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 KnowledgePart 2: Procedural Knowledge

Part I

Conceptual Knowledge – “The Facts”

Part I - Overview

Historical Premise Scope & Purpose CompositionOperationsImportant DefinitionsTypes of Review Types of ActionsPolicies

Historical Premise

Origins of Research EthicsStudies That Incited RegulationGuidelines and Ethical Principles

Nuremberg Code, 1947Declaration of HelsinkiNational Research Act, 1974The Belmont Report, 1979Federal 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 researchMaintaining records:

Copies of all reviewed research protocols, supporting documentation, correspondence, status reports, etc.

Minutes of IRB meetings IRB Membership Roster

Important Definitions

Human SubjectsResearch

Intervention Interaction Instances of Research vs. Non-Research

IdentifiablePrivate information

Types of Review

Exempt ReviewExpedited ReviewFull Board Review

Types of Actions

ApprovedRequest for ModificationsDeferred for ProvisionsDisapproved

Policies & Procedures

Exemption Policy & ProcedureEducational Training PolicyPolicy Recommendation for Students &

FacultyPolicy on External Survey InvitationsLegal Agreement/Legal Review

Part II

Procedural Knowledge – “The Know-How”

Part II - Overview

Planning ResearchSubmitting a ProtocolPoint 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 CertificationIf 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, IRBdoshana@kaplan.edu

IRB Share Point Sitehttp://ctl.kaplan.edu/sites/assessment/IRB/default.aspx

Thank You!

Office of Institutional Effectiveness/IRB StaffCraig N. Bach, Ph.D., IRB Chair

Cynthia Hasemeier, Associate ChairDomarina Oshana, Ph.D. Associate Chair