Beruflich Dokumente
Kultur Dokumente
GTU 301/3
Dr Idris Long (PhD)
Ext: 7778
Outcomes We l e a d
General outcomes
Understand research involving human subjects
Specific outcomes
conflict of interest
research ethics committee
Conflict of interest We l e a d
Conflict of interest
activities/situations with the potential to undermine
professional judgment and objectivity
potential for bias
not a misconduct in research
the use of persons authority for personal/financial
gain
may involve individuals and institutions
Conflict of interest We l e a d
Conflict of interest
Conflict of interest
primary interest
protection of integrity
quality of research
secondary interest
financial
recognition
favours
Conflict of interest We l e a d
Clinical research
basic elements:
scientific integrity,
patient safety and
investigator objectivity
COI
altruistic dedication to the pursuit of knowledge
while striving to maintain the welfare of the human
volunteers participating in the research
Conflict of interest We l e a d
COI
bias and decreased objectivity
research design
selection of research participants
reporting adverse events
statistical analysis
data interpretation
data reporting
rewards and risks
Conflict of interest We l e a d
Financial COI
tangible (measurable)
involves some type of financial payment, such as a
consulting fee, equity in a company, or other
monetary reward, which influences an individual to
prefer one outcome to another
academic research and commercial interests can lead
to financial conflicts of interest
Conflict of interest We l e a d
Financial COI
include
compensation from employment
paid consultancy
stock ownership
intellectual property right (royalty, trademark,
patents)
paid expert testimony
gifts
trips
Conflict of interest We l e a d
lay-members non-affiliated
at least 2: one man and one woman
no affiliation with the institution /organization
not currently involved in medical, scientific, or
legal work
preferably from the community in which the
institution /organization is located
community point of view
minister of religion
knowledge on multi-religions /cultures issues
Ethical basis for decision-making in the
research ethics committees We l e a d
Scientific misconduct
violation of standard codes of conduct and behaviour
in scientific research
fabrication making up research data
falsification manipulate research data
plagiarism taking credit for the work of others
Ethical basis for decision-making in the
research ethics committees We l e a d
(JEPeM, 2015)
Summary We l e a d
COI
tangible and intangible
should be declared
Research ethics committee
responsible to review all proposal according to ethical
standard
Thank you
Berg et all, 2001, Informed consent, oxford University press
Baylis, F. (2009). "For love or money? The saga of Korean women who
provided eggs for embryonic stem cell research." Theor Med Bioeth 30(5):
385-396.
Burgess Michael, M 2007, Proposing modesty for informed consent, social
sciences and Medicine 65(2007), 2284-2295
Mandal, J, Achaya S, Parija S., (2011) Ethics in Human Research. Trop Parasitol
1(1); 2-3
Presented by
Dr Idris Long | PPSK, USM