who can’t do their research activities at this time, is there a way to move their effort onto another project at Duke during the time when we are required to work remotely? Yes, first, talk with your Research Practice Manager (RPM) or Assistant Research Practice Manager (ARPM) to see if there are studies within your unit that may need extra effort.  Second, the Duke Office of Clinical Research (DOCR) is helping to coordinate shared effort across the School of Medicine during this time. You can submit an Available Effort Form to let them know the amount of available effort, potential duration, and technical skills.  They will work with you to find a match with studies that need extra staffing if one is available.

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I have studies that need extra staff, is there a way to find research staff who may have extra time available because their assigned research activities have slowed? Yes, first, talk with your Research Practice Manager (RPM) or Assistant Research Practice Manager (ARPM) to see if there are staff within your unit who have available effort.  Second, the Duke Office of Clinical Research (DOCR) is helping to coordinate shared effort across the School of Medicine during this time. You can submit a Request for Staff Effort form to let them know the amount of effort needed, potential duration, and technical skills required.  They will work with you to find a match with staff who have available effort.

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I am a student and I want to help with COVID-19 clinical research, how can I find a study to work on?  Duke School of Medicine graduate and medical students who are interested in helping with COVID-19 clinical research studies are invited to submit a volunteer application using the link below. Please note that there may be a great need for assistance with a variety of clinical research projects at this time, and some opportunities may be more scholarly (e.g., helping with grant applications) or maybe on studies other than COVID-19 studies. 

Once you complete an application, someone will reach out to you to discuss. In addition to capturing your information, this survey will let the team know what kind of training you may need to complete before starting research activities for a particular study, so we thank you for filling out the form completely. Student Research Volunteer form

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I have a new COVID study starting.  How do I enlist medical or graduate student volunteers to help? Talk with your Research Practice Manager (RPM) or Assistant Research Practice Manager (ARPM) about your needs.  They can guide you through the requirements of involving various types of students in your research as well as discuss with you oversight of the students clinical research activities.  A request for medical and graduate students who have volunteered to help with COVID research (Student Research Collaborative), can be requested using the Student Request Form.

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We have a study team that completes home visits. Is the current plan only applicable to research patients/participants that come to Duke?  The current screening recommendations include all research participants with whom you will have in-person visits, regardless of location. We have provided triage plans for DUHS and non-DUHS participants and for participants on and off Duke premises. Please see above.

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My study has international sites. Do we still need to screen participants at international sites?  At this time, Duke does not require screening at international sites. We recognize the difficulty in creating an implementation plan in countries where contacts, policies, and resources may be different or unknown.  We ask Principal Investigators to consider the relative risk to their research staff and research participants at these sites and to devise a plan that best ensures safety.  When possible, our travel aid screening tool may be used and supplemented with local procedures and contact numbers.

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How can I stay informed on the latest updates regarding COVID-19?  Information will be regularly updated on Duke Health’s COVID-19 Information Resource page (COVID-19 Info Page) and on DOCR’s website (DOCR Website). All critical changes will be communicated from the SOM to all faculty and staff via email. Furthermore, Dr. Naggie, DOCR, and CRU leadership will meet weekly to ensure information is disseminated to research teams. Updated information, resources, and Town Hall recordings are located on the DOCR COVID Resources Page.

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Will visitor restrictions be placed on friends or family who accompany research participants during their research visit?  Yes. Visitor restrictions are regularly updated on the DUHS COVID-19 page. All patients and visitors will be screened for symptoms of illness upon entry to Duke Health. If a visitor is found to have symptoms related to COVID-19, flu or a cold, they will be given information about what to do and asked to return home to help prevent the potential spread of illness. 

While Duke Health patients will be receiving notification of this new visitor policy, research participants that are not Duke Health patients will not receive this communication; thus research staff will need to contact participants who are not Duke Health patients to make them aware of this new policy before coming for their research visit. Please continue to complete the Maestro Care Travel Screener Tool Aid (or paper screener tool for non-Duke patient participants) for all research participants on arrival to the research visit.

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My research is FDA regulated. How is the FDA responding to the COVID-19 outbreak, and what should I do to make sure my studies are documented appropriately if research activities have?  The FDA has issued updated guidance for industry sponsors and Institutional Review Boards: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic. This updated document includes several FAQs including guidance on obtaining signed informed consent from COVID-19 patients in isolation. Notable indications are below. 

For all trials that are impacted by the COVID-19 pandemic, sponsors should describe in appropriate sections of the clinical study report (or in a separate study-specific document): 

1. Contingency measures implemented to manage study conduct during the disruption of the study as a result of COVID-19 control measures.  
2. A listing of all participants affected by the COVID-19 related study disruption by unique subject number identifier and by investigational site, and a description of how the individual’s participation was altered.  
3. Analyses and corresponding discussions that address the impact of implemented contingency measures (e.g., trial participant discontinuation from investigational product and/or study, alternative procedures used to collect critical safety and/or efficacy data) on the safety and efficacy results reported for the study. 

While Duke has issued specific recommendations regarding IRB amendments (link to memo), study teams should document in-house all protocol and operational changes for future use and reference.

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Are there guidelines that protect at-risk staff?  The CDC currently identifies the following as people at higher risk for severe illness: Older adults, people with HIV, people with asthma, and pregnant women. 

At this point, Duke has not placed any restrictions on specific staff. What is most important for your protection is that any patient/participant be screened for symptoms and risk and when the screen is positive, immediate measures are followed for infection prevention including deferring visits for patients who are not already present, and for patients who are present for a clinic visit, following triage processes as described above. 

If you are within one of the CDC-defined risk categories, please discuss with your manager options for working remotely or other options for protecting yourself from exposure.

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I have students working on my human research study.  Can they continue their research?   Please see the FAQ tab for Graduate and Undergraduate students for University information.

At this time Undergraduate, Medical Students and Graduate Students are permitted to conduct in-person clinical research on approved plans.  Students must be included on approved return to research plans by their CRU, and may only return to in-person research when they have completed requirements, received an on-site approval letter, AND when their study activities have been approved and are ready to resume.

They may also do remote research activities following usual restrictions and guidelines for students in clinical research as posted on the DOCR website.

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 IRB 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 has been IRB approved to record audio or video, please follow the general guidelines below:

• 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.

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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.

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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.

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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.

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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 File Box 

• Vaultz Personal Locking Tote 

• Vaultz Locking Chest 

• Vaultz Locking Chest Mobile (with wheels & handle) 

• Locking HIPAA Bag 

Additional details can be found in the Paper Documents Guidance Document linked here.  For questions, contact DUHS Compliance Office at (919) 668-2573 or compliance@mc.duke.edu.

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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. 

DOCR has made an eConsent template available which you can view here or email redcap-docr@duke.edu to request a copy of the project as a starting place for your electronic consent document. 

If you have questions or need assistance setting up your eConsent please email the DOCR Data Team at redcap-docr@duke.edu and they will arrange a time for a consult with you.

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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. 

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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.

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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.

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We have studies that require monitoring: How do we alter our monitoring plan to allow for remote monitoring?  The Duke School of Medicine External Monitoring Policy, which indicated the suspension of all in-person monitoring visits and scheduled meetings until June 30, 2020, has been lifted.  In-person monitoring visits are now allowed, though remote monitoring visits are still strongly recommended. Such visits must be requested and approved. Requests for external monitoring, whether in-person or remote, will follow the process as outlined on the DOCR COVID Resource Page under “Resources for Resuming Research Activities.

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: 

1. SPS Number or IRB Number 

2. Principal Investigator 

3. Sponsor and contact 

4. Protocol Title 

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 maria.manson@duke.edu in DOCR so she can assist you with agreement processing with ORC and your sponsor and assist with submission request to HIM. 

Will the IRB Operate on a Normal Schedule?   The DUHS IRB operations will continue uninterrupted during the COVID-19 outbreak.  Office personnel and Chairs will continue to be available even if working remotely.  Contingency plans are already in place to conduct convened IRB meetings remotely should it become necessary.  Staff and Chairs will still be available via email and regular office telephone numbers during normal business hours, even if working remotely.  

 If you need to consult with the IRB specifically about COVID-19 and its effect on your research, please call the IRB’s main line at 919-668-5111 from 8:30 am to 4:30 pm Monday through Friday and ask for an IRB Chair or the IRB Executive Director.  If calling after hours or on weekends, please call 919-668-5111 and follow the contact instructions for the Chair-on-call. 

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I’d like to temporarily suspend my study enrollment; how do I do this?   If you plan to temporarily suspend or revise any part of your study (enrollment, interventions, data/safety monitoring) due to COVID-19 (multiple bullets may apply) Please see up to date information in the Programmatic Impacts and Project Extensions section of the main Research FAQ page as well as information in recent communications for research administrators. We encourage investigators and study teams to work directly with sponsors for programmatic changes that ensure the continuity of the research. In the event a change materially impacts the scope, budget, ability to meet project aims, or where the sponsor requires an institutional official to sign off, please work through ORA, ORC, or ORS in advance of your communications with the sponsor. Specific contacts are indicated below: 

• For Federally funded studies and foundation-funded studies, please work through your grants manager and ORA 

• For Industry-funded studies, please contact ORC 

• For any studies for which a Duke PI holds the IND/IDE, please contact Duke ORAQ at oraq@duke.edu;  

• For Duke-funded studies, please inform your CRU Director via email. 

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What can I send to my sponsors to communicate necessary changes to our study? Please use the updated memos and communications linked within this FAQ. An example communication can be downloaded here, and additional guidance can be found in the Sponsor Communications Packet.

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Do I need IRB approval to make changes to the protocol to account for response to COVID-19?  Please refer to the Duke Health IRB policy entitled “COVID-19 and Research at Duke” released on March 11, 2020. As per this policy, the IRB has identified some deviations that do not require IRB notification or approval. For the purposes of this policy, “deviations” shall be considered to be deviations from the IRB-approved protocol that do not affect data integrity or subject safety, rights, or welfare.  Examples of deviations include missed study visits, out-of-window visits, elimination of minor assessments, changing the platform under which data is collected or safety is monitored (such as changing from clinic visit to a phone call), and home-delivery of drugs/devices. The DUHS IRB does not need to be notified of, or approve, 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.  

Any other revisions to the IRB-approved protocol (change in the frequency of safety monitoring, elimination of critical study visits, change in drug/device administration or composition), require submission of an amendment to the IRB.  Please put “COVID” in the amendment title.  These amendments will be given priority for IRB review/approval.