Final FDA Electronic Informed Consent Guidance: What Has Changed?

Posted by Jamie Colgin on Dec 20, 2016 5:35:35 PM

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The FDA recently issued the final guidance on the 'Use of Electronic Informed Consent Questions and Answers'. Here is your guide to eight important changes from the draft version. 


1. Increased Scope

The guidance scope grew to include research covered by the U.S. Health and Human Services’ Office for Human Research Protections under 45 CFR Part 46. Several of the Q&A have been appropriately amended.

guidebook.png2. Paper or Electronic?

Question 1 asks, “How should information in the Electronic Informed Consent Form (EIC or e Consent form) be presented to the subject?” The answer has been changed to further protect subjects: “Therefore, subjects should have the option to use paper-based or electronic informed consent methods completely or partially throughout the informed consent process.” This may make your life as sponsor, CRO, site staff, or IRB member more complicated.

3. Delegation of Authority

In Question 2, the FDA explicitly reiterates the investigator’s responsibility in the informed consent process: “The investigator cannot delegate authority to obtain informed consent to the electronic system.”

4. Electronic Signaturesesignature.png

Question 6 asks how electronic signatures can be used. In a surprising statement, the final guidance says, “IRBs, investigators, and sponsors may rely on a statement from the vendor of the electronic system used for obtaining the electronic signature that describes how the signature is created and that the system meets the relevant requirements contained in 21 CFR Part 11.” The implications of this statement on audits and inspections are still unclear.

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5. Verifying Identities

Question 7 is the first of two brand new additions to the guidance. The   FDA reminds us that complying with Part 11 helps prevent fraudulent use. In Question 7, the final guidance makes it clear the organization using electronic signatures must verify the signer’s identity. Question 8 adds language about doing this in paediatric studies.

6. Subjects’ Copies of the Electronic Informed Consent

Subjects are entitled to know what they’ve agreed to and must nearly always be given a copy of the informed consent document. Question 9 states if that copy (paper or electronic) contains any hyperlinks to the internet, “the hyperlinks should be maintained and information should be accessible until study completion.”

7. IRBs

Question 12 is the second of the two new additions to the guidance. It clarifies what materials the investigator should provide the IRB for their review, including anything “the subject will receive and view during the Electronic Informed Consent process.” Question 13 requires the IRB to “maintain and retain copies of materials that have been reviewed.”

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The draft guidance rambled on the original question about archiving. Question 15 in the final guidance is short and sweet, citing Part 11 and requiring appropriate archiving and easy retrievability of “all versions of the IRB-approved eIC.” Finally, if you were hoping Part 11 was going away, the numerous direct references to Part 11 requirements in the final guidance make it clear that won’t be happening any time soon!


About Jamie Colgin

As President of Colgin Consulting, Inc. and a member of our Longboat Advisory Board, Jamie Colgin helps pharmaceutical, biopharmaceutical, and contract research organizations assure the integrity of their preclinical and clinical data through risk assessments, integrated computer system compliance audits, mock inspections, remediation assistance, and training.

With over 20 years of hands-on experience in statistics, computer system validation, audits, and monitoring, Jamie has developed validated SAS programs to support GLP studies, managed the retrospective evaluation of hundreds of GLP and GCP systems, written policies and procedures, and set new standards for communicating audit findings by using process flow diagrams.

Recipient of the prestigious Charles H. Butler Excellence in Teaching Award, Jamie can provide training for your audit staff focused on updating skill sets and understanding regulatory trends relative to data integrity.

Prior to working in the pharmaceutical industry, Jamie proudly served with the US Peace Corps in the Philippines. She credits this experience for her resourceful nature.

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