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Rona S. Capones, M.D.,DPPS Lou Khristine D. Racca, M.D. Lorybeth  D.  Gonda  M.D. Maria  Kristeta  C. Manrique, M.D. Maria Karen B. Oviedo, R.N. Rainier F. Puig, R.N. Anthony Wills, R.N.

Ethical Aspects in the  Conduct of Research

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Ethical Principles Assessment of Risks and Benefits Informed Consent Confidentiality Procedures Debriefing and Referrals Ethics Committees

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Nazi Medical experiments exposed during the Nuremberg Trials (1946)

The Experiments:      “ NO CONSENT” On the most effective means of resuscitating subjects forced to remain in ice water for 3 hours)‏ For diseases troubling German occupation forces 	- malaria, tuberculosis typhus  	- infected wounds :  Sulfanilamide  clinical trial 	- organ transplantation On methods of sterilizing men and women  16 of 23 Nazi physicians convicted during the trial

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Directives for human experimentation Voluntary informed consent No unnecessary suffering and injury No experiment if death or disability may occur Adequate facilities and safeguards to protect subject Risks should never exceed humanitarian purpose Qualified researcher Participant can stop anytime

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US Public Health Service-sponsored, Tuskegee,  Alabama, USA Objective : To determine the clinical course of untreated syphilis. Subjects : 399 Afro American men with syphilis; 201 – no syphilis Methodology :  	No clear endpoints, no info, no permission Results : untreated patients fared poorly, many died; 40 wives got disease & 19 children born with congenital syphilis Subjects were not given penicillin  when it was discovered in 1945. Study continued till Nov 1972 when it was stopped.    May 16, 1997  : Public apology from US Pres. Clinton This & several other studies led  to establishment of the Office for Human Research Protection (OHRP) in the US.

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Willowbrook Hepatitis Experiment - 1960’s

Objective : To determine the mode of infection hepatitis virus and course of the disease and to test effectiveness of gamma globulin. Subjects : >700 mentally retarded children Methodology :   using gamma globulin antibodies (taken from the blood of hepatitis patients) as a way to create a vaccine.  The first group consisted of children who were previously admitted into the facility. Some received antibodies (experimental group) while others did not (control group). The second group was composed of new patients that were given the antibodies.   Defense : Majority of the children will acquire the infection at  Willowbrook  so it’s better for them to be infected under carefully controlled research conditions.

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Research Ethics  – The application of principles  & values in setting good goals  a nd defining right courses   of action  in the conduct of studies that involve human participants.           “If it is not scientifically sound, it will never be                                ethical.”

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Protects research participants Promotes  advocacy for research participants “Rights, safety, and well-being of [research participants] are the most important considerations and should prevail over the interests of science and society.”   (ICH-GCP, 2016) Preserves credibility, trust, and accountability Reduces liabilities, wasted time and resources Promote public trust of research & sustain public support.

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‏ 	 National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research 	- mandated  by US Congress to provide an ethical foundation for a human research protection system   	- identified  Three Ethical Principles  relevant to research involving human subjects:  Beneficence Respect for person Justice

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Do no harm Right to freedom from harm and discomfort Non maleficence- minimize harm Right to protection from exploitation

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Right to self-determination (absence of coercion Those with diminished autonomy like children, mentally challenged or prisoners etc. they have to be protected from exploitation Right to full disclosure

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Right to fair treatment Right to privacy (confidentiality, Autonomy)

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Ethics in research refers to the moral behavior in the conduct of research and use of its outcomes There are ethical ways of doing research Key word for ethical research Beneficence, respect for person and justice 	-Research participants must be valued as persons: protected 	from harm, benefited, respected, and treated fairly Controls and guidelines exist at every level, but the researcher has ultimate responsibility for ethics in research

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