26 - Beyond Spellcheck: Creation of an Editorial Team for the Development of Understandable and Accurate Informed Consent Forms

Background: Historically, clinical research professionals have discussed the need for informed consent forms (ICFs) to be at a readability level that is appropriate for all participants. Many ICFs contain text that is overly scientific or legalese. To ensure regulatory compliance and participant protection, institutions must develop understandable and accurate ICFs.

Program

Description: The Protocol Activation and Review and Human Research Protection Program (HRPP) at Memorial Sloan Kettering Cancer Center (MSK) is a centralized unit focused on activation and the rights and welfare of participants. The unit’s Editorial team specializes in developing understandable and accurate ICFs that meet institutional standards for the protection of participants. Editors have familiarity with clinical research and experience in editing materials for a lay audience.

Editorial’s responsibilities:
o Reviewing ICFs drafted by the unit’s Study Start-up Managers, who collaborate with investigators and sponsors to guide study documents through review and activation processes. Editorial reviews all ICF revisions (investigator, sponsor, and IRB revisions).
o Developing resource documents for those drafting consent language. Editorial works with the unit’s HRPP Office to shape ICF templates and an ICF instructions document (which includes standardized language for ICF sections).
o Developing sponsor-specific ICF templates that help minimize ICF negotiations and expedite ICF approval

Program

Assessment: Members of the unit analyzed a sample of 40 MSK IRB/Privacy Board (PB) initial review determination letters to evaluate ICF-related comments. Twenty letters were from a period before Editorial was established (2016-2017), and 20 were from a period when Editorial was reviewing ICFs (2021-2022). The ICFs were all associated with Phase I industry-sponsored studies for which MSK was the IRB of Record.

We focused on IRB/PB comments related to:

o Accuracy, such as discrepancies between the protocol and ICF and factual errors that don’t necessarily interfere with participant comprehension

o Participant understanding, such as problems with readability level, unclear language, or an incomplete explanation of terminology

We found a significant reduction in comments in the period when Editorial was reviewing ICFs. Our analysis showed a 4.3-fold decrease in comments related to understandability and a 2.3-fold decrease in comments related to accuracy.

TABLE 1: COMMENTS RELATED TO ACCURACY
Time Period * Total # IRB/PB comments
Pre-Editorial (2016-2017) * 61
Editorial (2021-2022) * 27

TABLE 2: COMMENTS RELATED TO PARTICIPANT UNDERSTANDING
Time Period * Total # IRB/PB comments
Pre-Editorial (2016-2017) * 210
Editorial (2021-2022) * 49



Since the creation of Editorial, IRB/PB and research teams have commented on the improved quality of MSK’s ICFs and the benefits of a team that tailors ICFs to aid in participant comprehension.

Limitations:
o Editorial does not review ICFs after studies are open to enrollment. Investigators and their research teams are responsible for leveraging MSK templates/resources for amendment-related revisions (modifications to approved research). However, if the IRB has concerns about readability, style, etc., the IRB can require the routing of the ICF to Editorial for review and improvement.
o Editorial does not complete a comprehensive review of ICFs that are sent to an external IRB.

Discussion:
Fully informed participants are vital for successful research studies that advance science. An understandable and accurate ICF enhances the informed consent process and aids in participant retention.

MSK will continue to rely on Editorial for ICF development. MSK may eventually expand the scope of the team.

The FDA has announced harmonization of its human subject protection regulations with the Common Rule, and this harmonization will include new elements of informed consent that emphasize participant understanding. By employing editors who specialize in developing readable and accurate ICFs, institutions can ensure compliance with regulations and demonstrate respect for the participant.