Transcript Slide 1

Learning objectives
After giving this lecture the student should be able to do
the following:
 Describe the historical background that led to the
development of ethical guidelines for the use of
human subjects in research.
 Identify the essential elementals of an informed
consent form.
 Evaluate the adequacy of an informed consent form.
 Describe the institutional review board’s role in the
research review process.
 Critique the ethical aspects of a research study.
Introduction
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Researchers and caregivers of research subjects
must take every precaution to protect people being
studied from physical or mental harm or discomfort.
The principle “ the ends justify the means” must
never be tolerated.
Researchers and caregivers providing care to
patients, who has happen to be research subjects,
must be fully committed to the tenets of informed
consent and patients rights.
Historical perspective:
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Ethical and legal consideration with regard to
research first received attention after world
war II .( when Nazi physicians do their trials
on war criminals).
Development of the Nuremburg code.
Articles of the Nuremberg code
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The voluntary consent of the human subject is absolutely
essential.
The study should be such as to yield fruitful results for
the good of society, unprocurable by other means of
study , and not random and unnecessary in nature.
The experimental should be so designed and based on
the results of animal experimentation and knowledge of
the natural history of the disease or other problems
under study that the anticipated results will justify the
performance of the experiment.
The experiment should be conducted to avoid all
unnecessary physical and mental suffering and injury.
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No experimental should be conducted to where there is a prior
reason to believe that death or disabling injury.
The degree of risk to be taken should never exceed that determined
by the humanitarian importance of the problem to be solved by the
experiment.
Proper preparations should be made and adequate facilities
provided to protect the subject against …. Injury, disability, or death.
The experiment should be conducted only by scientifically qualified
persons
The human subject should be at liberty to bring the experiment to an
end.
During the experiment, the scientist ….if he has probable cause to
believe that a continuation of the experiment is likely to result in
injury, disability or death to the experimental subject…. Will bring it
to a close.
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Several other international standards have followed such as:
“ Declaration of Helsink (1964)
The first set of proposed regulations on the protection of human
subjects were published by the department of health,
education, and welfare
The most impotent provision was a regulation mandating that
an institutional review board (IRB) must review and approve all
studies.
The national commission for the protection of human subjects
of biomedical and behavioral research, was created by the
national research Act(1974).
It identifies 3 basic ethical principles that should be followed in
any research.
Basic Ethical principles relevant to the
conduct of research
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Respect for person:
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Beneficence
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People have the right to self-determination and to treatment
as autonomous agents. Thus they have the freedom to
participate or not participate in research . Persons with
diminished autonomy are entitled to protection.
An obligation to do no harm and maximize possible benefits.
Persons are treated in an ethical manner when their
decisions are respected .they are protected from harm and
efforts are made to secure their well –being.
justice
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Human subjects should be treated fairly. An injustice occurs
when benefit to which a person is entitled is denied without
good reason or when a burden is imposed unduly.
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Belmont Report served as a model for many of the
ethical codes developed by scientific disciplines
In 1980, the department of health and human
services developed a set of regulations such as:
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General requirements for informed consent
Documentation of informed consent
Institutional review board (IRB) review of research
proposals.
Exempt and expedited review procedures for certain kinds
of research.
Criteria for IRB approval of research.
Examples of unethical research
studies
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In 1965 Doctors inspected aged & senile patients with
live cancer cells to study their rejection response.
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No informed consent.
No approval of the study from the ethical committee
In 1969 investigational drugs were used on mentally
disabled children without first obtaining the opinion of a
psychiatrist.
In 1932-1978 the researchers wanted to study the
untreated syphilis patients treatment was withheld from
the group having syphilis.
Current and Future Ethical Dilemmas
in Research :
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Area of biotechnology
Using Animals for research as in case of
transplantations
The ethics' as well as the risks and benefits of this
type of human / animal research are still in question ,
the issue is very controversial .
Other area of research that create discussion and
controversy are :
A Fetal tissue research .
Use of women who are of childbearing potential as
subject in drug/therapeutic studies.
Evolution of ethics in nursing research
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1897 : Nurses’ associated alumnae
organization (establishes a code of ethics for
the nursing profession )
1900 : - Isabel, Hampton, Robb wrote “Nursing
ethics” : for hospital and private use
They highlight a historical concern for ethical
action by nurses as health care providers.
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1970 : - The American nurses associations (ANA)
established the commission on nursing research. It
supports two sets of human rights :
1 – The right of qualified nurses to engage in research and
have access to resource necessary for implementing
scientific investigation .
2 – The rights of all persons who are participants in research
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ANA emphasized human rights in term of 3
domains :
1 – Right to freedom from intrinsic risk on injury .
2 – Right to privacy and dignity
3 – Right to anonymity .
1975 : - ANA published the human rights guidelines for nursing
in clinical and other research which reflect the nursing
professions code of ethics for research.
NB : the nurse as a researcher as caregiver must assure patients
that their human rights will be safe guarded .
 1988 : Fowler, a nurse ethicist , calls for as international code of
ethics for nursing research .
 1990 : Davis, supports the concept of shared values among all
nurses, stating that many of nursing shared values are found in
their professional codes.
NB. Some countries have their own codes others use the
international council of nurses (ICN) code for nurses .
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American nursing association human
rights guidelines for nurses in clinical
and other research
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Cuidline1 : Right to self Determination
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Implementation: where research participation is a
condition of employment, nurses must be informed in
writing of the nature of the activity involved in advance of
employment. If nurses are not so informed , they must
be given the opportunity potential of risk to others must
be clarified in relation to the types of risk involved, the
ways of recognizing when risk is present, and the ways
in which to counteract potential and unnecessary
danger.
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Cuidline2 : Right to Freedom from Risk or harm
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Implementation: Investigators must ensure freedom of
risk from harm by estimating the potential physical or
emotional risk and benefit involved vulnerable and
captive subjects, such as students, patients prisoners,
mentally incompetent , children , the elderly, and the
poor, must be carefully monitored for sources of
potential risk of injury so they can be protected.
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Cuidline3 : Scope of Application
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Implementation: Guidelines for protection of human
rights apply to all individuals, that is subjects involved in
research activities. The use of subjects with limited civil
freedom can usually be justified only when there is
benefit to them or others in similar circumstances.
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Cuidline4 : Responsibility to Support Knowledge
Development
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Implementation: Nurses have an obligation to support
the development of the scientific Knowledge or base of
nursing practice.
Cuidline5 : Informed consent
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Implementation: the right to self-determination is
protected when informed consent is obtained from the
prospective or legal guardian.
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Cuidline6 : Participation on institutional Review Boards
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Implementation: As Professionals accountable to the
public who are the consumers of health care, nurses
have an obligation to support the inclusion of nurses on
institutional review boards (IRBs). Nurses also have an
obligation to serve on IRBs to review ethical implications
of proposed and ongoing research. All studies involving
data collection from humans, animals, or records should
be reviewed by a review board of health professionals
and community representative who ensure the
protection of subject rights.
1 – right to self-determination :
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Based on the ethical principle of respect
for persons, people should be treated as
autonomous agents who have the freedom to
choose without external controls .
The right to participate in the study or not
The right to withdraw at any time of the study
with penalty.
2-Right to privacy as dignity:
Based on the principle of respect privacy is
the freedom of a person to determine the
time , extent , and circumstances under
which private information is shared as
withheld from others.
3- Right to anonymity and confidentiality:
Based on the principle of respect subjects
identity can not be lined to the information
they provided and not publicly repented.
4 - Right to fair treatment :
Based on the ethical principle of justice, people
should be treated fairly and should receive what they
are due or owed .
5 - Right to protection from discomfort
and harm:
Based on the ethical principle of beneficence.
People must take an active role in promoting
good and preventing harm in any thing, as well
as in research studies . Discomfort and harm can
be physical, psychological, social, or economic in
nature .
Procedure for protecting basic human right informed
consent
It the legal principle that , at least in
theory governs the patients ability to accept
or reject individual medical interventions
designed to diagnose determines or treats an
illness. It is also the doctrine that determines
and regulates participation in research
( Dubler, 1987 ) .
Elements of informed consent
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A statement that the study involves research.
An explanation of the purposes of the research,
delineating the excepted duration of the subject’s
participation.
A description of the procedures to followed, and
identification of any procedures which are
experimental.
A description of any reasonably risks or
discomforts to the subject.
A description of any benefits to the subject or to
others that may reasonably be expected from the
research.
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A disclosure of appropriate alternative procedures
course of treatment, if any, that might be
advantageous to the subject.
A statement describing the extent to which
anonymity and confidentiality of the records
identifying the subject will be maintained
For research involving more than minimal risk, an
explanation as to whether consist of, or where
further information may be obtained.
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An explanation about who to contact for answers
to questions about the research and researcher
subjects’ rights , and who to contact in the event of
a research-related injury to the subject.
A statement that participation is voluntary, that
refusal to participate will not involve any penalty or
less benefit to which the subject is otherwise
entitled and the subject may discontinue
participation at any time without penalty or loss of
otherwise entitled benefits.
What the research should downer
involving human being in research :
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Obtaining the legally effective informed consent of a subject
as legally authorized representative.
The language of the consent form must be understandable
(the use of technical research language should be avoided )
Informed consent could be obtained through personal
discussion with potential subject .
Assurance of anonymity and confidentiality is usually
conveyed in writing .
The consent from must be signed by the subject and dated.
Sometimes there is a witness to sign and also the research
signs the form to indicate commitment to the agreement
The consent should be kept by the subject and the
researcher should keep a copy also.
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Some researches such as a retrospective chart
audit , may not require informed consent , but only
institutional approval is enough. Sometimes there
is only a need to provide the subject with the
needed information though verbal explanation.
The IRB makes the final determination as to the
most appropriate documentation format.
Research consumers should note whether and
what kind of evidence of informed consent has
been provided in a research article.
The intuitional review boardd :
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Intuitional review boards ( IRBs) are boards that
review research projects to assess that ethical
standards are met in relation to the protection of
the rights of human subjects.
The national research act require that the IRB have
at least five members of various back grounds to
promote complete and adequate project review.
•The members must be qualified by virtue of their expertise and
experience and reflect professional , gender , racial , and cultural diversity.
• Membership must include one member whose concerns are primarily
nonscientific such as lawyer and at least one member from outside the
agency.
•The board reviews the study’s protocol to ensure that it meets the
requirements of ethical research.
•Most boards provide guideline as instructions for researcher that include
steps to be taken to receive IRB approval .e.g. guideline for writing a
standard consent form or criteria.
•The IRB has the authority to approve research require modification as
disapprove, or disapprove a research study.
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A researcher must receive some form of IRB
approval before beginning to conduct research
The IRB have the authority to suspend or terminate
approval of research that is not conducted in
accordance with IRB requirement or that has been
associated with unexpected serious harm to
subjects.
The IRB have mechanisms for reviewing research in
an expedited manner where there is minimal risk to
research subject (Federal code 1983)
Nurses who are critiquing published research should
be conversant with current regulation to determine
whether ethical standards have been met .
Special legal and Ethical
Considerations Related to Protecting
Basic Human Right
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Researchers are advised to consult their agency’s
IRB for the most recent federal and state rules
and guidelines when considering research
involving the elderly children , the mentally ill,
prisoners, the deceased, the unborn, student, and
persons with AIDS.
Critiquing criteria
1. Was the study approved by IRB or other agency
committee members?
2. Is there evidence that informed consent was obtained
from all subjects or their representatives? How was it
obtained?
3. Were the subjects protected from physical or emotional
harm?
4. Were the subjects or their representatives informed
about the purpose and nature of the study?
5. Were the subjects or their representatives informed
about any potential risks that might result from
participation in the study?
6. Did the benefits of the study outweigh the risks?
7. Were subject coerced or unduly influenced to
participate in this study? did they have the right to
refuse to participate or withdraw without penalty? Were
vulnerable subjects used?
8. Were appropriate steps taken to safeguard the privacy
of subject? How have data been kept anonymous
and/or confidential?