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Background
material by Professor Omar Hasan Kasule Sr. for Year 6 ethics lecture at the
Faculty of Medicine King Fahad Medical City 11th February 2012
1.0 GENERAL
Distinguish between
therapeutic and non-therapeutic research.
Define the concept
‘good clinical practice’ and list its main principles.
Discuss issues
relating to inclusiveness (emphasis on: include minorities and women in
research).
Explain the
application of confidentiality in clinical research (use anonymized data, no
disclosure of subject details to researchers until after consent).
2.0 GOVERNANCE
Describe the
composition of an institutional research ethics committee
Describe the
functions of an institutional research ethics committee (emphasis on:
scientific quality of the research, competence of the researchers, risks to
research subjects, disclosures, compensation, payments to researchers and
participants, confidentiality of the data).
3.0 AUTONOMY
Explain the
application of the principle of autonomy in clinical research (emphasis on:
informed consent, consent needed even for records based research that is
published anonymously if non-health care workers have access before
anonymizing).
Explain why
informed consent in clinical research is more important than in normal patient
treatment.
List information
items that patients involved in clinical research must be told (emphasis on:
what is the treatment, evidence about the treatment and missing information
that necessitates research, how the treatment differs from the standard
treatment, available alternatives treatments, likely risks and benefits,
measures to ensure safety).
Explain
ethico-legal guidelines on withdrawal from research at any time.
4.0 VULNERABLE
RESEARCH SUBJECTS…1
Explain ethical
guidelines on recruitment as research subjects of people in a dependent
capacity such as prisoners, students, and employees.
Explain
ethico-legal guidelines on material inducements for research subjects.
Discuss the
obligation of members of the armed forces to be research subjects without
consent.
5.0 VULNERABLE
RESEARCH SUBJECTS…2
Explain
ethico-legal guidelines on consent to research by children (emphasis on:
consent by competent children endorsed by parents, consent by parents, consider
special vulnerability of children’s physiology, research in child’s interests
so parents cannot consent to research that is against the child’s interests,
benefits must outweigh the harm, extra precautions to prevent abuse, parental
consent can be overridden by the child,).
Explain
ethico-legal guidelines on consent to research by mentally incompetent persons
(emphasis on: decision by proxy or advance consent or refusal, benefits must
outweigh the harm, extra precautions to prevent abuse,).
6.0 EMBRYO OR FETAL RESEARCH
Describe 2 sources
of embryos for research and explain the difference in ethical consideration
between them (embryos can be surplus from IVF procedures or can be created
specifically for research. Creation of embryos for the sole purpose of research
is a more serious issue).
List research that
requires use of embryos (emphasis on conception, contraception, infertility,
inherited diseases).
Explain ethical
guidelines on research on fetal tissue (emphasis: fetal tissue from spontaneous
abortion creates few problems. Fetal tissue from induced abortion created the
appearance that the abortion was for purposes of obtaining the tissue, consent
is needed, no financial inducements, the timing, place, and type of termination
procedure must not be related to the requirements of research).
7.0 RESEARCH USING HUMAN MATERIAL
Describe
ethico-legal guidelines on genetic testing of biological samples obtained from
individuals (emphasis on: informed consent must be obtained if the test is not
anonymized).
Describe
ethico-legal guidelines on research on material from living donors (emphasis
on: approval by ethics committee, information on the how long the material will
be stored and the benefits and risks of the research, informed consent is
needed to take more material than is needed for therapeutic purposes and
specific consent to a specific research, rules of confidentiality. There is no
need for consent to test surplus anonymized material).
Describe
ethico-legal guidelines on research on material from deceased donors (emphasis
on: consent by family after full information: what tissues to retain, the
purpose and nature of the research, confidentiality).
8.0 PROBLEMS OF
FRAUD IN RESEARCH:
Describe various
forms of fraud in research (emphasis on: failure to follow standards GCP,
failure to get consent, data falsification, plagiarism, including as
researchers senior professor who did not actually participate in the research,
researchers not trained in ethics, falsifying authorship).
Describe methods of
avoiding research malpractices (emphasis on: training researchers in GCP and
ethics, ethical and scientific review of the research proposal, detailed
recording of all research activities, the principal researcher should be
personally involved in the research activities, quality assurance and audit
programs, whistleblowers on fraud).