Ethical, Legal and Social Issues arising out of Advancements in New Biology Seyed E. Hasnain
Importance of Ethics in Infectious Diseases/Clinical Research
Ethics: separate right from wrong as a principle of human duty When applied to systematic studies in biology : Bioethics Why infectious diseases warrant more of bioethics attention? Infectious means contagious Contagious means isolation of patient from the rest Isolation means discrimination Discrimination means seclusion, loneliness, embarrassment, humiliation, loss of physical and mental health No isolation means threat to rest of the society BORDERLINE ZONE BETWEEN INFECTIOUS DISEASES RELATED RESEARCH AND HUMAN RIGHTS
Moral issues in doing research involving infectious diseases Primary Goal : generation of useful knowledge about human health and disease, its likely spread and extent of damage possible The Human Subjects: o Are means to gather information and knowledge about understanding the disease o Immediate health benefit to participants is not the purpose of such studies therefore may be at risk of exploitation
Ethics in clinical research Minimize exploitation Protect rights Maintain dignity Respect confidentiality Ensure welfare.while the subjects contribute to the generation of knowledge
Research in infectious diseases Starts with field observations involving human subjects Mimic similar situation in a laboratory In vitro studies, identification of targets Check polymorphism of the target in population Make a intervention molecule Studies involving cell culture and animal model Ends with human clinical trials
Some successful studies we can t call ethical Jenners experiment with a young boy of 8 years using Cow Pox (1796) Tuskegee Syphilis Study (1932-72) The Tuskegee Syphilis Experiment: A clear example of ethically unacceptable research by present standards Source:http://en.wikipedia.or g/wiki/file:syphilis-posster What do we do with the results of immoral research? the Tuskegee study was and remains a key source of information about syphilis. (Caplan, 419)
Codes of Research Ethics Nuremberg Code (1947) informed consent, societal value, unacceptable levels of risk Declaration of Helsinki (orig. 1964) added written protocol, independent review Belmont Report (1979) added justice, fair subject selection Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research (1993, Updated 2002)
Ethical framework while working with human subjects: 9 principles Valuable scientific question Valid scientific methodology Favorable risk-benefit evaluation Fair subject selection Informed consent Confidentiality Respect for enrolled subjects Scientific integrity Independent review Adapted from: Emanuel E, Wendler D, Grady C. What makes clinical research ethical? Journal of the American Medical Association 2000; 283(20):2701-11
Valuable scientific question Is the research outcome a burden or benefit? Research as benefit Research as burden Subjects need access Subjects need protection
Benefit-Risk-Balance Minimize risks to subjects Maximize benefits to individual subjects and to society Enough preliminary evidence before commencement of clinical trials Start with case control studies Benefit to society? RISKS Cease... investigation if: the risks are found to outweigh the potential benefits, or there is conclusive proof of positive and beneficial results (Helsinki Declaration)
Fair Subject Selection Selection of subjects related to the purpose of the study, not because they are readily available, vulnerable, or otherwise easily exploited, or are favoured. Do not exclude subjects without a good reason of science, vulnerability, or susceptibility to risk or burden. Choice of control population for proper conclusions from the study
Vulnerability There is an order of preference in selecting subjects, for instance, adults before children (Belmont Report) Exclude vulnerable subjects unless their participation is needed for scientific reasons (CIOMS) A human subject should be at liberty to bring the experiment to an end... Psychological harm Social stigma Cultural effects Economic repercussions or even without reasons Vulnerable group Research group
Informed Consent: Respect for Persons Voluntary agreement to participate: After weighing the objectives, risks, benefits, and alternatives of the research. Nuremberg Code CIOMS guidelines The Belmont Report Extra protections for those with limited capacity to consent
What happens when consent can t be taken When it is not possible to request informed consent from every individual to be studied, the agreement of a representative of a community or group should be sought, but the representative should be chosen according to the nature, traditions and political philosophy of the community or group. CIOMS
Epidemiological studies may involve genetic information Not only information about an individual, but also about those to whom the individual is related If genetic testing is involved for any study a nondirective, culturally adapted genetic counselling should be made available UNESCO Int l Declaration, Art. 11 Clear directions for sharing such information Is there a duty to warn family members of being at risk?
THE SUBJECT HAS A RIGHT TO BE, OR NOT TO BE INFORMED OF RESULTS UNESCO Int l Declaration, Art. 10
Independent Review: Institutional Review Board Ensure: Risks are minimized Risks are justified by expected benefits and knowledge to be gained Justifiable subject selection Fair treatment to subjects Informed consent is adequate Suggest: Possible methodology before commencement of the study
Biosafety is also an integral part of Bioethics Proper waste disposal Proper decontamination Proper segregation Proper packing
Reporting Ethics in Infectious Diseases - Is it research or audit or clinical practice? - Disclose if similar studies have been performed earlier - Disclose if it differs from earlier reports - Should not alter or ignore some data to make the results look statistically better - Patients identity and other relevant medical details should remain confidential Important to report exceptional cases
REGISTRATION A prerequisite for all Clinical Trials Trials must register at or before the onset of patient enrollment. Selective reporting distorts clinical decisionmaking. Financial benefits may hide important trials Right to information of trials Undue importance to some clinical trials for benefit of selected pharmaceutical companies Biased publications: Positive trials are more likely to be submitted for publication and also published quickly than negative trials JAMA 2002;287:2825-2828. Stern and Simes BMJ 1997;315:640-645
As they say. There are three ethical injunctions. Show Respect, Do Good, Be Fair X
Acknowledgements Sharmistha Bannerjee, Univ of Hyderabad