In This Section      
 

FAQs related to Resuming Research with Human Participants

A. Timeline for Resuming In-person Interaction and New Enrollment
Q1. When will in-person interaction and new enrollment resume for research involving human participants at Johns Hopkins University (JHU)?
Q2. What studies are eligible to restart research?
Q3. How many phases are in the University’s plan for research restart?

B. Restart Committee Approval Process
Q1. What approvals are required to resume in-person interactions/new enrollment for my research?
Q2. What is the contact information for each Committee?
Q3. Is a separate space assessment needed for KKI, SKCC, and JH-ACH studies?
Q4. Who should submit to the KKI Research Restart Committee?
Q5. My study takes place both in Baltimore and St. Petersburg Florida, do I need approval to resume in-person interactions/new enrollment from both sites?
Q6. Is there a different process for restart for the protocols conducted through the School of Nursing?
Q7. Will I have to receive approval from the restart committee for a new application?
Q8. If I rely on an external IRB [non JHM IRB] for my study, do I still have to submit to the restart committees for approval?
Q9. If my study was approved as a Tier 1 study but my approval was restricted to specific activities and I wish to expand the in-person research related activities and/or be permitted to allow new enrollment, do I have to submit a petition to restart to the Johns Hopkins IRB?
Q10. Do compassionate use/expanded access requests for previously approved or new applications need to submit the petition to re-start and get approval from the restart committee?

C. Process for Submitting a Petition to Resume In-Person Activities/New Enrollment to the IRB
Q1. Will I have to submit a change in research to the JHM IRB to resume in-person interactions/new enrollment for my previously-approved research?
Q2. If I am submitting a new application, what documents will I need to include to begin in-person interactions/new enrollment?
Q3. What documents will I need to include in my change in research?
Q4. If I rely on an external IRB [non JHM IRB] for my study, do I still have to submit a petition to resume in-person interaction/new enrollment to the JHM IRB for approval?
Q5. If my protocol was previously approved by the JHM IRB but not approved to start due to the COVID-19 restrictions, do I have to submit a request to resume my research?
Q6. If my study’s initial stamped consent form was held and I submit a change in research with a revised consent, will I receive a stamped consent form for the revised consent?
Q7. If my study’s stamped consent forms were held for a new application submission and one or more changes in research, will I receive all stamped versions once the study is approved to start?
Q8. Do I need to submit a petition to resume in-person interaction if my research is conducted outside of the US?

D. Exemptions from the Restart Process
Q1. Are any studies exempt from the process for resuming research activities?
Q2. If my study is not included in the first phase of re-opening, can I still submit a Tier 1 petition to the JHM IRB to request to continue with enrollment and/or in-person research related activities? 

E. Building in Flexibilities to Enable Research to Resume
Q1. If my study is not included in the first phase of re-opening, can I still revise my study to be conducted fully remotely?
Q2. If my study is not included in the first phase of re-opening may I continue to conduct remote visits instead of in-person visits and report it on the deviation log at continuing review?
Q3. Do I have to make any changes to the consent process for my studies?
Q4. How do I conduct the consent process using a teleconsent or remote process?
Q5. Are there additional steps if the physician/mid-level provider policy is implicated?
Q6. Has the IRB approved any standard language to describe the use of a remote consent process?
Q7. What should I do if I want to revise my protocol to allow for the use of telemedicine in place of in-person visits?
Q8. Are there best practices for using email in research?
Q9. Are there best practices for using text messaging in research?
Q10. Are there best practices for sending text messages using autodialer?
Q11. What general advice do you have about protecting data collected using remote mechanisms and platforms?
Q12. What platforms are approved for use by JHU investigators for e-data collection and storage?
Q13. What tools are best for video calls? Which ones does JHU have licenses for?
Q14. How can researchers call participants and avoid having the participant avoid the call and not pick up? 
Q15. If data are collected via mobile apps or text messaging, how are the records safely downloaded and stored?
Q16. What additional steps can be taken to secure email communication?
Q17. What guidance is available for issuing contactless electronic payment to study participants?

F. QA/QI projects
Q1. Do I have to submit any documentation to the JHM IRB for restart of my QA/QI project if I did not receive an acknowledgment for my QA/QI project from the JHM IRB?
Q2. Do I have to submit any documentation to the JHM IRB if I received an acknowledgment from the JHM IRB to conduct my QA/QI project?
Q3. Do I have to submit any additional documentation to the JHM IRB if I plan to submit a new QA/QI project to the JHM IRB for an acknowledgment and my project involves in person activities?
Q4.  Do I have to submit any additional documentation to the JHM IRB if I plan to submit a new QA/QI project to the JHM IRB for an acknowledgment and my project does not include in person activities?

A. Timeline for Resuming In-person Interaction and New Enrollment

Q1. When will in-person interaction and new enrollment resume for research involving human participants at Johns Hopkins University (JHU)?

On June 12, 2020, the University’s Return to Research Guidance was revised to include a description of a phased approach to the resumption of in-person human subject research activities. At the time of this announcement, the specific date(s) when JHU will initiate and progress through the various phases of the restart are not known.

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Q2. What studies are eligible to restart research?

As of 8/3/20, all research studies are eligible to restart with the following two exceptions:

  1. Studies that include research participant group activities (greater than 1 research participant plus a parent or LAR not sharing the same household seen at one time)
  2. Studies that include high risk aerosolizing procedures (such as sputum induction, pulmonary function tests in nonclinical space, sputum culture, pulmonary exercise test)

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Q3. How many phases are in the University’s plan for research restart?

There are 3-phases to the restart of research with human participants at JHM.

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B. Restart Committee Approval Process

Q1. What approvals are required to resume in-person interactions/new enrollment for my research?

All research must be reviewed and approved by a designated Human Subjects Research Protocol Restart Committee before submitting the request to the IRB. Which Committee you submit to depends on the primary appointment of the PI. At this time, there are four Committees, SOM Research Restart Committee, SKCCC Research Restart Committee, JHM ACH Research Restart Committee and KKI Research Restart Committee.

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Q2. What is the contact information for each Committee?

For the Human Subjects Research Protocol Restart Committee (HSRPRC): please contact Sumati Murli at smurli@jhmi.edu.

For the SKCCC Restart Committee, please contact Mike Carducci at carducci@jhmi.edu.

For the KKI Restart Committee, please contact Molly Timko at Timko@kennedykrieger.org

For the JH-ACH Restart Committee, please contact Neil Goldenberg at neil@jhmi.edu.

For the School of Nursing Restart Committee, please contact Sandra Panchalingam at spancha9@jhu.edu.

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Q3. Is a separate space assessment needed for KKI, SKCC, and JH-ACH studies?

The KKI, SKCCC and JH-ACH Restart committees will incorporate the staff space assessment into the restart process and a separate space assessment is not needed for protocols subject to review by these committees.

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Q4. Who should submit to the KKI Research Restart Committee?

If you are a KKI faculty employee doing research in KKI space/facilities only, then you must submit to the KKI Committee before submitting to the IRB. If you are a Hopkins faculty employee doing research in KKI space/facilities and submit your grants through KKI you must go through the KKI Committee before submitting to the IRB

If you are a KKI or Hopkins faculty employee and using both KKI and Hopkins space/facilities and have questions about the Restart process please contact Molly Timko (Timko@kennedykrieger.org).

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Q5. My study takes place both in Baltimore and St. Petersburg Florida, do I need approval to resume in-person interactions/new enrollment from both sites?

Yes, all studies must be reviewed and approved by a designated Human Subjects Research Protocol Restart Committee before submitting the request to the IRB. Which Committees you submit to depends on the primary appointment of the PI.

At this time, there are four Committees, SOM Research Restart Committee, SKCCC Research Restart Committee, JHM ACH Research Restart Committee and KKI Research Restart Committee.

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Q6. Is there a different process for restart for the protocols conducted through the School of Nursing?

Studies that have a School of Nursing PI will still complete the space plan through the SOM process (apply here) and will submit an application to restart to the Human Subjects Research Protocol Restart Committee (apply here). Applications submitted to the Human Subjects Protocol Restart Committee for SON projects are automatically routed to the SON Restart Committee for review. The application will be reviewed by the SON Research Restart Committee, and a decision on outcome of review will be sent via email to the principal investigator. If approved, this email from the SON Research Restart Committee can be printed as a pdf and uploaded into the JHMIRB application.

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Q7. Will I have to receive approval from the restart committee for a new application?

Yes. If you have a new research study, you will have to receive approval from the appropriate restart committee and include it in your eIRB application.

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Q8. If I rely on an external IRB [non JHM IRB] for my study, do I still have to submit to the restart committees for approval?

Yes. Investigators whose research is under the oversight of an external IRB must still submit a plan for their research space in accordance with the JHM guidelines and must submit a request for their specific protocol to re-open to the appropriate designated research restart committee.  A petition to the JHM IRB is also required before research activities may resume. See question C5 below.

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Q9. If my study was approved as a Tier 1 study but my approval was restricted to specific activities and I wish to expand the in-person research related activities and/or be permitted to allow new enrollment, do I have to submit a petition to restart to the Johns Hopkins IRB?

Yes, if your study was approved as a Tier 1 after 4/3/20 for limited research activities and you wish to expand in-person research related activities and/or be permitted to allow new enrollment  you must submit a restart petition to the IRB. You must receive IRB approval before you can proceed. Please note, you do not need a restart approval letter from the restart committee. 

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Q10. Do compassionate use/expanded access requests for previously approved or new applications need to submit the petition to re-start and get approval from the restart committee?

No. Since compassionate use/expanded access requests are designed to entail only treatment and not considered research, you do not have to submit the petition to initiate in-person activity or new research, or get permission from the restart committee. To avoid confusion we recommend you include the following sentence in Section 1, Item 6 when submitting new single patient/compassionate use requests. “This is a new [single/multiple] patient expanded access treatment request and therefore restart documents have not been submitted.”

Please note that occasionally protocols characterized as compassionate use/expanded access requests may contain separate research questions. In such cases restart petitions and committee approvals would be required. If you have a question about whether such a protocol involves a research question, please consult with a member of the Compliance Team in the OHSR.

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C. Process for Submitting a Petition to Resume In-Person Activities/New Enrollment to the IRB

Q1. Will I have to submit a change in research to the JHM IRB to resume in-person interactions/new enrollment for my previously-approved research?

Yes, before restarting any in-person activities, you must submit a Change in Research (CIR) application and include the CIR restart petition form.

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Q2. If I am submitting a new application, what documents will I need to include to begin in-person interactions/new enrollment?

You will need to submit the approval from the appropriate Restart Committee. This document should be uploaded to section 20 item 2. You should also submit the new application restart petition form. This form should be  uploaded to section 20 item 2 as well.

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Q3. What documents will I need to include in my change in research?

A Change in Research Petition to Resume In-Person Interactions/Begin New Enrollment and the Research Restart Committee approval documentation must be submitted. You should select the checkbox for Petition to Restart Research in-person activities and uploaded these documents to section 1 (General Information) item 1 of the Change in Research.

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Q4. If I rely on an external IRB [non JHM IRB] for my study, do I still have to submit a petition to resume in-person interaction/new enrollment to the JHM IRB for approval?

Yes. Investigators whose research is under the oversight of an external IRB must still submit a petition to the JHM IRB to resume in-person activities/new enrollment. This approval is considered part of JHM’s local context responsibilities and is required even if separate approval by the reviewing IRB is not required. Study teams should confirm with the reviewing IRB which changes, if any must be submitted to the reviewing IRB to enable research activities to resume. Research activities may not resume locally without JHM IRB approval.

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Q5. If my protocol was previously approved by the JHM IRB but not approved to start due to the COVID-19 restrictions, do I have to submit a request to resume my research?  

Yes, you will have to submit the change in research petition to resume your research to the appropriate Research Restart Committee and then submit a CIR to the IRB.

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Q6. If my study’s initial stamped consent form was held and I submit a change in research with a revised consent, will I receive a stamped consent form for the revised consent?

You will not receive stamped consent forms until you are approved to start the study as part of research restart. At that time, you will receive both the initially approved consent form and the revised consent form from the change in research with stamps. This will allow for both consents to be filed in the regulatory binder for the study. However, you should only use the most recent version of the stamped consent form.

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Q7. If my study’s stamped consent forms were held for a new application submission and one or more changes in research, will I receive all stamped versions once the study is approved to start?

Yes, once your study is approved to start, you will receive the stamped consent form for the initial submission and the revised consent forms from any change in research.  You will see all consent forms in the Stamped Documents section of eIRB, with the newest consent form on top. All versions will be available to file in the study’s regulatory binder. You should use the most recently approved stamped consent form to consent participants for your study.

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Q8. Do I need to submit a petition to resume in-person interaction if my research is conducted outside of the US?

Whether or not an international study must submit a petition to re-open a study to in-person activity/new enrollment depends on the role of the Johns Hopkins investigators. Please see the following:

  1. If the Johns Hopkins personnel are physically located in the international setting and are conducting research activities, then a petition to restart is required before any in-person activities/new enrollment may proceed. 
  2. If Johns Hopkins personnel are not conducting any research activities in the international setting but Johns Hopkins has regulatory responsibility for the whole study [e.g. Johns Hopkins is the prime awardee of a federal award and the JHM IRB is responsible for reviewing the study for compliance with the Common Rule], a change in research should be submitted to the JHM IRB with the local international approval to restart uploaded to section 20 item 1. If the local IRB requires any changes those should be embedded in the CIR submission.  
  3. If Johns Hopkins personnel are not conducting research activities in the international setting and have a limited role [e.g. data analysis only] and the JHM IRB is only responsible for the review of the limited role of Johns Hopkins investigators, then no change in research is needed because the Johns Hopkins activities qualify as remote only.

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D. Exemptions from the Restart Process

Q1. Are any studies exempt from the process for resuming research activities?

Studies for which there is no in-person interaction, studies that can be modified by submitting a change in research to the IRB to permanently alter the study so it may proceed without in-person interaction, and COVID-19 related research are exempt from this re-opening process. 

Additionally, studies that received a Tier 1 approval by the IRB after 4/3/2020 are exempt from this re-opening process as the IRB has already assessed the plans to minimize risks to participant safety and has determined the study may open.

Studies that qualify as “exempt” from the re-opening process do not need to submit to either a Protocol Restart Committee or the IRB.

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Q2. If my study is not included in the first phase of re-opening, can I still submit a Tier 1 petition to the JHM IRB to request to continue with enrollment and/or in-person research related activities?

Yes, you can still submit a Tier 1 petition to continue or begin enrollment and in-person activities. However, it is anticipated that most studies that would qualify for a Tier 1 exception would also qualify for re-opening in Phase 1. An exception may be therapeutic/interventional studies with direct benefit that are conducted outside of JHM clinical facilities.

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E. Building in Flexibilities to Enable Research to Resume

Q1. If my study is not included in the first phase of re-opening, can I still revise my study to be conducted fully remotely?

Yes, you can submit a CIR to change your protocol to conduct activities remotely at any time.

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Q2. If my study is not included in the first phase of re-opening may I continue to conduct remote visits instead of in-person visits and report it on the deviation log at continuing review?

Yes, you can continue to conduct activities remotely. Study teams are strongly encouraged to build in flexibilities that will enable study visits to occur remotely via a CIR so they are prepared for re-opening.

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Q3. Do I have to make any changes to the consent process for my studies?

Teleconsent or remote consent can be used as opposed to in person consenting where possible to reduce unnecessary in- person encounters specifically for a consent procedure. If your protocol does not include a teleconsent process and you wish to incorporate teleconsent as part of research restart, you must submit a change in research application to incorporate your teleconsent plan and receive IRB approval prior to implementation

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Q4. How do I conduct the consent process using a teleconsent or remote process?

A copy of the IRB approved Informed Consent document must be provided to the participant prior to the teleconsent meeting either via email, fax or mail or must have been previously provided during an in person visit. If the consent divulges PHI, such as a diagnosis, inform participants that email sent over the Internet is not secure prior to sending the consent form via email and confirm the participant agrees to receive the document via email. Information sent by email may not remain confidential.

The person conducting the consent process may conduct the process via telephone or video. The following is a step-by-step teleconsent / remote consent process:

  • After the consent designee and participant or LAR review the consent form, the participant or LAR is offered the opportunity to ask any questions and have those questions answered.
  • The consent designee must verify the participant or LAR physically signed the consent document either by viewing via video conference, obtaining a photo of the complete signed consent document; or obtaining verbal confirmation from the participant that he/she signed the consent form or agreed to participate electronically. 
  • The participant or LAR will sign and date/time the informed consent document. 
  • The signed document is then mailed, emailed or faxed to the consent designee.
  • If the signed consent is emailed or faxed or returned via photo, the participant or LAR will be asked to return the original signed document on their first in person visit.
  • If the informed consent form is mailed to the consent designee by the participant or LAR, the IRB-approved consent designee will sign the copy which they possess after the participant has acknowledged signature on their copy.  Once the original is received by the consent designee the copies will be attached to make a single document.
  • In all other instances, once received, the IRB-approved consent designee signs, dates/times the informed consent document. 

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Q5. Are there additional steps if the physician/mid-level provider policy is implicated?

 

Yes there are. At the time of the first clinical encounter post-teleconsent, the physician/mid-level provider will:

 

  • Review any additional study participant questions and discuss the risks, benefits and alternatives of the study in full detail, completing the physician/mid-level component of the consent process.
  • The Documentation of Physician Consent Form is then signed, dated/timed and all components of the consent are combined to one document.
  • After the informed consent process is completed, the IRB approved study team member files the consent document in EPIC, including a note confirming the consent process. The entire consent document is also then filed in the research record.

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Q6. Has the IRB approved any standard language to describe the use of a remote consent process?

Yes. The following standard language may be incorporated into section 15 (Written Consent) item 1 for studies that wish to incorporate a remote consent option into their consent process:

Revisions to the informed consent process are being permanently adopted for this research. Teleconsent will be used as opposed to in person consenting where possible to reduce unnecessary in person encounters specifically for a consent procedure. In the event teleconsent is utilized, participants will be provided with a copy of the Informed Consent prior to the teleconsent meeting either via email, fax, mail or previously provided during an in person visit. In events where a Physician/Mid-level provider consent signature is not required, the consent designee may proceed with teleconsent without an expectation for a follow-up in person consenting process.

Participants will be given adequate time to consider the research study and ask questions prior to signing the consent form. The consent designee must verify the participant physically signed the consent document either by viewing via video conference, obtaining a photo of the signed consent document, or obtaining verbal confirmation from the participant that he/she signed the consent form or agreed to participate electronically. The participant or LAR will sign and date/time the informed consent document. The document is then mailed, emailed or faxed to the consent designee. The participant will be asked to return the original signed document on their first in person visit. If the Informed Consent form is mailed to the consent designee by the participant the IRB-approved consent designee will sign the copy, which they possess after the participant has acknowledged signature on their copy. Once the original is received by the consent designee the copies will be attached to make a single document. In all other instances, once received, the IRB-approved consent designee signs, dates/times the informed consent document.

At the time of the first clinical encounter post teleconsent, where physician/mid-level provider consent is required, the physician/mid-level provider will review any additional study participant questions and discuss the risks, benefits and alternatives of the study in full detail, completing the physician/mid-level component of the consent process. If physician/Mid-level provider consent occurs remotely in a separate encounter from the main consent process, the previously stated process must be followed for the entire consent conversation. The Documentation of Physician Consent Form is then signed, dated/timed and all components of the consent are combined to one document. After the Informed Consent process is completed, the IRB approved study team member files the consent document in EPIC, including a note confirming the consent process. The entire consent document is also then filed in the research record.

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Q7. What should I do if I want to revise my protocol to allow for the use of telemedicine in place of in-person visits?

The IRB has developed template language that can be used to incorporate a plan utilize telemedicine in place of in-person visits where appropriate. The language is as follows:

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. Prior to initiating telemedicine for study visits the study team will explain to the participant, what a telemedicine visit entails and confirm that the study participant is in agreement and able to proceed with this method. Telemedicine acknowledgement will be obtained in accordance with the Guidance for Use of Telemedicine in Research. In the event telemedicine is not deemed feasible, the study visit will proceed as an in-person visit. Telemedicine visits will be conducted using HIPAA compliant method approved by the Health System and within licensing restrictions.

You should add the above telemedicine template language to your protocol. In doing so, you must upload a tracked changed copy to section 6 (Protocol Information) item 3 of the eIRB application as well as a clean copy to section 6 item 2.  

As a note, while revising your protocol and the application to account for telemedicine, investigators are encourage to revisit the wording in application documents to replace “in-person” visit with “visit where appropriate”. For additional information on the use of telemedicine, please see the following: Guidance for Incorporation of Telemedicine into Research with Human Participants

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Q8. Are there best practices for using email in research?

Yes. Include the Hopkins standard disclaimer and warning in all emails:

DISCLAIMER: This e-mail is intended only for the individual to whom it is addressed. It may be used only in accordance with applicable laws. If you received this e-mail by mistake, notify the sender and destroy the e-mail.

WARNING: E-mail sent over the Internet is not secure. Information sent by e-mail may not remain confidential.

If the message includes PHI, use secure email or inform participants of the risks associated with using unsecure email before sending electronic communications and confirm participants agree to receive communications by email.

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Q9. Are there best practices for using text messaging in research?

If the message sent is not PHI, it is permissible without any kind of disclaimer or warning.

If the message includes PHI, inform the participants of the risks associated with using unsecure text messaging before sending electronic communications and confirm participants agree to receive communication via text.
 

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Q10.  Are there best practices for sending text messages using autodialer?

 

If messages will be sent out via autodialer, include an opt out mechanism, such as:

Reply “STOP” If you do not wish to receive additional communications via text.


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Q11. What general advice do you have about protecting data collected using remote mechanisms and platforms?

Data collected via remote mechanism, including recorded calls and videos, are personally identifiable and need to be protected. Given the research purpose of remote data collection, it is likely that the content often includes information that is either PII, PHI, privileged, or proprietary.

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Q12. What platforms are approved for use by JHU investigators for e-data collection and storage?

  • SAFE Desktop
  • OneDrive-JHSPH
  • JHU OneDrive
  • JHSPH RedCAP
  • JHSPH HPCC
  • JHSPH Sharepoint
  • JHSPH-Shares

In addition the Data Trust Risk Calculator lists…

  • JH PMAP
  • JP Phoenix
  • MARCC
  • OpenSpecimen
  • Other RedCAP instances
  • JHM Qualtrics (JHSPH also has Qualtrics licenses)

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Q13. What tools are best for video calls? Which ones does JHU have licenses for?

JHU has licenses/agreements with Zoom on a per user enrollment/fee structure. It also has an enterprise agreement with Microsoft for use of Office 365 that includes Skype for Business and Microsoft Teams. Each of these tools (Zoom, Skype, Teams) provide Video Calls.

Guidance on the use of Zoom has been published here.

  • Ensure that the host and all cohosts are using the most updated version of Zoom.
  • Encourage participants to update to the latest version of Zoom prior to joining the meeting.
  • Always use a password for meetings to prevent unwanted participants from entering.
  • Use the Waiting Room to control access to the meeting. This allows the host to vet participants before providing access to the actual meeting.
  • When all participants have joined enable the “Lock Meeting” feature to prevent additional participants from joining.
  • Control the ability for participants to speak by muting them and preventing them from unmuting themselves. Unmute them as necessary to allow participation.  If a participant is disruptive or their content is inappropriate, immediately mute them, eject them from the meeting, or place them back in the “waiting room”.
  • Prevent participants from screen sharing unless doing so is a required component for the type of meeting that is being held.
  • Assign co-hosts to manage Zoom to allow presenter to focus on presentation.
  • Ensure that hosts and co-hosts know how to stop video for any participant should the need arise.
  • Test the scheduling and management of meetings in advance using the locations and hardware that will be used in the real meeting.   

Regarding the “best”… it depends on the use case.

  • For large conference type settings Zoom Conference (different from Zoom meeting) is best. This is what was used for the schoolwide conference with the Dean regarding reopening, for example.
  • Zoom meeting is good for meeting of up to maybe 100 people and can include people from inside and outside your organization. It’s important to attend to the security settings and to let people know if the session will be recorded. 
  • Skype and Teams are good for internal collaboration among smaller groups of people and can be used for groups beyond your organization.

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Q14. How can researchers call participants and avoid having the participant avoid the call and not pick up? 

When first recruited and consented for a study, researchers should ask participants to put the study number in their contacts list at that time.  The number should be one that is owned by JHU and not the personal phone number for a researcher or research team member.

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Q15. If data are collected via mobile apps or text messaging, how are the records safely downloaded and stored?

If these data contain protected information, any collection across the network should be encrypted; encryption in transit is key. Text messages are SMS traffic and are generally not encrypted. the data is being collected via a secure APP it is likely that the data is encrypted in transit. WhatsApp is a mobile App that provides end to end encryption for messages and is widely used throughout the world.  Each App or use case needs independent evaluation.

Another element of protection is the security of the mobile device itself. Research applications that use Mobile Apps must offer guidance to participants about securing their phones and mobile devices. Locking a phone with a password implements full device encryption.  This ensures a low likelihood of data compromise if the device is lost or stolen.

After data is collected on a mobile device it must be transmitted to its eventual storage platform using a secure process that uses end to end encryption. Data transmission to OneDrive, for example, uses encrypted SSL/TLS connections.

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Q16. What additional steps can be taken to secure email communication?

While email is generally not considered a secure method of transmitting information the following procedure will help to secure content that is being sent to external partners…

Type [secure] in the subject of outbound messages causes the email system to encrypt the message, protecting it in transit (note… the brackets are required). 

This feature is for encrypting messages that are going to recipients outside of Hopkins.  Messages within our email system (from one JH person to another) are inherently protected because they do not leave our system

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Q17. What guidance is available for issuing contactless electronic payment to study participants?

Specific guidance was created for the use of VENMO for digital payments.  Other services may be considered and evaluated for use, but the following general guidance derived from the VENMO standard should be followed.

  • Account used for payments should be owned and controlled by JHU or its affiliate/partner rather than by a person who would retain custody if they were to leave the organization.
  • Statements or evidence of transactions should be routinely saved, reviewed and reconciled by a person other than the one performing the transactions.
  • Account should be protected using 2 factor authentication where possible.
  • Guidance provided by the vendor for ensuring security of transactions should be followed.
  • Transactions should be tested to determine what information is visible to others, or through popup notifications. Subsequent transactions should be appropriately protected to ensure that the source or nature of payments to study participants is not inadvertently revealed to 3rd parties.
  • When using VENMO for JHU institutional uses, the use of PCard is required. The same requirement for use of similar apps should be assumed.

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F. QA/QI projects

Q1. Do I have to submit any documentation to the JHM IRB for restart of my QA/QI project if I did not receive an acknowledgment for my QA/QI project from the JHM IRB?

No. Given that your QA/QI project did not receive an acknowledgment from the JHM IRB, and therefore is not under JHM IRB purview, you do not need to submit a petition to restart for your QA/QI project  to the JHM IRB. 

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Q2. Do I have to submit any documentation to the JHM IRB if I received an acknowledgment from the JHM IRB to conduct my QA/QI project?

Yes. If you received an official QA/QI determination from the JHM IRB and your project involves in-person activities, then you must submit a petition to restart to the JHM IRB via a change in research. The petition must be uploaded to section 1 item 1 of the change in research. The petition to restart is located on the following link: Petition to Resume In-Person Human Subjects Research Activities and New Enrollment in a Previously Approved Study:

Please Note: If you received an official QA/QI determination from the JHM IRB and your project does not involve in-person activities, you do not have to submit any documentation to the JHM IRB in order to continue your project.

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Q3. Do I have to submit any additional documentation to the JHM IRB if I plan to submit a new QA/QI project to the JHM IRB for an acknowledgment and my project involves in person activities?

Yes. If you plan to submit a new QA/QI project to the JHM IRB for an acknowledgment, and your project involves in-person activities, you must upload the restart petition at the following link to section 20 item 2: Petition to Begin In-Person Human Subjects Research Activities and New Enrollment in a New Research Study

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Q4.  Do I have to submit any additional documentation to the JHM IRB if I plan to submit a new QA/QI project to the JHM IRB for an acknowledgment and my project does not include in person activities?

No.  If you plan to submit a new QA/QI project to the JHM IRB for an acknowledgment, and your project does not involve in-person activities, you do not need to submit any additional documentation with the application.

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