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.
2.
Explain the need to educate research staff in
obtaining valid informed consent
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 consent
Voluntary choice
1.
o
Free from coercion an undue influence
Information disclosure
2.
o
Risks, benefits, burdens, alternatives
Decision-making capacity
3.
o
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



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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; LeeperMajors 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 postintervention, 3 months post-intervention
Assess participants:



Knowledge - multiple choice test
Attitude - self reported confidence
Skills - observation of simulated consent process
Study Execution

Recruitment


Intervention


Internal staff responsible for conducting informed
consent discussions with potential clinical trial
volunteers
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


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Acknowledgements

Institutional Support

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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