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Ethics
- 1. Biomedical Ethics Biomedical Ethics BME-7030-A01 Developed By Ahmed El-Wali 1 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 2. Outlines • Motivation. • Current Work. • Ethics Vs Morals & Law. • Why are Ethics important for Biomedical Engineering? • General Ethics types. • Data, its History, & types. • Dealing with data. • Dealing with subjects • Respect for Persons, Concern for Welfare, & Justice. • Conclusion. • Questions. • References. 2
- 3. Motivation • Learning some of the Biomedical ethics. • Minimizing risks during the research. • Learning, how to design a study based on Biomedical ethics. • Being able to publish my work. 3 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 4. Ethics Vs Morals Ethics Morals The rules of conduct recognized in respect to a particular class of human actions. Principles or habits with respect to right or wrong conduct. Come from Social system - External Individual - Internal 5 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 5. Law • Law can be seen as a form of rules that reflects the values and interests of a society. • It is important to remember that ethics and law are not the same. An action may be legal but unethical or illegal but ethical (e.g. Selling Marijuana). 6 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 6. Why are Ethics important for Biomedical Engineering? • Medical deals with serious and personal issues “human life”. • Integrity and confidentiality are necessary to allow engineering conduct research with patients. • As technology advances, so does our capabilities in engineering and medical fields. • But that could cross or contradict religion, nature or our beliefs. 7 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 7. General Ethics types • Professional Ethics • Being honest & not biased. • Don’t fabricate your reports. • Patient Ethics • Confidentiality. • Full Disclosure “telling the full truth”. • Human and Natural ethics • You are not the God (creating a super man). • Don’t interfere the nature. • You’re working on improving life quality not changing the life itself. 8 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 9. Data & its History • Data provide the raw materials for reasoning, calculation and gaining new information. • Nowadays, There is a growing accumulation of data, mostly derived from the study of people. • It starts in Health-care IT systems, to facilitate basic administrative tasks. • After that and with response of demanding new treatments. Learning health system, which is our current system, is developed. 10 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 10. Types of Data • Clinical care data (e.g. primary care and hospital records). • Data from clinical trials and observational studies. • Patient-generated data (e.g. from lifelogging). • Laboratory data (e.g. imaging). • Administrative data. 11 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 11. Why Protecting data is hard? • It needs to meet two contradictory requirements at the same time: • To generate, use and extend access to data (to advance research and make public services more efficient). • To protect privacy as a requirement of human rights law (the more access is extended the greater the risks of abuse). 12 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 12. To reduce the risk of privacy violations • Aggregation of data makes it harder to distinguish individual cases. • Anonymization by the removal of identifiers. • Pseudonymization, the replacement of identifiers with a code, enables linking of data. • De-identification should be combined with further controls on the access to, and done by a specific authorized organization. • Building a firewall-protected, pseudonymized dataset administered by authorized organization. And setting group of authorized researchers that can access this dataset. 13 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 13. Try to • Use all available kinds of authentications on any device you used in your research. • Encrypt all the data used. • Make an encrypted backup of the data. • Return back the data after finishing the research. 15 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 14. Dealing with subjects • No researcher intends to harm participates in a research project, however, that’s not a guarantee that no harm will occur. • We have to put some questions to consider and understand the circumstances of the people who will be participants like: • Is there a power relationship between the researcher and the participants? • Are there any cultural norms or economic circumstances? 16 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 15. While doing the research • We have to take care of: • Respect for Persons • Concern for Welfare • Justice 18 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 16. Respect for Persons • Respect for Persons includes: • Individuals or groups directly involved in research as participants or indirectly through the use of their data or biological materials. • It is unacceptable to treat individuals solely as objects to achieve the research goal. • Individuals have the ability to make voluntary and informed decisions: Autonomy. 19 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 17. Respect for Persons • Respect for persons means to provide a clear information about the risks and potential benefits of the study. • Consider factors that can diminish participant autonomy (ex. Not enough information about the experiment is provided ) • Consider how to respect the dignity of those lacking autonomy • Researchers must seek consent from someone legally responsible of them, also It is important to involve the participant in the consent process as much as possible. 20 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 18. Concern for Welfare • Doing your best to ensure that participants are not exposed to unnecessary risks. • Physical, mental, spiritual health, social circumstances, privacy. • The treatment of human biological materials should be according to the consent of the donor. 21 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 19. Concern for Welfare • Working on Eliminating and minimizing risks. • Do the benefits justify the potential risks of participation? • Providing accurate and accessible information. • The consent materials must give an accurate account of the expected risks and potential benefits in suitable language and format. 22 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 20. Justice • The Principle of Justice refers to the obligation to treat all people fairly and equitably. • All individuals or groups have the right to benefit from knowledge generated by research. • Don’t be biased to a certain group of participants to make your study effective.(Be Honest) • You have to design the study so that the risks to participants are minimized and the goal of the researcher is achieved. 23 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 21. Conclusion • Ethics are providing the motive to act in a better way. • All Fields in this world have their own Ethics. • Biomedical Ethics are very important to follow to protect yourself and others from unexpected harmful things. 24 Ahmed El-Wali Biomedical Ethics BME-7030-A01
- 22. Thanks Ahmed El-Wali Biomedical Ethics BME-7030-A01
Editor's Notes
- Ethics are dependent on others for definition. Flexibility They tend to be consistent within a certain context, but can vary between contexts. Usually consistent, although can change if an individual’s beliefs change. Why we do it? Because society says it is the right thing to do. Because we believe in something being right or wrong.
- Health-care IT systems were originally introduced to facilitate basic administrative tasks, such as managing patient records, issuing repeat prescriptions and tracking patients through different encounters with health care professionals. However, they developed to provide business intelligence for service improvement and support for observational research. These come together in the concept of a ‘learning health system’ which is seen as an inevitable response to increasing pressures on health services and the demand for new treatments. about human biology, health, disease and functioning , such as managing patient records, and tracking patients to build their history.
- clinical care data (e.g. primary care and hospital records) ■ data from clinical trials and observational studies ■ patient-generated data (e.g. from ‘life logging’ or consumer genetic testing) ■ laboratory data (e.g. from imaging, genome sequencing and other ‘omics’) administrative data or metadata
- The need to meet two contradictory requirements at the same time places data initiatives in a double bind. In other words, they are required: ■ to generate, use and extend access to data (because doing so is expected to advance research and make public services more efficient); and, at the same time ■ to protect privacy as this is a similarly strong imperative, and a requirement of human rights law (and the more access is extended the greater the risks of abuse).
- A number of technical measures may be applied to prevent the identification of individual subjects and reduce the risk of privacy infringements:anonymisation ■ aggregation of data makes it harder to distinguish individual cases, although it is not wholly secure in the face of modern statistical techniques; it also makes further linking of data difficult anonymisation by the removal of identifiers also makes individuals difficult to reidentify, although re-identification may still be possible depending on what other data or information are available ■ pseudonymisation, the replacement of identifiers with a code, enables linking of data where the correspondence between the code and the case is known, although data may still be vulnerable to inferential re-identification To protect the privacy of data subjects, de-identification should therefore be combined with further controls on the access to and uses of data. While seeking consent respects rights that individuals may have to make decisions about matters that may affect their interests, it cannot protect them from potentially harmful consequences of data use. Merely acting in accordance with consent cannot excuse data users from their moral duties towards data subjects, prevent the identification of individual subjects and
- Ethical principles for data initiatives The use of data in biomedical research and health care should be in accordance with a publicly statable set of morally reasonable expectations and subject to appropriate governance. ■ The set of expectations about how data will be used in a data initiative should be grounded in the principle of respect for persons. This includes recognition of a person’s profound moral interest in controlling others’ access to and disclosure of information relating to them held in circumstances they regard as confidential. ■ The set of expectations about how data will be used in a data initiative should be determined with regard to established human rights. This will include limitations on the power of states and others to interfere with the privacy of individual citizens in the public interest (including to protect the interests of others). ■ The set of expectations about how data will be used (or re-used) in a data initiative, and the appropriate measures and procedures for ensuring that those expectations are met, should be determined with the participation of people with morally relevant interests. This participation should involve giving and receiving public account of the reasons for establishing, conducting and participating in the initiative in a form that is accepted as reasonable by all. Where it is not feasible to engage all those with relevant interests – which will often be the case in practice – the full range of values and interests should be fairly represented. ■A data initiative should be subject to effective systems of governance and accountability that are themselves morally justified. This should include both structures of accountability that invoke legitimate judicial and political authority, and social accountability arising from engagement of people in a society. Maintaining effective accountability must include effective measures for communicating expectations and failures of governance, execution and control to people affected and to the society more widely.
- Here are some examples of questions that should be asked: Is there a power relationship between the researcher and the participants (e.g. doctor/patient, teacher/student, supervisor/assistant)? Are there any cultural norms or practices that need to be factored into the recruitment, consent, or debriefing process? What are the economic circumstances of the prospective participants? Could there be any social repercussions of participation in this project? How can the privacy and confidentiality of participants be protected?
- Individuals are generally presumed to have the ability to make voluntary and informed decisions: autonomy. Respect for persons means respecting every individual's ability to give or refuse their consent to participate. Their decision must be based on clear information about the foreseeable risks and potential benefits of the study and must not be coerced or influenced. The principle of Respect for Persons recognizes the intrinsic value of human beings.
- means respecting every individual's ability to give or ref a guardian, parent or use their consent to participate after being informed by ., by providing appropriate explanations to their level of understanding.
- it is important to consider what is being asked of participants from their perspective. What may be a trivial matter to a researcher may be of greater significance to participants in different circumstances or different cultures the possible affect of the research on the welfare of participants' friends, family, or other groups. · Consider potential impacts on participants’ physical and mental health, on their social or economic circumstances, and on their privacy Could participants come to any physical harm as a result of the study? Could any part of the study be distressing or uncomfortable for participants? Would participating in this study put a participant at risk: of losing their job? of being ostracized? of harming their family, friends or community? of breaching their expectation of privacy? it is important to consider what is being asked of participants from their perspective different circumstances or different cultures
- Ultimately it is the individual who decides whether the risks justify the benefits in their decision to either consent or refuse to participate in the research. To help people make an informed decision, the consent materials must give an accurate account of the foreseeable risks and potential benefits. To ensure the participants fully understand this account it must be in the language and format (e.g. written, verbal, pictorial) most suitable to the participants. What are the potential benefits to the participant or to society as a whole? What are the potential benefits to the participant or to society as a whole?
- , meaning that treating all people with sufficient respect and concern for their welfare, distributing the benefits and burdens of research participation. effective.You have to generalize your study to be more effective by using Who are the participants? Why this group and not others? The generalizability and effectiveness of the study not compromised