STUDENT’S COPY

The Nuremberg Code

 The Nuremberg Code of 1947 was developed in response to unethical

medical practices during World War II.

 It sets forth fundamental principles for conducting ethical research involving

human subjects.

 https://youtu.be/Alv90bASoRI
 https://youtu.be/VcbPqhwJzcg
WMA DECLARATION OF HELSINKI
– ETHICAL PRINCIPLES FOR
MEDICAL RESEARCH INVOLVING
HUMAN PARTICIPANTS
 PREAMBLE

1.The World Medical Association (WMA) has developed the

Declaration of Helsinki as a statement of ethical principles for
medical research involving human participants, including research
using identifiable human material or data.

2.While the Declaration is adopted by physicians, the WMA holds that

these principles should be upheld by all individuals, teams, and
organizations involved in medical research, as these principles are
fundamental to respect for and protection of all research
participants, including both patients and healthy volunteers.
 GENERAL PRINCIPLES

3.The WMA Declaration of Geneva binds the physician with the words,
“The health and well-being of my patient will be my first
consideration,” and the WMA International Code of Medical Ethics
declares “The physician must commit to the primacy of patient
health and well-being and must offer care in the patient’s best interest.”

4.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. The physician’s knowledge and
conscience are dedicated to the fulfilment of this duty.
5.Medical progress is based on research that ultimately must
include participants.
Even well-proven interventions should be evaluated
continually through research for their safety,
effectiveness, efficiency, accessibility, and quality.

6.Medical research involving human participants is subject to

ethical standards that promote and ensure respect for all
participants and protect their health and rights.
7.The primary purpose of medical research involving human participants
is to generate knowledge to understand the causes, development
and effects of diseases; improve preventive, diagnostic and
therapeutic interventions; and ultimately to advance individual
and public health.
These purposes can never take precedence over the rights and interests
of individual research participants.

8.While new knowledge and interventions may be urgently needed

during public health emergencies, it remains essential to uphold
the ethical principles in this Declaration during such emergencies.
9.It is the duty of physicians who are involved in medical research to protect
the life, health, dignity, integrity, autonomy, privacy, and
confidentiality of personal information of research participants. The
responsibility for the protection of research participants must always rest
with physicians or other researchers and never with the research
participants, even though they have given consent.

10.Physicians and other researchers must consider the ethical, legal and
regulatory norms and standards for research involving human
participants in the country or countries in which the research originated
and where it is to be performed, as well as applicable international
norms and standards. No national or international ethical, legal or
regulatory requirement should reduce or eliminate any of the protections for
research participants set forth in this Declaration.
11.Medical research should be designed and conducted in a
manner that avoids or minimizes harm to the
environment and strives for environmental sustainability.

12.Medical research involving human participants must be

conducted only by individuals with the appropriate ethics and
scientific education, training and qualifications. Such
research requires the supervision of a competent and
appropriately qualified physician or other researcher.
13.Groups that are underrepresented in medical research should
be provided appropriate access to participation in
research.

14.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 and if the physician has good reason
to believe that participation in the research will not
adversely affect the health of the patients who serve as
research participants.

15.Appropriate compensation and treatment for participants who

are harmed as a result of participating in research must be
ensured.
 Risks, Burdens, and Benefits

16.In medical practice and in medical research, most

interventions involve risks and burdens.
Medical research involving human participants may only
be conducted if the importance of the objective
outweighs the risks and burdens to the research participants.

17.All medical research involving human participants must be

preceded by careful assessment of predictable risks and
burdens to the individuals and groups involved in the
research in comparison with foreseeable benefits to
them and to other individuals or groups affected by the
condition under investigation.
18.Physicians and other researchers may not engage in
research involving human participants unless they are
confident that the risks and burdens have been adequately
assessed and can be satisfactorily managed.
When the risks and burdens are found to outweigh the
potential benefits or when there is conclusive proof of
definitive outcomes, physicians and other researchers
must assess whether to continue, modify or
immediately stop the research.
 Individual, Group, and Community Vulnerability

19.Some individuals, groups, and communities are in a situation of more

vulnerability as research participants due to factors that may be fixed or
contextual and dynamic, and thus are at greater risk of being wronged
or incurring harm. When such individuals, groups, and communities
have distinctive health needs, their exclusion from medical research
can potentially perpetuate or exacerbate their disparities. Therefore,
the harms of exclusion must be considered and weighed against the
harms of inclusion. In order to be fairly and responsibly included in
research, they should receive specifically considered support and
protections.
20.Medical research with individuals, groups, or communities
in situations of particular vulnerability is only justified
if it is responsive to their health needs and priorities
and the individual, group, or community stands to
benefit from the resulting knowledge, practices, or
interventions. Researchers should only include those in
situations of particular vulnerability when the research
cannot be carried out in a less vulnerable group or
community, or when excluding them would perpetuate or
exacerbate their disparities.
 Scientific Requirements and Research Protocols

21.Medical research involving human participants must have a

scientifically sound and rigorous design and execution that are likely
to produce reliable, valid, and valuable knowledge and avoid
research waste. The research must conform to generally accepted
scientific principles, be based on a thorough knowledge of the
scientific literature, other relevant sources of information, and
adequate laboratory and, as appropriate, animal experimentation.
The welfare of animals used for research must be respected.
22.The design and performance of all medical research involving
human participants must be clearly described and justified in a research
protocol.
The protocol should contain a statement of the ethical
considerations involved and should indicate how the principles in
this Declaration have been addressed. The protocol should include
information regarding aims, methods, anticipated benefits and potential
risks and burdens, qualifications of the researcher, sources of funding,
any potential conflicts of interest, provisions to protect privacy
and confidentiality, incentives for participants, provisions for treating
and/or compensating participants who are harmed as a consequence
of participation, and any other relevant aspects of the research.
In clinical trials, the protocol must also describe any post-trial
provisions.
 Research Ethics Committees

23.The protocol must be submitted for consideration, comment,

guidance, and approval to the concerned research ethics committee
before the research begins. This committee must be transparent in
its functioning and must have the independence and authority to
resist undue influence from the researcher, the sponsor, or
others. The committee must have sufficient resources to fulfill its
duties, and its members and staff must collectively have adequate
education, training, qualifications, and diversity to effectively
evaluate each type of research it reviews.
 Privacy and Confidentiality
24.Every precaution must be taken to protect the privacy of
research participants and the confidentiality of their
personal information.

Free and Informed Consent

25.Free and informed consent is an essential component of
respect for individual autonomy. Participation by
individuals capable of giving informed consent in medical
research must be voluntary. Although it may be appropriate
to consult family members or community representatives,
individuals capable of giving informed consent may not be
enrolled in research unless they freely agree.
26.In medical research involving human participants capable of
giving informed consent, each potential participant must
be adequately informed in plain language of the aims,
methods, anticipated benefits and potential risks and
burdens, qualifications of the researcher, sources of
funding, any potential conflicts of interest, provisions to
protect privacy and confidentiality, incentives for
participants, provisions for treating and/or compensating
participants who are harmed as a consequence of participation,
and any other relevant aspects of the research.
27.When seeking informed consent for participation in research the
physician or other researcher must be particularly cautious if
the potential participant is in a dependent relationship with
them or may consent under duress. In such situations, the
informed consent must be sought by an appropriately qualified
individual who is independent of this relationship.

28.In medical research involving human participants incapable of

giving free and informed consent, the physician or other q ualified
individual must seek informed consent from the legally
authorized representative, considering preferences and values
expressed by the potential participant.
29.When a potential research participant who is incapable of
giving free and informed consent is able to give assent
to decisions about participation in research, the
physician or other qualified individual must seek that
assent in addition to the consent of the legally authorized
representative, considering any preferences and values
expressed by the potential participant. The potential
participant’s dissent should be respected.
30.Research involving participants who are physically or mentally
incapable of giving consent (for example, unconscious patients)
may be done only if the physical or mental condition that
prevents giving informed consent is a necessary characteristic of
the research group. In such circumstances the physician or other
qualified individual must seek informed consent from the legally
authorized representative. If no such representative is available
and if the research cannot be delayed, the research may
proceed without informed consent provided that the specific
reasons for involving participants with a condition that renders
them unable to give informed consent have been stated in the
research protocol and the research has been approved by a
research ethics committee.
31.The physician or other researcher must fully inform potential
participants which aspects of their care are related to
the research. The refusal of a patient to participate in
research or the patient’s decision to withdraw from
research must never adversely affect the patient-
physician relationship or provision of the standard of care.
32.Physicians or other qualified individuals must obtain free and
informed consent from research participants for the
collection, processing, storage, and foreseeable secondary
use of biological material and identifiable or re-identifiable
data. Any collection and storage of data or biological
material from research participants for multiple and
indefinite uses should be consistent with requirements set
forth in the WMA Declaration of Taipei, including the rights
of individuals and the principles of governance. A research
ethics committee must approve the establishment and
monitor ongoing use of such databases and biobanks.
 Use of Placebo
33.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:
• If no proven intervention exists, the use of placebo, or no
intervention, is acceptable; or
• If for compelling and scientifically sound methodological reasons the
use of any intervention other than the best proven one(s), the use of
placebo, or no intervention is necessary to determine the efficacy or
safety of an intervention; and the participants who receive any
intervention other than the best proven one(s), placebo, or no
intervention will not be subject to additional risks 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.
 Post-Trial Provisions

34.In advance of a clinical trial, post-trial provisions must be

arranged by sponsors and researchers to be provided
by themselves, healthcare systems, or governments for
all participants who still need an intervention identified
as beneficial and reasonably safe in the trial. Exceptions
to this requirement must be approved by a research
ethics committee. Specific information about post-trial
provisions must be disclosed to participants as part of
informed consent.
Research Registration, Publication, and Dissemination of Results

35.Medical research involving human participants must be registered in a

publicly accessible database before recruitment of the first
participant.
36.Researchers, authors, sponsors, editors, and publishers all have ethical
obligations with regard to the publication and dissemination of the
results of research. Researchers have a duty to make publicly
available the results of their research on human participants and are
accountable for the timeliness, completeness, and accuracy of their
reports. All parties should adhere to accepted guidelines for ethical
reporting. Negative and inconclusive as well as positive results must be
published or otherwise made publicly available. Sources of funding,
institutional affiliations, and conflicts of interest must be declared in the
publication. Reports of research not in accordance with the principles of this
Declaration should not be accepted for publication.
 Unproven Interventions in Clinical Practice

37. When an unproven intervention is utilized in an attempt to restore

health or alleviate suffering for an individual patient because
approved options are inadequate or ineffective and enrollment
in a clinical trial is not possible, it should subsequently be made
the object of research designed to evaluate safety and efficacy.
Physicians participating in such interventions must first seek
expert advice, weigh possible risks, burdens, and benefits, and
obtain informed consent. They must also record and share data
when appropriate and avoid compromising clinical trials. These
interventions must never be undertaken to circumvent the
protections for research participants set forth in this
Declaration.