Declaration of Helsinki

& Informed Consent Process

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Exercise
 Informed Consent Skit

 Need 3 Volunteers!

 The rest of you are Directors:

– Tell us what is wrong with this picture!

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Declaration Of Helsinki
 Developed as a statement of ethical principles for medical
research involving human subjects, including research on
identifiable human material and data
 Adopted by the 18th World Medical Assembly, Helsinki, Finland,
June 1964
– Amended 1975
– Amended 1983
– Amended 1989
– Amended 1996
– Amended 2000
– Amended 2004
– Amended 2008
– Amended 2013

 Current version can be found: https://www.wma.net/policies-post/wma-

declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-
subjects/
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General Principles

 A physician shall act in the patient’s best interest when providing medical
care; “The health of my patient will be my first consideration.”
 A physician must promote and safeguard the health, well-being and
rights of patients, including those involved in medical research.
 Primary purpose of medical research involving human subjects is to:
– Understand the causes, development and effects of diseases
– Improve preventive, diagnostic and therapeutic interventions (methods,
procedures and treatments)
– Interventions must be evaluated for safety, effectiveness, efficiency,
accessibility and quality
 New knowledge cannot take precedence over the rights of individual
research subjects.

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General Principles

 Physicians must protect the life, health, dignity, integrity, right to

self-determination, privacy, and confidentiality of personal
information of research subjects.
 The protection of research subjects must always rest with the
physician or other health care professionals and never with the
research subjects, even though they have given consent.
 Research should be conducted in a way that minimizes possible
harm
 Physicians must consider ethical, legal and regulatory norms and
standards for research involving human subjects in their own
countries as well as applicable international norms and standard
– No national or international ethical, legal or regulatory requirement should override
the principles laid out in this Declaration

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General Principles

 Medical research can only be carried out by individuals with the

appropriate ethical, scientific education, training and
qualifications.
– Patients and healthy volunteers require the supervision of a qualified and competent
physician or other health care professional

 Underrepresented groups in medical research should be provided

access to participate
 Physicians who practice medical care and research must justify
adding patients to studies
– Potential preventive, diagnostic or therapeutic value of the study to the patient
– Participation in the research study will not adversely affect the health of the patient

 Ensure appropriate compensation and/or treatment for those

subjects harmed as a result of their participation in a study

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Risks & Vulnerable Groups

 The importance of the study objective must outweigh the risk and
burden to the patient.
– Risks must be minimized and continuously monitored, assessed and documented

 When risks outweigh study benefits, or when there is proof of a

definitive outcome, physicians must assess whether to continue,
modify or halt the study
 Research on vulnerable groups is only justified if the study is in
response to the needs and priorities of the group and the research
cannot be carried out in a non-vulnerable group,
– The group should benefit from the knowledge, practice or interventions that result

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Requirements
 Follow scientific principles, knowledge of existing literature, other
relevant sources of information, laboratory and when appropriate,
animal experimentation.
– Animal welfare must be respected

 Study design and performance must be described and justified in a

protocol
 Protocols must be reviewed and approved by all concerned ethics
committees prior to study start.
– Committees must be independent of the physician, qualified, transparent and abide
by all applicable regulation.
– Committees cannot reduce any of the requirements set in this Declaration

 Committees monitor on-going studies, approve protocol

amendments, review adverse events and final study reports
 Subject privacy and personal information must be protected
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Informed Consent

 Individuals who give informed consent must be voluntary

participants in the research.
– Although family members may be consulted, individuals must give the consent
themselves and they must freely agree to participate

 Individuals must be informed of:

– Aims, methods, funding sources, conflicts of interest, and institutional affiliation of
the researcher
– Anticipated benefits and potential risks of the study, any discomfort it may bring and
any post-study provisions
– Must be informed of their right to refuse to participate or to withdraw consent at
any time during the study – without reprisal
– Special attention must be given to the specific information needs of the individual as
well as methods used to deliver the consent.

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Informed Consent
 Once the physician is sure the individual has understood all the
information, they can gain freely-given, informed consent
– Prefer this is in writing
– If the individual cannot write, non-written consent must be documented and
witnessed

 Participants should be given the option of being informed about

the study outcomes.
 Be aware of subjects in a dependent relationship with the
physician, or may consent under duress.
– Informed consent must be obtained by a qualified professional who is completely
independent of this relationship

 Potential participants who cannot give consent; consent must be

obtained from a legally authorized representative.
– The study must provide them some benefit

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Informed Consent

 Participants physically or mentally unable to give consent

(unconscious patient) require a legal representative. Their
condition must be a characteristic of the research.
 Physician must tell patient what aspects of their care is related to
the study
– Refusal to participate or decision to withdraw cannot affect the doctor-patient
relationship

 Research on identifiable human material or data, such as that

contained in biobanks or similar repositories requires consent for
collection, storage and use.
– If consent is impractical or impossible to obtain, it must be approved by an ethics
committee.

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Placebo Use / Post Study
 New interventions must be tested against the best, proven
interventions except:
– When no proven intervention exists, then placebo is acceptable
– Use of placebo, less effective or other intervention is necessary to prove efficacy or
safety
– Patients not subject to additional risk if treated with less than the best intervention

 Care must be taken not to abuse the use of placebo

 Access post study should be made for all participants who need
the a beneficial intervention, based on the study
– This must be disclosed during informed consent

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Registration & Publishing

 Studies must be registered in a publicly accessible database before

the first patient is entered.
 Researchers have an obligation to disseminate the results of the
study
– They are accountable for completeness and accuracy of data in their reports
– They should adhere to ethical guidelines for reporting
– Sources of funding must be declared in the publication

 Studies not adhering to the guidelines in this Declaration should

not be published.

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