1. Human Subjects Research at ASU An Overview

2. Overview Definitions Historical Framework Federal Guidelines Human Subjects Research at ASU

3. 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

4. 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

5. 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

6. History “Those who cannot remember the past are condemned to repeat it.” ~ George Santayana

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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/

14. ASU Human Subjects Review All Human Subjects Research must be reviewed & approved prior to data collection

15. 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.

16. 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)45 CFR 46.101(b) For additional information about Exempt categories, please see http://researchintegrity.asu.edu/humans/exemptstatushttp://researchintegrity.asu.edu/humans/exemptstatus Studies that fall under an exempt category must be submitted for review!

17. 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/expeditedreview45CFR46 http://researchintegrity.asu.edu/humans/expeditedreview Studies that fall under an expedited category must be submitted for review!

18. 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 http://researchintegrity.asu.edu/humans/process

19. Making Changes to a Protocol Submit 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.

20. 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

21. 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

22. The ASU Process Studies 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 http://researchintegrity.asu.edu/humans

23. Conclusions Treat human subjects ethically Be aware of Federal, State, and Institutional regulations and guidelines Ask questions

24. Contact Information ORIA staff are available to answer questions and assist you. Susan Metosky, Assistant Director – Susan.Metosky@asu.edu (480) 727-0871 Susan.Metosky@asu.edu Tiffany Dunning – Tiffany.Dunning@asu.edu (480) 639-7396 Tiffany.Dunning@asu.edu David Marin – David.Marin@asu.edu (480) 965-4796 David.Marin@asu.edu Debra Murphy, Director – Debra.Murphy@asu.edu (480) 965-2179 Debra.Murphy@asu.edu Research.integrity@asu.edu