Tiêu đề 9. RESEARCH AND ETHICAL COMMITTEE.pdf ✅

PHARMD GURU Page 1 RESEARCH AND ETHICAL COMMITTEE  A well Established hospital is frequently approached by pharmaceutical industries to conduct research on human subjects, for their products. Such research involving human subjects in the hospital should be routed through an important committee called RESEARCH AND ETHICAL COMMITTEE, or simply, INDEPENDENT ETHICS COMMITTEE (IEC).  As a rule of thumb, all research involving human subjects should be conducted in accordance with the ethical principles contained in the current revision of Declaration of Helsinki. The declaration is based on three basic considerations, namely, justice, respect for person & to maximize benefits & minimize harm.  The Indian council of medical research (ICMR) has adopted the declaration of Helsinki & has issued “ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN SUBJECTS”. The main responsibilities of this committee are to control and monitor the clinical trials and research conducted in the hospital and it looks after the following:  Approve new clinical trials as well as review the ongoing trials.  To protect the dignity, rights & well-being of the potential participants (human subjects) in the research projects.  Approve the research and other experiments on patients.  Promote ethical use of the drugs, equipment’s, clinical tests on the patients by hospital staff.  Help the staff involved in research by proper education, guidance and supervision.  Co-ordinate without side agencies and organizations in research activities like post marketing surveillance of drugs etc.  To ensure that universal ethical values & international scientific standards are expressed in terms of local community values & customs. HOSPITAL COMMITTEES
PHARMD GURU Page 2 For clinical trials subjects, has to be:  Safe guarding the rights.  Safety & well being.  Decision making.  Emergency.  Payments.  Documentation.  Qualification of subjects. COMPOSITION OF IEC: The number of persons in IEC should be kept fairly small, to 5-7 members & should not exceed more than 12 to 15 for smooth functioning of the committee.  The chairperson of the committee should be from outside the institution (hospital), & not the head of the same institution, to impart freedom to the committee.  1 to 2 basic medical scientists (one of them preferably a clinical pharmacologist).  1 to 2 clinicians from various institutions or departments.  Secretary, usually the chief pharmacist or hospital pharmacist.  One legal expert or retired judge.  One social scientist / representative of NGO.  One philosopher / theologian / clergy.  One common person from community. ETHICS COMMITTEE DURING CLINICAL RESEARCH (OR) FUNCTIONS (OR) REVIEW PROCEDURES: The committee should review every research proposal on human subjects. It should ensure that scientific evaluation has been completed before ethical review is taken up. The IEC should evaluate the possible risks to the subjects with proper justification, the expected benefits & adequacy of documentation for ensuring privacy, confidentiality & justice.
PHARMD GURU Page 3 In order to carry out all these objectives of review procedures, the following steps are suggested:-  Review of the application submitted by the chief investigator for clear objectives, rational & existing knowledge in the area of research.  The curriculum vitae of the investigator & his colleague in the project.  Subjects recruitment procedure.  Inclusion & exclusion criteria for entry of subjects in the study.  Precise methodology of the research project including intended dosage, mode of administration of the drug, duration of treatment, details of invasive procedures etc.  Description of plans & withdrawal or withholding of therapies, during the research period.  Plans of statistical analysis of the study.  Procedure for obtaining informed consent of the subjects in the study.  Safety data of the drug / vaccine to be tested with supporting laboratory data.  Plans for emergency treatment in the event of adverse drug reaction, or toxicity reaction, or injury to the subjects.  Proposed compensation, or reimbursement, of expenses to the subjects.  Storage & maintenance of all data of the trails.  Plans of publishing the results with due confidentiality of the subjects involved.  All the relevant documents should be submitted to the regulatory authorities for the clearance of the project.  Agreement to comply with national & international GCP protocols.  Details of funding by sponsors or other agencies. To carry out all these tasks, the ethical committee must formally meet, with proper quorum & proper intimation of the meeting, its venue & time.
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