Bioethics and the Defense of Human Dignity in Biomedical Research

1. Bioethics and the Defense of Human Dignity in Biomedical Research Dr. Derrick Au, Hospital Chief Executive Kowloon Hospital and Hong Kong Eye Hospital Congress of the Asian Federation of Catholic Medical Association 28th November 2008

2. Research Ethics - origins • 1947: 23 physicians were convicted of war crimes committed under the guise of medical experiments (Nuremberg trial and the Nuremberg Code). • 1964: Declaration of Helsinki (1st version) by WMA. It developed the ethical principles in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physician's ethical duties

3. Research Ethics – Whistle-blowing • 1966: Prof. Henry Beecher published in NEJM 22 examples of unethical experimentation, drawn from published articles by leading research scientists. • Early 1970’s: Scandals and misbehaviours from mid-1930’s to the 1970’s were exposed.

4. The case of Tuskegee Project (1932-1972) • In 1932, the US PHS worked with the Tuskegee Institute to study natural history of syphilis in hopes of justifying treatment programs for blacks.  ( "Tuskegee Study of Untreated Syphilis in the Negro Male." ) • 600 black men – 399 with syphilis, 201 control.  No informed consent (told they were treated for "bad blood“). No active treatment given. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance.  Originally projected to last 6 months, the study became a longitudinal study 40 years. • Whistle-blower - Jean Heller in July 1972. http://www.cdc.gov/tuskegee/timeline.htm

6. The Birth of Bioethics • “The study of the ethical dimensions of medicine and the biological sciences” (Encyclopedia of Bioethics, 1972) • The term ‘Bioethics’ was conceived just two years before by Dr Andre Helleger, a Jesuit-trained Catholic and an academic in ethics, in a chat with his friends of a vision of an institute for the study of religious and ethical aspects of biomedical advances. • The Kennedy Institute was subsequently established.

7. Meanwhile, Research Ethics Committees are institutionalized • 1975: Declaration of Helsinki revised. This first introduced the concept of oversight by an 'independent committee' (Article I.2) • A system of IRB (Institutional Review Boards) was developed and governed by Codes of Federal Regulations (CFR). In other countries, research ethics committees or ethical review boards also developed.

8. The Belmont Report • 1979: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978) produced the Belmont Report. • It became the principle guide for IRBs and RECs in the US

9. Belmont Report: 3 Basic Ethical Principles • Respect for Persons • Respect autonomy / Informed consent • Protect those with diminished autonomy • Beneficence • Weigh risk and benefit • Do not harm • Justice • Fair subject selection • Protect vulnerable subjects • Protect against exploitation

10. How about Human Dignity? • The concept of Human Dignity is used by the Council of Europe in its ethical protocols and guidelines • E.g. Additional Protocol to theConvention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, Strasbourg, 2005. • It is not popularly used in IRB protocols in the US

11. The Council of Europe Convention • Preamble: ‘(The convention is) convinced that biomedical research that is contrary to human dignity and human rights should never be carried out’ ; • Chapter III (Ethics Committee): ‘The purpose of the multidisciplinary examination of the ethical acceptability of the research project shall be to protect the dignity, rights, safety and well-being of research participants.’

12. Ruth Macklin: Dignity is a useless concept BMJ  2003;327:1419-1420 (20 December), • It appears mostly in international human rights instruments, such as the UN’s universal declaration of human rights. With few exceptions, these conventions do not address medical treatment or research. • In medical care, mainly used in connection with end-of-life issues.

13. Ruth Macklin: Why dignity is considered a ‘useless concept’ • “It means no more than to respect for persons or their autonomy, to protect confidentiality, and to avoid discriminatory or abusive practices.” • Argues that only a living person has right to be respected.

14. Matthew Eppinette: Human Dignity Still Defying Devaluation • Dignity is, simply, “the quality of being worthy of esteem or respect.” • Human dignity is the recognition that human beings are worthy of esteem or respect. • “Dignity bespeaks something inseparable from human nature, something placed there, something shared by all people. One comprehends dignity less through reason and more through intuition, in a way that is comprehensible to human reflection universally. No scientist or physician has ever observed human dignity; it is an inference.”

15. Human Dignity: The case of medical students and cadavers • Question: Is there any ethical concern for medical students to practice intubation techniques on a cadaver (without prior consent before death)? • Ruth Macklin: “There may be reasonable concern about how the dead person's relatives would feel if they knew that thebody was being used,but that concern has nothing to do with the dignity of the dead body and everything to do with respect for the wishes of the living.”

16. Tsu Chi University: The Silent Mentor慈濟大學: 同學向「大體老師」致敬

17. Words of a nurse, Hong Kong • “As a student nurse, the first thing that I learned from my senior was to perform the last (body-cleansing) service for the deceased patient with care and respect.”

18. Analects 論語 • 祭如在, 祭神如神在。子曰：「吾不與祭, 如不祭。」 (八脩) • [3:12] "Sacrificing as if present" means sacrificing to the spirits as if they were present. Confucius said, "If I do not personally offer the sacrifice, it is the same as not having sacrificed at all."

19. Respect for persons: Why? • May be incomplete if understood merely as the ‘rights’ of a living person • Personhood: If one takes a restrictive view, even the term ‘person’ is a problematic concept. An embryo has not yet become a ‘person’, and a severe demented elder may not be considered a full person.

20. Is the concept of ‘Human dignity’ outdated? • Nowadays, rights of patients and human subjects are adequately protected by institutionalized RECs and proper procedures • Human dignity is translated into ‘Respect for persons’, in term translated into specific, tangible items like ‘confidentiality’ and ‘informed consent’ • From a secular and pragmatic perspective, the concept of human dignity can be disputed

21. Possible arguments for ‘human dignity’ beyond personal rights • Empathy and intuitive argument: Reflect deeply how one would like to be treated by others • Even from a consequentialist perspective, it is likely that, in practice, a society in which ‘respect for persons’ goes beyond the minimally defined extent, will be a better society for all

22. The roots of ‘Human Dignity” • Christian faith: ‘Human dignity’ is intrinsic because we are all made in the image of God • Broader religious belief: Life is sacred / Life comes from higher order (「上天有好生之德」) • Humanism: Each human being has intrinsic value, even if s/he may no longer have self-awareness

23. Summary: Arguing for open-endedness • IRB is an essential part of the system protecting human subjects in modern research • Solely relying on system and procedures may be may be a form of complacency • ‘Human dignity’ is worth further exploring because it keeps the quest for true and full respect open-ended • Bioethics, as a young interdisciplinary field, bring together pluralistic perspectives to engage in the quest of ethics in a complex and fast-changing world of human research

24. Thank you for your attention