Bioethics Flashcards
Explain principle of equipoise
It relates to the ethical and scientific basis for conducting such trials and ensuring that the research is conducted in a fair and unbiased manner.
At its core, the principle of equipoise emphasizes the need for genuine uncertainty or equipoise regarding the comparative effectiveness of different treatments or interventions being studied in a clinical trial. It suggests that a trial should only be conducted if there is a state of honest and reasonable disagreement among the medical community regarding which treatment is superior or more beneficial.
The principle recognizes that it would be unethical to expose participants to the risks and potential harms of a clinical trial if there already exists overwhelming evidence favoring one particular treatment over others. In such cases, it would be more appropriate to provide patients with the established best standard of care. However, if there is a genuine lack of consensus or uncertainty among experts regarding which treatment is superior, then a clinical trial can be ethically justified.
Equipoise helps ensure that patients who participate in clinical trials are not subjected to unnecessary risks without the potential for personal benefit. It requires that researchers genuinely believe that the treatments being compared in the trial are reasonably balanced in terms of potential benefits and harms. This state of equipoise allows for a fair comparison of different interventions and helps generate reliable and unbiased scientific evidence.
When designing a clinical trial, researchers aim to establish a state of clinical equipoise by carefully reviewing the existing literature, consulting with experts, and considering the available evidence on the comparative effectiveness and safety of the interventions under investigation. It is important to note that equipoise is not an absolute state but rather a judgment made based on the available information and expert opinions at a given time.
By adhering to the principle of equipoise, researchers can conduct clinical trials in a way that respects the autonomy and well-being of participants while generating reliable evidence to advance medical knowledge and improve patient care.
Can you think of at least one of the ethical arguments for and against patents for novel pharmaceuticals
FOR
Justice/fairness: rewards inventors
Promotes useful consequences
- new products / research
- more research/(ers) (promotes beneficence)
If not permitted, useful information will become proprietary (trade secrets)
Our country/society needs to be competitive (other counties recognise patents)
Against
Justice/ fairness: materialism- produces excessive burdens on medicine (incl costs to consumers for generations)
Unhelpful consequences: inappropriate control over resources that should be ‘common heritage’
Impact on research participants (non maleficence)
Animal research/ animal welfare
Not all countries permit similar patents
draw a clear distinction between Medical Care and Medical
Research in terms of differences in 3 key areas [i] the overall purpose, [ii] the methods
involved, and [iii] the justification of risks involved?
edical Care: The primary purpose of medical care is to provide diagnosis, treatment, and management of individual patients’ health conditions. The focus is on delivering the best possible care to promote the patient’s well-being, alleviate symptoms, cure diseases, or improve their quality of life. The goal is to address the immediate health needs of the patient and ensure their welfare.
Medical Research: The overall purpose of medical research is to generate new knowledge, expand scientific understanding, and improve medical interventions and treatments. It aims to investigate the effectiveness, safety, and mechanisms of diseases, interventions, drugs, therapies, or medical devices. The focus is on contributing to the broader scientific and medical community’s understanding and potentially benefitting future patients rather than directly providing care to individual patients.
[ii] Methods Involved:
Medical Care: Medical care involves the application of established medical knowledge and evidence-based practices to diagnose, treat, and manage individual patients. It encompasses various methods such as physical examinations, medical history assessments, laboratory tests, imaging studies, surgeries, medications, therapies, and follow-up care. The treatment decisions are tailored to the specific needs, preferences, and circumstances of the patient.
Medical Research: Medical research employs systematic scientific methods to investigate research questions or hypotheses. It typically involves the design and implementation of studies or trials, data collection, statistical analysis, and interpretation of results. Researchers use specific methodologies such as randomized controlled trials, observational studies, laboratory experiments, or clinical investigations to gather evidence and answer research objectives. The methods aim to minimize biases, ensure rigor, and produce reliable and generalizable results.
[iii] Justification of Risks Involved:
Medical Care: In medical care, the risks associated with interventions or treatments are typically justified by the potential benefits they offer to the individual patient. The primary consideration is the well-being and best interests of the patient. Medical professionals carefully assess the risks and benefits of different treatment options, taking into account the patient’s medical condition, preferences, and values. The goal is to provide the most effective and safe care while minimizing potential harms.
Medical Research: In medical research, the justification of risks involves a careful balancing act between potential benefits to future patients and the ethical treatment of participants. The risks associated with research interventions are justified based on the potential advancement of medical knowledge, the potential benefit to society, and the scientific validity of the study. Researchers must adhere to ethical guidelines, obtain informed consent from participants, and ensure that the risks are minimized, reasonable, and proportionate to the potential benefits. The welfare and rights of research participants are paramount, and their well-being is closely monitored throughout the study.
Overall, while both medical care and medical research contribute to improving healthcare, they differ in their purpose, methods, and the ways in which risks are justified. Medical care focuses on individual patient treatment, employs established methods, and justifies risks based on individual benefit. On the other hand, medical research aims to generate knowledge, employs scientific methods, and justifies risks based on potential benefits to future patients and the scientific community while ensuring ethical treatment of participants.
identify some of the main legislation relevant to (medical) research and explain
what are the key associated ethical issues each piece of legislation helps protect?
Medicines for Human Use (Clinical Trials) Regulations (2004) & 2017 UK Policy Framework for Health & Social Care.
Informed consent
All clinical trials to have Research Ethics Committee (REC) approval
ie. All research must be REC approved & comply with all relevant legislation
Alder Hey Scandal: Human Tissue Act (2004)
consent
Declaration of Helsinki:
The Declaration of Helsinki provides ethical principles for medical research involving human subjects worldwide. It addresses the following ethical issues:
Informed consent: Ensuring participants have comprehensive information and freely give consent.
Research design and ethics review: Properly designed studies and independent ethical review to safeguard participants.
Risk-benefit assessment: Balancing potential risks against anticipated benefits.
Vulnerable populations: Special protections for vulnerable groups, such as children, prisoners, and mentally incapacitated individuals.
Good Clinical Practice (GCP) Guidelines:
GCP guidelines outline international standards for the design, conduct, and reporting of clinical trials. They address the following ethical issues:
Informed consent: Ensuring participants are fully informed and provide voluntary consent.
Data integrity and confidentiality: Protecting participant privacy and ensuring accurate and reliable data collection and management.
Safety monitoring: Implementing measures to detect and mitigate potential risks to participants’ well-being.
Investigator responsibilities: Ensuring researchers maintain professional and ethical standards.
European General Data Protection Regulation (GDPR):
The GDPR is a regulation that protects the privacy and personal data of individuals in the European Union. It addresses the following ethical issues:
Data protection: Safeguarding the privacy and security of participants’ personal data in research studies conducted within the EU.
Consent: Ensuring participants provide explicit and informed consent for the collection and use of their personal data.
Animals (Scientific Procedures) Act (ASPA) (1986; 2013)
3 Rs (Reduce, Replace, Refine); Animal Welfare (high standards)
What is fully informed consent?
Fully informed consent achieved and demonstrated by
up front participant information which includes clear aims, what is required of the participant, risks etc.
participant information in appropriate lay language and format
provide opportunity to ask Qs clarify understanding etc.
voluntary participation (free from coercion): can you think of any coercive factors?
consent should be recorded
provide capacity to withdraw consent (without prejudice)
provide debrief opportunity
nb. only competent people can provide consent
consent must be sought from proxy of non- competent person eg. parent/ guardian of a child etc (& assent from child)
Explain Clinical Trial Approval and what factors are required for success ?
All clinical trials are ultimately authorised by the MHRA (Medicines and Healthcare products Regulatory Agency)after the research plan/protocol is approved by independent Scientific and REC groups
Scientific review
independent peer review process
focus on clinical equipoise, originality and importance of proposed research
likely benefits of the new treatment are greater than the probable side effects
likelihood of successful outcome eg. trial is well planned, researchers are well qualified, correct facilities/ equipment are in place etc.
REC Review
Focus is on rights, safety, dignity and well being of voluntary participants.
≥1 in 3 must be lay members (outsider’s point of view).
Ensures
Ethical recruitment to the trial
Confidentiality and anonymity of participants
Appropriate compensation if anything should go wrong
Define Utilitarianism
refers to the principle of utility as the “Greatest Happiness Principle”: basic tenet is ‘the greatest good for the greatest number
Utilitarianism is an ethical theory that emphasizes maximizing overall happiness or well-being for the greatest number of people. In this case, a utilitarian approach would prioritize the decision that leads to the greatest overall benefit.
Define Deontology
Deontology is an ethical theory that focuses on following moral duties, principles, or rules regardless of the consequences. It places importance on acting in accordance with ethical principles rather than maximizing outcomes.
underpins universal human rights and duties
Define Principalism
Principalism is an ethical approach that combines various ethical principles, such as autonomy, beneficence, non-maleficence, and justice, to guide decision-making in healthcare ethics.
Define Autonomy
Autonomy:
Autonomy refers to an individual’s right to make decisions and act in accordance with their own values, preferences, and beliefs. It is the principle of respecting a person’s self-determination and their ability to make choices that affect their own life and well-being. In healthcare, autonomy involves respecting patients’ rights to be informed, provide informed consent, and participate in decisions regarding their medical care, treatment options, and other aspects of their health.
Define Justice
Justice is the principle of fairness, equity, and impartiality in the distribution of benefits, burdens, and resources within a society or healthcare system. It involves treating individuals fairly and equally, regardless of factors such as their age, gender, race, socioeconomic status, or medical condition. In healthcare, justice includes ensuring equal access to healthcare services, fair allocation of limited resources, and equitable treatment of patients based on their needs and the principle of fairness.
Define Beneficence
Beneficence refers to the ethical principle of acting in ways that promote the well-being and best interests of others. It involves the obligation to do good, promote health, prevent harm, and contribute positively to the welfare of individuals or society as a whole. In healthcare, beneficence involves healthcare professionals acting in the best interests of their patients, providing appropriate and effective treatments, interventions, or care that maximize benefits and improve health outcomes.
Define Non-maleficence
Non-maleficence, also known as the principle of “do no harm,” is the ethical obligation to avoid causing harm or injury to others. It entails a commitment to minimize the risks of harm and prevent unnecessary suffering. In healthcare, non-maleficence guides healthcare professionals to carefully assess and mitigate potential risks and harms associated with treatments, interventions, or actions. It emphasizes the importance of balancing potential benefits against potential risks and ensuring that the benefits outweigh any potential harm.
Explain informed consent and best practice for this
Provision of Information: The researcher or healthcare professional must provide clear, comprehensive, and understandable information about the purpose, nature, procedures, risks, benefits, alternatives, and any potential discomforts or inconveniences associated with the procedure or study. This information should be tailored to the individual’s level of understanding and cultural background.
Voluntary Participation: Participants should be informed that their participation is entirely voluntary and that they have the right to refuse or withdraw from the study at any time without facing any negative consequences or loss of benefits to which they are otherwise entitled.
Understanding and Comprehension: It is crucial to ensure that participants have understood the information provided. Researchers or healthcare professionals should use clear and plain language, provide visual aids if necessary, and encourage participants to ask questions to clarify any doubts or concerns they may have. Assessing participants’ understanding may involve asking them to explain the study or procedure in their own words.
Capacity and Competence: Researchers or healthcare professionals must ensure that participants have the capacity to provide informed consent. This means ensuring that participants have the mental competence to understand the information, evaluate their options, and make a voluntary decision. For participants who may have impaired decision-making capacity, additional steps may be necessary, such as involving a legally authorized representative or seeking independent ethics committee approval.
Documentation: Informed consent should be documented using a written consent form that includes all relevant information about the study or procedure. This form should be written in clear and understandable language, avoiding technical jargon. Participants should be given ample time to review the consent form and ask questions before signing it. A copy of the signed consent form should be provided to the participant for their records.
Ongoing Communication: Communication should be maintained throughout the study or procedure to ensure participants are informed of any significant changes, developments, or new risks that may arise. Participants should be encouraged to ask questions or express any concerns they may have during the course of their participation.
What are the ethical issues associated with offering trial participants money to participate
Coercion and undue influence: Providing monetary incentives can create a situation where individuals may feel coerced or unduly influenced to participate in a study solely for financial gain. This undermines the voluntary nature of informed consent, as participants may prioritize the monetary reward over fully understanding the potential risks and benefits of the study.
Exploitation: Offering money as an incentive may disproportionately attract individuals who are financially vulnerable or in need of the compensation. This raises concerns about exploiting vulnerable populations, as they may be more likely to take on risks without fully understanding the implications or potential harm.
Commodification of research participation: The use of financial incentives can be seen as reducing the value of research participation to a mere economic transaction. This can undermine the ethical principles of respect for persons and the inherent dignity of individuals, as it reduces their role to that of a paid participant rather than a willing contributor to advancing scientific knowledge.
Distorted motivations and decision-making: Monetary incentives can influence participants’ motivations for enrolling in a study, potentially overshadowing considerations of personal health interests or the scientific merit of the research. This may compromise the integrity of the study and the validity of the results.
Equitable access: The use of financial incentives may create inequities in access to research participation. Individuals from lower socioeconomic backgrounds may be more motivated by financial incentives, leading to disparities in representation within clinical trials. This can impact the generalizability of study findings and limit the ability to address health disparities.
Informed consent and understanding: Financial incentives may interfere with participants’ ability to fully understand the risks, benefits, and procedures involved in the study. Their decision to participate may be based primarily on the monetary reward rather than a genuine comprehension of the study details.
