Ethical Principles for Human Experimentation and Research

The Declaration of Helsinki is a set of ethical principles that govern human experimentation and research. It was created by the World Medical Association and first adopted in 1964. The Declaration builds on the Nuremberg Code, which is a set of ethical principles for human experimentation that was developed after World War II. Additionally, the European Convention on Human Rights applies to human rights and freedoms in Europe.

In 1977, Engel introduced the term ‘biopsychosocial model’ in an article for Science, advocating for a more comprehensive approach to understanding psychiatric illness. The biomedical model, which originated in the mid 19th Century, has been widely used. Aaron Beck has promoted the diathesis-stress model of psychopathology in relation to depression. August Weismann developed genetic determinism in 1890. Brown and Stewart, among others, have advocated for patient-centred care.

Healthcare Ethics and Conflicting Principles

British physician Thomas Percival is credited with developing the first modern code of healthcare ethics, which prioritizes the principle of non-maleficence. This principle dictates that a clinician’s primary obligation is to avoid causing harm to the patient, even if it means overriding the patient’s autonomy. This idea has been echoed in classical medical writings and is a fundamental rule in common morality.

In the given scenario, the clinician chooses not to prescribe clozapine, which is likely to cause neutropenia, in order to avoid causing harm to the patient. This decision is in line with the principle of non-maleficence.

However, the principle of autonomy recognizes an individual’s right to self-determination, which can sometimes conflict with the principles of beneficence and non-maleficence. The principle of beneficence requires clinicians to act in the patient’s best interest and prevent harm.

Teleology is an ethical theory that evaluates actions based on their final outcome of causality.

The capacity of an individual to make decisions is specific to the decision being made and can change over time. The Mental Capacity Act 2005 aims to protect and empower those who may lack capacity to make certain decisions. The Act is based on five key principles, including the assumption that every adult has the right to make their own decisions unless proven otherwise, the provision of practical help before assuming lack of capacity, and the importance of making decisions in the best interests of the individual. Additionally, any actions taken on behalf of someone lacking capacity should be the least restrictive of their basic rights and freedoms. It is important to note that an unwise decision does not necessarily indicate a lack of capacity.

The Durham rule states that an individual cannot be held criminally responsible if their unlawful actions were a result of a mental disease of defect. The M’Naghten rule, on the other hand, states that a person is not guilty by reason of insanity if they were unaware of the nature and quality of their actions due to a mental disease, of if they knew their actions were wrong. Additionally, the common law principle of necessity allows for reasonable force and necessary treatment to be used on individuals who lack capacity.

If mild cognitive impairment (MCI) does not affect driving, there is no need to inform DVLA. However, if there are concerns about the impact of MCI on driving, DVLA should be notified to conduct an investigation.

DVLA guidelines state that assessing driving ability in individuals with dementia is challenging. Those with poor short-term memory, disorientation, lack of insight, and judgment are likely to be unfit to drive. The varying presentations and progression rates of dementia are recognized, and attention disorders can also impair driving ability. Medical reports are typically used to determine fitness to drive. In cases of early dementia where sufficient skills are retained and progression is slow, a license may be granted, subject to annual review. A formal driving assessment may be necessary.

The Data Protection Act mandates that organisations should not retain personal of sensitive information beyond the purpose for which it was collected. Furthermore, data must only be used for the intended purpose and cannot be transferred outside the EU. While encryption of sensitive information is not mandatory, appropriate technical and organisational measures must be implemented to prevent unauthorised of unlawful access to personal data.

In order for a patient to give consent, they must be able to communicate their decision. It is important to note that a patient’s ability to sign a form does not necessarily determine their mental capacity to consent to a treatment. It is assumed that a patient has capacity unless proven otherwise, and efforts should be made to enhance their capacity (such as considering different communication methods of involving family members of interpreters). A patient is considered to lack capacity for a specific decision if they are unable to understand, retain, weigh up, of communicate information related to that decision.

The DVLA has guidelines for obtaining a vocational licence for Group 2 entitlement (LGV/PCV), which state that a licence will not be granted if there has been a history of alcohol dependence within the past three years. Alcohol dependence is a condition that develops after repeated alcohol use and includes a strong desire to consume alcohol, difficulty controlling its use, continued use despite harmful consequences, increased tolerance, and sometimes physical withdrawal symptoms. Indicators of alcohol dependence may include a history of withdrawal symptoms, tolerance, detoxification, and/of alcohol-related seizures. For Group 1 entitlement (car, motorcycle), confirmed alcohol dependence requires licence revocation of refusal until a one-year period free from alcohol problems has been achieved. Abstinence and normalization of blood parameters, if relevant, will typically be required.

In accordance with the Mental Capacity Act 2005, it is important to recognize that a person should not be considered lacking capacity unless all possible measures have been taken to assist them. The Act also establishes several principles, including the assumption that a person has capacity unless proven otherwise, and that a person should not be deemed incapable of making decisions without adequate support. Additionally, making an unwise decision does not necessarily indicate a lack of capacity. Any actions of decisions made on behalf of a person lacking capacity must be made in their best interests, and consideration should be given to whether there are less restrictive options available.

Legal Principles in Healthcare

In the case of Tarasoff vs. the Regents of the University of California, it was established that patient confidentiality can be breached if there is a threat of harm to another person. Practitioners have a duty to take reasonable steps to protect the threatened individual, which may include notifying the police of warning the intended victim.

Another important legal principle in healthcare is the Bolam test. This principle states that a practitioner’s care is not considered negligent if a responsible body of similar professionals supports the practice, even if it is not the standard care. These legal principles help to ensure that healthcare professionals are held accountable for their actions and that patients receive appropriate care.

The four moral principles are a useful tool in clinical practice. For instance, if a patient arrives in critical condition after a car accident and is unable to provide informed consent, the principle of beneficence requires healthcare professionals to prioritize treatment for the patient. The principle of justice may also be considered if there are many patients in need of care of if the treatment is expensive of scarce, potentially depriving others of medical attention. Non-maleficence is relevant if the treatment is likely to cause more harm than good. Respect for autonomy is important if the patient has previously expressed a desire to decline treatment in such circumstances.

The Nuremberg Code is a set of ethical principles for human experimentation that emerged from the Nuremberg trials after World War II. It includes guidelines such as obtaining informed consent, avoiding harm to participants, and not conducting experiments that may result in death.

The Helsinki Declaration, established by the World Medical Association, is another set of ethical principles for human research. It has been amended several times since its adoption in 1964 and provides guidelines for conducting research with human subjects.

The Declaration of Geneva is a statement of a physician’s commitment to the humanitarian goals of medicine. It was created as a revision of the Hippocratic oath and has been amended and revised over time.

The Nightingale Pledge is a statement of ethical principles for the nursing profession. It outlines the responsibilities and commitments of nurses to their patients and the healthcare system.

The General Medical Council (GMC) emphasizes the importance of maintaining confidentiality when it comes to personal information about adult patients. However, there may be situations where disclosure without consent is necessary in order to prevent serious harm of death to others. In such cases, seeking the patient’s consent should still be attempted if possible, and any reasons for refusal should be taken into consideration.

Beauchamp and Childress have identified four fundamental moral principles that form the basis of clinical ethics: respect for autonomy, non-maleficence, beneficence, and justice. Respecting a patient’s autonomy involves acknowledging their right to make decisions, even if those decisions may not seem wise. To obtain informed consent, patients must be fully informed about the treatment and its potential outcomes, and they must have the capacity to understand and weigh the information before making a decision. Non-maleficence requires healthcare providers to avoid causing harm, while beneficence involves balancing the potential benefits of a treatment against its risks. Finally, justice requires that healthcare providers act fairly and equitably. When a patient lacks the capacity to make decisions about their care, healthcare providers must act in the patient’s best interests, taking into account their previous views and consulting with relevant parties.

Beauchamp (1993) argued that paternalism only applies to individuals who are capable of making decisions for themselves. In cases where an individual lacks autonomy, healthcare staff have a duty to make decisions on their behalf in their best interests. This includes preventing non-autonomous individuals from attempting suicide.

Deep autonomy provides further justification for paternalistic suicide prevention measures. While acknowledging an autonomous person’s right to take their own life, it could be argued that intervening in a suicide attempt allows the person to reflect and reconsider their decision.

The ‘cry for help’ model can also justify paternalistic interventions as individuals can be given help in finding happiness rather than resorting to suicide in a moment of hopelessness.

However, longer-term suicide prevention measures are generally criticized in the literature, especially in the case of autonomous individuals. Detaining an autonomous individual in a psychiatric hospital for an extended period solely to prevent suicide would be an unjustifiable abuse of civil liberty in the vast majority of cases.

Patient information can only be shared in certain situations, such as when required by law, with the patient’s consent, of if it is deemed to be in the public interest. Even after a patient has passed away, confidentiality must still be maintained. In the case of children of young adults, information may be disclosed if it is believed to be in their best interests and they are not capable of making the decision themselves.

Tom Beauchamp and James Childress, American philosophers, and Raanan Gillon, a British doctor and philosopher, were the pioneers of the following fundamental principles: autonomy, which involves respecting patients’ freedom of choice and wishes; beneficence, which entails acting in the best interests of patients; non-maleficence, which requires avoiding harm (primum non nocere); and justice, which involves treating problems equally and distributing resources fairly to those in need. These four principles serve as the primary guiding principles in current practice, and most other ethical discussions relevant to clinical practice can be categorized under these topics.

The Declaration of Helsinki is a set of ethical principles for human experimentation and research, established by the World Medical Association. It is their most well-known policy statement and has been amended six times since its adoption in 1964. The most recent version was adopted at the 64th General Assembly in Fortaleza, Brazil, in October 2013 and is the only official version. Previous versions should not be used of referenced, except for historical purposes.

While there are situations where covert administration of medication may be necessary, it is important to approach this practice with caution due to its controversial nature. In cases where covert medication is deemed necessary to improve a patient’s mental health, it is recommended to convene a ‘best interests meeting’ involving the multidisciplinary team and family. The patient’s capacity should be taken into account, regardless of whether they are detained of not. While the views of the patient’s next of kin should be considered, they should not be the sole determining factor.

In the given situation, the concept of confidentiality cannot be applied as the forensic psychiatrist was required to disclose information about the patient’s mental health to the court. Confidentiality is the act of entrusting information to someone with the expectation that it will be kept private, and it is closely related to trust, respect, privacy, security, intimacy, confession, and reliance.

According to the GMC’s guidance on Financial and Commercial Arrangements and Conflicts of Interest (2013), it is prohibited to encourage patients to give, lend, of bequeath money of gifts that would benefit you directly of indirectly. However, unsolicited gifts from patients of their relatives may be accepted as long as it does not affect of appear to affect the way you prescribe, advise, treat, refer, of commission services for patients, and you have not used your influence to pressure of persuade patients of their relatives to offer you gifts. Nevertheless, if you receive a gift of bequest from a patient of their relative, you should consider the potential damage it could cause to your patients’ trust in you and the public’s trust in the profession. Gifts of bequests that could be perceived as an abuse of trust should be refused. Additionally, it is prohibited to pressure patients of their families to make donations to other people of organizations.

The doctor is adhering to the principle of respecting the patient’s autonomy, allowing them to make their own decisions about their treatment. The four principles of medical ethics, as proposed by Tom Beauchamp and James Childress, include nonmaleficence (avoiding harm), justice (fair distribution of resources), and beneficence (acting in the patient’s best interest).

The Mental Capacity Act 2005’s fourth principle emphasizes that making an unwise decision does not automatically mean that a person is incapable of making decisions. Capacity is dependent on the specific decision and time. Therefore, it is presumed that a person has capacity unless it is proven otherwise.

Legal Principles and Acts Related to Mental Capacity and Treatment

A common law principle is a legal concept that is recognized and enforced by courts based on societal customs. The doctrine of necessity allows for the use of reasonable force and necessary treatment for individuals who lack capacity and are in their best interests.

The Mental Capacity Act Deprivation of Liberty Safeguards (DoLS) provides protection for vulnerable individuals who lack capacity and are in hospitals of care homes. It applies to those who are 18 and over, have a mental disorder of disability of the mind, and cannot give informed consent for their care of treatment.

The Mental Capacity Act 2005 governs decision-making for individuals who may lose capacity of have an incapacitating condition. It applies to those aged 16 and over who cannot make some of all decisions for themselves.

Children who understand proposed treatments are considered competent to give consent (Gillick competent). The Mental Health Act 1983 covers the compulsory assessment and treatment of individuals with mental disorders.

The two main ethical approaches in philosophy are teleological ethics, which focuses on the end result, and deontological ethics, which focuses on an individual’s actions being morally right regardless of the end result. In medicine, deontology is patient-centered, while utilitarianism is society-centered. Deontological ethics judges the moral status of actions according to rules of principles, such as the duty not to harm the patient versus the duty to help them. Kantian ethics is a strict form of deontological ethics that emphasizes behaving as though one’s behavior is creating a universal ethical rule. Utilitarianism is a teleological approach that prioritizes the action that leads to the greatest happiness of the greatest number, regardless of how it is brought about. In medicine, autonomy is one of four ethical principles, along with beneficence, non-maleficence, and justice, that enable patients to choose their own treatment and ensure fairness and equality.

While quality adjusted life years (QALY) are a utilitarian measure, it would be extreme to suggest that individuals with illnesses that require expensive treatments should not be treated solely based on the cost-benefit analysis. The general population does not strictly adhere to utilitarian principles, and therefore, The National Institute for Health and Care Excellence (NICE) considers other factors such as justice and the availability of alternative treatments for a particular condition in addition to the cost per QALY when making recommendations.

Ethical Theories and Principles in Healthcare

Deontological theories, also known as Kantian theories, emphasize that an action is morally praiseworthy only if the person’s motive for acting is to perform a true duty. In healthcare, this principle upholds the idea that healthcare professionals should act in the best interest of their patients, regardless of personal gain. On the other hand, the principle of beneficence requires healthcare professionals to help others further their important and legitimate interests, often by preventing of removing possible harms. In a scenario where a psychotherapist chooses not to make changes to the patient list, even though a new patient requires urgent treatment, this goes against the principle of beneficence.

The principle of non-maleficence, which is the physician’s primary obligation, requires healthcare professionals to avoid causing harm to their patients. This principle is emphasized in classical medical writings and is reflected in basic rules of common morality, such as ‘Do not kill’, ‘Do not cause pain’, and ‘Do not break promises’. In the scenario mentioned above, the psychotherapist’s decision not to make changes to the patient list may result in harm to the new patient who needs urgent treatment, which goes against the principle of non-maleficence.

Overall, ethical theories and principles play a crucial role in healthcare, guiding healthcare professionals to act in the best interest of their patients and avoid causing harm.