Bioethics and

Research
 OBJECTIVES
General: After 1 hour and 30 mins. The BSN level 2 students will be able to
apply ethico-moral concepts and principles , discuss issues and concerns in
varied health care situations affecting the care of individuals, families,
population group and community in the concept of bioethics and research.
Specifically they will be able to:
Specific:
1. Identify the Principles of Ethics and Research
2. Discuss the historical events and development of Ethics and Research
in respect to the following :
2.1 Nuremberg Code
2.2 Declaration of Helsinki
2.3 Belmont Report
 OBJECTIVES

3. Recognize the role of the nurse in the application of ethical

principles in research
Research contributes to nursing
knowledge

Research influence patient care

standards
ETHICS
IN
Professional nurses are obliged to RESEARCH
ensure safe, robust and ethical
research
 A.
Principles
of
Ethics and NUREMBERG DECLARATION OF BELMONT
Research CODE HELSINKI REPORT
  Tuskegee Syphilis Study 1940s

 1940s Nazi Experiments

HISTORICAL
EVENTS AND
 Radiation Experiments Begins
DEVELOPMENT

 1947- Nuremberg Code

What happened in Tuskegee Syphilis
Study?
What was unethical about the
Tuskegee Syphilis Study?
How many people died in the
Tuskegee Syphilis Study?
What ethical principles were violated
by in the Tuskegee Syphilis Study?
Was the Tuskegee experiment
successful?
How and when did the information on
the Tuskegee experiment came to
public’s attention?
What is the Tuskegee effect?
Source: https://www.cdc.gov/tuskegee/timeline.htm
 Atrocious, unethical activities
implemented in Third Reich in Europe
from 1933-1945

NAZI MEDICAL Programs included sterilization,

EXPERIMENTS euthanasia, and numerous medical
(1933-1945) experiments in Nazi concentration
camps

Sterilized Jews whom Nazis considered

as racial enemies
 Medical experiments involved
exposing to high altitudes, freezing
temperature, malaria, poisons,
typhus fever, untested drugs and
NAZI MEDICAL surgery without anesthesia
EXPERIMENTS
(1933-1945) Selection of subjects was racially
based

Subjects had no opportunity to refuse

the participation
 (German: Nürnberger Kodex) is a set of research
ethics principles for human experimentation
created as a result of the Nuremberg trials at
the end of the World War II.
NUREMBERG The Code was formulated 70 plus years ago, in
CODE August 1947, in Nuremberg, Germany, by
American judges sitting in judgment of Nazi
doctors accused of conducting murderous and
torturous human experiments in the
concentration camps.
  It served as a blueprint for today’s principles
that ensure the rights of subjects in medical
research.
NUREMBERG  because of its link with the horrors of World
CODE War II and the use of prisoners in Nazi
concentration camps for medical
experimentation
 today debate continues about the authority of
the Code, its applicability to modern medical
research, and even its authorship.
 10 Basic Principles
 Voluntary informed consent
 Experiment should be for the good of society, results not
obtainable by other means
 Experiment should be based upon prior animal studies
 Physical and mental suffering and injury should be avoided
 there should be no expectation that death or disabling injury
NUREMBERG will occur from the experiment
CODE  Risk vs. benefit
 Protect subjects against injury, disability, or death
 Only scientifically qualified individuals should conduct human
experimentation
 Subject can terminate her/his involvement
 The scientist must be prepared to terminate the experiment
at any stage if the experiment results in injury, disability or
death to the experimental subject.
 1950s-1961 Thalidomide Tragedy

HISTORICAL
EVENTS AND 1962 Kefauver-Harris Amendments Food,
DEVELOPMENT Drug and Cosmetic Act

1964 Declaration of Helsinki

 In the United Kingdom, the drug was licensed in
1958 and withdrawn in 1961. Of the
approximately 2,000 babies born with defects,
around half died within a few months and 466
1950s-1961 survived to at least 2010.
Thalidomide The thalidomide disaster is one of the darkest
Tragedy episodes in pharmaceutical research history.
The drug was marketed as a mild sleeping pill
safe even for pregnant women. However, it
caused thousands of babies worldwide to be
born with malformed limbs.
The damage was revealed in 1962.
  The Declaration of Helsinki (DoH) is,
indisputably, a remarkable document. It is the
mission of the medical doctor to safeguard the
health of the people.
DECLARATION
OF  The British Medical Journal announced the
HELSINKI emergence of the DoH in its 18 July 1964
edition with the following words: ‘A draft code
of ethics on human experimentation was
published in the British Medical Journal of 27
October 1962.
 The primary purpose of medical
research involving human subjects is to
DECLARATION
understand the causes, development
OF
HELSINKI and effects of disease and improve
preventive, diagnostic and therapeutic
intervention.
 Greater care can be exercised to protect
subjects from harm
DECLARATION
OF Strong, independent justification for
HELSINKI exposing a healthy volunteer to
(1964) substantial risk of harm

Investigators must protect life and health

of research subjects
 Medical research is subject to ethical
standard that promotes and ensure
respect for all human subject and
protect their health and rights
 No national or international ethical,
General legal or regulatory requirement should
Principles reduce or eliminate any of the
protections for research subjects
 Medical research involving human
subjects must be conducted only by
individuals with the appropriate ethics
and scientific education, training and
qualifications.
  Appropriate compensation and
General treatment for subjects who are harmed
Principles as a result of participating in the
research must be ensured
  Medical research involving human subjects
may only be conducted if the importance of
the objectives outweighs the risk and the
Risks, burdens to the research subjects
Burdens and Physicians may not be involved in the
Benefits research study involving human subjects
unless they are confident that the risk have
been adequately assessed and can be
satisfactorily managed
  Medical research with vulnerable groups is
only justified if the research is responsive to
Vulnerable the health needs or priorities of this group
and the research can not be carried out in a
groups and non-vulnerable group and that this group
Individuals should stand to benefit from the knowledge,
practices or intervention that result from the
research.
  Medical research involving human subjects
must conform to generally accepted scientific
principles, be based on a thorough knowledge of
scientific literature, other relevant sources of
Scientific information and adequate laboratory and, as
appropriate, animal experimentation.
Requirements
The protocol should include information
and Research regarding funding, sponsors, institutional
Protocol affiliations, potential conflict of interest,
incentive for subjects and information regarding
provisions for treating and compensating
subjects who are harmed as a consequence for
participating in the research study.
Scientific
Requirements  In clinical trials, the protocol must also
describe appropriate arrangement for post
and Research trial provision.
Protocol
  The research protocol must be submitted
for consideration, comment, guidance and
approval to the concerned ethics committee
before the study begins
Research The committee must be transparent in its
Ethics functioning, must be independent of the
Committees researcher, the sponsor and any other undue
influence and must be duly qualified.
The committee must have the right to
monitor ongoing studies.
  Every precaution must be undertaken
Privacy and to protect the privacy of the research
Confidentiality subject and the confidentiality of the
information.
  Participation by individuals capable of
giving informed consent as a subject
must be voluntary
For potential research subjects who
Informed are not capable of giving informed
consent, the physician must seek
consent informed consent from legally
authorized representative.
The physician must inform the patient
which aspects of their care are related
to the research.
 For medical research using identifiable
human material or data, such as
Informed research on material or data contained
consent in biobanks or similar repositories, the
physician must seek informed consent
for its collection, storage and reuse.
 The benefits, risks, burdens and
effectiveness of a new intervention
must be tested against those of the
best proven intervention(s), except in
the following circumstances:
Where no proven intervention exist,
the use of placebo or no intervention is
Use of Placebo acceptable
Where for compelling and
scientifically sound methodological
reasons the use of any intervention
less effective than the proven one, the
use of placebo or no intervention is
necessary to determine the efficacy or
safety of an intervention
 The benefits, risks, burdens and
effectiveness of a new intervention
must be tested against those of the
best proven intervention(s), except in
the following circumstances:
 The patient who receive any
Use of Placebo intervention less effective than the
best proven one, placebo or no
intervention will not be subjected to
additional risk of serious or irreversible
harm as a result of not receiving the
best proven intervention. Extreme
care must be taken to avoid abuse of
this option.
 In advance of a clinical trial, sponsors,
Post trial researcher and host country governments
should make provision of a post trial access
Provision for all who still needs an intervention
identified as beneficial in the trial.
 Every research study involving human
subject must be registered in a publicly
accessible database before recruitment of
Research
the first subject.
Registration
and Publication Researchers have the duty to make the
result publicly available and are accountable
and for the completeness and accuracy of their
Dissemination reports.
of Result
Report of research not in accordance with
principles of the Declaration should not be
accepted for publication.
 In the treatment of an individual, where
proven intervention does not exist or other
known intervention have been ineffective,
Unproven the physician, after seeking an expert advice,
Intervention in with informed consent from the patient or
clinical Practice legally authorized representative, may use
unproven intervention if in the physicians
judgment it offers hope of saving life, re-
establishing health or alleviating suffering.
 Safeguarding research subjects
Important Informed consent
points to Minimizing risk
ponder: Adhering to an approved research
plan/protocol
  A revised version was accepted as the final
draft at the meeting of the World Medical
Association in Helsinki in June 1964, It is to be
known as the Declaration of Helsinki Attached
DECLARATION to just over 700 words of the text of the original
OF DoH.
HELSINKI
 In its 40-year lifetime the Declaration has been
revised five times and has risen to a position of
prominence as a guiding statement of ethical
principles for doctors involved in medical
research.
 The amendment was a response to the
1962 US thalidomide tragedy
Kefauver- It introduced a requirement for drug
Harris manufacturers to provide proof of the
Amendments effectiveness and safety of their drugs
and Fereral before approval, required drug
Food, Drug advertising to disclose accurate
and Cosmetic information about side effects, and
stopped cheap generic drugs being
Act marketed as expensive drugs under new
trade names as new "breakthrough"
medications.
Thus, Both the Nuremberg Code and the
Declaration of Helsinki served as models for
the current U.S. federal research regulations,
which require not only the informed consent
of the research subject (with proxy consent
sometimes acceptable, as for young children),
but also prior peer review of research
protocols by a committee (the institutional
review board of the hospital or research
institution) that includes a representative of
the community.
The Nuremberg Code focuses on the human
rights of research subjects.

The Declaration of Helsinki focuses on the

obligations of physician-investigators to
research subjects,

The federal regulations emphasize the

obligations of research institutions that
receive federal funds.
  1974 - National Research Act 1972

HISTORICAL
EVENTS AND  Tuskeegee Study Exposed 1979
DEVELOPMENT

 Belmont Report
  Due to the publicity from the Syphilis Study,
the National Research Act of 1974 was passed.
 The National Research Act created the National
Commission for the Protection of Human
Subjects of Biomedical and Behavioral
National Research.
Research Act  The Commission charge was to identify the
(1974) basic ethical principles that should underlie the
conduct of biomedical and behavioral research
involving human participants and to develop
guidelines which should be followed to assure
that such research is conducted in accordance
with those principles.
National Carrying out its charge, the Commission
Commission for prepared the Belmont Report in 1979.
the Protection of The Belmont Report is a statement of
Human Subjects basic ethical principles and guidelines
of Biomedical that provide “an analytical framework to
guide the resolution of the ethical
and Behavioral problems arising from research with
Research human subjects.”
  Thus, the Belmont Report attempts to summarize the
basic ethical principals identified by the Commission in
the course of its deliberations.
 It is the outgrowth of an intensive four-day period of
discussions that were held in February 1976 at the
BELMONT Smithsonian Institution’s Belmont Conference Center
supplemented by the monthly deliberations of the
REPORT Commission that were held over a period of nearly four
years.
 It is a statement of basic ethical principles and
guidelines that should assist in resolving the ethical
problems that surround the conduct of research with
human subjects.
The
Framework of A. boundaries between practice and
the Belmont research
Report is
 B. basic ethical principals
presented into
three C. applications.
discussion
topics:
 TERM TERM DEFINITION OUTCOME
Interventions designed Reasonable
Practice solely to enhance the expectation of Success
well-being of an
A. Boundaries individual

between
Practice and Activity designed to Permits a conclusion to
test hypothesis; be drawn
Research Research contributes to general
knowledge
 1.Respect for Persons

B. Consist of 3
basic Principles
2.Beneficence

 3. Justice
 Treat people as autonomous (having the
right to self-govern) agents.
1. Respect for
Persons Protect those who has diminished
autonomy (vulnerable populations), e.g.
children, prisoners, elderly.
  Do no harm,

Maximize benefits/minimize risks,

2.Beneficence
 NOT an act of kindness or charity,
but a concrete obligation
 Treat people fairly

Do not exploit those who are readily

3. Justice available or malleable

 Fair distribution of the risks and the

benefits of research based upon the
problem/issue under investigation
  Consideration of the three general
principals in the conduct of research lead
to the consideration of:

C. Application  Informed Consent process

 Risk/Benefits assessment

Selection of research participants

  Informed Consent Process
 Information - Does the consent form provide all
the information necessary for the individual to
make a reasoned decision?
 Comprehension - Is the consent form crafted in
language understandable to the potential
Application of participant?
Respect for  Voluntariness - Does the consent form clearly
indicate that participation in the research is
Persons voluntary?
 What additional protections can be in place to
protect those with limited autonomy?
 How to determine whether one lacks the
autonomy to make a reasoned decision?
  Assessment of Risks and Benefits
 Risk refers to the probability of harm; when
considering risk, one should consider both the
probability and the severity of the envisioned
harm; while the term, benefit refers to something
that promotes health, well-being, or welfare.
Application of  What are the risks of harm to the participants
Beneficence (consider physical, psychological, social, and
economic harms)? Are the risks justified? Can they
be minimized?
 Can the research design be improved to minimize
risk and maximize benefit?
 What are the benefits (to the participant; to
society)?
 Assessment Points

• Topic: Sensitive? Yes No

• Intervention: Risky? Yes No

Algorithm of
Risk • Population involved: Vulnerable? Yes No

Determination ------------------------------ _____________________

• Level of risk Low Medium High
  Selection of Subjects
 Is the potential subject pool appropriate for the
research?
 Is it appropriate to involve vulnerable populations
Application of (e.g., economically disadvantaged; limited
cognitive capacity) in the research or are they
Justice being enrolled coz it is convenient or coz they are
easily manipulated as a result of their situation?
 Are the recruitment procedures fair and impartial?
 Are the inclusion and exclusion criteria fair and
appropriate?
 Ethical Principles of Research Applications of Ethical Principles for
Research
Respect for Persons Informed Consent
· Individuals should be treated as · Volunteer research participants, to
autonomous agents the degree that they are capable, must be
given the opportunity to choose what shall
· Persons with diminished
Basic autonomy are entitled to protection.
or shall not happen to them
· The consent process must include
Principles of three elements:
o Information,
the Belmont o
o
Comprehension, and
Voluntary participation
Report Beneficence Assessment of risks and benefits
· Human participants should not · The nature and scope of risks
be harmed and benefits must be assessed in a
· Research should maximize systematic way
possible benefits and minimize
possible risks
Justice Selection of participants
· The benefits and risks of · There must be fair procedures
research must be distributed fairly and outcomes in the selection of
research participants
Philippine Setting…..
  Otherwise known as the Philippine
National Health Research System Act of
2013, of which Section 12 states that the
Philippine Health Research Ethics Board
Republic Act
(PHREB), created under DOST Special
No. 10532 Order No. 091 s. 2006, shall ensure
adherence to the universal principles for
the protection of human participants in
research.
  Philippine institutions that engage in
biomedical and behavioral research shall
establish an institutional REC, which shall
provide independent, competent, and timely
Institutional ethical review of proposed studies. The main
purpose of the REC is to help safeguard the
Research Ethics dignity, rights, safety, and well-being of all
Committees actual or potential research participants. To this
end, it is important that in its composition,
procedures, and decision-making, the REC shall
be independent of political, institutional,
professional, and market influences.
  The REC should consider both the scientific and ethical
aspects of the proposed research even when the REC is
distinct from the technical review committee.
 As of August 2017, more than 200 RECs have been
Institutional identified all over the Philippines. Of these, 77 have
Research Ethics been accredited by PHREB.
Committees

 Source: National Guidelines for Health and Health

Related 2017