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The informed consent process

Monday, December 21, 2015

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

To provide an informed consent process that’s transparent and equitable is the most sacrosanct assurance of safety we can provide research patients.

When creating the consent, the methodology is rooted in science, but content is structured to inform the layman. We reference regulations so that consent elements are representative of truth. Our institutional review boards (IRBs) convene to review the consent, to approve what best serves the population, to change or omit what does not protect. We entrust this responsibility to our scientists, scholars, nurses and educators.

Most investigative sites I’ve audited have compliant informed consent processes that assure preservation of a patient’s safety and promotion of a patient’s understanding. Most have a consent SOP that dictates a standardized informed consent explanation, provision, signature and documentation process by staff. Patient protections include investigator/staff explanation of the consent, allowances for the patient’s uninterrupted review of the consent, the opportunity for a patient to take the consent home to discuss with family and physicians, to ensure they are educated in study participation and what that entails. The investigator is involved in the consent process, and a real-time quality check of the consent is completed to ensure all parties signed and dated correctly. Sites are rigorous about documenting the informed consent process, including any reconsenting; this is critical to demonstrate a safe, compliant consenting environment for patients.

One of the most important source documents we review as researchers is the informed consent document. I was taught to review this document before all others (while on site), with painstaking attention to ensure essential elements and safety information were present, to ensure attributable, contemporaneous, authentic signatures on behalf of researchers and patients.

Two specific monitoring visits stand out in memory to me, opposing yet impactful informed consent scenarios at two different investigational sites. I benefited from both immeasurably.

In the first situation, the investigator was conducting a skin infection study; he had enrolled 15 patients, a large number, up until that point. He used a central IRB that had specific consent signature requirements; not only did the “individual obtaining consent” need to sign and date, but the investigator also needed to sign and date the consent form. The study coordinator (SC) was not particularly focused during the monitoring visit, nor was she experienced. This did not lend assurance considering the large amount of patients she had consented (her proud declaration).

In review of the consent documents, I noted that the signature space for the investigator was located on the back of each consent form, but the investigator’s signature was conspicuously absent from the signature page; he had not signed any of the forms. The investigator had entrusted this important responsibility to someone lacking appropriate knowledge of the process, risking potential negative impact if completed incorrectly. The study was thankfully simple, the product a topical agent for a superficial infection, so if the consent process had been less thorough than necessary, the potential negative impact would be far less severe due to the nature of the indication and study treatment.

To create a positive outcome from this unfortunate circumstance, I presented the corrective action plan to the investigator as an educational opportunity for his SC, without downplaying the significance of the deviation, or undermining investigator performance. I advised the investigator to have the SC observe him consent patients, for training purposes, and document the retraining for due diligence in corrective action. I offered to help the SC craft confirmatory documentation for the regulatory binder and IRB notification regarding the discrepancy. The investigator acknowledged his error and was most receptive to my suggestions. It was additional assurance that the SC would not repeat the mistake.

The other situation involved a dedicated research site responding to sponsor audit findings from a pivotal, well-conducted, well-enrolled trial. I admired their organizational procedures, for although their research infrastructure was well-established, they were always looking to improve standards of conduct.

They had a methodical process for obtaining/documenting consent. But in response to an audit finding, they had created additional measures to preserve the welfare of newly consented study patients. They had designated a senior SC to serve in the capacity of quality assurance, completing real-time review of study consent forms and screening source documents. This two-tiered process ensured that both consent and screening procedure errors were instantaneously corrected before the patient left the site. The process educated staff on best source document and ALCOA (attributable, legible, contemporaneous, original and accurate) practices, as well as the importance of preventative attention to mitigate the need for corrective action. I was very impressed.

Each scenario served an informational purpose; we teach as we learn, we learn as we teach. Whether a site is vigilant with best safety practices, or requires additional measures to ensure patients are fully informed and understand, it all comes back to the action of consent, how it is completed will influence patient health and study compliance. 


Elizabeth Blair Weeks-Rowe, LVN, CCRA, works in relationship development/study startup in the CRO industry. Email ebwcra@yahoo.com.

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