Evaluating Potential Participants in Eliciting Truly Informed Consent

IRB Eliciting Truly Informed Consent

Evaluating Potential Participants

Objectives:

This module offers information to support the Principal Investigator and the Research Staff in:

Identifying the Participant's reasons for volunteering
Evaluating the Participant's health literacy
Assessing the Participant's comprehension
Verifying the Participant's understanding

Introduction

The set of skills discussed in this section are less about transferring knowledge and more about defining a relationship. Participants make the decision to volunteer in research based on both understanding the facts and applying them subjectively to themselves. The RTM assisting in consent procedures can unintentionally influence the subjective part of the decision making process for the participant.

The RTM interacting with a research participant in an IC process must be aware that a statement of voluntary consent is necessary, but not necessarily adequate. The RTM should guard against the possibility of indirect, unintentional coercion. Other factors may inappropriately influence the Participant's decision, including fear of disappointing one of the RTM with whom the participant has a personal or clinical relationship; perceived lack of a therapeutic alternative; as a way to cover the costs of health care; a desire for research compensation; etc. It is the responsibility of the RTM to understand why the participant chooses to volunteer, and to be clear that the reasons are appropriate. Does the participant feel as comfortable saying, "No" as saying, "Yes"?

Below are two video clips. The first video demonstrates the impact of PI/RTM's willingness to coerce the potential participant. The second video demonstrates the PI/RTM's ability to recognize that the potential participant can be coerced and does not take advantage of this.

Evaluating Health Literacy

At one point in your life -whether you recall it or not - you didn't know what the liver did or where it was located in your body. Most Americans still don't. So why should you think the term "lymphocyte" is meaningful to a prospective participant? Not only is the term unfamiliar - so is the concept. On the other hand, there will be prospective participants with clinical experience that has given them an impressive command of medical or behavioral jargon and concepts. That is a bonus, since it makes the RTM's job of education easier. It is the RTM's responsibility to determine if the participant understands the information that has been presented. Health literacy is critical to that understanding. The video below demonstrates methods for the PI/RTM who recognizes a possible literacy issue:

Assessing Comprehension

Communication is a two-party process, and misunderstanding can occur on either end. The video clip below recognizes the potential for misunderstanding by both parties and demonstrates how the PI/RTM can take action:

The PI/RTM is responsible for how well he or she is understood. More specifically, your responsibility goes beyond giving every participant a fair opportunity to understand and to decide without overt coercion. You must design and carry out an informed consent process that ensures that each individual does indeed understand the nature of the research participation, and then makes a decision based solely on his or her own judgment and without coercion or intimidation. Often the best technique to confirm understanding is to have the participants paraphrase back the critical components of the information they have been given. Verbatim parroting is not very helpful, but an independently synthesized re-expression implies comprehension.

Methods for Verifying Understanding

Research professionals have identified a set of challenges they have experienced when trying to illicit truly informed consent. Below are challenges, examples, and suggested solutions. If these challenges are not overcome, the ability for the participant to give informed consent may be compromised.

Challenge: Decreased Sensory Input

Example:
Poor eyesight
Poor hearing

Social isolation, increased likelihood of culture issues: specifically Americans are very independent and this works in the individual's favor in ICD. Older Americans may be depression generation therefore more accustomed to accept authority blindly.

Suggestion:
Large font (e.g. as Ophthalmology routinely does now) or video consents with individually adjustable headphone volume or visual aids. Such approaches should be considered if there is a significant likelihood that patients who would benefit from these considerations (e.g. large numbers of very old) are to be enrolled. Also consider if screening for the individual needs will be routinely done.

Challenge: Literacy

Example:
How do you recognize poor literacy?
How to conduct IC without embarrassing the participant?

Suggestion: If the participant seems to be stumbling or struggling with reading, you may ask if they need reading glasses. If they admit they didn't bring reading glasses say, “I'd be happy to read this to you” This gives the participant a respectful way out without having to admit their literacy issue. Incidentally, RTM should also consider if independent literacy is required for the subject to safely participate in research. If so, such accommodation strategies should be avoided.

Challenge: Decisionality

Example:
Alzheimer's studies where the subject either already has a level of confusion impairing independent decision–making OR if decisionality is expected to become impaired at some point during the course of the study. A common example would be long-term Alzheimer's studies where subject is expected to go from decisional to non-decisional or ICU/Operative studies where patients may lapse in and out of consciousness.

Suggestion: A strategy for dealing with the specific anticipated situation should be developed and described in the protocol. For the IC Process, then, the question will no be the conditions of the ICD, but who will be the surrogate and how they will be selected. There is no one simple answer since each situation is different but what is common to all is that there should be identification of the potential and an individual plan developed to address it.

Challenge: Vulnerability

Example:
Use already published lists in OPRR IRB guide book. Global definition might be: Any subject who might be expected to be uniquely vulnerable to exploitation in the research process. Such subjects are specifically identified by federal regulations as requiring intentional and special protection by the PI, who is under the additional obligation to prove that “vulnerable subjects” (including all subjects in a “vulnerable population” – regardless of how individually vulnerable they might appear) are not being exploited (intentionally taken advantage of).

Suggestion: As with decisionality, key components of the issues in play are:

Identification of the potential.
Development of a strategy for dealing with it.

Challenge: Health Issues

Example:
Recent diagnosis of Cancer; Depression; other diseases

Suggestion: The physiological and/or a physiological impact of disease may impair the subject's ability to make considered and balanced decisions. As with decisionality and vulnerability, key components of the issues in play are:

Identification of the potential
Development of a strategy for dealing with it

There are too many permutations to cover them all here, and each one requires a potentially unique approach. Unfortunately, in the case of recent Cancer diagnosis, potential surrogates may be as impaired by the situation as the subjects themselves

Assessing Ability to Comply

Sometimes this is a subjective call on the part of the RTM, but usually there will be specific evidence in the dialogue if compliance is going to be an issue. Qualified commitments "I'll do this, unless, of course, something comes up" or pre-emptive excuses "sure I'll do this, but sometimes I can't make appointments. I mean, I'll do what I can, but if I can't make it, well that's just how it will have to be" suggest that this issue needs in-depth exploration. More commonly, the consenting RTM may get the impression that although claiming comprehension, the prospective participant "just doesn't quite get it". Does the participant understand enough to really volunteer? Can he or she safely complete the protocol, even if all that is required is to faithfully note and report side-effects? These requirements are protocol specific and require judgment on the part of the RTM. Often the safest course is to exclude the prospective participants about whom one has doubts.