INFO: Adobe Electronic Signatures (eSign or eSignature)

Adobe Sign  

Adobe Sign enables MGB researchers to collect Part 11 Compliant eSignatures.

Use this form to request Adobe Sign access for yourself or your team. Be sure to answer "Yes" for "Are you part of the MGB Research Community?" This is important to ensure Part 11 Compliance settings are applied to your account.

NOTE: To ensure your accounts are setup correctly, include the proper full name and email address for each person for whom an account is requested.

The specified email address will become the user's Adobe ID.

How are eSigs implemented?

Adobe has many ways to distribute forms to sign.  In general, the process involves:

1. You send / post the document to a website

• If emailed, the recipient gets an email with a link to your document
• If posted to website (Widget), documents can be access with a URL
• In both cases, the document is loaded in a web browser; NO downloads, installations or accounts needed by the recipient

2.  Recipient signs the document

3.  Document is filed automatically

• All parties can automatically receive a PDF copy of the signed document
• All documents are stored in your account for future access

Who can use eSigs?

Anyone at Mass General Brigham can use Adobe Sign.

Researchers interested in using Adobe Sign to electronically consent participants must receive IRB approval to use the technology.  Research protocols, new and ongoing (via amendment submission), will need to outline the use of Adobe Sign and the consent process.

Replacing the paper version with the eSig version and continuing in-person consent process or the protocol’s established consent process, is a good use case for eSignatures.  There may be certain use cases that the IRB does not approve – for example, consenting someone by emailing consent forms instead of engaging the participant in person.  Once the application is actively in use at Mass General Brigham, we will provide additional use cases.

Examples of the different signature types are are available on Adobe's site.

There is a lot of flexibility within Adobe Sign.  Each project group can create workflows for their different needs and processes.  For example, you can "share" signature authority in a group; so you can have multiple PIs / researchers review and sign consents.  You can have multiple people sign the document (parents, guardians).  You can designate the order each user signs a document.

If participants do not have an email address, you can use the Adobe Sign on a mobile device (iPad, tablet). Have the participant sign in-person, then an authorized study team member can then sign the consent document.  Documents can be printed for the participant if needed.

What compliance and security certifications has Adobe attained?

Adobe meets a number of strict industry and regulatory standards, including HIPAA Compliance. For a complete list, refer to the following pages: 

https://www.adobe.com/trust/compliance/compliance-list.html

https://www.adobe.com/trust/compliance/cloud-signatures-legality.html

Training

Training is self-service, and your research team is responsible for training the team's researchers on how to appropriately use Adobe Sign for your study or studies. 

For More FAQs about Adobe eSign Legality, Auditability and General use questions,
Refer to Adobe's website.

For More Information about Adobe Sign at Mass General Brigham
Refer to the Adobe Sign Hub

Can I use another eSignature technology?

MGB has standardized on using Adobe Sign. Exceptions are strongly discouraged. You will need to go through the same approval process as AdobeSign: VISP, BAA, OGC, Digital Research Operations, and ISPO approval.  This may take several months, and may not be approved.