IRB:Protecting the Rights and Welfare of Human Research Subjects              
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IRB:Protecting the Rights and Welfare of Human Research Subjects
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Guidelines & Procedures


     393 E. Walnut St. 2nd Floor
     Pasadena, California 91188
     Phone: (626) 405-3665
     Fax:     (626) 405-5186
     E-Mail: kpsc.irb@kp.org

kpsc_irb    


FEDERAL REGULATORY AGENCIES

CFR   Code of Federal Regulations

Ø      Federal Register Homepage

cdc  Center For Disease Control And Prevention

Ø      CDC Homepage

Ø      CDC Funding Opportunities

Ø      CDC Human Subjects Research

fda  Food And Drug Administration

Ø      FDA Homepage

Ø      FDA Electronic Orange Book

Ø      FDA Cancer Liaison Program

Ø      Guidance for IRBs and Clinical Investigators

Ø      Regulation relating to IRBs

Ø      Adverse Event Reporting

Ø      Center for Devices and Radiological Health

Ø      Center for Drug Evaluation and Research

Ø      Declaration of Helsinki

  nih      National Institute Of Health

Ø      NIH Homepage

Ø      NIH Office of Extramural Research - Grants and Funding Opportunities

Ø      NIH Forms and Applications

Ø      NIH Grants Policy and Guidance

Ø      NIH Office of Extramural Research website containing non-competing Progress Report (PHS form 2590) due date information

Ø      NIH Institutes, Centers and Offices

Ø      NIH Electronic Research Administration (eRA) Project

Ø      NIH Office of Human Subjects Research

Ø      Public Health Services Grants Policy Statement

dhhs      U.S. Department Of Health And Human Services

Ø      DHHS Homepage

Ø      Office of Research Integrity

Ø      Office for Human Research Protection Homepage

Ø      OHRP Common Findings & Guidance

Ø      OHRP Institutional Review Board Guidebook

Ø      Office for Civil Rights HIPAA Privacy Rule Regulations

Ø      Expedited Review Categories

Ø      Guidance on Written IRB Procedures

Ø      Belmont Report

Ø      Nuremberg Code

CLINICAL TRIALS

Ø      Bioethics Resources

Ø      National Library of Medicine

Ø      MEDLINEplus Clinical Trials

Ø      MEDLINEplus Drug Information.

Ø      Clinical Trials at the National Institutes of Health.

Ø      National Cancer Institute

Ø      Cancer Trials

Ø      Cancer Trials Education Series

Ø      Veterans Administration

Ø      National Eye Institute

Ø      National Institute of Mental Health

Ø      Centers for Medicare and Medicaid Services

Ø      Clinical Trials and Medicare Quick Reference Guide

Ø      Society Of Clinical Research Associates (SOCRA)

Ø      Association Of Clinical Research Professionals (ACRP)

Ø      Drug Information Association (DIA)

Ø      Association Of Nurses In Aids Care (ANAC)

Ø      Association Of Pediatric Oncology Nurses

Ø      Center Watch

Ø      Center For Clinical Research Practice (CCRP)

LITERATURE REFERENCES

Ø      AHRQ Guidelines

Ø      CancerNet

Ø      CDC-Diabetes Homepage

Ø      Clinical Pharmacology

Ø      NLM gateway Search

Ø      National Library of Medicine

Ø      PubMed