Overview of Human Subjects Research and the IRB

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Overview of Human Subjects Research and the IRB. KNR 164. Origins of Research 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 - PowerPoint PPT Presentation


Overview of Human Subjects Research and the IRB

Overview of Human Subjects Research and the IRBKNR 164Origins of Research ethics: a historical perspective1931 1946: WWII Medical War Crimes Nazi and Japanese Medical/Military Tests Dr. MengeleJapanese internment of Chinese British and U.S. animal/poisons testing U.S. atomic bomb testing/radiation (1945-1969)

Origins of Research ethics: a historical perspective1932 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.

International Declaration of Code of Ethics 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

1960-2000: 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 Guiding principles of IRB1979: 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

Guiding principles of IRB1.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 Guiding principles of IRB2. 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) Guiding principles of IRB3. 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) Who is the IRB?Responsibilities: To ensure the rights and welfare of any and all research participantsTo 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 Defining the IRBWho is A Human Research Participant?

Data collected through any Intervention or Interaction Identifiable information is obtained Living/deceased Guiding Principles of IRBWhen 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. Guiding Principles of IRBWho 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 studiesInformed ConsentPurpose of Informed Consent:

A legal proof of an individuals 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

Informed ConsentCertainties 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 Informed ConsentResearch 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 reputationResearch 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


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