O VERVIEW OF H UMAN S UBJECTS R ESEARCH AND THE IRB KNR 164

O RIGINS OF R ESEARCH ETHICS : A HISTORICAL PERSPECTIVE 1931 – 1946: WWII Medical War Crimes Nazi and Japanese Medical/Military Tests Dr. Mengele Japanese internment of Chinese British and U.S. animal/poisons testing U.S. atomic bomb testing/radiation ( )

O RIGINS OF R ESEARCH ETHICS : A HISTORICAL PERSPECTIVE 1932 – 1979: Tuskegee Syphilis Study Nurse Eunice Rivers Employed by US Public Health Recruited male subjects/syphilis Targeted illiterate, economically poor, no previous medical care, given hot meals, families given medical care, burial stipends Natural course of syphilis outlined (known by 1936) Treatment was available by 1948 but not offered Patients were told if they seek medical attention elsewhere they would be dropped from the study.

I NTERNATIONAL D ECLARATION OF C ODE OF E THICS 1950: Nuremburg Code of Ethics – (Political/Legal) Enacted by United Nations and adopted by the U.S. 1st International effort Voluntary consent, animal testing should proceed human testing, withdrawal or decline without prejudice, must outline risk/benefit : Declaration of Helsinki – (Medical) Enacted by World Medical Association 1st sign of Medicine to regulate itself Expanded upon Nuremburg Codes Allowed surrogate consent, legal guardian

G UIDING PRINCIPLES OF IRB 1979: U.S. National Commission for Protection of Human Rights U.S. Belmont Report: “Ethical Guidelines for the Protection of Human Subjects of Medical Research” Three fundamental principles that guide research ethics 1.Respect for Persons 2.Beneficence 3.Justice

G UIDING PRINCIPLES OF IRB 1.Respect for Persons: Persons with diminished autonomy need additional protections: Children, Fetuses Mentally challenged or diminished mental capacity (Acute/Chronic) Poorly educated, IRB mandates 8th grade reading proficiency Persons at risk of coercion (criminals, detention, students, immigrant) In all cases, every person must be given the option to chose freely, to the extent they are able, whether to participate or not

G UIDING PRINCIPLES OF IRB 2. Beneficence: (risk/benefit assessment) Maximize the benefits to society while minimizing all potential risks to an individual Research should benefit all society but not intentionally injure anyone When is it justifiable to seek certain benefits despite the involved harms or risks? (known diseases with unknown cures)

G UIDING PRINCIPLES OF IRB 3. Justice: All participants are treated fairly, equally without bias Risks are distributed fairly among class, race and creed without bias Research should avoid exclusion of future research applications Justifiable reason for exclusion/inclusion (availability, vulnerability, local-regional recruitment)

W HO IS THE IRB? Responsibilities: To ensure the rights and welfare of any and all research participants To ensure the research conforms to Declaration of Helsinki guidelines and those mandated by the FDA *IRB review does not guarantee an adequate study design, but may lever decisions if the research design is inappropriate

D EFINING THE IRB Who is A Human Research Participant? Data collected through any Intervention or Interaction Identifiable information is obtained Living/deceased

G UIDING P RINCIPLES OF IRB When does research require Human Participant Protections? Collected directly or indirectly. Any bodily fluids, tissues, materials, cells, DNA, even if you did not collect them (but acquire them through labs) Any medical history information, including family history even if data was not specifically collected for the current study.

G UIDING P RINCIPLES OF IRB Who is responsible for obtaining Human Subjects Protection Approval? The PI of any proposal The Co-Investigators named on the proposal All proposals should directly name investigators and personnel that will have access to the data or be in a position to have collected that data; or be in a position to recruit participants for studies

I NFORMED C ONSENT Purpose of Informed Consent: A legal proof of an individual’s right to jurisprudence Provides information to potential participants Must be provided in written form and also conveyed to participants in a discussion forum Must have a witness/ideally should not be the PI

I NFORMED C ONSENT Certainties of the Informed Consent: Voluntary participation Right to participate, refuse participation and/or withdraw at anytime without prejudice Assessment of risk and benefits Right to confidentiality (any identifiable information) Informed of alternative treatments if applicable Written signature of consent witnessed by third party IRB has some provisions for not obtaining this

I NFORMED C ONSENT Research exemption from IRB Review: Research in established, educational setting and capacity involving normal educational practices (i.e., giving exams, tests, quizzes) unless it places the participant in criminal or civil liability, or can affect employment, financial standing or reputation Research conducted in a purely observation fashion in a public arena Cannot include public officials or candidates for public offices Cannot include children Consumer acceptance surveys