Rapid City Regional Hospital - Institutional Review Board

Research Compliance

Regulatory Information Links

Federal Policy Regulations

Title 45 CFR 46 - Protection of Human Subjects (Common Rule)
   www.access.gpo.gov/
   nara/cfr/waisidx_03/45cfr46_03.html

Food and Drug Administration

Title 21 CFR 11 - Electronic records; electronic signature
   www.access.gpo.gov/
   nara/cfr/waisidx_03/21cfr11_03.html

Compliance Home
Research Compliance (IRB) Home
Communication Flow Chart (PDF)
Education
Frequently Asked Questions
Investigators Manual (under development)
RCRH IRB Forms
Regulatory Information
Support & Assistance
2008 IRB Meeting Dates & Submission Deadlines (PDF)

Title 21 CFR 54 - Financial disclosure by clinical investigators
   www.access.gpo.gov/nara/cfr/waisidx_03/21cfr54_03.html

Title 21 CFR 50 - Protection of human subjects - informed consent
   ww.access.gpo.gov/nara/cfr/waisidx_03/21cfr50_03.html

Title 21 CFR 56 - Institutional review boards
   www.access.gpo.gov/nara/cfr/waisidx_03/21cfr56_03.html

Title 21 CFR 312 - Investigational new drugs
   www.access.gpo.gov/nara/cfr/waisidx_03/21cfr312_03.html

Title 21 CFR 314 - FDA approval to market a new drug
   www.access.gpo.gov/nara/cfr/waisidx_03/21cfr314_03.html

Title 21 CFR 812 - Investigational devices
   www.access.gpo.gov/nara/cfr/waisidx_03/21cfr812_03.html

Title 21 CFR 814 - Pre-market approvals (PMAs) of medical devices
   www.access.gpo.gov/nara/cfr/waisidx_03/21cfr814_03.html

Good Clinical Practice: Consolidated Guidance
   www.fda.gov/cder/guidance/959fnl.pdf

Useful Links for Human Subjects Information

Belmont Report
   www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

Declaration of Helsinki
   www.wma.net/e/policy/b3.htm

Department of Health and Human Services
   www.dhhs.gov

Office of Human Research Protections (OHRP)
   www.hhs.gov/ohrp

U. S. Food and Drug Administration
   www.fda.gov

International Conference on Harmonization
   www.ich.org

Public Responsibility in Medicine and Research (PRIM&R)
   www.primr.org

IRB Forum
   www.irbforum.org

National Bioethics Advisory Commission
   www.bioethics.gov

How to Find Us

Research Compliance (IRB)
Rapid City Regional Hospital
Institutional Review Board
353 Fairmont Blvd.
Rapid City, South Dakota 57701

Phone: (605) 719-5690
Fax: (605) 719-5699
rcrhirb@rcrh.org

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