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FAQs related to Resuming Research with Human Participants

June 2021

A. General Information about Research Restart

Q1. What studies are eligible to restart research?
Q2. What is required to resume in-person interactions/new enrollment for my research?
Q3.What are the requirements for restarting previously approved research that was paused due to COVID-19 ?
Q4. 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?
Q5. Do compassionate use/expanded access requests for previously approved or new applications need to submit the request to resume in-person activities/new enrollment?
Q6. Is approval by a research restart committee required prior to IRB approval?
Q7. 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?
Q8. 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?
Q9. 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?
Q10. 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?
Q11. Do I need to submit a petition to resume in-person interaction if my research is conducted outside of the US?

B. Building in Flexibilities to Enable Research to Resume

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

C. 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?

A. General Information about Research Restart

Q1. What studies are eligible to restart research?

All research studies are eligible to restart except 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)

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Q2. What is required to resume in-person interactions/new enrollment for my research?

All requests to resume in-person interactions/new enrollment must be reviewed and approved by the JHM IRB. When you submit your new application to the JHM IRB, please consider the COVID measures that will need to be implemented depending upon where your study will take place as well as any other Hopkins policies.

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Q3 What are the requirements for restarting previously approved research that was paused due to COVID-19?

Previously approved research involving in-person interaction that was paused during the pandemic must be approved to restart by the JHM IRB. To secure this approval follow these steps:

  1. Submit a change in research application (CIR) with a request to restart.
  2. In Section 1 (General Information), Item 1 of the CIR, select “Petition to Restart”. You do not need to upload any forms.
  3. In Section 1 (General Information), Item 3 describe any measures you have put in place to modify your study to align with COVID restrictions in the locations where your research will occur and any other Hopkins guidelines regarding safe conduct of research during the pandemic.
  4. Please be sure to consider how to build flexibilities into your study to account for changing circumstances related to the pandemic. Additional information about these flexibilities can be found in our FAQs.
  5. Modify your study documents to incorporate any of the changes described and upload tracked and clean versions of your modified documents.

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Q4. 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?

No. However investigators should consider the safety precautions and any modifications required for each location.

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Q5. Do compassionate use/expanded access requests for previously approved or new applications need to submit the petition to resume in-person interactions/new enrollment?

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. To avoid confusion we recommend you include the following sentence in Section 1 (General Information), Item 6 when submitting new single patient/compassionate use requests. “This is a new [single/multiple] patient expanded access treatment request.”

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Q6. Is approval by a research restart committee required prior to IRB approval?

No. As of June 4, 2021 you do not need a research restart committee approval prior to IRB approval. All in-person research activity must be reviewed and approved by the JHM IRB before commencing. When you submit your application to the JHM IRB, please consider the COVID measures that will need to be implemented depending upon where your study will take place as well as any other Hopkins policies regarding safe conduct of research during the pandemic.

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Q7. 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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Q8. 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 a change in research (CIR) application with a request to resume your research to the IRB.

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Q9. 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?

Yes. If you submit a CIR requesting to resume in-person activities/new enrollment, and a revised consent form, you will receive both the initially approved consent form and the revised consent form from the CIR 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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Q10. 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. When 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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Q11. Do I need to submit a request to resume in-person interaction if my research is conducted outside of the US?

Whether or not an international study must submit a request to resume 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 you must revise your protocol to account for the locally required COVID measures.
  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 included 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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B. Building in Flexibilities to Enable Research to Resume

Q1. 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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Q2. How do I conduct the consent process using a teleconsent or remote process?

The teleconsent process described here is for NON- COVID related studies. For COVID related research, refer to this guidance at: https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information/Informed_Consent_for_COVID19_studies.docx

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 participant (or LAR) will sign and date/time the paper copy of the informed consent document.
  • 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 signed document is then mailed, emailed, photo/scanned to text or faxed to the consent designee.
  • If the signed consent is provided as an electronic copy (emailed ,photo/scanned to text, or faxed), the participant or LAR must return the original signed document on their first in person visit or by mail if there is no in person visit.
  • If the signed consent form is mailed to the consent designee by the participant or LAR, The IRB-approved consent designee will sign their copy which they possess after the participant has acknowledged signature on their copy. Once the participants original copy is received the consent designee copies will be attached to make a single document.
  • If the participant signed consent form is provided immediately by electronic format (emailed, faxed or photo/scanned to text, once received, the IRB-approved consent designee signs, dates/times this informed consent document.

NOTE: NO study related procedures can occur until a signed copy of the consent is in the possession of the study team. (This can be fax, email or mailed copy) unless the IRB has approved a waiver of documentation of consent to allow select activities to occur before written consent is finalized.

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Q3. 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.
  • If there will not be an in-person encounter, the physician/midlevel provider consent will be conducted as above in Q2.

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Q4. 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:

NOTE: NO study related procedures will occur until a signed copy of the consent is in the possession of the study team. (This can be fax, email or mailed copy) unless the IRB has approved a waiver of documentation of consent to allow select activities to occur before written consent is finalized.

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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Q5. 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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Q6. 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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Q7. Are there best practices for using text messaging in research?

Yes. 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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Q8. Are there best practices for sending text messages using autodialer?

Yes. 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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Q9. 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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Q10. 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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Q11. 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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Q12. 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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Q13. 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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Q14. 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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Q15. 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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Q16. What if my study does not need to incorporate any changes to safely restart?

If your study does not require any changes, then include in your summary of changes that no changes are needed to safely restart your research.

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C. 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.

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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 change in research (CIR) to the JHM IRB to resume in-person activities.

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 change in research to the JHM IRB.

Previously approved QA/QI projects involving in-person interaction that was paused during the pandemic must be approved to restart by the JHM IRB. To secure this approval follow these steps:

  1. Submit a CIR with a request to restart.
  2. In Section 1 (General information), Item 1 of the CIR, select “Petition to Restart”. You do not need to upload any forms.
  3. In Section 1 (General Information), Item 3 of the CIR describe any measures you have put in place to modify your study to align with COVID restrictions in the locations where your project will occur and any other Hopkins guidelines regarding safe conduct of research during the pandemic.
  4. Please be sure to consider how to build flexibilities into your study to account for changing circumstances related to the pandemic. Additional information about these flexibilities can be found in our FAQs.
  5. Modify your study documents to incorporate any of the changes described and upload tracked and clean versions of your modified documents.

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