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Helpful Links

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

 Policies and Procedures                                                      

TOC through SOP 400 

The following Presidential Policies are available from the HRPP Director upon request.

  • Independent Authority of the Institutional Review Boards
  • Organizational Official for Human Research Protection Program
  • Establishment of an Institutional Conflicts of Interest Committee

Note: The effective date of an individual policy can be found in its footer. If you need older versions of a policy, please contact the HRPP office.


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

102B

102C

103

Management of IRB Personnel

104

Conflict of Interest

 

104A

 

104B

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

 

303B

 

303C

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 Participants or Others and Protocol Deviations

 

408

Study Completion

 

409

Categories of Action

 

410

Study Recruitment and Advertisements

 

411

Suspension or Termination of IRB Approval

 

412

NCI Central Institutional Review Board

 

 

 

 

500

 

 

Specific Review Consideration

501

Special Populations

502

 

Categories of Research

502A

502B

502C

502D

502E

502F

502G

502H

502I

502J

 

 

 

 

600

 

 

IRB Communication & Notification

601

IRB Communication and Notification

602

 

Other Entities (Internal)

602A

602B

602C

602D

602E

602F

602G

602H

602I

 

 

603

 

Other Entities (External)

603A

603B

603C

603D

 

 

603E

   

603F

 

 

 

 

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

Health Insurance Portability and Accountability Act (HIPAA Privacy Rule)

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.ouhsc.edu/compliance/standards.asp

 

 

 

 

 

 

 

 

 

 

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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