1. The Institutional Review Board: A Community College Toolkit Dr. Geri J Anderson

2. Overview Why an IRB at Community Colleges Overview of the IRB Design Type of Research & Reviews Where to Begin: Implementation of the IRB The Research Proposal Process

3. History of the IRB The Belmont Report: Three Basic Ethical Principles Respect for Persons Beneficence Justice Federal Regulations & Policy – 45 CFR 46-Basic DHHE Policy for Protection of Human Research Subjects Federal Policy for the Protection of Human Subjects – “The Common Rule” June 18, 1991 Food & Drug Administration – 45 CFR 46-Basic DHHE Policy for Protection of Human Research Subjects

4. What is an IRB An Administrative Body Established to Protect the Rights of Welfare of Human Research Subjects Recruited To Participate in Research Activities Independent of Other Committees & Independent of the Needs of the Institution All Research Involving Human Subjects (or their records) Must Be Reviewed by an IRB

5. Duties of an IRB Review all research activities involving human participants and document the findings – Risks to subjects are minimized – Selection of subjects is equitable – Informed Consent is obtained – Privacy and confidentially is protected Responsible for ensuring compliance with FWA, federal regulations & institution policies

6. Additional IRB Duties Review research protocols with authority to: – Approve – Require Modifications – Deny – Terminate Conduct continuing reviews of approved research; review proposed amendments Ensure Progress Reports & Findings are provided

7. IRB Oversight Human Subjects Research – Review of records – Clinical investigations – New interventions Data Repositories Case Studies Internet Research Pilot Studies Non-human Subject/Non-research check

8. Composition of an IRB Membership = 5 Members – Scientific Area – Nonscientific Area – External to the Institution – Institutional Researcher – Institution General Counsel – Diversity of Representation – Diversity of Gender

9. Other IRB Components IRB Members May Not Participate in Review of Their Own or Students’ Projects IRB May Seek Advice From Non-Member Experts By Federal Definition, the IRB is a BOARD not an Institution COMMITTEE The Mission of an IRB is to Ensure the Protection, Safety and Welfare of Human Subjects

10. The Bottom Line  No One Can Be Objective About Their Own Work  People Underestimate The Risks Involved In Things in Which They Are Familar  People Overestimate The Benefit Of Things That Are Important To Them  Protects Subjects & The Institution  Ensures Research Is Shared

11. Establishing Your Institution’s IRB Create Charter. Written Procedures & Operating Principles Establish Approval Process (& Forms) For Types of Review Full Review Expedited Exempt Training IRB Decision Matrix BENEFICENCE JUSTICE Risk/Benefit AnalysisSubject Selection Experimental DesignInclusion/Exclusion Qualifications of PIRecruitment Respect For Persons Informed ConsentPrivacy & Confidentiality Surrogate ConsentProtection of Subjects

12. The Review Process Proposal Submitted Review by IRB Notification of Decision Changes? Need Additional Review Annual Review Required Share Results of Study

13. What Review Required FULL STANDARD REVIEW – More Than Minimal Risk Generally Invasive Studies – Requires Review & Approval (by Vote) of Full IRB – Should Be Reviewed Regularly Informed Consent (10 th Grade Reading Level) Research Design EXPEDITED REVIEW – Very Minimal Risk – Non-Invasive – Study of Materials Collected For Non-Research Purposes EXEMPT – Surveys, Educational Tests – No Follow-up Needed – Important: Study done with minors, inmates or other special populations cannot be exempt

14. Important Definitions – Research: a systematic investigation 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 Identifiable private information – Informed Consent: Not a single event or just a form—but, an educational process between investigator and the perspective subject

15. Informed Consent Elements o Full Disclosure of the Nature of the Research & The Subjects’ Participation o Adequate Comprehension on the Part of the Potential Subjects o The Subjects’ Voluntary Choice to Participate o Document Informed Consent and Assent In Accord With Federal Regulations and as Approved by the IRB

16. IRB Decision Matrix Approval Without Any Changes Approval Pending Minor Changes Tabled major questions raised about the study design but study is believed to be worthwhile Disapproved (rare)

17. Proposal Components An Application A Consent Form A Protocol Training Completion Certificate for PI Additional Supporting Documents (questionnaires, interview questions, surveys)

18. IRB Training It is a federal requirement that all institutions conducting federally-funded human subjects research provide proof of training in human subjects research protections Investigators who conduct human subjects research that is exempt from IRB review MUST comply with the education requirement

19. Basic Ethical Principles Underlying Research with Human Participants (The Belmont Report Guidelines) Federal Regulations for Protection of Research Participants History & Ethics of Research with Human Participants Note: Completion of training must be documented and maintained for 3 years Institution Designed Training

20. Training Options The Collaborative Institutional Training Initiative (CITI) Human Subjects Research Education Program through the University of Miami provides a comprehensive selection of educational modules that can be used to satisfy institutional instructional mandates Modules include:  17 basic modules focused on biomedical research  11 basic modules focused on Social and Behavioral research  Continuing Education (CE) modules  Completion Certificate Available www.citiprogram.org

21. Maintain Federalwide Assurance (FWA) and ensure compliance Develop & Implement human subject protection policies and procedures Conduct Required Trainings Preside over IRB meetings & ensure the IRB carries out duties appropriately Review & Approve Protocol Submissions For Review Notify Investigators/PI of IRB Decisions Maintain IRB Documentation; Track Needed Updates Suggested IRB Chair Responsibilities

22. Action Plan Review the OHRP Institutional Review Board Guidebook (http://www.hhs.gov/ohrp/)http://www.hhs.gov/ohrp/ Establish Charter, Written Procedures & Operating Principles Recruit and train IRB members using federal guidelines (http://ohsr.od.nih.gov/IRBCBT/intro.html)http://ohsr.od.nih.gov/IRBCBT/intro.html Design and Implement Training Program Establish Record Keeping Procedures

23. Thank You & Questions For Sample IRB Charter, Forms, or Questions, please feel free to contact: Geri J. Anderson gerijanderson@gmail.com