April 2022

Q1. What is the definition of remote consent, teleconsent, remote consent using a paper consent form, and electronic consent?

Remote consent (sometimes referred to as “teleconsent”) is a method of obtaining informed consent using a paper or electronic consent form where the study team and participant are not in the same physical location during the consent process.

Remote consent using a paper consent form (or remote paper consent) is a specific type of remote consent where a copy of the written informed consent form is provided to the participant via email, fax, mail or during a prior in-person visit. The informed consent process may be conducted over the phone or via video conference (e.g. Zoom). The participant signs and dates a hard copy of the consent form and returns it to the study team via email, fax, mail, or at their first in-person visit.

Electronic consent (e-consent) is a method of obtaining informed consent through the use of an electronic system instead of a paper consent form, e.g. in REDCap or DocuSign. Not all e-consent systems contain the ability to document legally effective signatures.

When an e-consent system is used, the consent process can occur in-person or remotely. An example of an in-person consent process that uses an e-consent system would be giving a potential participant an iPad that displays the consent form in REDCap, discussing the consent form in person, and then the participant agreeing to participate by tapping the appropriate button in REDCap. For a remote e-consent process, the study team may give the potential participant a link to the e-consent system and go over the consent information over the phone or via Zoom. The participant would provide their consent via the electronic platform.

Please note: If you wish to use remote consent and/or e-consent for your study, you must submit the consent plan to the IRB via your eIRB application. IRB approval must be obtained for any consent process or change to the consent process.

Q2. How do I know which e-consent system I can use for my study?

The most commonly used e-consent systems at Johns Hopkins are REDCap and DocuSign. To determine whether you can use a certain e-consent system, you need to consider the nature of your study, and which system can accommodate the consent requirements for your study.  For research that requires documentation of legally effective consent, an e-consent system that is able to document legally effective signatures must be used. Research that qualifies for waiver documentation of consent, such as minimal risk research, may use e-consent systems that do not meet these requirements.

If the research poses more than minimal risk, then documentation of legally effective signatures on the consent form is required. DocuSign may be used to obtain legally effective e-consent. The JHU instance of  REDCap is not automatically set up for documentation of legally effective signatures when using the e-consent framework;  however, the set-up may be customized to accommodate documentation of legally effective signatures. More information is provided in question 5 below: “Can REDCap be used to obtain legally effective consent for greater than minimal risk research where documentation of consent is required?"

If the research is FDA regulated (includes drugs or devices) and does not meet the criteria for a waiver of documentation of consent (i.e., the study poses more than minimal risk to the participants), the FDA requires that the e-consent system be Part 11 compliant (21 CFR Part 11).  DocuSign is the only Part 11 compliant system currently institutionally approved at Hopkins.

The table below summarizes the cases when DocuSign and REDCap may be used for e-consent. Other e-consent systems from another institution or sponsor may be used as well. Outside e-consent systems may or may not be Part 11 compliant. You will need to ensure that the system meets the requirements for e-consent depending on the study type.

 

Q3. What does it mean for consent to be 21 CFR Part 11 compliant?

FDA requirements for electronic records and electronic signatures are set forth in 21 CFR Part 11 of the FDA regulations. When referencing a “Part 11 compliant” electronic consent system, the Office of Human Subjects Research (OHSR) is referring to use of a system that complies with FDA regulatory requirements for electronic records and electronic signatures. Compliance with these regulatory requirements is required for all FDA-regulated research that is greater than minimal risk and minimal risk research where the requirement for documentation of consent has not been waived. Please visit the FDA’s guidance on electronic consent for additional information about the requirements set forth in 21 CFR Part 11 of the FDA regulations. DocuSign is the only Part 11 compliant system currently institutionally approved at Hopkins.

 

Q4. When can REDCap be used for an FDA-regulated study?

For FDA-regulated research that is greater than minimal risk, REDCap may not be used. DocuSign is the only system currently available at Hopkins that is able to document legally effective signatures and is Part 11 compliant (see question 3 above).

For FDA-regulated research, REDCap may be used only if the documentation of consent requirement has been waived. A waiver of documentation of consent may only be granted when the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context.

If documentation of consent is required for an FDA-regulated study, then REDCap may not be used since it is not Part 11 compliant.

Q5. Can REDCap be used to obtain legally effective consent for greater than minimal risk research where documentation of consent is required?

REDCap may be used for greater than minimal risk research that is not FDA-regulated [e.g. research that involves an invasive biopsy] only if certain actions are incorporated into the electronic consent set-up and process to ensure the consent will qualify as legally effective documented consent. The requirements are the same for research conducted in Maryland, DC or Florida.  Each of the following requirements must be addressed:

Authentication:

When using REDCap to document consent for greater than minimal risk research, the research team must incorporate a mechanism to verify that the person signing using the e-consent system is the correct person. One mechanism to do so is to provide a code during the consent conversation directly to the participant. This code must be unique and must be provided directly to the participant. A field to enter the authentication code must be added to REDCap as part of the e-consent build in REDCap for the study.

Documentation of decision to participate:

When using REDCap to document consent for greater than minimal risk research the research team must incorporate a mechanism where the participant can confirm agreement to participate in the study. Options for doing so would include:

• A place where a participant can type in their name to confirm willingness to participate

OR

• An “agree to participate” button or link where the clicking of that button/link can be captured in the REDCap system as evidence that the participant confirmed willingness to take part in the study

Please note that the study team is responsible for modifying REDCap to ensure it contains the required information. The IRB does not create or modify REDCap systems. The standard e-consent framework in REDCap is not automatically equipped with these features so customization is required as part of setting up your REDCap project.

You should indicate in eIRB application 15.1 that these steps have been taken.

Q6. Should I use DocuSign or REDCap?

If your research is FDA regulated (involves drugs or devices) and does not meet the criteria for waiver of documentation of consent, you will need to use DocuSign if you wish to use a JHU-based tool for e-consent.

In terms of revising the eIRB application and maintaining consent documents, DocuSign may be easiest because it only involves adding approved language to eIRB Section 15 and adding spacing around the signature lines of the written consent. You will not need to upload a separate consent form or signature page.

Some users have found the multiple logins for DocuSign cumbersome, so if your research is not required to adhere to FDA Part 11 requirements, you may wish to consider using and adapting REDCap as needed based on the risk level of your research.

Q7. How do I request to use remote consent using a paper consent form?

The following standard language should be incorporated into the eIRB section 15 (Written Consent) item 1 if you wish to incorporate a remote consent option into the consent process for your study.  You will not need to make any changes to your consent document(s). 

NOTE: NO study related procedures may occur until a signed copy of the consent is in the possession of the study team (this can be a faxed, emailed 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.”

Include the following in your eIRB application:

• eIRB Application 14.1: Check “Written Consent”
• eIRB application 15.1: Include required language

Q8. How do I request to use DocuSign?

To request to use DocuSign for your study, you will need to fill out a form to determine if your study is appropriate for DocuSign and email it to the DocuSign team at [email protected]. The instructions are provided at https://ictr.johnshopkins.edu/service/informatics/docusign/

If approved, you will be provided with instructions to include a plan for use of DocuSign in your new application or change in research.

Include the following in your eIRB application:

• eIRB Application 15.1: Include DocuSign language which will be provided by the Hopkins DocuSign team
• eIRB Application 15.3: DocuSign uses the written consent form with extra spaces added to the signature lines.  When requesting to use DocuSign, you should modify your consent form to add 6 12-point font Times New Roman spaces above each signature line. This extra space allows enough space for the DocuSign text overlay above each signature line in the DocuSign system.  If you do not make the required formatting changes, the IRB staff can make the changes for you. 

Q9. How do I request to use an outside company or sponsor’s e-consent system?

Include the following in eIRB:

• eIRB Application 14.1: Indicate whether written consent (required for FDA regulated research where documented consent is required) will be obtained or waiver of documentation of consent is being requested by checking the applicable box.
• eIRB Application 15.1 (for consent with legally effective signatures) or 16.1 (for consent without legally effective signatures): State what e-consent system you will be using
• eIRB Application 20.2:  If you seek to use an external e-consent system for FDA-regulated research that requires documented consent, see question 10 below (What do I need to submit to show the e-consent system I want to use from a sponsor or another institution is Part 11 compliant?) for the verification that needs to be uploaded in eIRB Section 20.2.

Q10. What do I need to submit to show the e-consent system I want to use from a sponsor or another institution is Part 11 compliant?

If you seek to use an external e-consent system for FDA-regulated research, the IRB requires verification that the system is Part 11 compliant to ensure the conduct of research at our site complies with FDA requirements for electronic records and electronic signatures. The following will be accepted as verification of Part 11 compliance:

1. A letter/email from the system “owner” verifying that the system is Part 11 compliant
2. An official product descriptor of the e-consent system (i.e. from the e-consent system’s official website) verifying it is Part 11 compliant
3. An email from an IT professional at the host institution verifying the system is Part 11 compliant
4. Documentation from the sponsor that the system is Part 11 compliant.

Please upload this documentation in eIRB Section 20.2.

Q11. What consent documents do I need to submit to the IRB if I want to use paper written consent/oral consent and e-consent?

If you want to have the option to obtain either paper written consent/oral consent OR e-consent, you should only upload the paper written consent/oral consent document and not a separate copy of the consent as it appears in the e-consent system into eIRB. This will reduce confusion from having 2 versions of the same consent document that would have to both be updated each time the consent is revised.  When you incorporate your consent document into the e-consent system, the format and content of the consent in the e-consent system should be as similar as possible to the paper consent form or oral consent script.

Although you will not upload the electronic copy of the consent document, you will have to include information about it in the eIRB application.  In eIRB application 15.1 or 16.1, you will need to confirm that the electronic version includes all of the same information as the paper consent form/oral consent script or explain how the electronic version differs from the paper consent form/oral consent.

You should upload the e-consent ‘agree to participate’/signature page in the consent section of eIRB if the signatures will be considered legally effective or if they differ from the paper consent/oral consent (e.g. if you will be collecting DOB or phone number in the e-consent system). We recommend you only include the ‘agree to participate’/signature page instead of the entire electronic consent because if the entire e-consent is uploaded in eIRB, it will need to be updated each time you revise the consent form. An exception to this would be a case where the presentation of information in the electronic tool would be substantively different than the paper version (e.g. include different graphics or imagery or present information in a different order). In these cases the entire e-consent showing the visual differences should be uploaded in eIRB.

Please note: For DocuSign, the currently approved written consent form is used, so no separate electronic version should be uploaded. You will need to ensure any future iterations of the approved consent are uploaded to the DocuSign system in order be using the current approved version.

Q12. What consent documents do I need to submit to the IRB if I only want to use e-consent?

If you only want to use e-consent (instead of both in-person consent or oral consent and e-consent), the e-consent form will need to be uploaded in eIRB. The e-consent should be in a Word document so the IRB can revise it if needed. Include the signature/‘agree to participate’ page from the e-consent system for the IRB to review. 

If the e-consent will obtain legally effective signatures:

Upload the e-consent form in eIRB application 15.3. The e-consent can be on the Hopkins written consent template or your own template, as long as all required consent elements are included. You may review the required consent elements here: https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/informed_consent_i.html#III

If the e-consent will not obtain legally effective signatures:

Upload the e-consent form in eIRB application 16.2. The e-consent can be on the Hopkins oral consent template, the written consent template without the signature lines, or your own template, as long as all required consent elements are included. You may review the required consent elements here: https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/informed_consent_i.html#III

Q13. How do I request to use REDCap to obtain consent with legally effective signatures?

Include the following in your eIRB application:

• eIRB Application 14.1: Check “Written Consent”
• eIRB Application 15.1: Include explanation of e-consent process and state that the REDCap system has been modified to document legally effective consent. [For instructions, see question 5 “Can REDCap be used to obtain legally effective consent for greater than minimal risk research where documentation of consent is required?”]
• eIRB Application 15.3: Are you also obtaining in-person consent with a paper consent form?
  • YES
    • You should not upload a separate copy of the consent as it will appear in the e-consent system unless the information will be significantly different than in the paper consent form. (This is not recommended since the electronic version should match the paper version as much as possible).
    • Upload the e-consent signature/agree to participate page in a Word document in 15.3 for IRB review.
  • NO 
    • Upload e-consent form including the signature/’agree to participate’ page in Word format
    • The consent can be on the oral consent template, the written consent template without signature lines, or your own template as long as all required consent elements are included.
    • The consent should be a Word document so the IRB can make revisions if needed

Q14. How do I request to use e-consent when legally effective signatures are not required? (e.g. using REDCap for minimal risk research)

• eIRB Application 14.1: Check “Waiver of documentation of consent”
• eIRB Application 16.1: Describe your plan for obtaining e-consent. If you want to use paper written consent/oral consent and e-consent, you should confirm that the e-consent includes all of the same information as is present in the paper written consent/oral consent. If there will be differences in the e-consent, please explain them here.
• Are you also obtaining consent in-person with a paper consent form or using an oral consent script?
  • YES
    • Application 16.2: You should not upload a separate copy of the consent as it appears in the e-consent system, since we only want one (1) copy of the consent form.
    • If the ‘agree to participate’/signature page in the e-consent system will be significantly different from the paper written consent or oral consent script, you should upload the ‘agree to participate’/signature page in a Word document in 16.2 for IRB review. Example: if you are collecting DOB or phone number in the consent page please upload a copy of the e-consent ‘agree to participate’ or signature page
  • NO
    • Application 16.2: Upload e-consent
    • The consent can be on the oral consent template, the written consent template without signature lines, or your own template as long as all required consent elements are included. The consent should include the ‘agree to participate’ or signature page from the e-consent system
    • The consent should be a Word document so the IRB can make revisions if needed

Q15. What will I receive from the IRB if I am approved to use e-consent?

The approval letter for your study will state that the study is approved to use e-consent.  If you are using a paper written consent or oral consent and e-consent, you will only receive a stamped version of the paper consent form or oral consent. If you are only using e-consent, then the Word version of the e-consent will be stamped.