Human subjects in research

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

circumstances that create a risk that professional

judgments or actions regarding a primary interest will
be unduly influenced by a secondary interest-
 Conflict of interest We l e a d

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

Willowbrook Hepatitis Studies (1956-72)

Staten Island's Willowbrook State School for the
Retarded
obj: vaccines to hepatitis
subject: mentally retarded children
method: hepatitis virus infection
COI: research objective and welfare of the children
(Intangible COI)
 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

Managing conflict of interest

zero tolerance policy
researchers have no financial relationship with
entities that support the research
"all investigators and team members directly
responsible for patient selection, the informed
consent process and/or clinical management in a
trial must not have equity, stock options or
comparable arrangements in companies
sponsoring the trial
 Conflict of interest We l e a d

Managing conflict of interest

disclosure policy
disclose financial relationships to the institution on
an annual basis and when an individuals situation
changes significantly
comprehensive
specific
informed consent process
participation of ombudsman
 Conflict of interest We l e a d

Managing conflict of interest

eliminating COI actions without obvious benefit
drug samples
free gifts
equity holding
industry control educational programme
Conflict of interest We l e a d
 Conflict of interest -cases We l e a d

Celebrex, Bextra and Vioxx (painkillers)

FDA advisory panel voted to allow these drugs in the
market despite the increased risk of heart attack
10 to 32 panel members provided consultations to the
drugs manufacturers
COI??
 We l e a d

RESEARCH ETHICS COMMITTEE

Research ethics committee We l e a d

multidisciplinary and multisectorial

gender balanced
reflects the social and cultural diversity of the
communities from which research participants are most
likely to be drawn
Research ethics committee We l e a d

appointing members -Helsinki Declaration

chairperson
managing agenda
adequate records
individuals with scientific expertise
expertise in behavioural or social sciences
health care providers
expertise in legal matters
Research ethics committee 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 design and conduct of the study

valid and sound scientific methods
qualifications of the researcher
the adequacy of provisions
the adequacy of the study site
Risks and potential benefits
risks have been minimized
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

Selection of study population and recruitment of

research participants
recruitment strategies
Inducements, financial benefits, and financial costs
reimburse cost transportation, child care
Protection of research participants privacy and
confidentiality
Ethical basis for decision-making in the
research ethics committees We l e a d

Informed consent process

examine the process through which informed consent
will occur and the information that will be provided
waive the requirement of informed consent
Community considerations
impact on the community (negative/ positive)
 JEPeM USM We l e a d

Jawatankuasa Etika Penyelidikan (Manusia) of USM

(JEPeM)
adopts research ethics guidelines outlined by
Declaration of Helsinki
World Medical Association
Council for International Organizations of Medical
Sciences (CIOMS)
 JEPeM USM We l e a d

To vet and regulate clinical proposals on;

Research involving human subjects [patients or
normal people]
Research involving human samples
Research involving data derived from humans
Research using products [biological or non-biological]
which will be tested on humans
Review process 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