Bioethics and Research Sterilized Jews whom Nazis considered as
racial enemies
Research contributes to nursing knowledge
Medical experiments involved exposing to high
Research influence patient care standards
altitudes, freezing temperature, malaria,
Professional nurses are obliged to ensure safe, poisons, typhus fever, untested drugs and
robust and ethical research surgery without anesthesia
Selection of subjects was racially based
ETHICS IN RESEARCH Subjects had no opportunity to refuse the
participation
Principles of Ethics and Research
NUREMBERGCODE
NUREMBERG CODE
DECLARATION OF HELSINKI
▪(German: Nürnberger Kodex) is a set of
BELMONTREPORT research ethics principles for human
HISTORICAL EVENTS AND DEVELOPMENT experimentation created as a result of the
Nuremberg trials at the end of the World War II.
Tuskegee Syphilis Study 1940s
▪The Code was formulated 70 plus years ago,
1940s Nazi Experiments in August 1947, in Nuremberg, Germany, by
Radiation Experiments Begins American judges sitting in judgment of Nazi
doctors accused of conducting murderous and
1947- Nuremberg Code torturous human experiments in the
concentration camps.
Tuskegee Syphilis Study 1930s- 1940s It served as a blueprint for today’s principles
that ensure the rights of subjects in medical
▪What happened in Tuskegee Syphilis Study? research.
▪What was unethical about the Tuskegee because of its link with the horrors of World
Syphilis Study? War II and the use of prisoners in Nazi
▪How many people died in the Tuskegee concentration camps for medical
Syphilis Study? experimentation
▪What ethical principles were violated by in the today debate continues about the authority of
Tuskegee the Code, its applicability to modern medical
research, and even its authorship.
Syphilis Study?
10 Basic Principles
▪Was the Tuskegee experiment successful?
Voluntary informed consent
▪How and when did the information on the
Tuskegee experiment came to public’s Experiment should be for the good of
attention? society, results not obtainable by other means
▪What is the Tuskegee effect? Experiment should be based upon prior
animal studies
Source:
https://www.cdc.gov/tuskegee/timeline.htm Physical and mental suffering and injury
should be avoided
there should be no expectation that death or
NAZI MEDICAL EXPERIMENTS disabling injury will occur from the experiment
(1933-1945) Risk vs. benefit
Atrocious, unethical activities implemented in Protect subjects against injury, disability, or
Third Reich in Europe from 1933-1945 death
Programs included sterilization, euthanasia, Only scientifically qualified individuals should
and numerous medical experiments in Nazi conduct human experimentation
concentration camps
Subject can terminate her/his involvement
The scientist must be prepared to terminate Investigators must protect life and health of
the experiment at any stage if the experiment research subjects
results in injury, disability or death to the
General Principles
experimental subject.
❑Medical research is subject to ethical
standard that promotes and ensure respect for
HISTORICAL EVENTS AND DEVELOPMENT all human subject and protect their health and
1950s-1961 Thalidomide Tragedy rights
1962 Kefauver-Harris Amendments Food, ❑ No national or international ethical, legal or
Drug and Cosmetic Act regulatory requirement should reduce or
eliminate any of the protections for research
1964 Declaration of Helsinki subjects
1950s-1961 ❑ Medical research involving human subjects
Thalidomide Tragedy must be conducted only by individuals with the
appropriate ethics and scientific education,
In the United Kingdom, the drug was licensed training and qualifications.
in 1958 and withdrawn in 1961. Of the
approximately 2,000 babies born with defects, ❑ Appropriate compensation and treatment for
around half died within a few months and 466 subjects who are harmed
survived to at least 2010.
as a result of participating in the research must
The thalidomide disaster is one of the darkest be ensured
episodes in pharmaceutical research history.
Risks, Burdens and Benefits
The drug was marketed as a mild sleeping pill
safe even for pregnant women. However, it ❑ Medical research involving human subjects
caused thousands of babies worldwide to be may only be conducted if the importance of the
born with malformed limbs. objectives outweighs the risk and the burdens
to the research subjects
The damage was revealed in 1962.
❑Physicians may not be involved in the
research study involving human subjects
DECLARATION OF HELSINKI unless they are confident that the risk have
been adequately assessed and can be
The Declaration of Helsinki (DoH) is, satisfactorily managed
indisputably, a remarkable document. It is the
mission of the medical doctor to safeguard the
health of the people. Vulnerable groups and Individuals
The British Medical Journal announced the
❑ Medical research with vulnerable groups is
emergence of the DoH in its 18 July 1964
only justified if the research is responsive to the
edition with the following words: ‘A draft code
health needs or priorities of this group and the
of ethics on human experimentation was
research can not be carried out in a non-
published in the British Medical Journal of 27
vulnerable group and that this group should
October 1962. stand to benefit from the knowledge, practices
or intervention that result from the research.
The primary purpose of medical research
involving human subjects is to understand the
causes, development and effects of disease
Scientific Requirements and Research
and improve preventive, diagnostic and
Protocol
therapeutic intervention.
❑ Medical research involving human subjects
DECLARATION OF HELSINKI (1964)
must conform to generally accepted scientific
Greater care can be exercised to protect principles, be based on a thorough knowledge
subjects from harmStrong, independent of scientific literature, other relevant sources of
justification for exposing a healthy volunteer to information and adequate laboratory and, as
substantial risk of harm appropriate, animal experimentation.
❑The protocol should include information Use of Placebo
regarding funding, sponsors, institutional
❑The benefits, risks, burdens and
affiliations, potential conflict of interest,
effectiveness of a new intervention must be
incentive for subjects and information regarding
tested against those of the best proven
provisions for treating and compensating
intervention(s), except in the following
subjects who are harmed as a consequence for
circumstances:
participating in the research study.
❑Where no proven intervention exist, the use
❑ In clinical trials, the protocol must also
of placebo or no intervention is acceptable
describe appropriate arrangement for post trial
provision. ❑Where for compelling and scientifically sound
methodological reasons the use of any
intervention less effective than the proven one,
Research Ethics Committees the use of placebo or no intervention is
necessary to determine the efficacy or safety of
❑The research protocol must be submitted for
an intervention Remove Watermark
consideration, comment, guidance and
approval to the concerned ethics committee ❑The benefits, risks, burdens and
before the study begins effectiveness of a new intervention must be
tested against those of the best proven
❑The committee must be transparent in its
intervention(s), except in the following
functioning, must be independent of the
circumstances:
researcher, the sponsor and any other undue
influence and must be duly qualified. ❑The patient who receive any intervention less
effective than the best proven one, placebo or
❑The committee must have the right to monitor
no intervention will not be subjected to
ongoing studies.
additional risk of serious or irreversible harm as
a result of not receiving the best proven
intervention. Extreme care must be taken to
Privacy and Confidentiality avoid abuse of this option. Remove Watermark
❑ Every precaution must be undertaken to
protect the privacy of the research subject and
the confidentiality of the information. Post trial Provision
❑In advance of a clinical trial, sponsors,
researcher and host country governments
Informed consent should make provision of a post trial access for
❑ Participation by individuals capable of giving all who still needs an intervention
informed consent as a subject must be identified as beneficial in the trial.Research
voluntary
Registration and Publication and
❑For potential research subjects who are not Dissemination of Result
capable of giving informed consent, the
physician must seek informed consent from ❑Every research study involving human
legally authorized representative. subject must be registered in a publicly
accessible database before recruitment of the
❑The physician must inform the patient which first subject.
aspects of their care are related to the
research. ❑Researchers have the duty to make the
result publicly available and are accountable
❑For medical research using identifiable for the completeness and accuracy of their
human material or data, such as research on reports.
material or data contained in biobanks or
similar repositories, the physician must seek ❑Report of research not in accordance with
informed consent for its collection, storage and principles of the Declaration should not be
reuse. accepted for publication.
Unproven Intervention in clinical Practice sometimes acceptable, as for young children),
but also prior peer review of research protocols
❑In the treatment of an individual, where by a committee (the institutional review board
proven intervention does not exist or other of the hospital or research institution) that
known intervention have been ineffective, the includes a representative of the community.
physician, after seeking an expert advice, with
informed consent from the patient or legally
authorized representative, may use unproven The Nuremberg Code focuses on the human
intervention if in the physicians judgment it rights of research subjects.
offers hope of saving life, re establishing
health or alleviating suffering. The Declaration of Helsinki focuses on the
obligations of physician-investigators to
research subjects,
Important points to ponder: The federal regulations emphasize the
Safeguarding research subjects obligations of research institutions that receive
federal funds.
Informed consent
Minimizing risk
HISTORICAL EVENTS AND DEVELOPMENT
Adhering to an approved research
plan/protocol 1974 - National Research Act 1972
Tuskeegee Study Exposed 1979
DECLARATION OF HELSINKI Belmont Report
A revised version was accepted as the final
draft at the meeting of the World Medical National Research Act (1974)
Association in Helsinki in June 1964, It is to be
known as the Declaration of Helsinki Attached Due to the publicity from the Syphilis Study,
to just over 700 words of the text of the original the National Research Act of 1974 was
DoH. passed.
In its 40-year lifetime the Declaration has The National Research Act created the
been revised five times and has risen to a National Commission for the Protection of
position of prominence as a guiding statement Human Subjects of Biomedical and Behavioral
of ethical principles for doctors involved in Research.
medical research.
The Commission charge was to identify the
basic ethical principles that should underlie the
conduct of biomedical and behavioral research
1962 US Kefauver Harris Amendments and involving human participants and to develop
Ferera lFood, Drug and Cosmetic Act guidelines which should be followed to assure
The amendment was a response to the that such research is conducted in accordance
thalidomide tragedy with those principles.
It introduced a requirement for drug
manufacturers to provide proof of the National Commission for the Protection of
effectiveness and safety of their drugs before Human Subjects of Biomedical and
approval,required drug advertising to disclose Behavioral Research
accurate information about side effects, and
Carrying out its charge, the Commission
stopped cheap generic drugs being marketed prepared the Belmont Report in 1979.
as expensive drugs under new trade names as
new "breakthrough" medications. The Belmont Report is a statement of basic
ethical principles and guidelines that provide
➢Thus, Both the Nuremberg Code and the “an analytical framework to guide the resolution
Declaration of Helsinki served as models for of the ethical problems arising from research
the current U.S. federal research regulations, with human subjects.”
which require not only the informed consent of
the research subject (with proxy consent
BELMONT REPORT 1. Respect for Persons
Thus, the Belmont Report attempts to Treat people as autonomous (having the right
summarize the basic ethical principals to self-govern) agents.
identified by the Commission in the course of
Protect those who has diminished autonomy
its deliberations.
(vulnerable populations), e.g. children,
It is the outgrowth of an intensive four-day prisoners, elderly.
period of discussions that were held in
February 1976 at the Smithsonian Institution’s
Belmont Conference Center supplemented by 2.Beneficence
the monthly deliberations of the Commission
that were held over a period of nearly four Do no harm,
years. Maximize benefits/minimize risks,
It is a statement of basic ethical principles NOT an act of kindness or charity, but a
and guidelines that should assist in resolving concrete obligation
the ethical problems that surround the conduct
of research with human subjects.
3. Justice
The Framework of the Belmont Report is Treat people fairly
presented into three discussion topics: Do not exploit those who are readily available
A. boundaries between practice and research or malleable
B. basic ethical principals Fair distribution of the risks and the benefits
of research based upon the problem/issue
C. applications. under investigation
A. Boundaries between Practice and C. Application
Research
Consideration of the three general principals
in the conduct of research lead to the
Practice consideration of:
Interventions designed solely to enhance the Informed Consent process
well Risk/Benefits assessment
-being of an individual Selection of research participants
Outcome
-Reasonable expectation of Success Application of Respect for Persons
Research Informed Consent Process
-Activity designed to test Information - Does the consent form provide
hypothesis;contributes to general knowledge all the information necessary for the individual
to make a reasoned decision?
Outcome
Comprehension - Is the consent form crafted
-Permits a conclusion to be drawn in language understandable to the potential
participant?
Voluntariness - Does the consent form
B. Consist of 3 basic Principles
clearly indicate that participation in the
1.Respect for Persons research is voluntary?
2.Beneficence What additional protections can be in place
to protect those with limited autonomy?
3. Justice
How to determine whether one lacks the
autonomy to make a reasoned decision?
Application of Beneficence Respect for Persons
Assessment of Risks and Benefits · Individuals should be treated as autonomous
agents
Risk refers to the probability of harm; when
considering risk, one should consider both the · Persons with diminished autonomy are
probability and the severity of the envisioned entitled to protection.
harm; while the term, benefit refers to
something that promotes health, well-being, or
welfare. Informed Consent
What are the risks of harm to the participants · Volunteer research participants, to the degree
(consider physical, psychological, social, and that they are capable, must be given the
opportunity to choose what shall or shall not
economic harms)? Are the risks justified? Can
happen to them
they be minimized?
· The consent process must include three
Can the research design be improved to
elements:
minimize risk and maximize benefit?
o Information,
What are the benefits (to the participant; to
o Comprehension, and
society)?
o Voluntary participation
Algorithm of Risk Determination
Beneficence
• Topic: Sensitive? Yes
· Human participants should not be harmed
• Intervention: Risky? Yes No
· Research should maximize possible benefits
• Population involved: Vulnerable? Yes No
and minimize possible risks
------------------------------
_____________________
Assessment of risks and benefits
• Level of risk Low Medium High
· The nature and scope of risks and benefits
Assessment Points
must be assessed in a systematic way
Application of Justice
Justice
Selection of Subjects
· The benefits and risks of research must be
Is the potential subject pool appropriate for distributed fairly
the research?
Selection of participants
Is it appropriate to involve vulnerable
· There must be fair procedures and outcomes
populations (e.g., economically disadvantaged;
in the selection of research participants
limited cognitive capacity) in the research or
are they being enrolled coz it is convenient or
coz they are easily manipulated as a result of
their situation? Philippine Setting…..
Are the recruitment procedures fair and Republic Act No. 10532
impartial? Otherwise known as the Philippine National
Are the inclusion and exclusion criteria fair Health Research System Act of 2013, of
and appropriate? which Section 12 states that the Philippine
Health Research Ethics Board
(PHREB), created under DOST Special Order
Basic Principles of the Belmont Report No. 091 s. 2006, shall ensure adherence to the
universal principles for the protection of human
Ethical Principles of Research Applications of
participants in research.
Ethical Principles for Research
Institutional Research Ethics Committees
Philippine institutions that engage in
biomedical and behavioral research shall
establish an institutional REC, which shall
provide independent, competent, and timely
ethical review of proposed studies. The main
purpose of the REC is to help safeguard the
dignity, rights, safety, and well-being of all
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 identified all over the Philippines. Of
these, 77 have been accredited by PHREB.
Source: National Guidelines for Health and
Health Related 2017
