Clinical Research Study notes, Slides of Pharmacy

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DEFINITION:

• (^) Ethics is the moral limitation placed

on power.

Or

• (^) Systematic reflection and analysis of

morality; it is a generic term for

various ways of understanding and

examining the moral life.

Morality:

• (^) Social beliefs and rights about pros &

cons in human conduct that are

widely shared that they form a stable

WHY A RESEARCH SHOULD BE ETHICAL?

 Involves many participants

 May induce exploitation of research participants.

 To prevent any maleficence to the subjects.

BASICS OF RESEARCH ETHICS:

 Minimize the possibility of subject exploitation

 Ensure the rights and welfare of subjects while

contributing to the generation of knowledge.

 (^) it emphasises on the following  (^) Voluntary consent of the human subject  (^) Anticipate scientific benefits  (^) Benefits always should outweigh risks  (^) human experimentation always be based on adequate animal experimentation.  (^) Avoid unnecessary physical mental suffering or injury  (^) Avoid experiments with high risks for death or disabling injury.

DECLARATION OF HELSINKI(1964):

The efforts of nuremberg code was reinforced by World Medical Association.

Brushes on the responsibilities of medical practitioners in clinical research  (^) It is revised 5 times by the association in conjugation with WHO the recent one being in

THE BELMONT REPORT(1979):  (^) The US National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research released the report  (^) Brushes ethical principles & guidelines for the protection of human subjects in a research study  (^) Basic elements of Belmont report were

1. Respect for the subject persons- first as an autonomous being who can make decisions on their own and second ones who cannot make decisions on their own (children, alzheimers patient, schizophrenic patients)
2. Voluntary consent of the subject for any research study and good knowledge about the goals of the study

 (^) Investigators and their institutions have to plan to maximise benefits & minimize risks.

The risks to the participants has to outweigh by the sum of both the anticipated benefit to the participants & the anticipated benefit to the society in the form of new knowledge

THE ICH-GCP GUIDELINES(1996):

 all together, these statements were known as

ETHICAL GUIDELINES FOR BIOMEDICAL

RESEARCH ON HUMAN PARTICIPANTS shortly

known as the ICMR code (Indian Council for Medical

Research)

 They were co- ordinated by the International

confrence on Harmonisation (ICH) on guidelines of

Good Clinical Practises(GCP)



Respect for persons

 (^) Includes two fundamental ethical considerations. a) Respect for autonomy (independence). Those who have concern about their personal choices should be treated with respect to their capacity for self-determination.  (^) b) Protection of persons with impaired or diminished autonomy. Those who are dependent or weak be given security against harm or abuse.

Justice

• (^) Requirement for fair and equitable subject selection.
• (^) Treat all participants fairly with no bias.

STATEMENT OF GENERAL PRINCIPLES:

1. PRINCIPLES OF ESSENTIALITY To prove that the research study involving humans is essential after due considerations of all alternatives of existing knowledge in the proposed area of research. The said research shall be necessary for the advancement of knowledge and be beneficial to the whole human race.

3.PRINCIPLES OF NON- EXPLOITATION:  (^) Irrespective of social, economic, educational levels, of the participants, they’re kept fully apprised of all dangers within the study

Each research shall include an in-built mechanism for compensation for the human participants either through insurance cover or any other means

Comprehensive after care shall be provided by the investigating managements.

4.PRINCIPLES OF PRIVACY & CONFIDENTIALITY:  (^) The identity & records of the human subjects in the research study are kept highly confidential.  (^) Any disclosure of identity done only with specific consent in written form from the subject  (^) To avoid any form of sufferings, hardships, discrimination or stigmatization as a result of being in a research study.