Ethical Principles In Clinical Trials

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,

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REVIEW

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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