Transcript Slide 1

The Role of Medical Humanism in
Clinical Research
Paula Bistak, D.MH, RN, MS, CIP, CHRC
Executive Director, Human Subjects Protection Program
Chris Asmann-Finch, D.MH, MS
Program Development Specialist, Human Subjects
Protection Program
Human Subjects Protection
Program
The mission of HSPP is to support the University's research enterprise by ensuring the
protection of individuals who participate in research; ensuring compliance with all
pertinent federal and state laws and regulations; fostering the ethical conduct of
human subjects research; and providing education and other services to the
University's researchers regarding regulatory requirements and best practices.
Components:
– Education (research community)
– Support IRB committees in moral deliberations
– Community Outreach
– Compliance (Quality Assurance)
Poetry
SUBJECT
I feel the blankness of meaningless combinations
of letter and numbers
Which say who I am according to them
No woman
No person
A count
A number of cells
A lack of antibodies
A statistic
A textbook case
No one wants to help me
To me to help
To help
They want me
To help
Them
To make discoveries
To write research papers
To make them famous
They don’t even want
to know my name
To know at all
That those counts of cells
Belong to a body
Who is a person
Who has suffered and is tired
Tired of all this poking and testing and number counting
Who is just tired
— Anonymous, August 1987 (McNeill, Paul M. The Ethics and Politics of Human Experimentation. Cambridge: Cambridge UP. 1993, p 178)
Clinicians most conflicted
Researcher/Scientist
versus
Physician/Caregiver
Learning Objectives
• Symposium attendees recognize that ethical conduct and
humanistic practice are necessary in the conduct of
clinical research, just as they are necessary in the
delivery of medical care.
• Symposium attendees are able to identify areas where
Medical Humanities efforts contribute to ethical conduct
and humanistic practices in clinical research and
oversight activities.
Session Overview
• Review current applications of Medical Humanities in
therapeutic medicine;
• Outline similarities and differences between therapeutic
medicine and human subjects research and highlight
need for professional conduct and humanistic practices
in both; and
• Identify current applications of Medical Humanities in
Human Subject Protection Programs to support and
nurture professional conduct and humanistic practices in
human subjects research.
Therapeutic Medicine
• Medicine is the “science or practice of
diagnosing, treating and/or preventing
disease”. (Oxford Dictionary)
• “I will prescribe regimens for the good of
my patients according to my ability and my
judgment and never do harm to anyone.”
(Hippocratic Oath)
Medical Ethics and Humanities: A Foundation
for Medical Professionalism
•
Association of American Medical Colleges (AAMC)
– Education in argument-based reasoning in medical ethics, narrative-based
reasoning in literature, creative reasoning in the fine arts, and historical
reasoning in learning
•
Accreditation Council for Graduate Medical Education (ACGME)
– Demonstrate respect, compassion, integrity, commitment to ethical principles,
sensitivity and responsiveness to patients’ culture, age, gender and disabilities
•
Liaison Committee on Medical Education (LCME)
– Education must include medical ethics and human values, communication….to
exhibit scrupulous ethical principles in caring for patients and in relating to
patients’ families and to other involved in patient care
See Doukas, D., et al. 2012. “Medical Education in Medical Ethics and Humanities as the foundation for
Developing Medical Professionalism.” Academic Medicine 87(3): 1-8.
Medical Humanities…

an interdisciplinary study of humanities (literature, philosophy, ethics, history and
religion), social science (anthropology, cultural studies, psychology, sociology), and
the arts (literature, theater, film, and visual arts) as a form of moral development and
which concepts are applied to better understand notions of health, disease and
medical policy and practice;

employs the methods, concepts and content from one or more of the disciplines to
investigate illness, pain, disability, suffering, healing, therapeutic relationships, and
other aspects of medicine and health care practice;
Medical Humanities (continued)

activities nurture collaboration among scholars, professionals, healers, and patients
to design humane health care practices and systems;
•
demands that we never lose sight of the complexity and beauty of our humanity,
especially in times of illness.
See also:
Brody, Howard. 2011. “Defining the Medical Humanities: Three Conceptions and Three Narratives.” Journal of Medical
Humanities 32(1): 1-7.
Drew University Medical Humanities Program Committee. 2011. “Medical Humanities for Primary Care Providers.”
Shapiro, Johanna, et al., 2009. “Medical Humanities and Their Discontents: Definitions, Critiques, and Implications.”
Academic Medicine 84(2):192-198.
Applications of Medical Humanities in
Therapeutic Medicine
Engaging with the humanities, social sciences and art aids:
-Medical students to develop skills of observation, communication, analysis, empathy
and self-reflection and by this sharpen diagnostic skills, develop respect for patients
and enhance the quality of the clinical encounter;
–Medical ethics committees to develop narrative competence skills in order to
attend more carefully to the details—nuances and complexities—and to strengthen
moral imagination in order to identify who and what is at stake in ethical dilemmas;
–Health policy makers and interested publics to analyze how the stories, as told,
inform how policy is formed and with what consequences; and
–Patients to find ways to express their suffering and, through that expression,
facilitate healing.
Clinical Research
• Definition of research:
a systematic investigation, including research
development, testing and evaluation,
designed to develop or contribute to
generalizable knowledge.
45 CFR 46.102(d)
Differences between therapeutic
medicine and clinical research
• Therapeutic Medicine prioritizes needs and
interests of patient. Research prioritizes the
needs of the experiment.
• Therapeutic Medicine strives for specific
knowledge to benefit the patient. Research
strives for generalizable knowledge to benefit
society.
Challenges Unique to Clinical
Research
• Communicating Adequately with Subject
• Weighing/Balancing Interests of Subject
with that of Science
• Just Inclusion on a Shoestring Budget
How Research is Similar to
Therapeutic Medicine
• Researcher competency/skills
– Responsible Conduct of Research/Good Clinical Practice (GCP)
– Collaborative Institutional Training Initiative (CITI)
• Researcher Professionalism
– Ethical Conduct of Research
• Truth-telling
• Adequate information
• Understanding diverse values and beliefs
• Empathy
Examples of High Profile
Problematic Research
• Tuskegee Syphilis Study (truth-telling)
• Havasupi v University of Arizona
(communication/understanding health
beliefs)
• Abney v Amgen, Inc. (empathy/moral
imagination)
Tuskegee Syphilis Study
Havasupi Tribe Members Recover
Specimens for Burial
Abney v Amgen, Inc.
• No picture!
Nurturing Humanism in Research
Practices
• Ethical research can yield better science
• Individuals grounded in medical humanism
can be better researchers
Consent Process
• Informed consent is an application of the
principle of Respect for Persons
• To be a truly informed consent:
– Information
– Comprehension
– Voluntariness
Purpose of the Consent Process
• Assist the potential subject in making a
decision about their participation in a
research study
• Language impacts the experience of
illness (research)
Medical Humanist Scientist
• Information
– Communicating adequately with the subject
• Comprehension
– Weighing/balancing the interests of the subject with that of
science
• Voluntariness
– Just (fair) inclusion in research
Using Medical Humanities to
Strengthen IRB Deliberations
• Develop moral imagination
– Finding stories
– Critical reflection on the ways we deliberate
Medical Humanities and IRB
Deliberations
Primary function of an IRB:
“An IRB is a committee that performs
ethical review of proposed research.”
U.S. Department of Health and Human Services
GENERAL ETHICAL PRINCIPLES
Respect for Persons (Principle of Autonomy):
 Acknowledging the value and decision-making rights of persons by enabling
them to act autonomously and respecting their autonomously made decisions.
Principle of Beneficence:
 We should do no harm and act in ways that promote the welfare of other
people.
Principle of Justice:
 Benefits and burdens of research ought to be distributed in ways that are fair and
just.
IRB Deliberations
Application of ethical principles difficult because information about
subjects is NOT regularly available for IRB Review
•Patients’ and/or Subjects’ Stories
– Experience living with disease
– Experience in clinical trials
•Community Stories
– Identifying what is important to research
– Experience with research and/or researchers
•Other Evidence
– Periodic stopping points in research to assess expectations/problems (not even
for studies conducted by PIs with history of problematic conduct)
– Satisfaction surveys at end of study
– Comparative Effectiveness Research
Narrative Exercise:
Phase III: Pharmacokinetics, Safety and Tolerability of Zavesca (Miglustat) in Patients with
Infantile Onset Gangliosidosis [Tay-Sachs]: Single and Steady State Oral Doses
The primary objective of the study is to investigate the pharmacokinetics of ZAVESCA (miglusatat,
OGT918), when given as a single dose and a steady state, in infantile patients with GM2
gangliosidosis. The secondary objectives are to evaluate the tolerability and safety of single and
multiple doses of miglustat and to monitor disease progress using physical and developmental
assessments and disease-specific biomarkers.
Endpoints:
o Biomarkers (level of GM2 ganglioside, chitotriosidase activity, anti-GM2 antibodies) in
plasma, serum and CSF will be measured at initial visit (run-in period), Week 13, and Week
25.
o Neurophysiologic Assessment – EEG and BEAR tests will be done at initial visit (run-in
period), Week 13, and Week 25.
o Ophthalmology Assessment – comparison of the “cherry-red” macula changes will be made
at initial visit (run-in period) and Week 25.
ClinicalTrials.gov; Trial #NCT00672022
A Parent’s Story
Ronan [our son] has given us a terrible freedom from expectations, a magical world
where there are no goals, no prizes to win, no outcomes to monitor, discuss,
compare….Our son won’t prosper or succeed in the way we have come to understand
this term in our culture; he will never walk or say ‘Mama’, and I will never be a tiger
mom…
Our goals are simple and terrible: to help our [son] live with minimal discomfort and
maximum dignity. […the day-to-day is often peaceful, even blissful…cuddling, feeding
naps. He can watch television if he wants to; he can have pudding and cheesecake for
every meal…The only task here is to love…].
We will not launch our [child] into a bright and promising future, but see [him] into [an]
early [grave]. We will prepare to lose [him] and then, impossibly to live on after that
gutting loss. This requires a new ferocity, a new way of thinking, a new animal. We are
dragon parents: fierce and loyal and loving as hell. Our experiences have taught us how
to parent for the here and now, for the sake of parenting, for the humanity implicit in the
act itself….
Rapp, Emily. “Opinion: Notes From a Dragon Mom.” New York Times Sunday Review, October 16, 2011. pg. 12.
Problems Result When IRBs Fail
to Imagine the Other
• Biology becomes a ‘superfact” in
deliberations
• Application of Ethical Principles distorted
• Good science does not guarantee an
ethical study
A Problem with Stories
• …there are so many of them!
2,405,000 people in clinical trials in 2006 alone:
775,000 govt.-funded trials
880,000 pharma-funded I-III
750,000 pharma-funded post-marketing
CISCRP
Need to Develop Deliberative
Reflexivity (narrative competence)
• Who are the “stakeholders” narrated in the proposed research? Are
there other important stakeholders we need to know about? If so,
who and why? What is at stake for each?
• How does the story, and the particular way it is told, define or
redefine those stakes, raising or lowering them?
• How does the story change our sense of what is possible, what is
permitted, and what is responsible or irresponsible?
• How will the study alleviate suffering?
See Frank, A. 2010. Letting Stories Breathe: A Socio-Narratology. U of Chicago Press. pp. 74-5.
Application of Medical Humanities in Clinical
Research
Engaging with the humanities, social sciences and art aids:
- Clinical Researchers to develop skills of communication, analysis,
empathy, community engagement and self-reflection and by this sharpen
research skills, develop respect for research subjects and enhance the
quality of the research encounter; and
- Research ethics committees (IRBs) to develop narrative competence to
attend more carefully to the details—nuances and complexities—and
strengthen moral imagination in order to identify who and what is at stake
in proposed clinical research.
The Goal of Medical Humanities
Activities
Regardless of context, be it medical practice or
clinical research, we endeavor to never lose sight
of the complexity and beauty of our humanity,
especially in times of illness.