GCP Training on Informed Consent: The Basics for Compliance


GCP Informed Consent Training

Informed Consent: Protecting Participants in Clinical Trials


The most serious GCP compliance concerns in a clinical trial are frequently regarding informed consent. FDA recently issued several Warning Letters about clinical sites failing to appropriately consent a clinical trial participant. Training that informed consent is a Process and not just a form to fill out is essential to a quality clinical trial. FDA looks closely at the Qualifications of research staff obtaining informed consent. In this guest commentary Mikki O’Neal discusses the importance of informed consent training from the perspective of a clinical site.

Guest Commentary:

By Mikki O’Neal, CCRP, CCRC
Regulatory Compliance Manager
Houston, Texas

Informed Consent Training: A Site Perspective

Lack of {adequate} training frequently seems to be a standard hot topic in research circles. What constitutes solid training? By what measures should a researcher be deemed qualified to obtain informed consent? While I feel that online training modules provide a good basic foundation, institutions are often relying on them as the sole requirement to satisfy the training process of a researcher. I like to refer to this as theory-based training. While online modules and classroom training do give a researcher a good grasp of how research evolved into what it is today, what is often missing from these training methods is application training. How do you take what you have learned in a module and apply it to every day research activity? Informed consent training is a perfect example. You can speak about informed consent theory until you are blue in the face, but until a researcher is able to see an actual consent process applied, how can they truly grasp the relevance of “it’s all in the details”? This is one of the first steps that foster the communication gap between a poor consenter and a well informed research subject.

More and more you see non-research clinical staff being burdened with the additional responsibility of consenting a subject for a trial while they are performing their basic job functions. Not only does it add extra responsibility to their plate, but obtaining proper research informed consent is typically not even a topic that gets entertained because they don’t understand the reasons, importance, or implications.

GCP Training

GCP Training for Informed Consent Compliance

What is more surprising is that very often these observations occur with “experienced” research personnel, which begs to question the methods in which they were trained. One of the largest mistakes that I think a site manager can make is to hire a researcher based on experience listed on paper and then assume that because of said experience, training will not have to occur (or that very minimal training will suffice). Taking it “back to the basics”, in my opinion, is a critical factor with this topic. It is very easy to start cutting corners and minimizing the importance of a true informed consent process when a study seems simple or the researcher is rushed.

Food for thought: Should researchers be required to demonstrate informed consent ability with an annual practical assessment? Would it be beneficial for sites to implement random “audit” shadowing of researchers during an informed consent process? Is there a “one size fits all” solution to solving informed consent issues? A vital piece of the puzzle is oversight. Know what is going on at your site. Assess the capability of your research personnel. Standardize your training so that all personnel are trained in the same manner regardless of experience. Require continued education. And most of all, never assume that someone is adequately trained just because they have worked in the field of research for an extended amount of time.

Please read other Guest Commentary on the page at the top of the Blog.

UPDATE 6 January 2011: Two Important New GCP Documents:

There is a Draft Guidance on Electronic Source Documentation in Clinical Investigations. The comment period is for 90 day (April 4, 2011 ?)

There is a new Final Rule on required elements of Informed Consent. You can read the Federal Register Announcement here that includes FDA comments in the preamble. The exact change in 21 CFR Part 50 is:

“Sec. 50.25 Elements of informed consent.

* * * * *
(c) When seeking informed consent for applicable clinical trials,
as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be
provided to each clinical trial subject in informed consent documents
and processes. This will notify the clinical trial subject that
clinical trial information has been or will be submitted for inclusion
in the clinical trial registry databank under paragraph (j) of section
402 of the Public Health Service Act. The statement is: “A description
of this clinical trial will be available on
http:[sol][sol]www.ClinicalTrials.gov, as required by U.S. Law. This
Web site will not include information that can identify you. At most,
the Web site will include a summary of the results. You can search this
Web site at any time.”

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2 Responses to GCP Training on Informed Consent: The Basics for Compliance

  1. Very interesting and informative blog, we linked to you through our chapter newsletter. Thank you, Lyn.

    • Carl's Blog on FDA Stuff says:

      Thank you. This comment is from the New York Metro chapter of ACRP which has an interesting website for those in the NYC area. It is on the Blogroll under NYC ACRP, check it out.

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