The Declaration of Helsinki - C Flashcards
What is the purpose of the Declaration of Helsinki (June 1964 - last update October 2024)?
It’s a statement of ethical principles for medical research involving human participants, including research using identifiable human material or data.
These principles are fundamental to respect for and protection of all research participants, including both patients and healthy volunteers.
Who developed the Declaration of Helsinki?
WMA = The World Medical Association
Who does the Declaration apply to?
These principles should be upheld by all individuals, teams, and organizations involved in medical research.
What are the sections of the Declaration?
- General principles
- Risks, Burdens, and Benefits
- Individual, Group, and Community Vulnerability
- Scientific Requirements and Research Protocols
- Research Ethics Committees
- Privacy and Confidentiality
- Free and Informed Consent
- Use of Placebo
- Post-Trial Provisions
- Research Registration, Publication, and Dissemination of Results
- Unproven Intervention in Clinical Practice
- General principles
- The physician must commit to the primacy of the patient health and well-being and must offer care in the patient’s best interest
- Duty of physician to promote and safeguard the health, well-being and rights of patients, also in research
- Even well-proven interventions should 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 participants and protect their health and rights. Careful consideration how benefits, risks, and burdens are distributed
- Primary purpose can never take precedence over the rights and interests of research participants
– generate knowledge (causes, development, effects of diseases)
– improve preventive, diagnostic and therapeutic interventions
– advance individual and public health - Duty to protect the life, health, dignity, integrity, autonomy, privacy, and confidentiality of personal information of participants
- No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections set forth in this Declaration
- Should avoid or minimize harm to the environment
- Must be conducted only by individuals with the appropriate ethics and scientific education, training and qualification
- Underrepresented groups in research should be provided appropriate access
- Physician should involve their patients in research only if by its potential preventive, diagnostic or therapeutic value and if research will not adversely affect the patient
- Appropriate compensation for harm as a result of research must be ensured
- Risks, Burdens, and Benefits
- Importance of the objective must outweigh the risks and burdens to the research participant
- Measures to minimize the risks and burdens must be implemented. Continuous monitoring, assessment and documentation of risks and burdens.
- 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. If risks and burdens outweigh potential benefits, re-evaluate continuation, modification or termination of the research.
- Individual, Group, and Community Vulnerability
- For vulnerable subjects, the harms of exclusion must be considered and weighed against the harms of inclusion.
– For fair and responsible inclusion, they should receive specifically considered support and protections. - In situations of particular vulnerability, medical research is justified only 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. - Include vulnerable subjects only when
– 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
- Medical research 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 thorough knowledge of the scientific literature - The design must be clearly described and justified in a research protocol which should include information regarding
– aims
– methods
– anticipated benefits and potential risks and burdens
– qualifications of the researcher
– source of funding
– potential conflicts of interest
– provisions to protect privacy and confidentiality
– incentives provisions for treating and/or compensating participants who are harmed
– any other relevant aspects
– in clinical trials, must also describe any post-trial provisions.
- Research Ethics Committees
- Protocol must be submitted for consideration, comment, guidance, and approval to the concerned research ethics committee before the start
- The committee must
– be transparent and independent and must have authority to resist undue influence from the researcher, the sponsor, or others
– have staff with adequate education, training, qualifications, and diversity
– have sufficient familiarity with local circumstances and context, and include at least one member of the general public
– take into consideration the ethical, legal, and regulatory norms and standards of the country
– have right to monitor, recommend changes, withdraw approval, and suspend research - when conducted internationally, protocol must be approved by committees in both sponsoring and hosting country
- amendments must be approved by the committee
- at the end, researchers must submit a final report to the committee with summary of findings and conclusions
- Privacy and Confidentiality
Every precaution must be taken to protect the privacy of participants and the confidentiality of their personal information.
- Free and Informed Consent
- Free and informed consent is an essential component of respect for individual autonomy. Consent must be voluntary.
- Participants 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
– potential conflicts of interest
– provisions to protect privacy and confidentiality
– incentives
– provisions for treating and/or compensating harmed as consequence of research
– any other relevant aspects
– right to refuse to participate or to withdraw without reprisal and how to deliver that information - consent must be freely given and documented on paper or electronically
– if cannot be expressed on paper or electronically, the non-written consent must be formally witnessed and documented - all participants should be given the option of being informed about the general outcome and results of the research
- caution about dependent relationship of the participant and researcher/physician
- Must inform which aspects of their care are related to research
- decision to refuse or withdraw must never adversely affect the patient-physician relationship or provisions of the standard of care
- Free and Informed Consent - vulnerable participants
- if not capable to give free and informed consent, must seek informed consent from LAR - vulnerable safeguards
- If not capable of giving consent but able to give assent, must seek assent in addition to consent of LAR. Dissent of the participant should be respected
- if physically or mentally incapable giving consent, research may be done only if the physical/mental condition is a necessary characteristic of the research group - must seek informed consent from LAR, if research cannot be delayed, may proceed without consent if LAR not available (must be in protocol). Informed consent must be obtained asap
- Free and Informed Consent - secondary research
Must obtain free and informed consent from participants for the collection, processing, storage, and foreseeable secondary use of biological material and identifiable or re-identifiable data
- where consent is impossible or impracticable, secondary research on stored data or biological material may be done only after approval by ethics committee
- Use of Placebo
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 reasons the use of any intervention other than the best proven, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and their will be no additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.
- Post-Trial Provisions
In advance of a clinical trial, post-trial provisions must be arranged by the sponsor 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 must be approved by the ethics committee.
- Research Registration, Publication, and Dissemination of Results
- Medical research must be registered in a publicly accessible database before recruitment of the first participant
- researchers have duty to make publicly available the results and are accountable for the timelines, completeness, and accuracy
– 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
- Unproven Intervention in Clinical Practice
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 must first seek expert advice, weigh possible risks, burdens, and benefits and obtain informed consent
– physicians must record and share data when appropriate
– these interventions must never be undertaken to circumvent the protections for research participants
