Ethical%20Principles%20for%20Biomedical%20Research%20Involving%20Human%20Subjects:%20Overview%20of%20International%20Guidelines - PowerPoint PPT Presentation

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Title: Ethical%20Principles%20for%20Biomedical%20Research%20Involving%20Human%20Subjects:%20Overview%20of%20International%20Guidelines


1
Ethical Principles for Biomedical Research
Involving Human Subjects Overview of
International Guidelines
  • Maria Fidelis C. Manalo, MD,
  • MSc Epidemiology
  • Department of Community Family Medicine
  • Far Eastern University-
  • NRMF Medical Center
  • Philippines

2
Public Concern for Vulnerable Subjects
  • Nazi Experiments and the Nuremberg Trials
  • Tuskegee Syphilis Study-involvement of black
    males
  • Willowbrook Study-hepatitis study among children
    in New York State institution for mentally
    defective persons
  • Jewish Chronic Disease Hospital Study-injection
    of live cancer cells into patients to study
    transplant rejection process
  • San Antonio Contraceptive Study-study of side
    effects of contraceptives on Mexican American
    women

3
  • In research using human subjects, several
    categories of persons maybe involved
  • Normal healthy adults, including the
    investigator, and elderly persons
  • Sick adults, including the acutely and terminally
    ill
  • People living in highly controlled situations,
    such as, prisoners, soldiers, and students
  • Children, both healthy and ill
  • Mentally incompetent persons, whether adults or
    children
  • Unborn fetuses or still living aborted fetuses

4
Use of Vulnerable Persons
  • Not forbidden by ethical codes or regulations
  • Need for justification for their inclusion
  • Unsuitability of less vulnerable populations
  • Use of mitigation to address vulnerability

5
NUREMBERG CODE INFORMED CONSENT
  • The voluntary consent of the human subject is
    absolutely essential.
  • This means that the person involved should have
    legal capacity to give consent
  • Should be . . . able to exercise free power of
    choice, without the intervention of any element
    of force, fraud, deceit, duress, . . . or
    coercion
  • Should have sufficient knowledge and
    comprehension . . . .

6
NUREMBERG CODE INFORMED CONSENT
  • The duty and responsibility for ascertaining the
    quality of consent rests upon . . .each
    individual who initiates, directs, or engages in
    the experiment.
  • It is a personal duty that may not be delegated

7
ELEMENTS OF INFORMED CONSENT
  • (1) DISCLOSURE
  • In general necessary items to disclose include
  • a) the patients current medical status
    including the likely course if no treatment is
    provided.
  • b) the contemplated procedure or medication
  • c) alternative available procedures or
    medication
  • d) anticipated risks and benefits of both
  • e) a statement offering an opportunity to ask
    further questions
  • f) in case of research, his right to withdraw
    any time
  • g) a professional opinion about the alternatives

8
ELEMENTS OF INFORMED CONSENT
  • (2) COMPREHENSION
  • 7th grade level (US Standard)
  • Language understood by the subject
  • Oral or written quizzes to assess comprehension
  • Use of educational intervention prior to getting
    consent
  • Allowed into research environment to experience
    routine and procedures

9
ELEMENTS OF INFORMED CONSENT
  • (3) VOLUNTARINESS - The patient must of his own
    free will make a choice without being unduly
    pressured by anyone else.
  • Being free in making a decision means that the
    patient owns the decision, that the decision is
    the patients alone, that the patient has chosen
    the option based on the information disclosed to
    him/her.

10
ELEMENTS OF INFORMED CONSENT
  • (4) COMPETENCE - patients capacity for decision
    making. One is considered competent when
  • (a) one has made a decision (i.e. one can choose
    between alternatives)
  • (b) one has the capacity to justify ones choice
  • (i.e, give reasons for ones choice)
  • (c) one justifies ones choice in a reasonable
  • manner

11
HUMAN SUBJECTS OVER SCIENCE AND SOCIETY
  • . . . considerations related to the well-being
    of the human subject should take precedence over
    the interests of science and society.
    (Helsinki Declaration, par. 5)

12
Protection of Special Populations
  • Embryos And Human Fetuses
  • Since the human individual, in the prenatal
    stage, must be given the dignity of a human
    person, research and experimentation on human
    embryos and fetuses is subject to the ethical
    norms valid for the child already born and for
    every human subject.

13
Protection of Special Populations
  • Pregnant Women, Embryos And Human Fetuses
  • Research in particular, that is the observation
    of a given phenomenon during pregnancy, can be
    allowed only when there is moral certainty that
    there will be no harm either to the life or the
    integrity of the expected child and the mother,
    and on the condition that the parents have given
    their consent.

14
THERAPEUTIC CRITERIA ONLY
  • Experimentation is possible only for clearly
    therapeutic purposes, when no other possible
    remedy is available.
  • No finality, even if itself noble, such as the
    foreseeing of a usefulness for science, for other
    human beings or for society, can in any way
    justify experimentation on live human embryos and
    fetuses, whether viable or not, in the maternal
    womb or outside of it.

15
Protection of Special Populations
  • Experimentation of embryos or fetuses has the
    risk, indeed in most cases the certain
    foreknowledge, of damaging their physical
    integrity or even causing their death.
  • To use a human embryo or the fetus as an object
    or instrument of experimentation is a crime
    against their dignity as human beings.

16
Protection of Special Populations
  • The practice of keeping human embryos alive,
    actually or in vitro, for experimental or
    commercial reasons, is especially and
    altogether contrary to human dignity.
  • The informed consent, normally required for
    clinical experimentation on an adult, cannot be
    given by the parents, who may not dispose of the
    physical integrity or the life of the expected
    child.

17
PROPORTIONALITY OF RISKS TO BENEFITS
  • Degree of risk to be taken should never exceed .
    . . humanitarian importance of the problem to be
    solved . . . . (Nuremberg, 6)
  • Medical research . . . should only be conducted
    if the importance of the objective outweighs the
    inherent risks and burdens to the subject.
    (Helsinki, 18)

18
Right to refusal or withdrawal of treatment
  • the patient has the right to refuse or withdraw
    from treatment to the extent permitted by law and
    to be informed of the medical consequences of his
    action.- Patients Bill of Rights
  • a patient may refuse or withdraw from medical
    treatment because their religious convictions
    prohibit them from doing so (e.g., a patient who
    is a member of a particular religious sect may
    refuse to undergo blood transfusions)

19
PLACEBO MAY BE USED
  • When there is no established effective
    intervention
  • When withholding an established effective
    intervention would expose subjects to, at most,
    temporary discomfort or delay in relief of
    symptoms
  • When use of an established effective intervention
    as comparator would not yield scientifically
    reliable results and use of placebo would not add
    any risk of serious or irreversible harm to the
    subjects (CIOMS 11)

20
USE OF PLACEBO CONTROLS
  • The benefits, risks, burdens and effectiveness of
    a new method should be tested against those of
    the best current prophylactic, diagnostic, and
    therapeutic methods.
  • This does not exclude the use of placebo, or no
    treatment, in studies where no proven
    prophylactic, diagnostic or therapeutic method
    exists. (Helsinki 29)

21
Are there ethical issues in social science or
behavioral research?
  • Most common methodology used involves
    interviewing people and asking questions
  • We would just like to ask some questions
  • We would just like to observe
  • We would just like to share your life
  • Focus Group discussion (FGDs), Survey
  • Does not involve invasive procedures

22
Ethical Issues in Social Science Behavioral
Research
  • Privacy
  • Confidentiality
  • Linking behavior
  • with medical
  • procedure

23
DO NO HARM
  • Experiment should . . . avoid all unnecessary
    physical and mental suffering and injury.
    (Nuremberg, 4)

24
Forms of Harm to Human Subjects in Behavioral
Research
  • Psychological harm recalling a traumatic event
  • Social stigma loss of reputation
  • Cultural effects going against existing
    cultural norms
  • Political effects disturbing existing power
    relationships
  • Economic repercussions loss of jobs

25
HOW TO AVOID HARM
  • The experiment should be conducted only by
    scientifically qualified persons. (Nuremberg 8)
  • . . . human subject should be at liberty to bring
    the experiment to an end . . . (9)
  • . . . terminate the experiment at any stage, if .
    . . continuation of the experiment is likely to
    result in injury, disability, or death (10)

26
HOW TO AVOID HARM
  • Ensure that risks involved have been adequately
    assessed and can be satisfactorily managed.
  • Cease . . . investigation if
  • the risks are found to outweigh the potential
    benefits, or
  • there is conclusive proof of positive and
    beneficial results (Helsinki 17)

27
Mitigating harm to human subjects
  • Research design- community inputs
  • Adequate research preparation-familiarization
    with local culture, sociopolitical structures,
    traditions and cultural norms
  • Good reason to conduct research in a particular
    community
  • Ethical Consideration Section in the protocol

28
NBAC Guideline
  • Whenever possible, preceding the start of
    research, agreements should be negotiated by the
    relevant parties to make effective intervention
    or other research benefits available to the host
    country after the study is completed.

29
Mitigating harm to human subjects
  • Research methodologies should avoid harm
  • Mechanisms for protection of privacy and
    confidentiality
  • Avoidance of social stigmatization
  • Process of data storage
  • Adequate infrastructure to protect privacy
  • Research methodologies should provide
    opportunities for empowerment-reflexivity

30
Mitigating harm to human subjects-Reviewing the
protocol
  • Technical review
  • Risk-benefit analysis
  • Benefits should be defined in the protocol
  • Provisions for support mechanisms
  • Consent process should be as strict as
    requirements in clinical trials
  • Recruitment procedures
  • Full disclosure of information
  • Reconsenting mechanisms
  • Feedback to community

31
Mitigating harm to human subjects- Reviewing the
protocol
  • Culturally competent consent form
  • Individual consent
  • Family consent-secondary subjects
  • Community consent
  • Mechanisms for protection of privacy and
  • confidentiality defined in the consent form
    of
  • information sheet
  • Provision of support/coping mechanism
  • Need to take precaution to protect identity
  • of host community

32
Informed consent Community Context - CIOMS
  • When it is not possible to request informed
    consent from every individual to be studied, the
    agreement of a representative of a community or
    group should be sought, but the representative
    should be chosen according to the nature,
    traditions and political philosophy of the
    community or group.

33
Feedback to the Community
  • Reporting results to the community
  • A good means to highlight good practices
    positive reinforcement
  • Suggestions for improvement should be presented
    as constructive recommendations
  • Public forum a means to get public commitment
    from public officials
  • Opportunities for researchers to connect
    community to larger community

34
RELEVANCE
RESPONSIVENESS OF RESEARCH
  • Medical research is only justified if there is a
    reasonable likelihood that the populations in
    which the research is carried out stand to
    benefit from the results of the research.
    (Helsinki 19)

CIOMS
35
RELEVANCE AND RESPONSIVENESS
  • The sponsor and the investigator must make every
    effort to ensure that
  • the research is responsive to the health needs
    and the priorities of the population . . . and
  • any intervention or product developed, or
    knowledge generated, will be made reasonably
    available for the benefit of that population.
    (CIOMS 10)

36
GENETIC RESEARCH Privacy, Confidentiality and
Integrity
  • Respect the privacy of the subject,
  • the confidentiality of the patient's information
    and minimize the impact
  • of the study on the subject's physical and
    mental integrity (Helsinki 21)

37
MEDICAL RECORDS BIOLOGICAL SPECIMENS
  • Exempted from individual consent requirement only
    if an ethical review committee has determined
    that
  • Research poses minimal risk
  • Rights or interests of the patients will not be
    violated
  • privacy and confidentiality or anonymity are
    ensured
  • Research is designed to answer an important
    question
  • Impracticable if the requirement for informed
    consent were to be imposed (CIOMS)

38
HUMAN GENETIC DATA
  • Clear, balanced, adequate and appropriate
    information shall be provided to the person whose
    prior, free, informed and express consent is
    sought.
  • Information shall . . . specify the purpose for
    which human genetic data . . . are being derived,
    . . . used and stored (International Declaration
    on Human Genetic DataAdopted by the UNESCO
    General Assembly on 16 October 2003)

39
DISCRIMINATION AND STIGMATIZATION
  • (a) The use of . . .human genetic . . . and . .
    . proteomic data should not . . . have the
    effect of infringing human rights, fundamental
    freedoms or human dignity of an individual or . .
    . lead to the stigmatization of an individual, a
    family, a group or communities.
  • (b) . . . Appropriate attention should be paid to
    the findings of population-based genetic studies
    and behavioural genetic studies . . . .

UNESCO Intl Declaration, Art. 7
40
WITHDRAWAL OF CONSENT
  • (a) . . . Consent may be withdrawn by the person
    concerned unless such data are irretrievably
    unlinked to an identifiable person.
  • (b) When a person withdraws consent, the persons
    genetic data, proteomic data and biological
    samples should no longer be used unless they are
    irretrievably unlinked to the person concerned.
  • (c) If the persons wishes cannot be determined
    or are not feasible or are unsafe, the data and
    biological samples should either be irretrievably
    unlinked or destroyed.

UNESCO Intl Declaration, Art. 9
41
RIGHT TO BE, OR NOT TO BE INFORMED OF RESULTS
  • The person concerned has the right to decide
    whether or not to be informed of the results

UNESCO Intl Declaration, Art. 10
42
GENETIC COUNSELLING
  • . . . When genetic testing . . . is being
    considered, genetic counselling should be made
    available . . . .
  • Genetic counselling should be non-directive,
    culturally adapted and consistent with the best
    interest of the person concerned.

UNESCO Intl Declaration, Art. 11
43
CLINICAL TRIAL REGISTRATION A Requirement for
Publication
  • Trials must register at or before the onset of
    patient enrollment.
  • Selective reporting . . . distorts the body of
    evidence available for clinical decision-making.
  • Trial results that place financial interests at
    risk are particularly likely to remain
    unpublished and hidden from public view.
  • Anyone should be able to learn of any trial's
    existence and its important characteristics.

44
BIBLIOGRAPHY
  • 1.   Ethical Review of Research Overview of
    International Guidelines and Principles by Prof.
    Leonardo de Castro, Ph.D, Department of
    Philosophy, University of the Philippines,
    Diliman
  • 2. Ethical Issues in Social Science Research by
    Prof. Cristina E. Torres, Ph.D, College of Arts
    and Sciences, University of the Philippines,
    Manila National Institute of Health
  • 3. Protection of Vulnerable Subjects by Prof.
    Cristina E. Torres, Ph.D, College of Arts and
    Sciences, UP Manila National Institute of
    Health
  • 4. World Medical Association (WMA) Declaration
    of Helsinki, Tokyo, 2004
  • 5. The Nuremberg Code 1947
  •  

45
BIBLIOGRAPHY
  • 6. The CIOMS Guidelines Nov 2000, International
    Ethical Guidelines for Biomedical Research
    Involving Human Subjects
  • 7.   The NBAC Report Aug 2001, Ethical and Policy
    Issues in Research Involving Human Participants
  • 8.   International Declaration on Human Genetic
    Data, UNESCO, October 16, 2003
  • 9.   The Belmont Report, 1979, Ethical Principles
    and Guidelines for the Protection of Human
    Subjects of Research
  • 10.  Fifth Global Forum for Health Research,
    Paris, 2004
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