Realistic Expectations in Eliciting Truly Informed Consent

IRB Eliciting Truly Informed Consent

Realistic Expectations

Objectives:

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

The time commitment of managing a human research study
The potential internal and external pressures related to recruitment
Their right not to feel pressured to recruit
Their responsibility to present the study without bias

Introduction

A PI does not decide to engage in clinical research lightly. The work is not easy, and the PI must be highly motivated to carry a project through to completion. Enthusiasm for one's research is good, but if it prejudices or coerces a participant into enrolling, the IC process is corrupted. Particularly in trials of new therapies or interventions, the PI designing the IC process, and the RTM presenting it to the prospective participant, must scrupulously guard against suggesting any benefit in excess of that objectively defined at the time of protocol approval. Motivation comes in many forms and can be direct or indirect, altruistic or self serving. For instance, a sponsor's contribution to the PI's research account in response to additional enrollment of participants in a study can be construed as an inducement to enroll inappropriate participants. There should be no pressure in the research process on participants, the RTM or the PI.

Benefit of Study to Participants

Equipoise means that the risk-benefit ratio for being in different arms of a study are equal. If it turns out that an experimental intervention is better or poorer than a standard treatment, it would be wrong to continue to randomize participants into the trial. It is certainly acceptable and necessary to conduct research to discover the truth when it is not known. Once the PI is confident that he/she knows the truth however, it must be communicated to the participants, and the study must be stopped.

Recruitment Numbers

The originator of a clinical research project (the sponsor or the PI) frequently has a stake in the outcome. There may be internal or external pressure to recruit as many participants as quickly as possible into the project. Finder's fees and recruitment bonuses are sometimes suggested. Do not be associated with either. Recognition is the first step in prevention. You should not feel any "pressure" or "eagerness" to enroll participants other than to conduct the study as objectively as possible.

Time Commitment

The IC process is time consuming and interrupts the flow of clinical work. There is a strong incentive to speed up the IC process and get on with the "real work" of research. Resist the temptation. Are you sure that the participants have had adequate time to make an informed, thoughtful decision? Would they have felt comfortable taking the consent home for review? Were you thorough in obtaining IC, or did you cut some corners?

Academic and Professional Recognition

The PI almost certainly has personal expectations from the project. One of the most common is that additional research will bring about additional recognition, usually by publication of research results. This in turn may indirectly, impact the potential of the PI for promotion and even personal income. Would you in any way change your approach if an IRB representative were looking over your shoulder during the IC process?