Transcript Ethical challenges in human participant research: a

PROF KEYMANTHRI MOODLEY
CENTRE FOR MEDICAL ETHICS & LAW
DEPT OF MEDICINE
FACULTY OF HEALTH SCIENCES
STELLENBOSCH UNIVERSITY
COPYRIGHT 2013 – ALL RIGHTS RESERVED
Medical Generalism
Medical Generalism
“An approach to the delivery of
health care, be it to individuals,
families, groups or to communities”.
Spectrum
Pure
generalism
breadth
Pure
specialism
depth
Generalism:
Systems thinking & complexity
Applies across disciplines – medical
and non-medical
 Holistic approach vs reductionism
 Inter-connectedness
Medical Generalism
- aging population
- chronic illness
- vulnerable patients
- end of life issues
Generalism:
1. Scientific data
& EBM
3 challenges
2. Public = direct
access to
specialists
3. Other professions
taking on additional
responsibilities
Challenge 1 : Growing scientific
data and EBM
Generalism & Evidence :
Research?
Sufficient?
Resource depleted settings?
Reliable?
EBM
Evidence Based Medicine
False Claims Act
GlaxoSmithKline (GSK)
$3 billion lawsuit:
Misbranding - Paroxetine (Paxil) &
Bupropion (Wellbutrin)
Failure to report safety data –
Avandia (Rosiglitazone)
False Claims Act
Whistleblowing
Amgen - $ 24.9 million 2013
Challenge 2: Relationships
between generalists & specialists
Professionalism
Communication
Generalist as co-ordinator &
gatekeeper
Specialists
Radiology &
Lab Reports
GP
Pharmaceutical
Industry
Medical
Funders
Medical Generalism
 applies equally to individuals & clinical teams
 = “one facet of medical professionalism”
Generalist-Specialist
Relationships:Guiding Principles
1. Patient welfare and best interest
2. Mutual integrity and respect
3.Use health resources appropriately &
prudently
4. Ultimate responsibility for patient
care – referring doctor
Pearson 1999. Principles of Generalist-Specialist
Relationships J Gen Intern Med
Challenge 3: Other professions
taking on additional responsibilities
Pharmacists
Specialists
Integrative Medicine
The ethos of medical
generalism
empathy – intelligent use of insight into the
whole setting of the patient’s plight
engagement – a commitment to active
involvement in every aspect of patient’s care
appreciation of limits – understanding &
acknowledging specialist aspects of care
professionalism – in clinical communication,
interactions & behaviour.
Medical
Generalism
&
ETHICS
The ethics of medical
generalism
Professionalism
Acknowledging limitations
Patient autonomy
Communication & social media
Electronic Health Records

Communication & Social Media
E mail
Twitter
Facebook
Whatsapp
Blogs
BBM
Communication & Social Media
American Medical Association Guidelines
Hippocrates +/- 2500 years ago…
“Whatever I see or hear, in the life of
men, which ought not to be spoken of
abroad, I will not divulge, as reckoning
that all such should be kept secret”
Geneva Declaration
I will respect the secrets that are
confided in me, even after the
patient has died;
“Confidentiality in Medicine – A
Decrepit Concept”
Health records of a typical patient at
his teaching hospital were viewed by
at least 75 health professionals and
hospital personnel during an in
patient stay.
Dr Mark Siegler – 1982, NEJM, 307 (24) : 1518-1521
The 4 Principles
Respect for autonomy
Beneficence
Non-Maleficence
Justice
Beneficence & Non-Maleficence
Benefits & Risks of Electronic
Health Records
Electronic Health Records: Benefits
Improved
patient care
health outcomes
safety
efficiency
Electronic Health Records:
Risks
Security of data
Privacy
Discrimination – HIV, genetic test results
Secondary use of data
Costs
Children/adolescents
Potential non-medical harms of
excessive disclosure of health
information
Embarrassment
Strains on intimate relationships
Stigmatisation
Discrimination
Secondary Use of Patient Data
Policy, research, audit, public health
Exploitation of health data – clearing houses..data
mining……
- pharmaceutical industry
-Insurance companies
-Employers
-Police
-Government
Autonomy
Patients want control over who
has accessed their records &
who can see their data.
Patients have always controlled
disclosure to doctors
“It is a fantasy to believe that
patients are always completely open
and honest with their doctors, but
nevertheless many doctors and
patients cling to this fantasy with
devotion”
Wynia and Dunn 2011 J of Law,Med & Ethics
Autonomy – Sequestration of
Information
Domestic violence
Genetics
Mental health
Reproductive health
Substance abuse
Informed Consent
Respect patients’ choices
regarding information disclosure
and to disclose information only
in accordance with the law &
prior agreements with patients
HPCSA Regulations
HPCSA: Guidelines on the keeping of
Patient Records 2008
4.2 RECORDS SHOULD BE KEPT IN NONERASABLE INK AND ERASURE FLUID SHOULD
NOT BE USED.
8.
ALTERATION
DELETION RULES
OF
HEALTH
RECORDS
–
HPCSA: Guidelines on the keeping of
Patient Records 2008
RULE 17:
TYPE-WRITTEN, COMPUTER GENERATED, PRE -TYPED,
PRE=PRINTED OR STANDARDISED PRESCRIPTIONS SCHEDULE 1-4 OF MEDICINES & RELATED SUBSTANCES
CONTROL ACT 1965.
HANDWRITTEN - SCHEDULES 5, 6, 7,8
Generalism – The Way Forward…
Geneva Declaration
The health of my patient will be
my first consideration…