Ethics and Integrity
What is Ethics?
Imagine a person who lives alone in a house. In this setting, they are under no obligation to account for their actions to anyone and enjoy the freedom to do as they please, whether it involves having a late dinner, watching television for extended periods, or even painting the walls a vivid yellow!
The consequences of their actions are confined solely to themselves. However, if another person, such as a friend or a family member, subsequently joins them in the same dwelling, the dynamics change. The presence of two individuals necessitates the establishment of new behavioural guidelines, as the actions of one person can impact the other. These guidelines, which regulate an individual's behaviour or the manner in which activities are carried out in the presence of others, are collectively referred to as "ethics."
Ethics plays a critical role in various aspects of life, including personal relationships, healthcare, education, and governance. Ethics refers to the moral principles, values, and standards of conduct that guide human behaviour and decision-making. It encompasses a set of rules and principles that help individuals and societies differentiate between right and wrong actions and choices. Ethics provides a framework for evaluating the morality of actions and for making choices that are considered just, fair, and in line with societal norms and values.
Ethics, human and Healthcare
Human research has a high risk, and even with the greatest of intentions and meticulous preparation and execution, mistakes can still happen. Accidents can occasionally occur as a result of technical faults, insensitivity, carelessness, or disdain for ethics. There have even been a few instances in which research has deliberately and horribly violated human beings.
In recent times, to reduce risk and promote health, the conduct of research in health and social services has become subject to a growing amount of global regulation, requirements, and control.
Healthcare practitioners are required to make well-informed decisions about the best course of therapy and patient care on a daily basis. Research frequently influences these choices, affecting treatment, care, and services. Therefore, it is crucial that we safeguard our patients in all of our decisions and activities. The core principles of ethics in healthcare focuses on - respect of patients, beneficence, justice, utility, and solidarity (WHO - last line title: health ethics)
Ethics in healthcare settings is a crucial and complex field that guides the conduct and decision-making of healthcare professionals, organizations, and patients. It involves a set of principles and values that help ensure the provision of high-quality, patient-centred care while addressing moral dilemmas and ethical challenges. Here are some key aspects of ethics in healthcare settings:
- Patient Autonomy: Patient autonomy is a fundamental principle of healthcare ethics. It emphasizes the right of patients to make informed decisions about their medical care, including the right to accept or refuse treatment. Healthcare professionals should respect and support a patient's autonomous choices.
- Beneficence: The principle of beneficence requires healthcare providers to act in the best interests of their patients. It involves providing care that maximizes benefits while minimizing harm. Beneficence is closely related to the concept of "do no harm" (non-maleficence).
- Non-Maleficence: Non-maleficence is the ethical duty to do no harm. Healthcare professionals should avoid actions that may harm patients and should carefully consider the potential risks and benefits of medical interventions.
- Justice: The principle of justice pertains to the fair and equitable distribution of healthcare resources and access to care. It requires healthcare systems to be just and unbiased in their allocation of services and treatments.
- Confidentiality: Healthcare providers must uphold patient confidentiality. Patients have the right to expect that their medical information will not be disclosed without their consent, except in situations mandated by law or public safety.
- Informed Consent: Informed consent is the process through which patients are provided with comprehensive information about their medical condition, proposed treatments, potential risks and benefits, and alternative options. Patients must give their voluntary and informed consent before any medical procedure.
- End-of-Life Care: Ethical issues in end-of-life care include decisions about withholding or withdrawing life-sustaining treatment, do-not-resuscitate (DNR) orders, advance directives, and physician-assisted suicide or euthanasia. These issues require careful consideration of the patient's wishes, quality of life, and ethical principles.
- Resource Allocation: The allocation of limited healthcare resources, such as organ transplants or critical care during a pandemic, poses ethical challenges. Ethical guidelines and decision-making frameworks help healthcare professionals make difficult choices while considering fairness and patient welfare.
- Cultural Competence: Healthcare professionals should be culturally competent, understanding and respecting the diverse cultural beliefs and values of their patients. Cultural competence ensures that care is provided in a culturally sensitive and respectful manner.
- Professional Codes of Ethics: Healthcare professionals, such as doctors, nurses, and pharmacists, are bound by their respective codes of ethics, which set forth principles and standards of conduct specific to their professions.
Patient and Public Involvement and Engagement
The ultimate beneficiaries of health care and health service research are patients and the general public, and improving patient outcomes is the primary goal of this field of study. As a result, any type of research must involve both the public and the patient. (Ethics module - paraphrased).
When it comes to research, public involvement refers to work that is done "with" or "by" the public rather than "to," "about," or "for" them. It indicates that patients and other individuals with relevant experience are involved in the planning, execution, and dissemination of research. (NHS Health Research Authority- paraphrased).
Research teams which involve patients and the public run better studies because - they provide a better research experience, are created in a way that participants can accept, contain participant information that participants can understand, and have better results communication to participants at the end of the study.
Patients and the general public can participate in research in a variety of ways, such as by helping to identify the research topic and establish the research agenda, by assisting in the creation of the research proposal, by offering feedback on the proposal, and by participating in advisory groups for studies. In fact, they are able to participate in every step of the research process (R. Module).
Good Clinical practice
An worldwide standard of ethical and scientific excellence for the planning, carrying out, and documentation of human subjects' research is called Good Clinical Practise, or GCP. The public can be assured that research subjects' rights, safety, and well-being are protected and respected when GCP is followed, as it aligns with the values stated in the Declaration of Helsinki and other globally accepted ethical guidelines. Additionally, it guarantees the accuracy of study data.
The 13 GCP principles are listed below:
The 13 Good Clinical Practice Principles
Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over the interests of science and society.
The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
Freely given informed consent should be obtained from every subject prior to clinical trial participation.
All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
Systems with procedures that assure the quality of every aspect of the trial should be implemented.
GCP adapted but it is standard.
Participant Information Sheet
Potential research volunteers are provided a written document called the Participant Information Sheet (PIS), which has been ethically approved and includes comprehensive study details. The purpose of a PIS is to ensure that participants are fully informed about the research, its objectives, procedures, risks, benefits, and their rights, enabling them to make an informed and voluntary decision about their participation.
Typical content of PIS or share a pictorial example of PIS? (example to add or content)?
Informed Consent
Prior to collecting data, participants are informed of the research's aim, objectives and methods, and their consent is requested.
The idea behind informed consent is that people shouldn't be forced into participating in research "against their will," but rather out of a sense of voluntarism and after fully understanding all of the potential consequences. 2018 Thorogood, page 89.
Definition:
A two-way conversation with the prospective participant is what constitutes informed consent. Consent should be viewed as an information cycle because it is a process, not a single event.
While obtaining consent from participants, ensure:
- they are adequately informed about the study
- they understood the information
- they had time to consider being involved in the study
- They are free to decline or withdraw at any time, without having to give a reason.
- they have the power of free choice
What does a Consent form look like?
[ a Sample from anywhere UoS etc here the in box ]
Vulnerable Groups
Every human subject in the study has the potential to be vulnerable. People can be vulnerable in different ways and to varying degrees depending on their current circumstances. Some participants might be especially susceptible for taking part in research. While working with potentially vulnerable individuals, researchers will need to take additional ethical considerations into account.
Vulnerable groups in research and healthcare ethics refer to individuals or populations who may be at an increased risk of harm, exploitation, or discrimination due to their characteristics, circumstances, or conditions. Ethical considerations for research and healthcare involving vulnerable groups are paramount, as these individuals often require special protections to ensure their rights, well-being, and dignity are upheld.
The following groups of people are perceived to be particularly vulnerable in a research context:
| Vulnerable Group | Description | Example |
|---|---|---|
| Children Infants and children under 18 years of age |
Children (under 18 years old) lack the capacity to provide informed consent; therefore, the informed consent of the children's parents or legal guardians should be obtained. | Balancing Parental Rights and Child's Best Interests: Balancing parental decision-making authority with the best interests of the child is a critical ethical consideration. In some cases, parental decisions may conflict with the child's well-being, requiring an assessment of the child's best interests. |
| People who lack mental capacity | People who cannot weight the risks and benefits of participation and make an informed decision. In cases where individuals lack the capacity to make decisions, substitute decision-makers, such as legal guardians, family members, or healthcare proxies, may be appointed. | People with learning disabilities, dementia, or stroke |
| People with physical disability | Certain physical disabilities may necessitate special consent procedures, for example, an entire consent procedure in writing | People with hearing problems or deaf |
| People who are terminally ill | Participants in research who are terminally ill can rarely expect to gain personal benefits from the study, so the risk/benefit ratio must be carefully considered. | Respect for Autonomy: Terminally ill patients have the right to make informed decisions about their medical care. This includes choices about treatment options, pain management, and end-of-life decisions, such as advance directives and do-not-resuscitate (DNR) orders. |
| Pregnant women | Pregnant women present a specific and important ethical consideration in healthcare and research due to their unique circumstances and vulnerabilities. | Maternal-Fetal Conflict: Ethical dilemmas can arise when the interests of the pregnant woman conflict with the interests of the fetus. In such cases, healthcare providers should prioritize the pregnant woman's well-being while considering the best interests of the fetus, striving to reach a balance that respects both. |
| People in various circumstances | People whose circumstances may unduly influence decisions to consent | people who are frail or in poor health; elderly, or people who are in care. |
Sensitive Topic and Ethics
Sensitive topics in research and healthcare often involve issues that are deeply personal, emotionally charged, or potentially stigmatizing. Ethical considerations when dealing with sensitive topics are crucial to ensure the well-being, rights, and dignity of individuals or communities involved.
'Sensitive' research entails unique risks that must be managed, taking into account the possible outcomes of these risks.
In this regard, the sensitivity of the research subject matter is also important. For instance, participants may be more vulnerable in a study focusing on any of the following topics:
- ‘race’ or ethnicity;
- political opinion;
- trade union membership;
- religious, spiritual or other beliefs;
- physical or mental health conditions;
- sex life, sexuality and/or gender identity;
- identity of an individual resulting from processing of genetic or biometric data;
- abuse (child, adult);
- nudity and the body;
- criminal or illegal activities;
- political asylum;
- conflict situations;
Generic principle of carrying out research with vulnerable individuals
When conducting research involving vulnerable individuals, the following general guidelines are helpful to keep in mind:
- Always consider your actions and decisions when conducting research.
- Recognise that the type and extent of participant vulnerability can vary depending on the specifics of a research project.
- When planning the study, try to keep potential participant risks to a minimum.
- Recognise that you might need to assist participants in finishing the study, and make the necessary preparations (not the least of which is an exit strategy).
- Offer a variety of options to potential participants when appropriate.
- Recognise that the type and extent of participant vulnerability can vary depending on the specifics of a research project.
- Recognise the dangers to participants, other potential participants, and researchers themselves.
Adapted from the University of Sheffield
Support and Approvals in Ethics - Ethic Boards
The majority of universities, hospitals, and other research-conducting organisations have formal committees in place to review research proposals.
Ethical guidelines and ethics committees serve the dual purpose of safeguarding research participants and institutions by discouraging researchers from engaging in unethical behaviour that could have implication for research participants as well as negative consequences for their institutions.
The study protocol is submitted to the appropriate ethics committee for approval along with any supporting documentation (such as the Participant's information sheet and the informed consent form).
Research projects involving staff and service evaluations frequently don't need NHS approval, but they do need to be registered with the departments of research and development.
Research Ethics Committee:
Data and Ethics:
Big data is produced, stored, and analyzed by healthcare systems with the goal of enhancing the services they offer. Hospital records, patient medical records, exam results, and internet-of-things-enabled devices are just a few examples of the big data sources used in hospitals (Dash et al., 2019).
In order to advance science and healthcare knowledge and to keep the public's trust in the research enterprise, it is crucial to ensure the integrity of research data (Ethic module -rephrased). The term "integrity" of such data refers to a strict adherence to moral principles, honesty, and complete avoidance of deception.