Research Ethics Applications in Health Care

The process of ensuring that participants in a research study understand the nature, risks, and benefits of the study before agreeing to participate. It's a crucial element of ethical research.

The ability of an individual to understand information, weigh up options, and make decisions based on their own preferences. This ability can be affected by various factors, including mental illness.

No, having a mental illness doesn't automatically mean someone lacks capacity. Capacity assessment is individual-based and should be based on specific situations.

Yes, individuals lacking capacity may be included in research, but it's essential to have appropriate safeguards in place. A legally authorized representative (LAR) or a guardian may need to provide consent on their behalf.

Children's participation in research requires specific safeguards and ethical considerations. They may not fully understand the implications of research, so parental consent is typically needed, along with child assent.

Most research involving NHS patients or services needs to get full ethical approval. It's a process to ensure the research is ethically sound and meets certain standards.

After ethical review, the research proposal is either approved, amended, or rejected. If approved, the research can be conducted according to the ethical guidelines.

Evaluates research proposals for ethical considerations to ensure the well-being of participants and the integrity of research.

A written document outlining the purpose, procedures, risks, and benefits of a research study, provided to potential participants to obtain informed consent.

The researchers involved in the study should be qualified, experienced, and have the necessary resources to conduct the research properly.

A research study should provide meaningful and impactful findings that benefit participants and future patients.

Potential risks and discomforts for participants must be clearly identified and minimized through appropriate safeguards.

Participants should feel free to decline or withdraw from a study without fear of negative consequences or pressure.

Protecting the privacy and identity of participants is essential, including in recruitment and data management.

Research involving children under 16 years old requires parental consent for participation in clinical trials of medicinal products.

Ethical review processes for research are proportionate to the level of risk and sensitivity involved. Some studies may be reviewed under a 'light touch' approach.

Research not involving NHS service users or addressing sensitive ethical issues may be reviewed by university ethics committees, using similar principles but with a lighter touch.

Research is defined as a systematic investigation that aims to generate new knowledge, test hypotheses, and address specific research questions. It often involves allocation of patients to specific treatments.

Service evaluations measure the performance of services against established standards. They are often simple data collection exercises and do not involve random allocation of treatments.

University ethics committees can approve research involving general populations, students, school samples, online surveys, and NHS staff, even if the research involves potentially contentious topics.

After approval, researchers must report study results to the ethics committee and relevant authorities. Major delays, protocol changes, and adverse events must also be reported.

It is unethical to withhold study results from the public. This promotes the sharing of research findings and advances scientific knowledge.

A legal framework in the UK that safeguards individuals who may lack the ability to make decisions for themselves.

The ability to understand information relevant to a specific decision, weigh it up, and communicate a choice. It's not a fixed state and depends on the complexity of the decision.

A person's ability to understand, retain, and weigh information, and communicate a decision about their participation in a research study.

Individuals lacking capacity may still participate in research if there's no significant harm, it's relevant to their condition, benefits outweigh risks, and a representative acts as a consultee.

A legal document that allows individuals to express their wishes about research participation if they lose capacity. It helps ensure their preferences are followed even if they are unable to make decisions later.

16-17 year olds are generally assumed to have capacity unless there's evidence to the contrary. For under 16s, consent from both children and parents is typically required, unless the child objects.

Even without capacity, children can be involved in research by getting their assent, meaning their agreement and understanding is sought. They should be informed about the research and given opportunities to express their views.

The Nuremberg Code, developed after the Nazi war crimes trials, established fundamental ethical standards for medical research, emphasizing respect for human subjects and the need for informed consent.

The Tuskegee Syphilis Study, conducted from 1932 to 1972 in Alabama, involved withholding treatment for syphilis from African American men for decades. This study violated ethical principles because it exploited vulnerable participants.

Ethical review processes in research aim to ensure the safety and well-being of participants by evaluating the study's design, risks, benefits, and potential harms. They involve careful consideration by research ethics committees.

The General Data Protection Regulation (GDPR) is a European law that sets standards for handling personal data of individuals. It aims to protect individuals' privacy and control over their personal information.

The GDPR emphasizes the importance of ensuring that personal data is processed fairly and transparently. This means individuals should be informed about how their data is being used and given the choice to consent or object to its use.

The GDPR requires organizations to protect personal data by implementing appropriate technical and organizational measures. This includes measures to prevent unauthorized access, use, disclosure, alteration, or destruction of personal data.

The GDPR gives individuals the right to access their personal data, rectify inaccuracies, erase their data in certain circumstances, restrict its processing, and data portability. These rights empower individuals to control their personal information.

In the UK, the Human Research Authority (HRA) plays a key role in regulating ethical research involving humans. The HRA ensures that research is conducted ethically and protects the well-being of research participants.

The Declaration of Helsinki is a set of ethical principles for medical research, put together by the World Medical Association. It emphasizes the well-being of participants and requires informed consent, balancing risks and benefits, and high-quality research.

The Declaration of Helsinki states that the well-being of each research participant must take priority over scientific or societal interests. This means researchers must carefully consider the potential risks and benefits for individuals involved in a study before proceeding.

The Declaration of Helsinki requires that all participants in research studies are fully informed about the risks and benefits of participating and agree to take part voluntarily. This process is known as informed consent.

The Declaration of Helsinki emphasizes the importance of fairness in research. This means that the risks and benefits of research should be distributed fairly across different groups of people, and that vulnerable groups should be protected.

The Declaration of Helsinki stresses the need for high-quality research that is likely to produce useful evidence. This means studies should be well-designed, use appropriate methods, and be conducted by qualified researchers.

Autonomy in research means individuals have the right to make their own decisions about participating. This includes being given enough information to understand the study and being free from coercion or pressure.

Justice in research involves balancing the risks and benefits of participating. Researchers must consider the potential harms to participants, such as physical injuries, psychological stress, or breaches of confidentiality, against the potential benefits for individuals or society.

Confidentiality in research is essential for protecting the privacy of participants. This means keeping personal information secure and using appropriate safeguards. The General Data Protection Regulation (GDPR) emphasizes the importance of protecting personal data.

A process ensuring research with NHS patients and staff meets ethical standards. It involves a committee, sponsorship, data protection approvals, and researcher checks.

A crucial document outlining the purpose, risks, and benefits of research, ensuring participants make an informed decision about participation. It's often the most scrutinized part of an application.

This involves evaluating the study's scientific value, potential benefits, risks, feasibility, and researcher qualifications to ensure it meets ethical standards.

These committees regulate research involving human participants across multiple settings. They are crucial for upholding ethical standards for research in various university settings.

The process of verifying that all necessary governance procedures are in place before a research study can begin at a specific location.

A key consideration in ethical review. The researcher must disclose any potential conflicts of interest (e.g., financial gain, personal relationships) that might influence the study

This requires researchers to follow established guidelines for protecting participant privacy and ensuring data security, including measures for confidentiality and data encryption.