OVERVIEW OF HUMAN SUBJECTS RESEARCH AND THE IRBKNR 164

ORIGINS OF RESEARCH ETHICS: A HISTORICAL PERSPECTIVE1931 – 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 (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 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

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 studies

INFORMED CONSENTPurpose 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

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 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