1. Unesco – Universal Declaration on Bioethics and Human Rights https://en.unesco.org/themes/ethics-science-and-technology/bioethics-and-human-rights

General provisions

Article 1 – Scope

1. This Declaration addresses ethical issues related to medicine, life sciences and associated technologies as applied to human beings, taking into account their social, legal and environmental dimensions.

2. This Declaration is addressed to States. As appropriate and relevant, it also provides guidance to decisions or practices of individuals, groups, communities, institutions and corporations, public and private.

Article 2 – Aims

The aims of this Declaration are:

(a) to provide a universal framework of principles and procedures to guide States in the formulation of their legislation, policies or other instruments in the field of bioethics;

(b) to guide the actions of individuals, groups, communities, institutions and corporations, public and private;

(c) to promote respect for human dignity and protect human rights, by ensuring respect for the life of human beings, and fundamental freedoms, consistent with international human rights law;

(d) to recognize the importance of freedom of scientific research and the benefits derived from scientific and technological developments, while stressing the need for such research and developments to occur within the framework of ethical principles set out in this Declaration and to respect human dignity, human rights and fundamental freedoms;

(e) to foster multidisciplinary and pluralistic dialogue about bioethical issues between all stakeholders and within society as a whole;

(f) to promote equitable access to medical, scientific and technological developments as well as the greatest possible flow and the rapid sharing of knowledge concerning those developments and the sharing of benefits, with particular attention to the needs of developing countries;

(g) to safeguard and promote the interests of the present and future generations;

(h) to underline the importance of biodiversity and its conservation as a common concern of humankind.

Principles

Within the scope of this Declaration, in decisions or practices taken or carried out by those to whom it is addressed, the following principles are to be respected.

Article 3 – Human dignity and human rights

1. Human dignity, human rights and fundamental freedoms are to be fully respected.

2. The interests and welfare of the individual should have priority over the sole interest of science or society.

Article 4 – Benefit and harm

In applying and advancing scientific knowledge, medical practice and associated technologies, direct and indirect benefits to patients, research participants and other affected individuals should be maximized and any possible harm to such individuals should be minimized.

Article 5 – Autonomy and individual responsibility

The autonomy of persons to make decisions, while taking responsibility for those decisions and respecting the autonomy of others, is to be respected. For persons who are not capable of exercising autonomy, special measures are to be taken to protect their rights and interests.

Article 6 – Consent

1. Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.

2. Scientific research should only be carried out with the prior, free, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include modalities for withdrawal of consent. Consent may be withdrawn by the person concerned at any time and for any reason without any disadvantage or prejudice. Exceptions to this principle should be made only in accordance with ethical and legal standards adopted by States, consistent with the principles and provisions set out in this Declaration, in particular in Article 27, and international human rights law.

3. In appropriate cases of research carried out on a group of persons or a community, additional agreement of the legal representatives of the group or community concerned may be sought. In no case should a collective community agreement or the consent of a community leader or other authority substitute for an individual’s informed consent.

Article 7 – Persons without the capacity to consent

In accordance with domestic law, special protection is to be given to persons who do not have the capacity to consent:

(a) authorization for research and medical practice should be obtained in accordance with the best interest of the person concerned and in accordance with domestic law. However, the person concerned should be involved to the greatest extent possible in the decision-making process of consent, as well as that of withdrawing consent;

(b) research should only be carried out for his or her direct health benefit, subject to the authorization and the protective conditions prescribed by law, and if there is no research alternative of comparable effectiveness with research participants able to consent. Research which does not have potential direct health benefit should only be undertaken by way of exception, with the utmost restraint, exposing the person only to a minimal risk and minimal burden and, if the research is expected to contribute to the health benefit of other persons in the same category, subject to the conditions prescribed by law and compatible with the protection of the individual’s human rights. Refusal of such persons to take part in research should be respected.

Article 8 – Respect for human vulnerability and personal integrity

In applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken into account. Individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected.

Article 9 – Privacy and confidentiality

The privacy of the persons concerned and the confidentiality of their personal information should be respected. To the greatest extent possible, such information should not be used or disclosed for purposes other than those for which it was collected or consented to, consistent with international law, in particular international human rights law.

Article 10 – Equality, justice and equity

The fundamental equality of all human beings in dignity and rights is to be respected so that they are treated justly and equitably.

Article 11 – Non-discrimination and non-stigmatization

No individual or group should be discriminated against or stigmatized on any grounds, in violation of human dignity, human rights and fundamental freedoms.

Article 12 – Respect for cultural diversity and pluralism

The importance of cultural diversity and pluralism should be given due regard. However, such considerations are not to be invoked to infringe upon human dignity, human rights and fundamental freedoms, nor upon the principles set out in this Declaration, nor to limit their scope.

Article 13 – Solidarity and cooperation

Solidarity among human beings and international cooperation towards that end are to be encouraged.

Article 14 – Social responsibility and health

1. The promotion of health and social development for their people is a central purpose of governments that all sectors of society share.

2. Taking into account that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition, progress in science and technology should advance:

(a) access to quality health care and essential medicines, especially for the health of women and children, because health is essential to life itself and must be considered to be a social and human good;

(b) access to adequate nutrition and water;

(c) improvement of living conditions and the environment;

(d) elimination of the marginalization and the exclusion of persons on the basis of any grounds;

(e) reduction of poverty and illiteracy.

Article 15 – Sharing of benefits

1. Benefits resulting from any scientific research and its applications should be shared with society as a whole and within the international community, in particular with developing countries. In giving effect to this principle, benefits may take any of the following forms:

(a) special and sustainable assistance to, and acknowledgement of, the persons and groups that have taken part in the research;

(b) access to quality health care;

(c) provision of new diagnostic and therapeutic modalities or products stemming from research;

(d) support for health services;

(e) access to scientific and technological knowledge;

(f) capacity-building facilities for research purposes;

(g) other forms of benefit consistent with the principles set out in this Declaration.

2. Benefits should not constitute improper inducements to participate in research.

Article 16 – Protecting future generations

The impact of life sciences on future generations, including on their genetic constitution, should be given due regard.

Article 17 – Protection of the environment, the biosphere and biodiversity

Due regard is to be given to the interconnection between human beings and other forms of life, to the importance of appropriate access and utilization of biological and genetic resources, to respect for traditional knowledge and to the role of human beings in the protection of the environment, the biosphere and biodiversity.

Application of the principles

Article 18 – Decision-making and addressing bioethical issues

1. Professionalism, honesty, integrity and transparency in decision-making should be promoted, in particular declarations of all conflicts of interest and appropriate sharing of knowledge. Every endeavour should be made to use the best available scientific knowledge and methodology in addressing and periodically reviewing bioethical issues.

2. Persons and professionals concerned and society as a whole should be engaged in dialogue on a regular basis.

3. Opportunities for informed pluralistic public debate, seeking the expression of all relevant opinions, should be promoted.

Article 19 – Ethics committees

Independent, multidisciplinary and pluralist ethics committees should be established, promoted and supported at the appropriate level in order to:

(a) assess the relevant ethical, legal, scientific and social issues related to research projects involving human beings;

(b) provide advice on ethical problems in clinical settings;

(c) assess scientific and technological developments, formulate recommendations and contribute to the preparation of guidelines on issues within the scope of this Declaration;

(d) foster debate, education and public awareness of, and engagement in, bioethics.

Article 20 – Risk assessment and management

Appropriate assessment and adequate management of risk related to medicine, life sciences and associated technologies should be promoted.

Article 21 – Transnational practices

1. States, public and private institutions, and professionals associated with transnational activities should endeavour to ensure that any activity within the scope of this Declaration, undertaken, funded or otherwise pursued in whole or in part in different States, is consistent with the principles set out in this Declaration.

2. When research is undertaken or otherwise pursued in one or more States (the host State(s)) and funded by a source in another State, such research should be the object of an appropriate level of ethical review in the host State(s) and the State in which the funder is located. This review should be based on ethical and legal standards that are consistent with the principles set out in this Declaration.

3. Transnational health research should be responsive to the needs of host countries, and the importance of research contributing to the alleviation of urgent global health problems should be recognized.

4. When negotiating a research agreement, terms for collaboration and agreement on the benefits of research should be established with equal participation by those party to the negotiation.

5. States should take appropriate measures, both at the national and international levels, to combat bioterrorism and illicit traffic in organs, tissues, samples, genetic resources and genetic-related materials.

Promotion of the Declaration

Article 22 – Role of States

1. States should take all appropriate measures, whether of a legislative, administrative or other character, to give effect to the principles set out in this Declaration in accordance with international human rights law. Such measures should be supported by action in the spheres of education, training and public information.

2. States should encourage the establishment of independent, multidisciplinary and pluralist ethics committees, as set out in Article 19.

Article 23 – Bioethics education, training and information

1. In order to promote the principles set out in this Declaration and to achieve a better understanding of the ethical implications of scientific and technological developments, in particular for young people, States should endeavour to foster bioethics education and training at all levels as well as to encourage information and knowledge dissemination programmes about bioethics.

2. States should encourage the participation of international and regional intergovernmental organizations and international, regional and national non governmental organizations in this endeavour.

Article 24 – International cooperation

1. States should foster international dissemination of scientific information and encourage the free flow and sharing of scientific and technological knowledge.

2. Within the framework of international cooperation, States should promote cultural and scientific cooperation and enter into bilateral and multilateral agreements enabling developing countries to build up their capacity to participate in generating and sharing scientific knowledge, the related know-how and the benefits thereof.

3. States should respect and promote solidarity between and among States, as well as individuals, families, groups and communities, with special regard for those rendered vulnerable by disease or disability or other personal, societal or environmental conditions and those with the most limited resources.

Article 25 – Follow-up action by UNESCO

1. UNESCO shall promote and disseminate the principles set out in this Declaration. In doing so, UNESCO should seek the help and assistance of the Intergovernmental Bioethics Committee (IGBC) and the International Bioethics Committee (IBC).

2. UNESCO shall reaffirm its commitment to dealing with bioethics and to promoting collaboration between IGBC and IBC.

Final provisions

Article 26 – Interrelation and complementarity of the principles

This Declaration is to be understood as a whole and the principles are to be understood as complementary and interrelated. Each principle is to be considered in the context of the other principles, as appropriate and relevant in the circumstances.

Article 27 – Limitations on the application of the principles

If the application of the principles of this Declaration is to be limited, it should be by law, including laws in the interests of public safety, for the investigation, detection and prosecution of criminal offences, for the protection of public health or for the protection of the rights and freedoms of others. Any such law needs to be consistent with international human rights law.

Article 28 – Denial of acts contrary to human rights, fundamental freedoms and human dignity

Nothing in this Declaration may be interpreted as implying for any State, group or person any claim to engage in any activity or to perform any act contrary to human rights, fundamental freedoms and human dignity.

2. Decision making and consent – UK General Medical Council https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/decision-making-and-consent

Shared decision making and consent are fundamental to good medical practice.

This guidance explains that the exchange of information between doctor and patient is essential to good decision making. Serious harm can result if patients are not listened to, or if they are not given the information they need – and time and support to understand it – so they can make informed decisions about their care.

This guidance will support you in your conversations with your patients, and help you to be confident you’re sharing the information they need to make decisions that are right for them. By following it, it will help you make sure that you have informed consent from your patient.

It has advice on:

  • What you should tell a patient when talking about risks.
  • What to do if your patient doesn’t want to hear information you think is relevant.
  • What to do if your patient may lack capacity to make a decision
  • What you should record.

This guidance came into effect on 9 November 2020. 

The information you give patients

10 You must give patients the information they want or need to make a decision.

This will usually include:

  1. diagnosis and prognosis
  2. uncertainties about the diagnosis or prognosis, including options for further investigation*
  3. options for treating or managing the condition, including the option to take no action
  4. the nature of each option, what would be involved, and the desired outcome
  5. the potential benefits, risks of harm, uncertainties about and likelihood of success for each option, including the option to take no action.
    By ‘harm’ we mean any potential negative outcome, including a side effect or complication.*

11 You must try to make sure the information you share with patients about the options is objective. You should be aware of how your own preferences might influence the advice you give and the language you use. When recommending an option for treatment or care to a patient you must explain your reasons for doing so, and share information about reasonable alternatives, including the option to take no action. You must not put pressure on a patient to accept your advice. 12

You should not rely on assumptions about:

  1. the information a patient might want or need
  2. the factors a patient might consider significant
  3. the importance a patient might attach to different outcomes.

13 Other examples of information that might be relevant and, if so, should be shared with patients include:

  1. whether an option is an innovative treatment designed specifically for their benefit
  2. whether there is a time limit on making their decision and what the implications of delaying might be
  3. the names and roles of key people who will be involved in their care, and who they can contact (and how) if they have questions or concerns
  4. their right to refuse to take part in teaching or research
  5. their right to seek a second opinion
  6. any bills they will have to pay
  7. any conflicts of interest that you or your organisation may have
  8. any treatments that you believe have greater potential benefit for the patient than those you or your organisation can offer.

Exceptional circumstances in which you may decide not to share all relevant information

14 There may be circumstances in which you decide not to share all relevant information with a patient straight away. If you delay sharing information necessary for making a decision, you should let the patient know there’s more to discuss and make sure arrangements are made to share the information as soon as it’s appropriate to do so. You must make a record of the information you still need to share, your reasons for not sharing it now, and when it can be shared. 15

You should not withhold information a patient needs to make a decision for any other reason, including if someone close to the patient asks you to. In very exceptional circumstances you may feel that sharing information with a patient would cause them serious harm and, if so, it may be appropriate to withhold it. In this context ‘serious harm’ means more than that the patient might become upset, decide to refuse treatment, or choose an alternative. This is a limited exception and you should seek legal advice if you are considering withholding information from a patient.

Finding out what matters to a patient

16 You must listen to patients and encourage them to ask questions.

17 You should try to find out what matters to patients about their health – their wishes and fears, what activities are important to their quality of life, both personally and professionally – so you can support them to assess the likely impact of the potential outcomes for each option.

18 You must seek to explore your patient’s needs, values and priorities that influence their decision making, their concerns and preferences about the options and their expectations about what treatment or care could achieve.

19 You should ask questions to encourage patients to express what matters to them, so you can identify what information about the options might influence their choice.

20 You should explore with patients what risks they would and wouldn’t be prepared to take to achieve a desired outcome, and how the likelihood of a particular outcome might influence their choice.* 

Discussing benefits and harms

21 You must give patients clear, accurate and up-to-date information, based on the best available evidence, about the potential benefits and risks of harm of each option, including the option to take no action.

22 It wouldn’t be reasonable to share every possible risk of harm, potential complication or side effect. Instead, you should tailor the discussion to each individual patient, guided by what matters to them, and share information in a way they can understand. * 

23 You should usually include the following information when discussing benefits and harms.

  1. Recognised risks of harm that you believe anyone in the patient’s position would want to know. You’ll know these already from your professional knowledge and experience.
  2. The effect of the patient’s individual clinical circumstances on the probability of a benefit or harm occurring. If you know the patient’s medical history, you’ll know some of what you need to share already, but the dialogue could reveal more.
  3. Risks of harm and potential benefits that the patient would consider significant for any reason. These will be revealed during your discussion with the patient about what matters to them.
  4. Any risk of serious harm, however unlikely it is to occur.* 
  5. Expected harms, including common side effects and what to do if they occur.

24 You should consider using visual or other explanatory aids to support patients to understand their personalised risk, taking account of their individual clinical and personal circumstances, compared with population level risk.

25 You must answer patients’ questions honestly and accurately, and as fully as is practical in the circumstances. You must be clear about the limits of your knowledge and, if you can’t answer a question, explain whether it is something you are uncertain of or something that is inherently uncertain. 26

If you are uncertain about the diagnosis, or the clinical effect a particular treatment might have, or if the available evidence of benefits and harms of an option is unclear, you should explain this to the patient. Some things will become clearer after treatment starts, so you should discuss in advance what the arrangements will be for monitoring the effect of the treatment and reviewing the decision to provide it. You should also explore in advance what options the patient might prefer in the future, depending on how treatment progresses, and the factors that might influence their choice.*

Supporting patients’ decision making

27 Patients need relevant information (see paragraph 10) to be shared in a way they can understand and retain, so they can use it to make a decision. To help patients understand and retain relevant information you should:

  1. share it in a place and at a time when they are most likely to understand and retain it
  2. anticipate whether they are likely to find any of it distressing and, if so, be considerate when sharing it
  3. accommodate a patient’s wishes if they would like to record the discussion*
  4. accommodate a patient’s wishes if they would like anyone else – a relative, partner, friend, carer or advocate – to be involved in discussions and/or help them make decisions
  5. use an interpreter or translation1 service if they have difficulty understanding spoken English
  6. share it in a format they prefer – written, audio, translated, pictures or other media or methods
  7. give them time and opportunity to consider it before and after making a decision.

28 You should be alert to signs that patients may need support to understand and retain the relevant information, use it to make a decision, or communicate that decision to you.

29 You should make sure that reasonable adjustments2 are made so that patients with additional needs have enough time and support to understand relevant information and make a decision. In all cases, you must treat patients fairly and not discriminate against them.

30 You must check whether patients have understood the information they have been given, and if they would like more information before making a decision.

The scope of decisions

31 You must be clear about the scope of decisions so that patients understand exactly what they are consenting to. You must not exceed the scope of a patient’s consent, except in an emergency.* 

Agreeing the scope of a patient’s consent with them in advance is particularly important if:

  1. treatment or care will be provided in stages with opportunities to review and adjust in between
  2. different healthcare professionals will provide different parts of the treatment or care
  3. there may be opportunity, once an intervention is underway and the patient’s decision-making ability is compromised, to carry out another intervention
  4. there is significant risk of a specific harm occurring during an intervention, which would present more than one way to proceed

3. There are plenty of moral reasons to be vaccinated – but that doesn’t mean it’s your ethical duty https://theconversation.com/there-are-plenty-of-moral-reasons-to-be-vaccinated-but-that-doesnt-mean-its-your-ethical-duty-158687

4. US Informed Consent – Code of Medical Ethics Opinion 2.1.1 https://www.ama-assn.org/delivering-care/ethics/informed-consent

Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making.

The process of informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention. In seeking a patient’s informed consent (or the consent of the patient’s surrogate if the patient lacks decision-making capacity or declines to participate in making decisions), physicians should:

  1. Assess the patient’s ability to understand relevant medical information and the implications of treatment alternatives and to make an independent, voluntary decision.
  2. Present relevant information accurately and sensitively, in keeping with the patient’s preferences for receiving medical information. The physician should include information about:
    1. The diagnosis (when known)
    2. The nature and purpose of recommended interventions
    3. The burdens, risks, and expected benefits of all options, including forgoing treatment
  3. Document the informed consent conversation and the patient’s (or surrogate’s) decision in the medical record in some manner. When the patient/surrogate has provided specific written consent, the consent form should be included in the record.

In emergencies, when a decision must be made urgently, the patient is not able to participate in decision making, and the patient’s surrogate is not available, physicians may initiate treatment without prior informed consent. In such situations, the physician should inform the patient/surrogate at the earliest opportunity and obtain consent for ongoing treatment in keeping with these guidelines.

5. UK Government – Reference guide to consent for examination or treatment https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/138296/dh_103653__1_.pdf

Valid consent
1. For consent to be valid, it must be given voluntarily by an appropriately informed person who has the capacity to consent to the intervention in question (this will be the patient or someone with parental responsibility for a patient under the age of 18,11 someone authorised to do so under a Lasting Power of Attorney (LPA) or someone who has the authority to make treatment decisions as a court appointed
deputy12). Acquiescence where the person does not know what the intervention entails is not ‘consent’

Is the consent given voluntarily?
10. To be valid, consent must be given voluntarily and freely, without pressure or undue influence being exerted on the person either to accept or refuse treatment. Such pressure can come from partners or family members, as well as health or care practitioners. Practitioners should be alert to this possibility and where appropriate should arrange to see the person on their own in order to establish that the decision is
truly their own.

Has the person received sufficient information?
13. To give valid consent, the person needs to understand the nature and purpose of the procedure. Any misrepresentation of these elements will invalidate consent. Where relevant, information about anaesthesia should be given alongside information about the procedure itself.

15. Although informing people of the nature and purpose of procedures enables valid consent to be given as far as any claim of battery is concerned, this is not sufficient to fulfil the legal duty of care to the person. Failure to provide other relevant information may render the practitioner liable to an action for negligence if a person subsequently suffers harm as a result of the treatment received.

16. The requirements of the legal duty to inform patients continues to develop in case law. In 1985, the House of Lords decided in the Sidaway16 case that the legal standard to be used when deciding whether adequate information had been given to a patient should be the same as that used when judging whether a doctor had been negligent in their treatment or care of a patient: a doctor would not be considered negligent if their practice conformed to that of a responsible body of medical opinion held by practitioners skilled in the field in question. This is known as the ‘Bolam test’. Whether the duty of care had been satisfied was therefore primarily a matter of medical opinion. However, Sidaway also stated that it was open to the courts to decide that information about a particular risk was so obviously necessary that it would be negligent not to provide it, even if a ‘responsible body’ of medical opinion would not have done so.

17. Since Sidaway, judgments in a number of negligence cases (relating both to the provision of information and to the standard of treatment given) have shown that courts are willing to be critical of a ‘responsible body’ of medical opinion. It is now clear that the courts will be the final arbiter of what constitutes responsible practice, although the standards set by the healthcare professions for their members will still be influential. In Chester v Afshar, a majority of the House of Lords held that a neurosurgeon who failed to warn a patient of the small risk of injury inherent in surgery, even if properly performed, was liable to the patient when that risk materialised, even though the risk was not increased by the failure to warn and the patient had not shown that she would never have had an operation carrying the same risk. The Lords departed from the traditional ‘but for’ test of causation on the basis
that, exceptionally, policy and justice required a modification to causation principles. The fundamental principle underlying the decision was the right of a patient to make an informed choice as to whether – and if so, when and by whom – to be operated on.

6. Australian Government – Informed consent to medical treatment https://www.alrc.gov.au/publication/equality-capacity-and-disability-in-commonwealth-laws-dp-81/10-review-of-state-and-territory-legislation/informed-consent-to-medical-treatment/

10.47 At common law, all competent adults can consent to and refuse medical treatment. If consent is not established, there may be legal consequences for health professionals. Under the law of trespass, patients have a right not be subjected to an invasive procedure without consent or other lawful justification, such as an emergency or necessity. At the international level, the CRPD expresses this in terms of a ‘right to respect for his or her physical and mental integrity on an equal basis with others’.[35]

10.48 ‘Informed consent’ refers to consent to medical treatment and the requirement to warn of material risk prior to treatment. As part of their duty of care, health professionals must provide such information as is necessary for the patient to give consent to treatment, including information on all material risks of the proposed treatment. Failure to do so may lead to civil liability for an adverse outcome, even if the treatment itself was not negligent.[36]

10.49 The common law recognises that there are circumstances where an individual may not be capable of giving informed consent (for example, due to impaired decision-making ability) or where consent to treatment may not be required, as in the case of emergency. However, except in the case of children—where the High Court has recognised the courts’ parens patriae jurisdiction in authorising treatment[37]—it does not provide significant guidance on supported decision-making in health care settings.

7. The ethical questions raised by COVID-19 vaccines: 5 essential reads https://theconversation.com/the-ethical-questions-raised-by-covid-19-vaccines-5-essential-reads-163604

8. Getting vaccinated is a personal choice https://www.washingtonexaminer.com/opinion/op-eds/getting-vaccinated-is-a-personal-choice

9. Ethical Principles for Medical Research and Practice https://sites.jamanetwork.com/research-ethics/

The Nuremberg Code

The Nuremberg Code is a 10-point set of rules for the conduct of human experiments articulated in 1947 in the trials of Nazi doctors and bureaucrats convicted of crimes against humanity for their roles in concentration camp experiments.

  1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
  2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
  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 or other problem under study that the anticipated results will justify the performance of the experiment.
  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; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
  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. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
  9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
  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 to the experimental subject.

World Medical Association Declaration of Helsinki https://jamanetwork.com/journals/jama/fullarticle/1760318

Ethical Principles for Medical Research Involving Human Subjects

Preamble

1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.

2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.

General Principles

3. The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”

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 studies involving human subjects.

6. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.

7. Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.

8. While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.

9. 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. The responsibility for 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.

10. 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. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

11. Medical research should be conducted in a manner that minimises possible harm to the environment.

12. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.

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 study will not adversely affect the health of the patients who serve as research subjects.

15. Appropriate compensation and treatment for subjects 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 subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

17. All medical research involving human subjects 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.

Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.

18. Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.

When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.

Vulnerable Groups and Individuals

19. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm.

All vulnerable groups and individuals should receive specifically considered protection.

20. Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

Scientific Requirements and Research Protocols

21. Medical research involving human subjects 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 each research study involving human subjects 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 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.

In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.

Research Ethics Committees

23. The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.

The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions.

Privacy and Confidentiality

24. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information

Informed Consent

25. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.

26. In medical research involving human subjects capable of giving informed consent, 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. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.

After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

All medical research subjects should be given the option of being informed about the general outcome and results of the study.

27. When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.

28. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.

29. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.

30. Research involving subjects 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 must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.

31. The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never adversely affect the patient-physician relationship.

32. For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee.

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:

Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or

Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, 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, 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. This information must also be disclosed to participants during the informed consent process.

Research Registration and Publication and Dissemination of Results

35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.

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 subjects and are accountable for the 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. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.