What is Research

What does the KPSC IRB do

Who is on the IRB and how are members chosen

What about studies approved by other IRBs

Why does the IRB require a special application form

Understanding the IRB process

C. Review

What are the procedures for Review

Full Committee Review
       a. Process
       b. Timeline for Review

Expedited Review
       a. Process
       b. Timeline for Review
       c. (Appendix 1) Research that Federal Law Defines as Having No Risk or Minimal Risk

Administrative Certification of Exempt Status
         a. (Appendix 2) Research that Federal Law Defines as Exempt 

Continuing Review
        a. Does Research require continuing (annual) review?

D. Consent

Does the IRB require written consent for all research

Consent Procedure for Survey’s and Questionnaires 

Studies That Require Written Consent

Informed Consent Guidelines (Consent Form Checklist.PDF)

II. IRB OPERATIONS

Schedule (IRB Schedule, Deadlines, & Events.DOC)

The Common Rule (The Common Rule.DOC)

Health & Human Services (DHHS.DOC)

Food & Drug Administration
      1. FDA Regulations (FDA TOC.DOC)
      2. Human Subjects (21 CFR 50.DOC)  
     3. IRBs (21 CFR 56.DOC) 
     4. INDs (21 CFR 312.DOC)
      5. IDEs (21 CFR 812.DOC) 

Protected Health Information 
    1. HIPAA Regulations (PHI.DOC) 
   2. Standards For Privacy of Individually Identifable Health Information [45 CFR Parts 160 & 164] (HIPPA Privacy  Guidance.PDF) 
    3. Privacy Rule Research Requirements (Privacy Rule Table.PDF) 
    4. Protecting the Privacy of Patients’ Health Information Summary of the Final Regulation (PHI Summary.DOC)

Terms of KP Federal Wide Assurance (FWA Terms.PDF)

III. IRB ETHICS

The Belmont Report (The Belmont Report.DOC)

Declaration of Helsinki (Helsinki.PDF)

Nuremberg Code (Nuremberg Code.PDF)

IV. IRB CONTACT

KPSC IRB Staff (KPSC IRB Contact List.DOC)

KPSC Area Research Chairs (KPSC Area Research Chair Contact List.DOC)

Federal Government (KP Government Contact List.DOC)

V. IRB RELATED RESOURCES & SITES

Federal Regulatory Agencies
       Code of Federal Regulations (URLs) 
      Center for Disease Control & Prevention (URLs) 
      Food & Drug Administration (URLs) 
      National Institute of Health (URLs) 
      U.S. Department of Health & Human Services (URLs)

Clinical Trials (URLs) 

Literature References (URLs)

Medical Journals (URLs)

Research Organizations & Associations (URLs)

Resources for Research (URLs)

External Funding for Researchers (URLs) 

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