Providing Informed Consent Information in Eliciting Truly Informed Consent

IRB Eliciting Truly Informed Consent

Providing Informed Consent Information

Objectives:

This module offers information for the Principal Investigator and the Research Staff to examine the importance of Communication Skills in the areas of:

Presenting the Informed Consent Information
Writing an Informed Consent Document
Explaining Informed Consent information in Lay Terms

Introduction

There is no substitute for personal interaction in determining comprehension, giving reassurance, and helping participants to develop trust in the IC process. The IC process includes human interactions where the participants, based on their unique set of values, make a personal commitment involving significant trust in the investigator and the institution. This is not a calculation or a "sale". No external criteria - no matter how objectively defined or applied - can substitute for what is fundamentally a subjective decision. The decision whether or not to participate is entirely the participant's. Any attempt by the RTM to influence that decision is misguided.

Helpful Tips

To increase understanding the PI or RTM should use lay terminology at a 6 th grade level.
Ask the participant to repeat the information back. Having the participant repeat the information (in their own words) to find out if they have a clear understanding of the information.
Encourage the participant to ask questions, and then repeat what you thought you heard.
Approaches to providing IC information might include:
- Delivering information in small pieces and then confirming what had been said
- Ask participant to repeat information
- Encourage questions
- Ask participant questions
Listen for misunderstandings the participant might have then correct and verify.

PI / RTM Presentation Skills

Assisting a potential participant through the IC process requires more than just a genuine concern for the participant and the process. It also requires specific skills such as teaching, cultural literacy, and "reading the participant" (e.g. body language and hearing the unsaid)...

As with any skill set, some individuals are naturally better at the task, and quickly acquire a high functional level. Education, training, and, especially, mentoring can be useful in developing these competencies. Such skills cannot be "picked up with practice," since that would imply that at least some ICs were obtained by untrained RTM.

Writing an Informed Consent Document

Drafting a good IC document is not as easy as it may look. Although a well-developed IC template with imbedded instructions and examples is useful, it does not guarantee an adequate document. Mentoring in the preparation of an IC document can be quite helpful. Although the IRB is in a sense the PI's partner in research, it must maintain its distance to be objective. The IRB must be retrospective and independent - and therefore is unable to directly collaborate with the PI in design or implementation of any part of a research study.

A poorly written IC document can be confusing and even opaque to the participant. If unnecessarily long and complicated, the IC document can either intimidate a participant into consenting without full understanding (embarrassment at lack of comprehension; de facto delegation of decision to RTM on the assumption that the topic is beyond the participant's ability to understand), or scare off an appropriate candidate. Neither outcome serves the participant or the research project well. An IC comment should be only long enough to convey all needed information succinctly and clearly.

Explaining Informed Consent Information in Lay Terms

This requirement cannot be over-emphasized. Medicine has its own language, as obscure to the lay person as the Latin and Greek from which much of it is derived. Often we in health care do not realize that we are speaking in unfamiliar terms. It takes just as much conscious effort for the RTM to solicit the IC clearly as it takes the PI to write it understandably. The presenter should not "speak down" to the prospective participant, since that can be interpreted as intimidation (coercion issue) or condescension (trust issue). Typically, language should be targeted at a 6th grade level - the same level that most public speakers (news anchors, politicians, preachers) use, although in the case of IC it can, to a certain extent, be tailored to the individual. Writing in a simple and straight forward manner is a complex language skill that requires development to acquire and effort to apply. But it can be done.

The video below shows an Informed Consent dialogue with the PI using medical terminology. Note the potential participant's two different responses when the PI uses only medical jargon (and does not recognize the lack of comprehesion by her potential participant) versus when she defines the medical words in lay terminology.