Research Team Responsibilties in Eliciting Truly Informed Consent

IRB Eliciting Truly Informed Consent

Research Team Responsibilties

Objectives:

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

Their working knowledge of the IC Process
Their roles and responsibilities in the IC Process
The role ethics plays in research and during the IC Process
Their knowledge about the rights of the research participant
How to ensure that participants know their rights
A research participants right for safety during the study

Introduction:
Working Within the Informed Consent Process .

Without a working knowledge of the IC process, the PI cannot design a reasonable procedure and the RTM cannot implement it. The IRB has put in place specific guidelines for IC design. In most institutions teaching modules on IC design and use are available for the RTM. The IRB reviews the PI's design of an IC to confirm that it adequately follows the guidelines and template. The IC process also needs to be properly deployed in the recruitment of participants. The IRB is charged with ensuring that IC procedures are designed and executed properly. Representatives from the IRB may audit your IC procedures and even sit-in during IC sessions with participants to confirm that the IC procedures are appropriate, well-understood, and applied properly by the RTM.

PI / RTM Responsibilities

For each project a plan must be developed specifying how, where, and by whom the informed consent process will be presented to a prospective participant. An important feature of any plan is that the PI is in charge of, and has responsibility for, the IC Process. Every project will be different, and so will its IC procedures. Although the PI may delegate some aspects of participant education and IC documentation to other Research Team Members (RTM), important duties should not be delegated without supervision. The PI selects the research staff, directs their training, defines their roles, and determines their working environment. The PI also sets expectations and is responsible for maintaining quality standards in the conduct of the research, including the IC Process. Ultimately, it is the PI's responsibility to ensure that the research staff has what they need to do their jobs, and that they are doing them correctly. For an inexperienced PI the complexity of this responsibility can be a bit daunting.

The PI must supply the research staff with the education and training to do the job. This training should make the RTM conversant with medications and their actions in a biomedical study, or interventions in a behavioral study, any anticipated adverse effects, techniques required (e.g. blood drawing), and the lines of authority and responsibility for each person on the team. For the informed consent process, this training also includes an understanding of the components of consent, the rationale for each, their applications, and the barriers to their effective implementation. Mentoring and monitoring, especially during early application of these skills, can speed the acquisition of proficiency and assure quality and accountability. Once training has been completed, trained and knowledgeable RTM become a valuable resource for the institution.

A trained staff will know the participant's rights and will make sure they are protected while empowering the participant to become a full and informed partner in the project. The approach must not only ensure that a complete and competent process can take place, but also confirm that it actually does. All of this occurs intentionally by the PI and through the research staff, with the oversight of the institution via the IRB.

It is also the responsibility of each RTM to know the Scope of Practice (SoP) and to adhere to it. The SoP is the "job description" for any specific research project. It defines the duties of the RTM and the competencies each member is expected to employ. The PI is responsible for ensuring that each RTM member has had the training required to do the job properly. But as an RTM member, you also have a responsibility. If you do not feel that you have the "tools" necessary to fulfill the SoP, you should bring this insecurity to the attention of the PI for correction. It is often easier to identify when you do not have enough supplies for the study than it is to define when your training or time available to obtain an IC is inadequate to fulfill the role of assisting the research participant. If you are concerned about any inadequacy in your training, or any other problem associated with carrying out the SoP, and the PI is not responsive to those needs, it is your responsibility to contact the IRB directly. Remember, your obligation is to the research participant first, the institution second, and the PI third. Ideally, all entities are moving in the same direction with the same priorities. If they are not, then you need to understand your responsibilities and options.

Research Ethics

Informed Consent is a collaborative process between the research team and the research participant. As a member of the RTM, you should have completed your core training in research ethics and be familiar with the Belmont principles of Respect for Persons, Beneficence, and Justice. [If you are not familiar with these principles, you should become so at http://www.fda.gov/oc/ohrt/IRBS/belmont.html

Beneficence and Justice are critical considerations in the design and execution of the research protocol, whereas Respect for Persons is primarily relevant to the IC process. The goal of IC is to ensure that the prospective research participant is (a) truly informed in order to (b) make a truly autonomous choice about participating in the research. This sounds very straight-forward; as is often the case with simple goals, however getting there can be quite torturous and contain many opportunities for failure and/or unintended consequences. A firm grounding in the ethics from which the IC process is derived is essential in avoiding and dealing with such problems.

Know Participant Rights

By definition, the research participant is the person at greatest risk in the research environment - both from the research procedure and from possible abuse in the research relationship. Ethical standards have been developed to control the risk and avoid abuse. The Belmont principles and report were developed in response to the Tuskegee syphilis study. The Belmont Principles of Respect for Persons, Beneficence, and Justice underlie the design of all clinical studies in the US , including the IC process. Derived from the principles are a set of rights defined ethically in the Belmont Report, contractually in the Informed Consent Document (ICD), and legally in 45CFR46 (21CFR for FDA studies).

During the IC Process, Research Participants rights include notification and explanation about:

Their Right to keep personal information confidential
Their Right to volunteer
Their Right not to volunteer or to withdraw if they are already in a research study
Their Right to receive information about the research study in a way that makes sense to them
Their Right to ask questions: At any time research participants can ask questions about the research study. The following person(s) should be available to answer their questions:
- Principle Investigator (PI)
- Research Staff
- Patient Advocate/Research Subject Advocate
- Human Research Protection Program (HRPP)
Their Right to know that vulnerable persons or groups exist and have special protections in place. Examples of vulnerable persons or groups are:
- Children
- The Mentally Ill
- Fetuses
- Pregnant Women
- Prisoners
- Students
- Employees
- Patients who have been recently diagnosed with an illness or medical condition
- Socially or economically underprivileged

RTM whose SoP includes assisting a participant in granting IC should have completely read and understood all parts of the IC document.

Ensure Participants Know Their Rights

Participant rights are a critical component of the information research participants must understand before they can give a valid IC. Any RTM assisting participants in the IC process must ensure that participants granting an IC understand not only the research for which they are volunteering, but also their rights as a volunteer participant. Occasionally, a participant will ask to skip over the "long explanation" and "just sign the form". This not only shortchanges the participant; but it also puts the RTM, PI, and institution at risk. The obligation to be fully informed is a participant responsibility, but the research team can never intentionally under-inform the participant during the IC process.

Ensure Participant Rights are Adhered to

Knowingly violating a participant's rights is a serious but, fortunately, a very rare offense. If a PI or an RTM were found to have intentionally misled a patient about the risk or benefit of a study, or were to use a subject for research without his/her knowledge, in a situation that does not qualify for waiver of consent the impact on the research project would be immediate and profound. Ramifications would be significant to the PI's career, the institutional research enterprise (including legal liability) and the trust necessary for medical research with human participants to thrive in society. More commonly, if the rights of the participant are violated, it is done unintentionally and less flagrantly. There are still consequences to this, but they are typically less far-reaching.

Safety

Participants in a research study have a right to be assured that every measure will be taken to keep them safe during the study. Participants should be encouraged to ask questions about the study and any risks they may encounter. The questions should be answered as simply and completely as possible, and the participants should be asked to describe their understanding of the answers verbally. The IC should describe the risks of participating in the study in a manner that participants can comprehend. Participants in a study should understand that the study is as safe as it can be, and that if unsafe conditions arise, the study will be stopped.