ethics

Biomedical Ethics

Biomedical Ethics BME-7030-A01

Developed By Ahmed El-Wali

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Ahmed El-WaliBiomedical Ethics BME-7030-A01

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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.

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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.


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Ethics Vs Morals

Ethics MoralsThe 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


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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).


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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.


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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.


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EthicsWhile dealing

with

Data Human

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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.


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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.


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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).


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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.


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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.


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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?Ahmed El-WaliBiomedical Ethics BME-7030-A01

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While doing the research

• We have to take care of:• Respect for Persons

• Concern for Welfare

• Justice


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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.


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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.


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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.


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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.


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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.


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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.


Thanks


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