Composition of lay summary for IACUC protocols: A challenging task

by Farah Moulvi, PRIM&R Blog Squad Member

PRIM&R is pleased to bring you the first live posts from the 2011 IACUC Conference and the PRIM&R Blog Squad. The Blog Squad is composed of members who are devoted to blogging prior to, live from and after the PRIM&R’s conferences. Read on to find out what’s happening on the ground in Chicago, IL.

Hello from Chicago! I hope you are as excited to be a part of the 2011 IACUC Conference as I am. The week started with a dynamic, engaging, one-and-a-half-day pre-conference course for IACUC administrators and compliance staff members titled Essentials of IACUC Administration. The course provided an overview of how to effectively manage an animal care and use program. One topic of conversation during the course that resonated with me was the use of lay language in IACUC protocols.

Investigators are commonly unaware why certain portions IACUC protocols must be written in terms a layperson can understand. The lay description sections in IACUC protocols originate from the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training -US government principle II , which states that “procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.”

Using animals in research and teaching is a privilege given to the scientific community by the general public on the basis that researchers meet the highest ethical and regulatory standards; consequently, the burden rests on the scientific community to justify and assure the public that the use of animals, per the federal guidelines, has scientific benefit “to human or animal health, the advancement of knowledge, or the good of society.”

Most IACUC applications require that summarized research objectives are written in lay language understandable to members of the general public. This is reinforced in the 2011 edition of the Institute for Laboratory Animal Research (ILAR) Guide for the Care and Use of Laboratory Animals (Guide) that specifies protocols include “clear and concise descriptions” that non-scientists and unaffiliated members of the IACUC understand.

These people represent the interest of the general public and, as laypeople, serve as a litmus test for the clarity and conciseness of a protocol’s language. That is to say, the federal law mandating clear and concise writing allows the IACUC members to understand the study and make informed decisions.

As IACUC members often possess diverse backgrounds, the inclusion of lay language also assists non-scientist and scientific members understand material that may not lie within their realm of knowledge.

Providing an adequate lay summary can be a challenging task for research investigators. It is common that the lay summaries provided for IACUC review are neither brief nor in lay terminology. When writing an application for vertebrate animal use, investigators should compose the lay summaries as if explaining the concepts to an audience of high school students with non-scientific backgrounds. Some institutions define the lay language as a ninth-grade level, while others use approaches such as, “imagine explaining it to your elderly neighbor, or your kid, or writing it for a newspaper.” As an investigator, you should try to convey how you’re trying to explore new treatments that benefit society, resolve a scientific dilemma, or advance the understanding of an area of science.

Frequently, investigators use abstracts directly from their grant proposals and overlook the fact that the purpose and relevance of the study should be in lay language. Researchers should be cognizant of the fact that some institutions may use the lay summary section of the IACUC protocol for press releases and public relations announcements. Therefore, the procedure descriptions should be simple, brief, and general. This section should be limited to what you intend to do and why it is important, rather than the specific details of the “how.”

There are several resources available for investigators, such as a glossary of non-scientific terminology provided by various institutions, and examples of well written lay summaries from IACUC applications. Investigators can also use high school educators’ tools for determining readability levels (e.g. Flesch Reading Ease and the Flesch-Kincaid Grade Level), which are commonly built into the newest versions of word processing software. It is important that investigators pay special attention to this requirement as protocols not written in lay language may be returned to the investigator for revisions. This can be both time consuming and frustrating for the investigator, especially those who are inexperienced in addressing a non-scientific public. What approaches do you use at your institutions use to inform, instruct, guide, and educate investigators? What grade level is reasonable to be defined as lay language?

In the interest of full disclosure, this blog has a Flesch Reading Ease of 40.7 (numbers 30 and below are more difficult to read) and a Flesch-Kincaid Grade Level of 13.4. The score correlates to the number of years of education generally required to understand this text

Happy Flesching!