Continuing the Informed Consent Process in Eliciting Truly Informed Consent

IRB Eliciting Truly Informed Consent

Continuing the Informed Consent Process

Objectives:

This module offers information for the Principal Investigator and the Research Staff to recognize the significance of the:

Participant receiving ongoing information about the study they are participating in
Research Staff allowing themselves adequate time and staff while the research is underway
Research Staff seeking ongoing Informed Consent training

Introduction

IC neither begins nor ends with a signature on an IC document. The process continues throughout the research. Withdrawal of the Participant without prejudice at any time must be as free of intentional and unintentional barriers as the initial IC. For the participant to make an informed decision to continue, he or she must have ongoing access to any information about changes in the facts on which the original decision was based. If the ongoing research experience suggests a change in the predicted nature or likelihood of risks; if the benefits turn out to be less than originally hoped for; if other participants are pulling out of the study for reasons that any remaining participant might in retrospect consider relevant - then each active participant must be informed. They trust you to do that.

Adequate Time and Staffing

The IC process is resource-intensive. It is sort of a "tax on research". Once you have invested in writing the ICD; developing protocols for "consenting" (responsible RTM identified, paperwork available, environment defined); and training your RTM in the IC process, you have paid most of these costs. But personnel, time, and space will still be needed to carry the project to completion. These are expensive resources. Your grant will pay for some, but departmental resources may be needed. Once you start the research, you are committed to certain aspects, the IC process being the first among them. Legally, you must fulfill your IC obligations, even if you don't think you have the resources to comfortably do so. Before you make the decision to start (with its implicit commitment of resources), it is wise to confirm that you actually have access to the resources needed.

Training on the Informed Consent Process

Ongoing IC training is required of the PI and the RTM. Things change; new issues emerge; and existing knowledge and skills get rusty. Mandatory continuing education is not just for clinical medicine. Your institution either requires mandatory yearly research education, or soon will. This may seem inconvenient, but it is the cost of doing research right. And it is much less expensive in time and money than the cost of doing research wrong.