Office of Research Integrity Assurance All rights reserved GTRC Presented by Georgia Institute of...

Office of Research Integrity AssuranceAll rights reserved GTRC

Presented byGeorgia Institute of Technology

Institutional Review Board

Presented byMelanie Clark, CIPAssociate Director

Office of Research Integrity Assurance

Office of Research ComplianceAll rights reserved GTRC

Significant Events

PHS Syphilis Study, formerly PHS Syphilis Study, formerly ““Tuskegee StudyTuskegee Study” Nuremberg Code 1947 Nuremberg Code 1947

U.S. ScandalsU.S. ScandalsHenry Beecher: "Ethics and Clinical Research" Henry Beecher: "Ethics and Clinical Research" Public Health Service Policy Adopting IRBs Public Health Service Policy Adopting IRBs

Declaration of HelsinkiDeclaration of Helsinki Stanford Prisoner Study (1971)Stanford Prisoner Study (1971) PHS PHS ““Tuskegee StudyTuskegee Study”” Revealed (1972 Revealed (1972)) National Research Act & 45 CFR 46National Research Act & 45 CFR 46

Belmont Report (1979)Belmont Report (1979)

1930 1940 1950 1960 1970 1980


Military Tribunal led to Nuremberg Code

Voluntary consent

Anticipated scientific benefits

Benefits outweigh risks

Animal experiments first

No intentional death or disability

Subjects may withdraw at anytime

Investigators must be qualified

Investigators will stop if harm occurs


1950s: 1950s:

Willowbrook State SchoolWillowbrook State School

Staten Island, New York Staten Island, New York

1960s:1960s:Jewish Chronic Disease Hospital Jewish Chronic Disease Hospital Cancer ExperimentsCancer Experiments


Milgram StudyYale University


Stanford Prison Experimentwww.prisonexp.org


1932, Public Health Service study, in collaboration with the 1932, Public Health Service study, in collaboration with the Tuskegee Institute in Macon County, Alabama, undertook a study of Tuskegee Institute in Macon County, Alabama, undertook a study of untreated syphilis in hopes of justifying treatment programs for untreated syphilis in hopes of justifying treatment programs for blacks. blacks. 600 black men (399 with syphilis, 201 without) were told they had 600 black men (399 with syphilis, 201 without) were told they had "bad blood," a local term used to describe syphilis, anemia, and "bad blood," a local term used to describe syphilis, anemia, and fatigue.fatigue.Penicillin, treatment of choice, was discovered in 1940s but was Penicillin, treatment of choice, was discovered in 1940s but was withheld.withheld.In exchange for taking part in the study, the men received free In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for originally projected to last 6 months, the study actually went on for 40 years.40 years.


Ethical Principles and Guidelines for the Protection of Human Subjects of Research

Respect for PersonsIndividual autonomyProtection of individuals with reduced autonomy

BeneficenceMaximize benefits and minimize harms

JusticeEquitable distribution of research costs and benefits

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

April 18, 1979


Significant Events

1990 1996 1997 1999 2000 2001 2002

Common Rule 1991 Nicole Wan dies at Rochester 1996

President Clinton apologizes to PHS Syphilis study survivors

Jesse Gelsinger dies at U Penn VCU Twins Study OPRR shuts down LA VA Medical, Duke, U Ill, U Colo, U

Penn

OPRR shuts down VCU, UAB, U Okla OPRR reorganized as OHRP, moved to Cabinet level

and Director replaced, June 2000

Ellen Roche dies at Johns Hopkins; OHRP suspends JH federally funded research

Secretary's Advisory Committee on Human Research Protections replaces National Human Research Protections Advisory Committee


1999: Jesse Gelsinger & University of Pennsylvania

18-year old volunteer in U Penn’s gene therapy study of partial omithine transcarbamylase deficiency (OTC)


2001: Ellen Roche & Johns Hopkins

Healthy lab technician volunteered for asthma study of hexamethonium bromide.Respiratory effects of hexamethonium bromide were not known to investigator prior to study.Previous participant had respiratory problems, solution was changed without IRB being informed.Johns Hopkins forced to halt $300 million in medical researchEllen Roche died. Compensation for her participation: $365. Johns Hopkins settled out of court with her family.


Oh No! The Feds Shut Us Down


What Happens When the Research Enterprise is Shut Down

All federal research funding involving human subjects suspended (payroll, operations, etc.)

All experiments halted (except to treat enrolled subjects on a case-by-case basis)

IRB must re-review all protocols

Millions of dollars in lost revenue and expenses to bring institution into compliance


What is an IRB?Faculty committee with the purpose of reviewing research

activities involving human participants

Constituted in accordance with federal law:

Minimum of five members

Community representation

Scientific and non-scientific members

Adequate expertise to review the proposed work

Consultants, when needed


What is a human subject? As defined by 45 CFR 46 Is a living individual about whom an investigator obtains either:

Data through intervention or interaction with the individual; or

Identifiable private information


What is research?Research: As defined by 45 CFR 46, "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge"


Categories of Research

Exempt

Expedited

Full


What you need to submitIRB application

IRBWISE

Project description

Consent/Assent/Parental Permission

All recruitment flyers & scripts

Human Subjects Training Certificate

Questionnaire, surveys or interview guides


§46.116 General requirements for informed consent

Statement that it is researchPurpose & proceduresHealth and financial riskCompensation/costsConfidentialityIn case of injurySubjects rightsAppropriate reading level


Anything Else?All Amendments must be submitted to IRB for review and approval prior to commencement.

Any change to the protocol or consent form

All Adverse Events must be submitted for IRB review even if they are not study related.


Principal Investigator’s RESPONSIBILITIES

Obtain approval prior to start of research

Inform IRB of:

Adverse events

Changes in protocol

Violations

Continuing review request

Obtain consent prior to enrolling subjects


Case Study

“Check List”

Johns Hopkins University

Intensive Care Units in State of Michigan

Office for Human Research Protections


Important Information

http://www.researchintegrity.gatech.edu

IRBWISE information

Human Subjects Training (CITI)

Policy and Procedures

Consent templates


Contact InformationMelanie Clark, Associate Director

[email protected]

Kelly Winn, Research [email protected]

Barbara Henry, [email protected]

404-894-6949Dennis Folds, IRB Chair

[email protected]

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