Human Subjects Research at ASU

An Overview

Overview• Definitions• Historical Framework• Federal Guidelines • Human Subjects Research at ASU

Institutional Review Board (IRB)• Reviews all proposed research involving human subjects to

ensure that subjects are treated ethically and that their rights and welfare are adequately protected

• Diverse membership– At least 5 members – Males and Females– Scientists– Non-scientists– At least one unaffiliated member

Human Subjects Research

Research “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”

Human Subject “a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information”

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102

Principal Investigator (PI)

Faculty or full-time staff member who assumes the following responsibilities:

• Submission of all required forms to the appropriate review committee

• Conduct of the research• Compliance with IRB decisions• Submitting proposed changes to previously approved

research

History• “Those who cannot remember the

past are condemned to repeat it.” ~ George Santayana

Tuskegee Syphilis Study

• Initiated by the US Public Health Service• Participants were told that they were being treated for “bad

blood” • Individuals were deceived by the officials that conducted the

study • In 1997, President Clinton apologized on behalf of the United

States Government to living survivors of the study

Nazi War Crimes World War II

• "Medical experiments" were performed on thousands of concentration camp prisoners

• Examples of tortures: – Forced killings– Injecting people with gasoline – Immersing people in ice water– Forcing people to ingest poisons

• 23 physicians and administrators were indicted before the War Crimes Tribunal at Nuremberg

Nuremberg Code (1947)

• Voluntary consent• Anticipate scientific benefits• Benefits must outweigh risks• Perform animal experiments first• Avoid suffering• No intentional death or disability• Do no harm• Subjects can withdraw at any time• Investigators must be qualified• Research will stop if harm occurs

Belmont Report (1979)

• The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issues a report: “Ethical Principles and Guidelines for the Protection of Human Subjects”

• Expanded upon Nuremberg Code

• Established 3 ethical principles for human subjects protection

http://www.hhs.gov/ohrp/policy/belmont.html

Federal Regulations

45CFR46 – Federal Policy for the Protection of Human Subjects

21CFR50 (Protection of Human Subjects)– Regulations about FDA-regulated clinical investigations

21CFR56 (Institutional Review Boards)– Regulations about responsibility of IRBs that review FDA-

regulated clinical investigations

What are the differences?

• Common Rule is based on funding • FDA regulations are based primarily on use of FDA regulated

products: drugs, devices, or biologics

The Office for Human Research Protections (OHRP) regulates

• Federally-supported research• Institutional Review Boards (IRB)• All research if a university chooses to apply 45CFR46 to

research

http://www.hhs.gov/ohrp/

ASU Human Subjects Review

All Human Subjects Research must be reviewed & approved prior to data collection

3 Types of Review

• Exempt Studies• Expedited Review• Full Board

Review time depends upon the type of study! Review takes approximately 1-6 weeks from receipt by the Office of Research Integrity and Assurance.

Exempt Studies• Research activities in which the only involvement of human

subjects will be in one or more of the exempt categories as defined by 45 CFR 46.101(b)

• For additional information about Exempt categories, please see http://researchintegrity.asu.edu/humans/exemptstatus

Studies that fall under an exempt category must be submitted for review!

Expedited Review

Studies are reviewed by the IRB Chair or a qualified member of the IRB. This type of review is carried out for studies which involve minimal risk to subjects and fit into an expedited review category of research as defined by 45CFR46. To review the expedited review categories, see http://researchintegrity.asu.edu/humans/expeditedreview

Studies that fall under an expedited category must be submitted for review!

Full Board review

This type of review is carried out for studies that pose greater than minimal risk to subjects.

For more information, please see http://researchintegrity.asu.edu/humans/process

Making Changes to a ProtocolSubmit any proposed changes for review and approval before implementing the changes.

Examples of such changes include:• Alteration of study design, methodology, or recruitment• Changes to any instruments• Changes to informed consent documents• Alteration of project title• Addition of research sites• Addition/deletion of investigators

Changes to exempt studies do not need review unless the change makes the study non-exempt.

Study Approval• Non-exempt studies may be approved for up to 1 year• Study is complete when data analysis and data collection are

complete.

What happens if research lasts longer than 1 year?• Submit a Continuing Review/study closure application if the

project is to last longer than the approval period, which is typically 1 year

• If data analysis is continuing, submit a Continuing Review/study closure application

What happens when the research is done?• Submit a Continuing review/study closure application when

data analysis and data collection are complete• There is no expiration date for studies that were determined

to be exempt

The ASU ProcessStudies that fall under any category must be submitted for review!

• Use ERA-IRB to submit all:– New Studies (whether Exempt, Expedited, or Full Board),– Continuing Reviews/Study Closures– Modifications,– Reportable New Information, and

• For information on using ERA-IRB, see http://researchintegrity.asu.edu/humans

Conclusions• Treat human subjects ethically• Be aware of Federal, State, and Institutional regulations and

guidelines• Ask questions

Contact Information

ORIA staff are available to answer questions and assist you.• Susan Metosky, Assistant Director

– Susan.Metosky@asu.edu (480) 727-0871

• Tiffany Dunning – Tiffany.Dunning@asu.edu (480) 639-7396

• David Marin – David.Marin@asu.edu (480) 965-4796

• Debra Murphy, Director – Debra.Murphy@asu.edu (480) 965-2179

Research.integrity@asu.edu