Protecting Human Subjects in Research A Primer on Understanding the Scope, Purpose, and Process of the Kaplan University IRB Prepared by the Office of Institutional Effectiveness -11/07

Overview Part 1: Conceptual Knowledge Part 2: Procedural Knowledge

Part I Conceptual Knowledge – “The Facts”

Part I - Overview Historical Premise Scope & Purpose Composition Operations Important Definitions Types of Review Types of Actions Policies

Historical Premise Origins of Research Ethics Studies That Incited Regulation Guidelines and Ethical Principles Nuremberg Code, 1947 Declaration of Helsinki National Research Act, 1974 The Belmont Report, 1979 Federal Regulations & Policy, 45 CFR 46

Scope & Purpose Ascertaining acceptability of all proposed human subject research at KU Safeguarding rights & welfare of human subjects in research at KU Assuring quality of the design and methodology of research at KU

Composition Number of members Experience and expertise Experience with vulnerable populations Knowledge of applicable laws, regulations, standards Understanding of institutional commitments & policies Diversity of members By gender and qualifications Racial diversity Cultural diversity Professional diversity

Operations Conducting reviews of research Maintaining records: Copies of all reviewed research protocols, supporting documentation, correspondence, status reports, etc. Minutes of IRB meetings IRB Membership Roster

Important Definitions Human Subjects Research Intervention Interaction Instances of Research vs. Non-Research Identifiable Private information

Types of Review Exempt Review Expedited Review Full Board Review

Types of Actions Approved Request for Modifications Deferred for Provisions Disapproved

Policies & Procedures Exemption Policy & Procedure Educational Training Policy Policy Recommendation for Students & Faculty Policy on External Survey Invitations Legal Agreement/Legal Review

Part II Procedural Knowledge – “The Know-How”

Part II - Overview Planning Research Submitting a Protocol Point of Contact & Resources

Planning Research Research Methodology Validity & reliability of instruments Quality/Appropriateness of design and methodology Human Subjects’ Protections Basic Elements of Informed Consent/Assent Waivers to Obtaining Informed Consent Retaining and Storing Records Guidelines for Classroom Projects Conditions where IRB approval is required Conditions where IRB approval is NOT required Common Pitfalls to Avoid Not obtaining permissions BEFORE IRB review Exaggerating anticipated benefits to human subjects Not anticipating the unexpected

Submitting A Protocol Complete IRB Submission Form Include brief summary of research methodology and protections for human subjects IN the submission form Acquire IRB Training Certification If available, submit above materials together with full proposal (i.e., Lit Review & Methodology) to the IRB

Point of Contact & Resources Submit Protocols to: Domarina Oshana, Ph.D. Associate Chair, IRB IRB Share Point Site

Thank You! Office of Institutional Effectiveness/IRB Staff Craig N. Bach, Ph.D., IRB Chair Cynthia Hasemeier, Associate Chair Domarina Oshana, Ph.D. Associate Chair