Home 
Contact 
Profile 
Videos 
Presentation
at the Workshop on Research Ethics held at Jazan University 14-15th
May 2012 by Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH
(Harvard) Chairman Institutional Review Board and Department of Bioethics King Fahad Medical City Riyadh EM: omarkasule@yahoo.com
1.0 INTRODUCTION
·
Recommendations of the National Commission for
the Protection of Human Subjects of Biomedical and Behavioral Research resulted
in changes to the ethical regulation of federally funded human subjects
research that persist to the present day.[1]
Social scientists and medical researchers habe
different/conflicting notions: medics focus on protection of the individual
through preservation of autonomy-principally expressed through the requirement
of informed consent-social scientists focus on political implications[2]
·
Biobehavioral research (new techniques of
control) in prisons not well regulated[3].
CIA research on detainees vs common rule
2.0 Ethical issues in behavioral research include[4]:
·
Respect for person and autonomy,
·
Risk minimization,
·
Exploitation,
·
Inducement and compensation,
·
Benefit sharing,
·
Gaining access to participant,
·
Third party issue,
·
Informed consent,
·
Coercion,
·
Discrimination,
·
Conflict of interest and scientific misconduct
3.0 VACCINES AGAINST ADDICTION
·
Vaccines reduce or eliminate neurological effect
of addictive substances
·
Vaccines generate specific immune resistance to
an addictive drug
·
Antibody binds to drug and prevents it from
reaching the neural sites
·
Immune protection can be overcome by increasing
the dose of the addictive substance requiring repeat vaccination which has low
acceptability. Slow release vaccines may have to be used
4.0 ON GOING RESEARCH
·
Research is on going on vaccines against
nicotine, cocaine, and methamphetamine dependency
·
Phase 1 and phase 2 studies have shown nicotine
and cocaine vaccines to be safe and well tolerated
5.0 PROBLEMS WITH VACCINES
·
Vaccination will have to be compulsory to be
effective
·
Vaccines will change human behavior and
individual life style and identity
·
High potential for misuse of the vaccines
·
Use of medicine to solve a non-medical problem
6.0 ETHICAL ISSUES: BENEFIT
·
Compulsory vaccination justified by high
benefit, individual and public.
·
Vaccination of students improves educational
achievement and discipline.
·
Compulsory vaccination of people in sensitive
occupations like pilots.
·
Compulsory vaccination of criminals
7.0 ETHICAL ISSUES: RISKS
·
Withdrawal effects.
·
Vaccines will stay in blood for ever: no
confidentiality.
·
Elimination of the possibility of therapeutic
switching ie future good uses for addictive substances.
·
Repeat injections and Immune resistance.
8.0 ETHICAL ISSUES: INFORMED CONSENT
·
Vaccination under coercion with an irreversible
vaccine.
·
Cultural issues: what drug to vaccinate against;
alcohol is accepted in many societies
·
Vaccination of detainees and prisoners
·
Drug addicts not competent to consent
·
Parents deciding for children
9.0 ETHICAL ISSUES: JUSTICE
·
Research on vaccines takes resources away from
treatment because addiction is not a normal disease
·
Unjust distribution of the vaccines
REFERENCES
[1] J Hist Behav Sci. 2006
Summer;42(3):203-20. The social
control of behavior control: behavior modification, Individual Rights, and
research ethics in America, 1971-1979. Rutherford
A. Source York University, Toronto, Ontario, Canada. Abstract. In 1971, the
U.S. Senate Subcommittee on Constitutional Rights began a three-year study to
investigate the federal funding of all research involving behavior
modification. During this period, operant programs of behavior change,
particularly those implemented in closed institutions, were subjected to
specific scrutiny. In this article, I outline a number of scientific and social
factors that led to this investigation and discuss the study itself. I show how
behavioral scientists, both individually and through their professional
organizations, responded to this public scrutiny by (1) self-consciously
altering their terminology and techniques; (2) considering the need to more
effectively police their professional turf; and (3) confronting issues of
ethics and values in their work. Finally, I link this episode to the formation
of the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research, whose recommendations resulted
in changes to the ethical regulation of federally funded human subjects
research that persist to the present day.
[2] Soc Sci Med. 2005
Oct;61(8):1741-9. Epub 2005 Apr 25. Conflicting
notions of research ethics. The mutually challenging traditions of social
scientists and medical researchers. Hoeyer
K, Dahlager
L, Lynöe
N. Source Department of Health Services Research, University of Copenhagen,
Øster Farimagsgade 5, P.O. Box 2099, DK-1014 Copenhagen K, Denmark. k.hoeyer@pubhealth.ku.dk Abstract Tensions
over ethics in research occasionally arise when anthropologists and other
social scientists study health services in medical institutions. In order to
resolve this type of conflict, and to facilitate mutual learning rather than
mutual recrimination, we describe two general categories of research ethics
framing: those of anthropology and those of medicine. The
latter, we propose, has tended to focus on protection of the individual through
preservation of autonomy-principally expressed through the requirement of
informed consent-whereas the former has attended more to political
implications. After providing few examples of concrete conflicts, we
outline four issues that characterise the occasional clashes between social
scientists and medical staff, and which deserve further consideration: (1) a
discrepancy in the way anthropologists perceive patients and medical staff; (2)
ambiguity concerning the role of medical staff in anthropological research; (3)
impediments to informed consent in qualitative research projects; and (4)
property rights in data. Our contention is that enhanced dialogue could serve
to invigorate the ethical debate in both traditions.
[3] Behav Sci Law.
2003;21(5):671-86. Ethical and
legal standards for research in prisons. Kalmbach
KC, Lyons
PM Jr. Source Department of Psychology, Sam Houston State University,
Huntsville, TX 77341-2296, USA. Abstract Biobehavioral research, especially
that which is conducted with prisoners, has become much more closely regulated
in the last 30 years. State and federal law, as well as professional standards,
regulate the conduct of many types of research; in the case of prisoners, this
regulation is even more stringent. However, currently no mandatory, uniform,
national regulatory or oversight process exists, and many privately funded
research endeavors are operating in a regulatory void. In response to this, the
National Bioethics Advisory Commission has argued for the creation of a single,
national, independent regulatory body to oversee all human participant
research, regardless of funding source. As ethicolegal research standards
evolve alongside advances in science and technology, an appreciation of the
history of prisoner research and an awareness of current standards is critical
to conducting ethical prison research.
[4] Afr J Med Med Sci. 2009 Jun;38
Suppl 2:31-40. Ethics of social
and behavioural research in cancer. Jegede
AS. Source Department of Sociology,
Faculty of the Social Sciences, University of Ibadan, Ibadan, Nigeria. sayjegede@yahoo.com Abstract Unlike
biomedical research, social and behavioural research has not been thought to
require rigorous or mandatory ethical review on the assumption that it can do
no harm. As a result, little or no attention is paid to its involvement in
health researches. This paper discusses the ethical challenges of social and
behavioural research in cancer to identify potential areas for research.
Inferences were made from documentary analysis of characteristics of cancer
patients. A total of 76 papers were reviewed covering the period from1960 to
2007. The data shows that conducting social and behavioural research on cancer
patients in Africa is associated with ethical challenges. These include; respect for person and autonomy, risk minimization,
exploitation, inducement and compensation, benefit sharing, gaining access to
participant, third party issue, informed consent, coercion, discrimination,
conflict of interest and scientific misconduct. The paper concludes that
cultural challenges of cancer research, management and administration of
informed consent, access to research participant, compensation of research
participant and benefit sharing are major potential areas of research.