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Code of Federal Regulations Title 45 Part 46 Protection of Human Subjects
Food and Drug Administration FDA
Office for Human Research Protections OHRP

II INTRODUCTION
III LIST OF ABBREVIATIONS
IV GLOSSARY
V LIST OF ATTACHMENTS
VI MISSION STATEMENT
VII STATEMENT OF AUTHORITY AND PURPOSE

100			GENERAL ADMINISTRATION
	101		Standard Operating Procedures Maintenance
	102		Training and Education
		102A	IRB Member
		102B	Faculty / Staff
		102C	IRB Staff
	103		Management of IRB Personnel
	104		Conflict of Interest
		104A	Conflict of Interest - Investigators
		104B	Conflict of Interest - IRB Members and Consultants
	105		Signatory Authority

200			IRB Organization
	201		Composition of IRB
	202		Management of IRB
	203		Duties of IRB Members

300			Functions & Operations
	301		Research Submission Requirements
	302		Administrative Review and Distribution of Materials
	303		IRB Meeting Function and Operation
		303A	IRB Meeting Agenda
		303B	IRB Meeting Administration
		303C	IRB Meeting Minutes
	304		Documentation and Document Management
	305		Filing & File Folders
	306		IRB Fees and Invoicing
	307		Copy & Data Requests
	308		Reporting to Regulatory Agencies and Institutional Officials


400		Review of Research
	401	Research Exempt from IRB Review
	402	Expedited Review
	403	Initial Review - Criteria for IRB Approval
	404	Continuing Review
	405	Amendments
	406	Determination of Human Research
	407	Unanticipated Problems Involving Risks to Problems or Others and Protocol Deviations
	408	Study Completion
	409	Categories of Action
	410	Study Recruitment and Advertisements
	411	Suspension or Termination of IRB Approval


500			Specific Review consideration
	501		Special Populations
	502		Categories of Research
		502A	Clinical Research Involving Drugs
		502B	Clinical Research Involving Biologics
		502C	Clinical Research Involving Devices
		502D	Medical Records, Chart Reviews, and Case Studies
		502E	Treatment Use Protocols
		502F	Humanitarian Use Devices
		502G	Emergency Use of FDA Regulated Products
		502H	Banking of Biological Specimens, Genetic Testing, and Gene Therapy
		502I	Cell Lines and Cloned DNA/RNA
		502J	Social/Behavioral


600			IRB Communication & notification
	601		IRB Communication with the Investigator
	602		Other Entities (Internal)
		602A	Office of Compliance
		602B	Office of Legal Counsel
		602C	Office of Research Administration (ORA) - Oklahoma City Campus
		602D	Office of Research Services (ORS) – Norman Campus
		602E	General Clinical Research Center (GCRC)
		602F	Institutional Biosafety Committee (IBC)
		602G	Reciprocal Review Policy (Norman – Oklahoma City)
		602H	Cancer Center Scientific Review Committee (SRC)
		602I	Radiation Safety Office (RSO)

	603		Other Entities (External)
		603A	Veterans Affairs Medical Center
		603B	Office for Human Research Protection (OHRP)
		603C	Food and Drug Administration (FDA)
		603D	Communication with Research Participants
		603E	Participant Outreach Program

700			Informed consent
	701		Consent Process and Documentation

800			Responsibilities of Investigators & Sponsors
	801		Investigator Qualifications & Responsibilities
	802		Sponsor Responsibilities

900			QUALITY IMPROVEMENT
	901		Quality Improvement Program
	902		Audits by Regulatory Agencies
	903		Non-compliance/Scholarly Misconduct

1000			Research related privacy issues, privacy board
	1001		HIPPA

1100			Oklahoma state laws
	1101		Oklahoma State Law Pertaining to Research

	Appendices
A	21 CFR 50	http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title21/21cfr50_main_02.tpl
B	21 CFR 54	http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title21/21cfr54_main_02.tpl
C	21 CFR 56	http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title21/21cfr56_main_02.tpl
D	21 CFR 312.	http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title21/21cfr312_main_02.tpl
E	21 CFR 600	http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title21/21cfr600_main_02.tpl
F	21 CFR 812	http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title21/21cfr812_main_02.tp l
G	21 CFR 814, Subpart H, Humanitarian Use Devices	http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=827b4ffd256288db09fcf346b52dfaec&rgn=div6&view=text&node=21:8.0.1.1.11.7&idno=21
H	38 CFR 16 38 CFR 17	http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=827b4ffd256288db09fcf346b52dfaec&tpl=/ecfrbrowse/Title38/38cfr16_main_02.tpl http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=827b4ffd256288db09fcf346b52dfaec&tpl=/ecfrbrowse/Title38/38cfr17_main_02.tpl
I	45 CFR 46	http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=827b4ffd256288db09fcf346b52dfaec&tpl=/ecfrbrowse/Title45/45cfr46_main_02.tpl
J	45 CFR 160	http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=827b4ffd256288db09fcf346b52dfaec&tpl=/ecfrbrowse/Title45/45cfr160_main_02.tpl
K	The Belmont Report	http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
L	FDA Information Sheet Guidance, Significant Risk and Non-Significant Risk Medical Device Studies, January 2006	http://www.fda.gov/oc/ohrt/irbs/devrisk.pdf
M	OHRP Guidance Document, IRB Guidebook	http://www.hhs.gov/ohrp/irb/irb_guidebook.htm
N	NIH Notice: OD-00-39 Required Education in the Protection of Human Research Participants	http://hsc.unm.edu/crtc/intranet/dots/documents/SOP1_3_06.pdf
O	NIH National Center for Research Resources (NCRR), Division of Clinical Research Resources, Guidelines for the General Clinical Research Centers Program (M01), October 2005	http://gcrc.case.edu/admin/downloads/GCRC_Guidelines_October2005.pdf
P	FDA Information Sheet, FAQ’s, Section II, question 12	http://www.fda.gov/oc/ohrt/irbs/faqs.html
Q	FDA Humanitarian Device Exemptions; Final Guidance	http://0-www.fda.gov.lilac.une.edu/cdrh/ode/guidance/1381.html
R	Federal Register, Vol. 69, No. 92, 05-12-04, Notices, DHHS Financial Relationships and Interest in Research Involving Human Participants: Guidance for Human Subject Protection	http://www.hhs.gov/ohrp/humansubjects/finreltn/finalguid.pdf
S	OHRP Guidance on Written IRB Procedures, July 11, 2002	http://www.hhs.gov/ohrp/humansubjects/guidance/irbgd702.htm
T	OHRP Guidance on Continuing Reviews, July 11, 2002	http://www.hhs.gov/ohrp/humansubjects/guidance/contrev2002.htm
U	FDA Information Sheet, Guidance for IRBs and Clinical Investigators, 1998 Update	http://www.fda.gov/oc/ohrt/irbs/toc4.html
V	OHRP Guidance on the Involvement of Prisoners in Research, May 23, 2003	http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm
W	Office for Protection From Research Risks-Issues to Consider in Research Use of Stored Data or Tissues, November 7, 1997	http://www.er.doe.gov/ober/humsubj/appendix_i.pdf
X	Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles, March 19, 2002	http://www.hhs.gov/ohrp/humansubjects/guidance/stemcell.pdf
Y	Health Insurance Portability and Accountability Act, 45 CFR Parts 160 and 164, August 2003	http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title45/45cfr160_main_02.tpl http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title45/45cfr164_main_02.tpl
Z	NIH Notice OD-00-031, May 1, 2000
AA	Compliance Oversight Procedures, Letter from Dr. Koski, Director, OHRP, December 4, 2000	http://ohrp.osophs.dhhs.gov/references/ohrpcomp.pdf (this link is from http://www.ahrp.org/ethical/OHRPdalglish021901.php & the 1st link seems to be broken) http://www.hhs.gov/ohrp/humansubjects/guidance/aohrpcomp.pdf --have printed to confirm
AB	OHRP Guidance, Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English, November 9, 1995	http://www.hhs.gov/ohrp/humansubjects/guidance/ic-non-e.htm
AC	DHS Final Guidance Document, Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection, May 5, 2004	http://www.fas.org/sgp/crs/misc/RL32909.pdf --although Google’s synopsis of this file says “May 5, 2004,” the file’s update is June 2, 2005) ????
AD	NIH Guidelines for Research Involving Recombinant DNA Molecules	http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm
AE	Oklahoma Statutes, Title 63 §3102A	http://www.oscn.net/applications/oscn/deliverdocument.asp?id=100318&hits=716+275+261+256+
AF	Oklahoma Statutes, Title 63 §1-730	http://www.oscn.net/applications/oscn/Index.asp?ftdb=STOKST63&level=1
AG	Oklahoma Statutes, Title 51 §24A.19	http://www.oscn.net/applications/oscn/deliverdocument.asp?id=80307&hits=
AH	University of Oklahoma, Compliance and Quality Improvement Program
AI	Department of Veterans Affairs, VHA Handbook 1200.5, July 15, 2003	http://www1.va.gov/VHAPUBLICATIONS/ViewPublication.asp?pub_ID=418
AJ	University of Oklahoma Institutional Statement of Commitment
AK	Regent’s Policy Manual for the University of Oklahoma	http://www.ou.edu/regents/official_agenda/ProposedCURSUPolicyManual-June.pdf
AL	University of Oklahoma Faculty Handbook	http://www.ouhsc.edu/Provost/FacultyHandbook/ http://www.ou.edu/provost/pronew/content/Faculty-Handbook-Revised-March-2005.pdf
AM	University of Oklahoma Standards of Conduct	http://www.ou.edu/ohr/standards/standards.pdf

Institutional Review Board (IRB) - OU Health Sciences Center
Library Building, Room 176
Phone: 405/271-2045 - Fax: 405/271-1677
IRB@ouhsc.edu

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TABLE OF CONTENTS

100

GENERAL ADMINISTRATION

102

Training and Education

104

Conflict of Interest

200

IRB Organization

300

Functions & Operations

303

IRB Meeting Function and Operation

400

Review of Research