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Compliance In Focus
Posted by Brandy Chittester on Mon, Jul 1, 2013

Documentation of the Informed Consent Process – What is Required?

We have had this discussion numerous times over the years.  Many believe that the informedinformed consent document consent form is documentation enough.  On the other hand, others would like to see all consent processes documented with a progress note, in addition to the consent document.

What would we base this requirement on? Of course, the regulations: 312.62(b) and 812.140(a)(3)(i). The case history for each individual shall document that informed consent was obtained prior to participation in the study.  It seems that, depending on the circumstances, both methods may meet this requirement.

In seeking further clarification, consider this ruling from the FDA: Protection of Human Subjects; Informed Consent Verification; Final Rule (11/5/1996).  In this ruling summary, the FDA amended the regulations in response to problems they had on verifying that informed consent was obtained prior to participation in a study. It does indeed indicate that separate documentation may be necessary in addition to the informed consent: Rather than requiring the time of day to accomplish the agency’s verification goal, the agency has modified Secs. 312.62(b) and 812.40(a)(3)(i) (noted above) to allow for flexibility in approaches to providing verification.  This case history documentation may be contained in the case report form, in the individual’s medical record, (e.g., in progress notes of the physician, on the individual’s hospital chart, in the nurse’s notes), on the consent form, in a combination of these documents, or elsewhere in the individual’s case history.  The documentation may consist of a chronological record of the sequence of events that establishes that informed consent was obtained prior to a procedure required by the clinical investigation, or the time that consent was obtained and the time of the first study-related procedure performed on the individual.

Additionally, in Good Clinical Practice:  A Question and Answer Reference Guide the authors indicate that source documents are necessary to verify the signed informed consent form.  They note that Industry fulfills this FDA requirement in one of two ways:

  • Documenting consents in source documents
  • Documenting consents on case report forms

They also go on to say that best practices, however, call for a “contextual” statement in a source document regarding exactly how and when the consenting process occurred.  Of note, the introduction to this guide specifically indicates that their thoughts may surpass those mandated or recommended by FDA GCP. 

Would it be easier for all if IRBs required a time on all informed consent documents? From our experience, that may have inherent problems as we find that the subject and or investigator may inadvertently omit the time, or the time of one signature varies from the time of another, casting doubt on the validity.  Also, oftentimes the consent is not signed on the same day as enrollment into the study, or the same day study specific procedures are performed, and therefore mandating a time may indeed be cumbersome.

As monitors, one of the things we encourage the Clinical Investigator to do is dictate any discussion of the study with the potential subject in their progress notes, as he may have had multiple discussions with the subject prior to the actual date the informed consent is signed.  We have also worked on projects where the Sponsor does not allow subjects to be enrolled on the same day the informed consent form is signed, to ensure it is signed prior to any study-procedures.

For studies that enroll subjects the same day of the consent being signed, how does the monitor verify that the subject signed the consent prior to any study procedures being performed? 

Also, what are your thoughts on requiring the informed consent process be documented separately from the informed consent document?

Photo Credit: Mike Paradise

Documentation in Devices




Topics: Informed Consent Process, Documentation, Protection of Human Subjects

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