Ethical Conduct Research involving humans should be Research involving humans should be scientifically sound scientifically sound and conducted in and conducted in accordance with basic ethical principles, accordance with basic ethical principles, which have their origin in the Declaration of which have their origin in the Declaration of Helsinki. Three basic ethical principles of Helsinki. Three basic ethical principles of equal importance, namely equal importance, namely respect for respect for persons, beneficence, and justice persons, beneficence, and justice, permeate all other GCP principles
Principle 2 Research Described in a Protocol Principle
Research Described in a Protocol Research involving humans should be Research involving humans should be scientifically justified and described in a clear, scientifically justified and described in a clear, detailed protocol.
Principle 3: Risk Identification Principle 3: Risk Identification
Before research involving humans is initiated, Before research involving humans is initiated, foreseeable risks and discomforts and any foreseeable risks and discomforts and any anticipated benefit (s) for the individual anticipated benefit (s) for the individual research subject and society should be research subject and society should be identified. Research of investigational products identified. Research of investigational products or procedures should be supported by or procedures should be supported by adequate non adequate non -clinical and, when applicable, clinical and, when applicable, clinical information.
Principle 4: Benefit -Risk Assessment
Risk Assessment Research involving humans should be initiated Research involving humans should be initiated only if the anticipated only if the anticipated benefit(s benefit(s) for the ) for the individual research subject and society clearly individual research subject and society clearly outweigh the risks. Although the benefit of the outweigh the risks. Although the benefit of the results of the trial to science and society should results of the trial to science and society should be taken into account, the most important be taken into account, the most important considerations are those related to the rights, considerations are those related to the rights, safety, and well safety, and well-being of the research subjects.
Principle 5 : Review by IEC/IRB
Research involving humans should receive Research involving humans should receive independent ethics committee/institutional independent ethics committee/institutional review board (IEC/IRB) approval/ review board (IEC/IRB) approval/favourable favourable opinion prior to initiation opinion
prior to initiation,
Principle 6 : Protocol Compliance
Research involving humans should be Research involving humans should be conducted in compliance with the approved conducted in compliance with the approved protocol.
Principle 7 : Informed Consent
Freely given informed consent should be Freely given informed consent should be obtained from every subject prior to research obtained from every subject prior to research participation in accordance with national participation in accordance with national culture (s) and requirements. When a subject culture (s) and requirements. When a subject is not capable of giving informed consent, is not capable of giving informed consent, the permission of a legally authorized the permission of a legally authorized representative should be obtained in representative should be obtained in accordance with applicable law.
Principle 8 : Continuing Review/Ongoing
Research involving humans should be Research involving humans should be continued only if the benefit continued only if the benefit-risk profile risk profile remains favorable. remains favorable.
Principle 9 : Investigator Qualifications
Qualified and duly licensed medical personnel Qualified and duly licensed medical personnel (i.e. physician or, when appropriate, dentist) (i.e. physician or, when appropriate, dentist) should be responsible for the medical care of should be responsible for the medical care of research subjects, and for any medical research subjects, and for any medical decision (s) made on their behalf. decision (s) made on their behalf.
Principle 10: Staff Qualifications
Each individual involved in conducting a trial Each individual involved in conducting a trial should be qualified by education, training, should be qualified by education, training, and experience to perform his or her and experience to perform his or her respective task (s) and currently licensed to respective task (s) and currently licensed to do so, where required. do so, where required.
Principle 11 : Records
All clinical trial information should be All clinical trial information should be recorded, handled, and stored in a way that recorded, handled, and stored in a way that allows its accurate reporting, interpretation, allows its accurate reporting, interpretation, and verification.
Principle 12 : Confidentiality/Privacy
The confidentiality of records that could The confidentiality of records that could identify subjects should be protected, identify subjects should be protected, respecting the privacy and confidentiality respecting the privacy and confidentiality rules in accordance with the applicable rules in accordance with the applicable regulatory requirement (s) regulatory requirement (s).
Principle 13 : Good Manufacturing Practice
Investigational products should be Investigational products should be manufactured, handled, and stored in manufactured, handled, and stored in accordance with applicable Good accordance with applicable Good Manufacturing Practice (GMP) and should be Manufacturing Practice (GMP) and should be used in accordance with the approved used in accordance with the approved protocol.
protocol.
Principle 14: Quality Systems
Systems with procedures that assure the Systems with procedures that assure the quality of every aspect of the trial should be quality of every aspect of the trial should be implemented.