Ethics of Research: Theoretical framework

Four basic principles of biomedical ethics:

1. Respect for autonomy: Informed consent and all that

2. Beneficence: Who benefits from this research?

3. Non-maleficence: Make sure no one gets hurt, have good preparation and appropriate facilities, etc.

4. Justice: Equitable aka fair and impartial

Ethical theory should be the foundation of the principles and rules, and ultimately our judgement.

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Action-based approaches to ethics

Principlism:

• Developed in 1970 by Beauchamp and Childress

• Applies the principles of respect for autonomy, beneficence, non-maleficence and justice to contemporary ethical dilemmas

• Used as practical ethical decision-making in the clinical, technological and epidemiological professions

Consequentialism:

• Maintain moral status of an action is determined by the goodness or badness of its consequences

• One common type of consequentialism is utilitarianism (ex. cost-benefit analysis)

• Application of theory is concerning since according to these principles, then slavery is acceptable given that the benefits outweigh the harms

Non-consequentialism:

• Ethical theory that does not determine moral status solely on benefit and harm of its consequences

• Most referred to non-consequentialist ethical theory is deontology

• Deontologist uses a rights-based or duty-based system of analysis, they have the right to posses something (example)

• Decisions are made using duty-based justifications

• Sometimes confronted with the problem of conflicting duties or rights

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Agent-based approaches to ethics

Virtue-based approaches

• Place importance of the characters of the person performing the action rather than on. the action itself

• roots in Greek philosophy (Aristotle) and most recently in the work of Foot and MacIntyre

• Hierarchies of virtues have changed. over time but include justice, temperance, charity, mercy and wisdom

• Inner character traits in ethical decision making is more important than moral theories

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Situation-based Approaches to Ethics

Casuistry

• Thought to originate in 16th century Spain

• Specific cases --> moral principles (and not the other way around)

Relativism:

• Moral appraisals are essentially dependent upon a moral code that is specific to time, place and culture

• No absolute criteria with which moral actions may be appraised

• A relativist may cite geographical, historical or anthropological data in support of his case

• Moral relativism accepts what all human beings do as appropriate in their context

• There is no basis for ethical argument or discussion

Modern Feminist approaches:

• Developed in the 70s as a response to criticisms that contemporary fundamental moral principles generally failed to consider the importance of moral relationships, the role of emotion and the subjective in moral reasoning and generally failed to redress the repression of women in decisions concerning themselves

• From moral judgements to moral impulse or moral attitude

Geocultural approaches:

• Vary considerably from region to region

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Conflict of Interest

• Situations in which financial or personal considerations may compromise an investigator's professional judgement in conducting or reporting research

• Scientist have the responsibility to maintain the highest standards of objectivity and freedom from bbias

• Unacceptable and alarming

Academic institutions must have:

1. Standard conduct that differentiate the boundaries of conflict of interest and commitment

2. Requirements for timely disclosures of relevant information

3. Adequate review of disclosed information and potential conflicts of interest

4. Procedures for enforcing standards and providing sanctions for violations.

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Therapeutic Fallacy

Research is not treatment. Subjects can hope for therapeutic benefit, but must not expect it. Since participants may get placebo and some may possibly experience adverse effects from the new drug.

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Clinical Equipoise

It is only ethical to study an intervention where genuine uncertainty exists about which of the options is better.

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Privacy

Privacy is regulated by the Health Records Acct 2001 (Vic). It states that:

• Give individuals a legally enforceable rights to access to health information about them that is contained in records held in Victoria by the private sector

• Establishes Health Privacy Principles (HPPs) that will apply to health information collected and handled in Victoria by the Victorian public sector and the private sector.

This is aimed to protect privacy and promote patient autonomy, while ensuring safe and effective service delivery, and the continued improvement of health services.

Health Privacy Principles:

Principle 1: Collection

• Information can only be collected if individual has consented

• If collected for research, cannot obtain data that can identify the individual

Principle 2: Use and Disclosure

• Use = within the organisation

• Disclosure = to another organisation

Principle 3: Data quality

Principle 4: Data security and data retention

• Health service provider must not delete health information relating to an individual, even if it is inaccurate

• Unless permitted by law or data was collected as a child and now above 25 years old or after 7 years

Principle 5: Openness

• Person should be told what information is held

Principle 6: Access and correction

• Access = person should have access, with some exceptions

• Correction

Principle 7: Identifiers

• Only if necessary. Don't use Medicare numbers

Principle 8: Anonymity

Principle 9: Transborder data flows

Principle 10: Transfer or closure of the practice of a health service provider

Principle 11: Making information available to another health service provider

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Declaration of Helsinki

1. Developed by the World Medical Association as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects

2. Duty of physicians to promote and safeguard health of the people

3. Physician shall act only in the patient's interest when providing medical care

4. Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects

5. The best proven treatment, management, and preventions must be continuously challenged through research for their effectiveness, efficiency, accessibility and quality

6. Current medical practice and medical research involve risk and burdens

7. Particular needs for vulnerable populations must be recognised

8. No national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration

9. Duty of physicians in medical research to protect the life, health, privacy, and dignity of the human subject

10. Based on prior studies and animal experimentation

11. Caution should be exercised in the conduct of research that may affect the environment or welfare of the animals used in research

12. Studies involving human subjects should be clearly formulated in an experimental protocol and submitted to ethics committee for review

13. Information about sponsors, affiliations, and other potential conflicts of interest should be reported

14. Research protocol should always contain a statement of the ethical considerations involved and should indicate that there is compliance with the principles enunciated in this Declaration

15. Medical research involving human subjects should be conducted only by scientifically qualified persons under supervision of a clinically competent medical person

16. Predictable risk and burdens should be anticipated

17. Physicians should avoid engaging in research projects unless confident that risks have been assessed and managed

18. Only be done if benefit outweigh the risk

19. Is justified if population on which research is conducted on can benefit from the study

20. Subjects must be volunteers and informed participants in the research project

21. Every precaution should be taken to respect the privacy of the subject

22. Written informed consent is recommended, if unavailable a spoken informed consent under a witness is acceptable.

23. Subject has the autonomy to abstain from the study

24. Recommended that a physician not involved in the study obtain the informed consent, to prevent dependent relationship with the physician in charge of the research

25. Legally incompetent, physically or mentally of providing informed consent, the consent is obtained from a legally authorised representative in accordance with the applicable law

26. Additional informed consent is required in studies involving minors

27. Informed consent can be achieved in people physically/mentally incapable of providing consent if that is their population of interest. Specific reasons should be stated and informed consent is obtained from authorised surrogate.

28. Both authors and publishers have ethical obligations

29. When medical research is combined with medical care, additional standards apply to protect patients who are research subjects

30. At the end of the study, patient should be assured of access to best care possible

31. Physician must fully inform patient which aspects of the care are related to the research.

32. If no treatment is currently available, research can be done based on what the physician thinks is the best. Results must be published.