Supporting the Needs of Supporting the Needs of Human Subjects in ResearchHuman Subjects in Research

•Carol Johnston, Chair, Bioscience IRB

• Mark Roosa, Chair, Social Behavioral IRB

Overview

Historical Perspective

IRB/Compliance Office Priorities

Review Process

Questions and Answers

20th Century Research

1972 Syphilis Study Exposed

1966 The Beecher Article (NEJM)

1932 Tuskegee Syphilis Study begins

Kefauver-Harris Amendments Food, Drug and Cosmetic Act 1962

Common Rule 1991

1940’s Nazi Experiments

Clinton Apology 1997

OPRR shuts down programs 1999OPRR shuts down programs 1999

•Informed consent is essential. •Research should be based on prior animal work. •The risks should be justified by the anticipated benefits. •Only qualified scientists must conduct research. •Physical and mental suffering must be avoided

Nuremberg Code 1947

•response to the Thalidomide tragedy

Declaration of Helsinki 1964•Reinterpreted the Nuremberg Code for medical research with therapeutic intent •Journal requirements that research be conducted accordance with the Declaration •Sets the stage for the implementation of Institutional Review Boards (IRB)

Belmont Report 1979Identifies three basic ethical principles that underlie human subject research:

•Respect for persons•Beneficence•Justice

•Compliance by research institutions•Record-keeping,

More Significant Events

1991 1996 1997 1999 2001 2006

Common Rule 1991

Nicole Wan dies at Rochester 1996 volunteer subject in a study of the role of airborne chemicals in lung cancer dies two days after she underwent a bronchoscopy

President Clinton apologizes to PHS Syphilis study survivors

Jesse Gelsinger dies at U Penn the first person publicly identified as having died in a clinical trial for gene therapy - he was 18 y old

OPRR shuts down U Penn

Ellen Roche dies at Johns Hopkins a 24-year-old technician at the

university's asthma and allergy center and trial volunteer died from lung failure

OHRP suspends JH federally funded research

Eight healthy male volunteers were admitted to the critical care unit at Northwick Park and St. Mark's Hospital in London with multiorgan failure following the first day of a double-blind, randomized, placebo-controlled phase 1 study of the safety of a novel monoclonal antibody.

Universities, Hospitals Shut Down

Mar 1999 West Los Angeles Veterans Administration Medical Center

May 1999 Duke University Medical Center Aug 1999 University of Illinois Sep 1999 University of Colorado Sep 1999 University of Pennsylvania Jan 2000 Virginia Commonwealth University Jan 2000 University of Alabama at Birmingham Jun 2000 University of Oklahoma – Tulsa Jun 2001 Johns Hopkins Medical University August 2008 – Indiana University voluntarily moves IRB reviews

to Indianapolis campus

Where is ASU?

3 Federal Audits at ASU in recent yearshttp://www.hhs.gov/ohrp/detrm_letrs/YR07/jul07c.pdf Havasupai Lawsuit

Compliance Office/IRB Priorities

Protect human subjects

Provide a service to researchers

Prevent ASU from experiencing sanctions

ASU Human Subjects ReviewAll human subjects research must be reviewed &

approved prior to data collection

Exempt Studies >900 <25

Expedited Review >500 ~225

Full Board 50 33

REVIEW TIME DEPENDS UPON THE TYPE OF STUDY!Generally the review takes 1-6 weeks from receipt in office!

Social/Behavioral Biosciences

The Review Process

MissionTo protect the rights and welfare of research

subjects

Reviewers’ quandary: Will a change in the research protocol likely improve

the welfare of research subjects to a meaningful degree?

Criteria for IRB Approval

Introduction, specific aims, background Are the specific aims clearly specified? Are there adequate preliminary data to justify the research? Is there appropriate justification for this research?

Scientific design Is the scientific design adequately described and justified?

Criteria for IRB Approval – continued

Inclusion/exclusion criteria Are inclusion and exclusion criteria clearly specified and appropriate? If women, minorities, or children are included or excluded, is this

justified? Is the choice of subjects appropriate for the question being asked? Is subject selection equitable?

Recruitment of subjects Are the methods for recruiting potential subjects well defined? Is the individual performing the recruitment appropriate for the process? Are all recruitment materials submitted and appropriate?

Criteria for IRB Approval – continued

Research procedures Are the rationale and details of the research procedures accurately

described and acceptable? Are the individuals performing the procedures appropriately trained? Is

the location for the procedures acceptable? Are there adequate plans to inform subjects about specific research

results if necessary (e.g., clinically relevant results)?

Data analysis and statistical analysis Is the rationale for the proposed number of subjects reasonable? Are the plans for data and statistical analysis defined and justified?

Criteria for IRB Approval – continued

Potential risks, discomforts, and benefits for subjects Are the risks and benefits adequately identified, evaluated, and

described? Are the potential risks minimized and likelihood of benefits maximized? Is the risk/benefit ratio acceptable for proceeding with the research?

Compensation and costs for subjects Is the amount or type of compensation or reimbursement reasonable? Are there adequate provisions to avoid out-of-pocket expenses by the

research subject?

Criteria for IRB Approval – continued

Privacy and confidentiality Are there adequate provisions to protect the privacy and ensure the

confidentiality of the research subject? Are there adequate plans to store and code the data? Is the use of identifiers or links to identifiers necessary, and how is this

information protected?

Consent document Are the Federally mandated components addressed? Are these components clearly explained in laymen's terms?

Questions ??

Contact InformationSusan Metosky, IRB Administrator (480) 727-0871 Susan.Metosky@asu.edu

Alice Garnett, IRB Specialist(480) 965-4796 Alice.Garnett@asu.edu

Debra Murphy, Director for Research Compliance(480) 965-2179 Debra.Murphy@asu.edu