NCM67: BIOETHICS
to the experimental subject
WEEK 8: PRINCIPLES OF ETHICS IN RESEARCH
(7/05/2022)
A. PRINCIPLES OF ETHICS IN RESEARCH
1. NUREMBERG CODE
In August 1947 the judges included a section
called Permissible Medical Experiments. This section
became known as the Nuremberg Code and was the
first international code of research ethics. This set of
directives established the basic principles that must be
observed in order to satisfy moral, ethical, and legal
concepts in the conduct of human subject research.
1. The voluntary consent of the human subject is
absolutely essential.
2. The experiment should be such as to yield fruitful
results for the good of society.
3. The experiment should be so designed and based on
the results of animal experimentation and a knowledge
of the natural history of the disease.
4. The experiment should be so conducted as to avoid
all unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an
a priori reason to believe that death or disabling injury
will occur.
6. 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.
7. Proper preparations should be made and adequate
facilities provided to protect the experimental subject
against even remote possibilities of injury, disability, or
death.
8. The experiment should be conducted only by
scientifically qualified persons.
9. During the course of the experiment the human
subject should be at liberty to bring the experiment to an
end.
10. During the course of the experiment the scientist in
charge must be prepared to terminate the experiment at
any stage, if he has probable cause to believe, in the
exercise of the good faith, superior skill and careful
judgment required of him that a continuation of the
experiment is likely to result in injury, disability, or death
2. DECLARATION OF HELSINKI - A formal statement
developed by the World Medical Association. It provides
ethical guidelines that physicians and other medical
research participants should adhere to when conducting
research that uses human subjects.
○ Human Subjects
■ Any living person that a researcher
obtains data from, including data
obtained through interacting with the
person and identifiable information
about the person or their opinion.
The Declaration of Helsinki was first adopted in Helsinki,
Finland by the 18th World Medical Association General
Assembly in June 1964.
ORIGINS AND EARLY REVISIONS
● The 1947 Nuremberg Code was established.
○ Developed in response to the horrors of this
experimentation, with the aim of protecting
human subjects in medical research.
● Followed in 1948 by the WMA’s Declaration of
Geneva.
○ An oath for physicians that was first adopted
by the World Medical Association in 1948.
● Both documents influenced the development of the
Declaration of Helsinki.
● The Declaration of Helsinki took the ten principles from
the Nuremberg Code and merged them with the
Declaration of Geneva, which states that the patient's
health is always the doctor's first consideration, and the
International Code of Ethics, which states that in the
circumstance where the physical and mental condition of
a patient is impaired, the physician must act only in the
interest of the patient.
● Since its development in 1964, the Declaration of
Helsinki has undergone seven revisions, with the most
recent revision occurring at the World Medical
Association General Assembly in 2013.
GENERAL PRINCIPLES
● The physician is bind with the words, “The health of
my patient will be my first consideration” and “A
physician shall act in the patient’s best interest when
providing medical care.”
● It is the duty of the physician to promote and
safeguard the health, well-being and rights of patients,
including those who are involved in medical research.
● Medical progress is based on research that ultimately
must include studies involving human subjects.
● Even the best proven interventions must be evaluated
continually through research for their safety,
effectiveness, efficiency, accessibility and quality.
● Medical research is subject to ethical standards that
promote and ensure respect for all human subjects and
protect their health and rights.
● The goal of the medical research can never take
precedence over the rights and interests of individual
research subjects.
● It is the duty of physicians who are involved in medical
research to protect the life, health, dignity, integrity, right
to self-determination, privacy, and confidentiality of
personal information of research subjects.
● Physicians must consider the ethical, legal and
regulatory norms and standards for research involving
human subjects in their own countries as well as
applicable international norms and standards.
● Medical research should be conducted in a manner
that minimizes possible harm to the environment.
● Medical research involving human subjects must be
conducted only by individuals with the appropriate ethics
and scientific education, training and qualifications.
● Groups that are underrepresented in medical research
should be provided appropriate access to participation in
research.
● Physicians who combine medical research with
medical care should involve their patients in research
only to the extent that this is justified by its potential
preventive, diagnostic or therapeutic value.
● Appropriate compensation and treatment for subjects
who are harmed as a result of participating in research
must be ensured.
VULNERABLE GROUPS AND INDIVIDUALS
● All vulnerable groups and individuals should receive
specifically considered protection.
● This group should stand to benefit from the
knowledge, practices or interventions that result from the
research.
SCIENTIFIC REQUIREMENTS AND RESEARCH
PROTOCOLS
● The design and performance of each research study
involving human subjects must be clearly described and
justified in a research protocol. The protocol should
contain:
○ statement of the ethical considerations
involved and should indicate how the principles
in this Declaration have been addressed
○ information regarding funding, sponsors,
institutional affiliations, potential conflicts of
interest, incentives for subjects and;
○ information regarding provisions for treating
and/or compensating subjects who are harmed
as a consequence of participation in the
research study
RESEARCH ETHICS COMMITTEES
● The research protocol must be submitted for
consideration, comment, guidance and approval to the
concerned research ethics committee before the study
begins.
● The committee must have the right to monitor ongoing
studies.
INFORMED CONSENT
● Participation by individuals capable of giving informed
consent as subjects in medical research must be
voluntary
● Each potential subject must be adequately informed of
the aims, methods, sources of funding, any possible
conflicts of interest, institutional affiliations of the
researcher, the anticipated benefits and potential risks of
the study and the discomfort it may entail, post-study
provisions and any other relevant aspects of the study.
● All medical research subjects should be given the
option of being informed about the general outcome and
results of the study.
● The potential subject’s dissent should be respected.
● The physician must fully inform the patient which
aspects of their care are related to the research.
● For a potential research subject who is incapable of
giving informed consent, the physician must seek
informed consent from the legally authorized
representative.
USE OF PLACEBO
● The benefits, risks, burdens and effectiveness of a
new intervention must be tested against those of the
best proven intervention(s)
● Extreme care must be taken to avoid abuse of this
option.
POST-TRIAL
In advance of a clinical trial, sponsors, researchers and
host country governments should make provisions for
post-trial access for all participants who still need an
intervention identified as beneficial in the trial.
Every research study involving human subjects must be
registered in a publicly accessible database before
recruitment of the first subject.
Negative and inconclusive as well as positive results
must be published or otherwise made publicly available.
3. BELMONT REPORT
In July 1974, the National Research Act was signed into
law, creating the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral
Research. The creation of the Commission was
prompted by a National Institutes of Health study that
tracked the long-term health of a group of black males
with untreated syphilis. The subsequent outcry over the
allowance of such clear human suffering prompted a
charge to the Commission to develop guidelines that
would protect an agreed set of ethical principles that
should underlie any research involving human subjects.
After an intensive four-day meeting at the Smithsonian
Institution’s Belmont Conference Center, followed by
many months of additional deliberation, the Belmont
Report was presented to the Commission in April 1979.
The Belmont Report is a federal document that provides
the ethical principles and guidelines that must be
followed in research involving human participants. The
main purpose of the report is to protect the rights, well-
being, and safety of the participants involved in a
research study. The most important aspect of the
Belmont Report are the ethical principles it establishes,
which include respect for persons, beneficence, and
justice.
BASIC PRINCIPLES
The report was designed to offer clear guidance to any
scientists and members of Institutional Review Boards
(IRB) as to the basic ethical principles that should be
followed in any biomedical and behavioral research
involving human subjects.
The acceptable code of conduct was stipulated in
three categories:
● Respect for Persons – recognition of the personal
dignity and autonomy of individuals, 6 especially those in
need of special protection as a result of diminished
autonomy. In practice, this introduced the requirement of
informed consent, based on the provision of complete
information that is fully comprehensible by the research
subject, with complete confirmation that participation is
voluntary.
● Beneficence – protecting research subjects from
potential harm by designing research protocols so as to
maximize anticipated benefits and minimize possible
risks of harm. In practice, it falls to the IRB to accept or
challenge all assessments of potential risk in the
research design.
● Justice – the selection of research subjects must be
fair and equitable. In practice, their selection cannot be
influenced by favor (as friends or colleagues of the
researcher) or “disdain” (responding to the historical
practice of subjecting “undesirable” persons to high risk
research).
APPLYING THE PRINCIPLES
The Belmont Report consists of specific
principles and guidelines that must be followed in
biomedical and behavioral research. To ensure that
each principle is followed and met, various applications
were developed. Belmont Report applications include
the following:
● Informed consent — All participants should be allowed
the opportunity to decide what can and cannot happen to
them. All participants should be informed of the purpose,
risks, and benefits of the study. Participants should be
provided with information that is easy to understand and
should not be coerced into participating.
● Assessment of risks and benefits — The probability
and degree of harm that may occur during the study
must be considered. Additionally, benefits of the study
must be carefully considered.
● Selection of subjects — Selection of research
participants must be fair and should not discriminate
against race, ethnicity, social class, or gender. The rights
of vulnerable populations should be protected during the
selection process.
V. ETHICAL ISSUES RELATED TO TECHNOLOGY IN
THE DELIVERY OF HEALTHCARE
Technology has changed the way industry professionals
approach the idea of healthcare. Technology in health
care can continue to move fast and break things,
including breaking the trust between patients, family, and
staff. An ethical issue affects quality of care, and it may
impact patient safety. These are 7 challenges tech has
brought to healthcare.
1. Keeping Up with Old Tech - In spite of all of these
technological advances, many facilities still use out-of-
date technology. Outdated software creates security
holes like the one that allowed hackers. It's easy to
upgrade a computer to the next operating system in line.
However, for medical equipment running an older OS,
upgrading isn't as straightforward. The best way to avoid
problems is to upgrade when possible. The facility's IT
department should be fluent in every operating system
that's currently 7 in use.
2. User- Unfriendly Interfaces - Medical technology is
advancing by leaps and bounds. Yet one thing left in the
dark ages is user interface. These devices might change 8 it most may not have time to learn how to use it.
the world, but it won't matter if they're too difficult to use. Without a comprehensive understanding, trying to use
For medical professionals, there are two possible medical technology can lead to practitioner error and
courses of action to avoid an interface problem. First, malpractice. Hospital administrators, medical
engage with manufacturers during the research and professionals and IT teams need to tackle this challenge
development phase and let them know what's needed. head-on. Technology is going to change and shape the
Second, take the time to learn how unfriendly interfaces medical industry for decades to come. Those that don't
work. It may be challenging, but it could be the lesser of adapt will be left behind, struggling to keep up with the
two evils. tidal wave of innovation that's sweeping through
healthcare
3. Privacy and Confidentiality - EHRs or Electronic
Health Records have been encouraged to be used and
thus keeps patient’s data into a system. When patient's
health data are shared or linked without the patients'
knowledge, autonomy is jeopardized. The patient may
conceal information due to lack of confidence in the
security of the system having their data. As a
consequence, their treatment may be compromised.
There is the risk of revelation of thousands of patients'
health data through mistakes or theft.

4. Exacerbating Malpractice Claims - MedTech has

made many practices easier, but it overcomplicates
others. One case from 2013 is an ideal example. A 16-
year-old patient was supposed to take a single dose of
antibiotics before a routine procedure. A lack of
interoperability meant everyone who saw the patient —
between admissions and when he complained of anxiety
— thought he needed to take another dose. Overall, he
took nearly 39 times the recommended dose of this
medication. Problems like the one above cost hospitals
lots of money. Health Management Associates, LLC, is
another excellent example. They agreed to pay more
than $260 million to settle lawsuits surrounding
emergency room misconduct. Allegations claim the
organization forced physicians to make unnecessary
admissions. While medical malpractice cases involving
technology aren't common, representing around 1.3
percent of all claims between 2007 and 2014, they could
climb in the coming years. The best way to avoid EHR-
related issues is to be diligent when inputting information
into a patient's health record.

5. Overcomplicated Asset Tracking - Asset tracking

through electronic health records can be both a blessing
and a curse. Medical workers can use it to find anything
with a barcode or RFID tracking chip. However,
physicians often complain that poorly designed systems
impede their work, making them a slave to their EHRs.
The problem lies within the electronic health records
themselves. Experts designed the system to facilitate
billing, not improve patient care, though it should be able
to do both. While EHRs aren't avoidable, physicians can
reduce the strain and chance of technology burnout by
participating in training offered by providers.

6. Overall Implementation - Implementing technology

in medicine has a steep learning curve. Those who need