Valid Informed Consent Education Pilot Project
2nd Annual Nursing Research & Evidence-Based Practice Symposium
Sandra Knowlton-Soho, MS, RN
Sara Simeone, BSN, RN
November 5, 2010
Financial Disclosure
We do not have any conflict of interest to report in relation the information being presented today.
Objectives
1. Explain the need to educate research staff in obtaining valid informed consent
2. Describe how the Valid Informed Consent Project seeks to determine if the teach back method is effective to assess study participant understanding
Background: Clinical Research
Clinical study of a drug to device to test safety and/or efficacy
Involve human subjects Obligation: Protection of Human Subjects Obligation: Choice
Informed Consent in Clinical Research
Components of informed consent1. Voluntary choice
o Free from coercion an undue influence
2. Information disclosureo Risks, benefits, burdens, alternatives
3. Decision-making capacityo Able to understand nature and consequences of
decisions
Informed Consent in Clinical Research
A Process Conversation with PI or designee such as
Research RN Review of Informed Consent Document Signature Documentation of process Ongoing assessment of consent to participate
Nursing and Clinical Research
Role of the Research Nurse
Overlap with Nursing Research
Framework
Identify Need
Understand what is already known (literature search)
Project development and implementation
Project assessment and sharing of knowledge (present/publish)
Challenge: Health Literacy
National Center for Education Statistics, 2003; Baker, 2010
Challenges: Regulations
October 2009 FDA Guidance Guidance for the Industry on Investigator
Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects
Framework
Identify Need
Understand what is already known (literature search)
Project development and implementation
Project assessment and sharing of knowledge (present/publish)
Literature Review: Teach Back & Simulation Importance of a volunteer’s level of understanding when discussing
participation in study (Flory & Emanuel, 2004; Paris et al, 2010; Titus, 1996).
Different interventions have been proposed to improved the process (Davis et
al, 2002; Flowers, 2006; Kripalani et al, 2008; Lorenzen, 2008) but there is limited research on training research staff in using these interventions.
As an interactive method to improve skills, simulation training with standardized patients has been proven to be effective (Brindley & Dunn, 2009; Leeper-
Majors et al, 2003; Taekman et al, 2004). No literature describing the use of an Informed Consent Simulation Training
to improve the consent process. University of Michigan developed a training program similar to the one we
are proposing, but we were unable to find any citations for articles related to validating their project (Valid consent and refusal to participate in research, S. Goold).
A Solution: The Teach Back Method
● Asking patients to repeat in their own words what they need to know or do, in a non-shaming way.
● NOT a test of the patient, but of how well you explained a concept.
● A chance to check for understanding and, if necessary, re-teach the information.
Framework
Identify Need
Understand what is already known (literature search)
Project development and implementation
Project assessment and sharing of knowledge (present/publish)
The Intervention
An Educational Program:
Two hour class that will involve lecture, video, discussion, and role playing.
Objectives: explain the purpose of obtaining informed consent describe the components of informed consent identify issues associated with health literacy and
informed consent demonstrate the use of the teach-back method in
informed consent discussions
Study Design
Pilot study utilizing quantitative and qualitative design
Pre-intervention, immediately post-intervention, 3 months post-intervention
Assess participants: Knowledge - multiple choice test Attitude - self reported confidence Skills - observation of simulated consent process
Study Execution
Recruitment Internal staff responsible for conducting informed
consent discussions with potential clinical trial volunteers
Intervention 2 cohorts of 14-16 participants
Data analysis Quantitative: Analysis of Variance over the 3 time
points Qualitative: Participant feedback
Framework
Identify Need
Understand what is already known (literature search)
Project development and implementation
Sharing of knowledge (present/publish)
Lessons Learned Thus Far
Multidisciplinary Collaboration Regular meetings to stay on track Realistic timeline Make adjustments as needed
Acknowledgements
Project team members
Liz Bankert, Assistant Provost for Research, Dartmouth College Ann O’Hara, Human Research Analyst, Committee for the
Protection of Human Subjects, Dartmouth College Dianne Ferris, Human Research Analyst, Committee for the
Protection of Human Subjects, Dartmouth College Judi Forman, Research Associate/Program Coordinator, Clinical
Trials Unit at The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College
Acknowledgements
Institutional Support Dartmouth Hitchcock Patient Safety Training
Center D-H Quality Research Grant Program Dartmouth Clinical Trials Office Committee for the Protection of Human Subjects Norris Cotton Cancer Center – Office of Clinical
Research The Dartmouth Institute for Health Policy and
Clinical Practice