Ethical principles in clinical trials

♦ Declaration of Helsinki

 JUSTICE
♦ RESPECT FOR THE PARTICIPANTS
♦ BENEFECIENCE
♦ AND NON MALFACIENCE
a..Principles of essentiality

♦ Proposed research should be necessary

for the advancement of knowledge and
for the benefit of all members of the
human species.

♦?
a..Principles of essentiality
♦ Is the research project duely essential after due
consideration of alternatives Does it suit our
local requirements of the community?

♦ What are the risks to the subjects and to the

recepients of the medication in future

♦ Is it worth compared to the benefits?

♦ E.G.Inflammation vs.Multiple sclerosis
a..Principles of essentiality
Recommended
♦ Thorough Literature suvey to avoid
repetitions of mistakes
b.Principles of
voluntariness,informed consent and
community agreement
♦ Informed consent first proclaimed in the
Nurembeg code
Information
♦ provided in the local language,
♦ adequate disclosure about the
medication,
♦ The individuals must be able to
compehend the information
Principles of voluntariness,informed
consent and community agreement

♦ Recommended--- researchers develop

innovative methods to obtain consent
after thorough appraisal
b.Principles of
voluntariness,informed consent and
community agreement
Consent
♦ Written consent
♦ Witness
Community participation to obtain
informed consent
♦ understand the cultural and social
barriers
c.Principles of non exploitation
♦ Remuneration irrespective of their social
or economic status,literacy or
educational levels
♦ Keep the subjects fully appraised on the
risks involved
♦ Involve competent subjects,Do not
presume their understanding capabilities
♦ E.g.IUD quinacrine
d.Principles of privacy and
confidentiality
♦ No details of identity should be disclosed
without valid and legal reasons necessary
for intervention

♦ After obtaining the volunteers consent

consent

♦ Ensuring that no harm is ensued to the

person affected as a result of disclosure
e.Principles of precaution and
risk minimisation
♦ Minimum risk,suffer from no
irreversible adverse effects and benefit
from and by research project

♦ Caution at all stages of development

f.Principles of professional
competence
♦ Conduct of research should be by
competent and qualified persons

♦ Integrity and impartiality

♦ E.G.Wans participation in broncoscopic

examination
g.Principles of accountability and
transparency
♦ Fair,honest and transparent manner

♦ Conflict of interest?
h.Principles of maximisation of the
public interest and distributive justice
♦ Research or experiment and its
subsequent use should benefit all
irrespective of the social or economic
status
j.Principles of public domain
♦ Reasearch,experimentation or any
evaluations should be brought into public
domain through scientific publications
subjected to rights available to the
researcher and the laws in force at that
time
k.Principles of totality and
responsibility
The moral and professional responsibility of
allconcerned to duely observe the guidelines or
prrescriptions laid down for the research in
question
♦ Sponsor,
♦ Institutions,
♦ Research team
♦ patients
♦ Marketing team
♦ prescribers
k.Principles of totality and
responsibility
♦ MONITOR,

♦ REVIEW

♦ REMEDIAL MEASURES IF
REQUIRED
Principles of Compliance
♦ All persons conducting or connected with
should comply to the specific guidelines
and the applicable guidelines in letter as
well as spirit.

♦ Assurances of compliance