Vulnerable Subjects

Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

Good Clinical Practice (GCP)

GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies

GCP compliance provides public assurance that the rights, safety and well-being of human subjects involved in research are protected

GCPGCP

Goals of GCP

To protect the rights, safety and welfare rights, safety and welfare of humans participating in research

To assure the quality, reliability and integrityquality, reliability and integrity of data collected

To provide standards and guidelinesstandards and guidelines for the conduct of clinical research

Good Clinical Practice = Ethics + Quality Data

GCP

Foundations for the ethical conduct of clinical research

The Nuremberg CodeNuremberg Code (1947)

The Declaration of HelsinkiDeclaration of Helsinki (1964)

The Belmont ReportBelmont Report (1979)

International Conference on Harmonisation (ICH-GCP)

International Standards Organization 14155

Code of Federal Regulations

A Historical Perspective

Nuremberg Code (1947) Voluntary participationVoluntary participation

Informed ConsentInformed Consent

Minimization of risk Minimization of risk

Belmont Report (1979)Respect for PersonsRespect for Persons

BeneficenceBeneficence

JusticeJustice

Declaration of Helsinki (1964)Well-being of subject takes precedenceWell-being of subject takes precedence

Respect for personsRespect for persons

Protection of subjects health and rightsProtection of subjects health and rights

Special protection for vulnerable populationsSpecial protection for vulnerable populations

THE PRINCIPLES OF ICH GCPEthicsEthics: 1. Ethical conduct of clinical trials 2. Benefits justify risks3. Rights, safety, and well-being of subjects prevail

Protocol and science:Protocol and science:4. Nonclinical and clinical information supports the

trial 5. Compliance with a scientifically sound, detailed

protocol

GOODGOODCLINICALCLINICALPRACTICEPRACTICE

THE PRINCIPLES OF ICH GCP

Responsibilities:Responsibilities: 6. IRB/IEC approval prior to initiation 7. Medical care/decisions by qualified physician8. Each individual is qualified (education, training,

experience) to perform his/her tasks

Informed Consent:Informed Consent:9. Freely given from every subject prior to

participation

THE PRINCIPLES OF ICH GCP

Data quality and integrity:Data quality and integrity: 10. Accurate reporting, interpretation, and verification11. Protects confidentiality of records

Investigational ProductsInvestigational Products12. Conform to GMP’s and used per protocolQuality Control/Quality Assurance 13. Systems with procedures to ensure quality of every

aspect of the trial

EDC

IPIP

THE PRINCIPLES OF ICH GCP The rights, safety, and well-beingrights, safety, and well-being of the trial

subjects are the most important considerations and should prevail over interests of science and society.

The available nonclinical and clinical informationnonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

THE PRINCIPLES OF ICH GCP Clinical trials should be scientifically sound, and

described in a clear, detailed Protocol.

A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.

THE PRINCIPLES OF ICH GCP The medical care given to, and medical decisions

made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.

Each individual involved in conducting a trial should be qualified by education,training, and experience to perform his or her respective task(s).

THE PRINCIPLES OF ICH GCP Freely given informed consent should be obtained

from every subject prior to clinical trial participation.

All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification.

THE PRINCIPLES OF ICH GCP The confidentiality of records that could identify

subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).

Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.

Clinical Trial Drug