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Ethics in Clinical Research The patient rights Clinical


Ethics in Clinical Research The patient rights Clinical trials the ABC What is a Clinical Trial? A clinical trial tests the effects of a medication, medical treatment ... – PowerPoint PPT presentation

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Title: Ethics in Clinical Research The patient rights Clinical

Ethics in Clinical ResearchThe patient rights
Clinical trials the ABC
What is informed consent? What is IRB?
What is a clinical trial? How is a drug approved
for testing? Who is a research subject? Who can
be in a clinical trial?
What is a Clinical Trial?
  • A clinical trial tests the effects of a
    medication, medical treatment, or device on a
    group of volunteers. Clinical trials are an
    important step in making new medications
    available. They measure the drug's ability to
    treat a condition, its safety and possible side

How is a Drug Approved for Testing?
  • The U.S. Food and Drug Administration (FDA)
    typically must authorize a drug company's
    proposal to conduct clinical trials. Drug
    companies must do years of laboratory research
    before they can begin testing medicines in

Who Can Be in a Clinical Trial?
  • People with the condition being studied as well
    as healthy people can volunteer to participate in
    a trial. There are strict requirements that
    specify which trials involve healthy volunteers
    and which trials involve patients with the
    condition being studied.

Who Can Be in a Clinical Trial?
  • Each trial has specific requirements such as age,
    sex, or medical condition for participants.
  • The physician conducting the trial must review
    each volunteer's medical history and the trial
    requirements to determine who can participate.
  • Known risks and discomforts will be explained by
    the trial physician prior to participating in the
  • In addition to the known risks, there may be
    unknown risks such as medication side effects
    involved in participating in a clinical trial.
  • Trial procedures, risks, and benefits are
    explained to volunteers during the informed
    consent process.

The research subject
  • A research subject is any object or phenomenon
    that is observed for purposes of research.
  • In survey research and opinion polling, the
    subject is often called a respondent.
  • In human subject research, one highly important
    topic is informed consent and human subject
  • There are many guidelines, all to insure that the
    subject is clearly informed of what the study
    will be, their participation, any possible
    consequences, that they can quit any time without
    consequences, who to contact with questions, and
    so forth.
  • All research involving human subjects should
    include aspects of human subject protection.

What is Informed Consent?
  • Informed consent is the process designed to give
    volunteers the information that they need to
    decide about participating in a clinical trial.
  • This process allows the volunteer to ask
    questions and to exchange information freely with
    the clinical investigator.
  • The clinical investigator is responsible for
    ensuring that informed consent is obtained from
    each research volunteer before that person
    participates in the research trial.

History of Experiments on Humans
  • Human experimentation and research ethics evolved
    over time.
  • Much of the time, the subjects of human
    experimentation were prisoners, slaves, family
    members, or the experimenter him/herself.

Who is the Institutional Review Board ?
  • The IRB is a group of healthcare professionals
    and members of the local community which must
    review and approve a clinical trial before it
  • The IRB reviews trial activities because its
    primary responsibility is to protect the safety
    and rights of the trial participants.
  • The purpose of an IRB review is to assure, both
    in advance and by periodic review, that
    appropriate steps are taken to protect the rights
    and welfare of humans participating as subjects
    in a research study.

Institutional review Board IRB
  • To accomplish their purpose, IRBs review research
    protocols and related materials (e.g., informed
    consent documents and investigator brochures) to
    ensure protection of the rights and welfare of
    human subjects of research.
  • The chief objectives of every IRB protocol review
    are to assess the scientific merit of the
    research and its methods, to promote fully
    informed and voluntary participation by
    prospective subjects who are themselves capable
    of making such choices (or, if that is not
    possible, informed permission given by a suitable
    proxy) and to maximize the safety of subjects
    once they are enrolled in the project.

Progress in science and medicine is essential for
human advancement.
  • Ethical values are essential in directing the
    application of scientific and medical advances.
  • Moral progress requires that benefits of progress
    be shared more widely and equitably throughout
    the world.
  • Scientific and medical progress should be
    inextricably linked to moral progress.

Ethical Values
  • Newer ethical values in research ethics
  • Justice
  • Fair access to participation in research studies
  • Fairness in distribution of harms/benefits - long
    term as well as short-term
  • Non-Exploitation of the vulnerable
  • Coupling the research endeavor to improvements in
    health care through partnerships and improves
    overall standards of care in research
  • Relevance of research to local needs - the
    importance of context
  • Narrowing the 10 90 gap by reshaping the
    research agenda
  • Cultural and linguistic sensitivity in obtaining
    informed consent
  • Solidarity and interdependence - acknowledging
    and facing global threats
  • Addressing deteriorating global health
  • Focusing on re-emerging and new infectious
  • Global health information equity
  • Long-standing ethical values in research ethics
  • Do not harm
  • Minimization of risk
  • Protection of the vulnerable
  • Respect for dignity of patients/ subjects
  • Informed consent
  • Protection of confidentiality
  • Freedom to withdraw
  • Justice
  • Compensation for injury
  • Appropriate remuneration for participation

The Declaration of Helsinki
  • Declaration of Helsinki was developed by the
    World Medical Association (WMA), as a set of
    ethical principles for the medical community
    regarding human experimenting.
  • It is widely regarded as the cornerstone document
    of human research ethics (WMA 2000, Bošnjak 2001,
    Tyebkhan 2003), although it is not a legally
    binding instrument in international law.
  • It draws its authority from the degree to which
    it has been codified in, or influenced national
    or regional legislation and regulations (Human
    and Fluss 2001).
  • However codes and guidelines impact on practice
    in both symbolic and instrumental roles. Its role
    was described by a Brazilian forum in 2000 in
    these words "Even though the Declaration of
    Helsinki is the responsibility of the World
    Medical Association, the document should be
    considered the property of all humanity" (Human
    and Fluss 2001).

HELSINKI Ethical Principles for Medical Research
Involving Human Subjects
  • Adopted by the 18th WMA General Assembly,
    Helsinki, Finland, June 1964, and
  • Amended by the 29th WMA General Assembly, Tokyo,
    Japan, October 1975
  • 35th WMA General Assembly, Venice, Italy, October
  • 41st WMA General Assembly, Hong Kong, September
  • 48th WMA General Assembly, Somerset West,
    Republic of South Africa, October 1996 and the
  • 52nd WMA General Assembly, Edinburgh, Scotland,
    October 2000
  • Note of Clarification on Paragraph 29 added by
    the WMA General Assembly, Washington 2002
  • Note of Clarification on Paragraph 30 added by
    the WMA General Assembly, Tokyo 2004

  • Some of the wisest words on this critically
    important aspect have been written by Justice
    M.N. Venkatachaliah, a former Chief Justice of
    India, in his Foreword to the 2000 Indian
    Guidelines referred to above
  • Genome-mapping, Genetic Recombinant Engineering,
    Assisted Reproductive technology, Stem-Cell
    Research, Human cloning, etc. have opened up
    hitherto unimagined vistas in the practical
    application of Biomedical Technologies for the
    benefit of the mankind.
  • Biomedical Research is perched on the threshold
    of a bold and brave new world. Crucial to its
    management is the ability of the scientists and
    the society to handle these forces of change.
  • Correspondingly, as in all frontier-line
    researches, our ignorance of the areas of the yet
    unknown might, paradoxically, expand with the
    expansion of our knowledge.
  • Biomedical Research has acquired dimensions which
    are at once exciting and awesome.It raises some
    delicate and difficult issues of ethics which
    need to be addressed with sensitivity to human
    values and with great circumspection.
  • While research which promises to mankind the
    great blessings of Science should not be stifled
    by too restrictive an approach, however, great
    care should be taken to ensure that something
    does not go out of hand. Therefore, any system of
    ethical guidelines on research needs to be
    cognizant of, and informed by, a sensitive
    balance of the risks and benefits.

Landmarks in protection of human subjects in
clinical trials
  • Nuremberg Code
  • Belmont Report
  • Declaration of Geneva
  • International Conference on Harmonisation of
    Technical Requirements for Registration of
    Pharmaceuticals for Human Use
  • Informed consent
  • Medical ethics
  • Clinical trial
  • Code of Federal Regulations

International Conference on Harmonization (ICH)
  • The International Conference on Harmonization of
    Technical Requirements for Registration of
    Pharmaceuticals for Human Use (ICH) is a project
    that brings together the regulatory authorities
    of Europe, Japan and the US and experts from the
    pharmaceutical industry in the three regions to
    discuss scientific and technical aspects of
    pharmaceutical product registration.
  • The purpose of ICH is to reduce or obviate the
    need to duplicate the testing carried out during
    the research and development of new medicines by
    recommending ways to achieve greater
    harmonization in the interpretation and
    application of technical guidelines and
    requirements for product registration.
  • Seven parties that represent the regulatory
    bodies and the research-based industries of the
    founding members are responsible for the decision
    making process the European Commission, the
    European Medicines Agency (EMEA), the European
    Federation of Pharmaceutical Industries and
    Associations (EFPIA), the Ministry of Health,
    Labor and Welfare, the Japan Pharmaceutical
    Manufacturers Association (JPMA), the Food and
    Drug Administration (FDA), and the Pharmaceutical
    Research and Manufacturers of America (PhRMA).

  • Good Clinical Practice is an international
    quality standard that is provided by
    International Conference on Harmonisation (ICH),
    an international body that defines standards,
    which governments can transpose into regulations
    for clinical trials involving human subjects.
  • Good Clinical Practice guidelines include
    protection of human rights as a subject in
    clinical trial. It also provides assurance of the
    safety and efficacy of the newly developed
  • Good Clinical Practice Guidelines include
    standards on how clinical trials should be
    conducted, define the roles and responsibilities
    of clinical trial sponsors, clinical research
    investigators, and monitors. In the
    pharmaceutical industry monitors are often called
    Clinical Research Associates.

Overview of the guidance
  • 1.9 When planning research in developing
    countries, researchers and sponsors may have to
    refer to
  • International guidelines or conventions
  • European Union Directives
  • National laws or guidelines
  • Regulations and guidelines for research sponsored
    by the pharmaceutical industry
  • Guidelines produced by funding agencies
  • Institutional guidelines
  • Guidelines relating to a specific disease and
  • Recommendations from advisory bodies.

Guidance for Research in Developing countries
  • World Medical Association (WMA 2000)
  • Declaration of Helsinki as last revised in Oct
  • Note of Clarification on Paragraph 29, Dec 2002
    Workgroup Report on the revision of Paragraph 30,
    Sep 2003 and
  • Note of Clarification on Paragraph 30, October
  • Not legally binding, but referred to in other
    forms of guidance and regulations
  • The Council for International Organizations of
  • Sciences (CIOMS) in collaboration with WHO (CIOMS
  • International Ethical Guidelines for Biomedical
    Research Involving Human Subjects, as last
    revised in Sep 2002.
  • Not legally binding, but referred to in other
    forms of guidance and regulations

Guidance for Research in Developing countries
  • Council of Europe (CoE 2004)
  • Additional Protocol to the Convention on Human
    Rights and Biomedicine concerning Biomedical
    Research, prepared by the Steering
  • Committee on Bioethics (CDBI) of the Council of
    Europe adopted by the Committee of Ministers,
    June 2004. (A draft Protocol, approved by the
    CDBI in June 2003, was discussed during the
    Workshop in February 2004.)
  • Legally binding if signed and ratified.
  • European Council and European Parliament (Eurpean
    Union)(EU 2001)
  • Directive 2001/20/EC of the European Parliament
    and of the Council on the approximation of the
    laws, regulations and administrative provisions
    of the Member States relating to implementation
    of good clinical practice in the conduct of
    clinical trials on medicinal products for human
    use, April 2001, adopted by Member States by May
    2003, brought into force May 2004.
  • Incorporated into national law for EU Member
    States applies within the EU and for
    multi-center clinical trials taking place in
    Member States and other countries

Guidance for Research in Developing countries
  • The European Group on Ethics in Science and New
    Technologies (EGE 20030
  • Its an advisory Opinion Nr 17 on the ethical
    aspects of clinical research in developing
    countries, published in Jan 2003.
  • Nuffield Council on Bioethics (NCOB 2002)
  • An advisory on the The ethics of research related
    to healthcare in developing countries, April
  • Whereas the other documents listed earlier
    provide specific guidelines on externally
    sponsored research, this Report focuses on
    establishing an ethical framework for those
    conducting such research, and provides

Informed consent is a legal condition whereby a
person can be said to have given consent based
upon an appreciation understanding of the facts
and implications of an action.
  • The individual needs to be in possession of
    relevant facts and also of his reasoning
    faculties, such as not being mentally retarded or
    mentally ill and without an impairment of
    judgment at the time of consenting. Such
    impairments might include illness, intoxication,
    insufficient sleep, and other health problems.
  • Some acts cannot legally take place because of a
    lack of informed consent. In cases where an
    individual is considered unable to give informed
    consent, another person is generally authorized
    to give consent on their behalf. Examples of
    this include the parents or legal guardians of a
    child and caregivers for the mentally ill.
  • In cases where an individual is provided limited
    facts, serious ethical issues may arise. Examples
    of this in a clinical trial in medical research
    are anticipated and prevented by an ethics
    committee or Institutional Review Board.

Individual consent requiredNo research on a
person may be carried out without the informed,
free, express, specific and documented consent of
the person. Article 14
Who should give consent?
  • Provision of information Article 13 lists the
    information that should be addressed during the
    consent process Persons being asked to
    participate in a research project shall be given
    adequate information in a comprehensible
    formcovering the purpose, the overall plan and
    the possible risks and benefits of the research
  • i. of the nature, extent and duration of the
    procedures involved, in particular, details of
    any burden imposed by the research project
  • ii. of available preventive, diagnostic and
    therapeutic procedures
  • iii. of the arrangements for responding to
    adverse events or the concerns of research
  • iv. of arrangements to ensure respect for private
    life and ensure the confidentiality of personal
  • v. of arrangements for access to information
    relevant to the participant arising from the
    research and to its overall results
  • vi. of the arrangements for fair compensation in
    the case of damage
  • vii. of any foreseen potential further uses,
    including commercial uses, of the research
    results, data or biological materials
  • viii. of the source of funding of the research
    project. and their right to refuse consent or
    to withdraw at any time without being subject to
    any form of discrimination.Article 13

Who should give consent?
  • Recording consent
  • Consent must be documented. Express consent may
    be either verbal or written as long as it is
    documented. Best practice demands that written
    consent be obtained, except in exceptional
    circumstances. Explanatory Report, paragraph
  • Inducements
  • Details of all payments and rewards to be made in
    the context of the research project must be
    considered by the ethics committee. Appendix
    Information to be given to the ethics committee
  • Other points
  • Article 15 discusses protection of persons not
    able to consent to research Article 19 discusses
    research in emergency clinical situations, when a
    person is not in a state to give consent.
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