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  Informed Consent
  Exempt & Expedited Criteria
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  Investigator Manual
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LIST OF ATTACHMENTS

List of Standard Operating Procedures Attachments 


101-A

SOP Revision Log

 

101-B

Forms Revision Log

 

101-C

SOP Template

 

102A-A

Bibliography & Resource List

 

102A-A-1

Bibliography & Resource List-NC

 

102A-B

Training Checklist And Documentation – IRB Members

 

102B-A

Written Attestation

 

102B-B

Memorandum Dated 08/01/05 From Dr. Joseph Ferretti, OUHSC Sr. Vice President & Provost

 

102B-B-1

Email Correspondence dated 3/07/05 from Director of Compliance/University Privacy Official

 

102B-C

Oklahoma City Campus: In-House Program Reference Manual “OUHSC Human Participant Protection In Research”

 

102C-A

Training Checklist And Documentation-IRB Staff

 

103-A

HRPP/IRB Job Descriptions

 

103-B

HRPP/IRB Performance Standards

 

103-C

Performance Evaluation Form

 

103-D

Description of Delegation of Authority

 

104A-A

Conflict of Interest Disclosure Form

 

201-A

IRB Roster Template

 

201-B

Oklahoma City Campus IRB Membership Rosters

 

201-C

Norman Campus IRB Membership Rosters

 

201-D

Oklahoma City Campus IRB Meeting Schedules

 

201-E

Norman Campus IRB Meeting Schedules

 

202-A

New Member Information Packet Checklist

 

202-A-1

Norman Campus New Member Information Packet Checklist

 

202-B

Oklahoma City Campus New Member Welcome Letter

 

202-B-1

Norman Campus New Member Welcome Letter

 

202-C

Oklahoma City New Member Appointment Letter

 

202-C-1

Norman Campus New Member Appointment Letter

 

202-D

IRB Member Confidentiality Agreement

 

202-E

IRB Guest Confidentiality Agreement

 

202-F

Letter From Joseph Harroz, Jr., Vice President And General Counsel Regarding Indemnification And Personal Liability

 

202-G

IRB Member Evaluation Form

 

202-G-A

IRB Chair/Vice-Chair Evaluation Form

 

203-A

New Study Reviewer Checklist – Full Board

 

203-A-1

Norman Campus New Study Reviewer Checklist – Full Board

 

203-B

New Study Reviewer Checklist – Expedited

 

203-B-1

Norman Campus New Study Reviewer Checklist -- Expedited

 

203-C

New Study Reviewer Checklist – Exempt

 

203-C-2

Categories of Exemption Checklist

 

203-C-3

Categories of Exemption Checklist

 

203-D

VA Research Reviewer Checklist

 

203-E

Reviewer Checklist for Research Involving Research Involving Pregnant Women, Fetuses and Neonates

 

203-F

Reviewer Checklist for Research Involving Prisoners

 

203-G

Reviewer Checklist for Research Involving Children

 

203-H

Continuing Review Reviewer Checklist

 

203-H-1

Continuing Review Reviewer Checklist

 

203-I

Modification Reviewer Checklist

 

203-I-1

Norman Campus Modification Reviewer Checklist

 

203-J

Waiver of Consent Documentation Checklist

 

203-J-1

Norman Campus Waiver of Consent Documentation Checklist

 

203-K

VA Research Reviewer Checklist

 

203-L

Member Responsibilities-Member

 

203-M

Member Responsibilities-Chairperson

 

203-N

Member Responsibilities-Alternate Member

 

203-O

Member Responsibilities-Reviewer Duties

 

301-A

Application For New Research Project

 

301-A-1

Institutional Review Board Application – Norman Campus

 

301-A-2

FDA IND Worksheet

 

301-A-3

FDA IDE Worksheet

 

301-A-4

Description of Study Protocol – Norman Campus

 

301-A-5

International Research Review Form – Norman Campus

 

301-B

Application For Continuing Review

 

301-B-1

Continuing Review Of Approved Research

 

301-C

Protocol Modification Form

 

301-C-1

Request For Modification Of Approved Research

 

301-D

Research Protocol Outline

 

301-E

Report Of Emergency Use Of A Test Article

 

301-F

IRB Final Closure Report

 

303A-A

Agenda And Addendum To Agenda Template

 

303A-B

IRB Database Manual

 

303B-A

Board Meeting Checklist

 

303B-B

Sign-In Sheets-OKC

 

303B-B-1

Sign-In Sheets-Norman

 

303B-C

Email From George Pospisil, Osophs, DHHS

 

303C-A

Minutes Review Checklist

 

303C-B

Meeting Minutes Template

 

304-A

State Universities And Colleges General Records Disposition Schedule

 

305-A

File Folder Set-Up

 

305-B

Yellow Note Sheet

305-C

New Study Approval Checklist

 

306-A

OUHSC IRB Sample Invoice

 

306-B

OUHSC IRB Sample Collection Letter

 

306-C

OUHSC Cash Receipts Policy, Section 510

 

401-A

Exempt Criteria List

 

402-A

Criteria For Expedited Status

 

404-A

Determination Of Approval & Expiration Date Examples

 

406-A

Determination of Human Research Worksheet

 

406-A-1

Norman Campus Determination of Human Research Worksheet

407-A

Unanticipated Problem Report Form

 

407-B

Protocol Deviation Report Form

 

407-B-1

Protocol Deviation Report Form-NC

 

501-A

OHRP Prisoner Determination Letter

 

502G-A

Sample Consent Form For Emergency Use

 

502I-A

Application for Research Use of Commercially or Publicly Available Human Cell Lines and Derived Products

 

502J-A-1

Debriefing Template

601-A

Protocol Pre-Review

 

601-B

Protocol Contingent Approval-Full Board

 

601-C

Protocol Final Approval-Full Board, Expedited, Exempt

 

601-D

Protocol Deferral-Full Board

 

601-F

Protocol Form 310

 

601-G

Protocol Inactivation By Board, PI, Sponsor

 

601-H

Protocol Pending Withdrawal

 

601-I

Protocol Withdrawal Request By PI, Admin.

 

601-J

Protocol Exempt Status

 

601-K

Protocol Development Approval

 

601-L

Protocol Emergency Use Approval

 

601-M

Amendment Pre-Review

 

601-N

Amendment Contingent Approval

 

601-O

Amendment Final Approval-Full Board And Expedited

 

601-OS-A

Continuing Review Deferral

 

601-OS-B

HIPAA, No PHI

 

601-OS-C

Notice Of Study Expiration

 

601-OS-D

Protocol Disapproval-Full Board

 

601-OS-E

Amendment Disapproval

 

601-OS-F

QI Routine Evaluation Letter

 

601-OS-G

QI For-Cause Evaluation Letter

 

601-OS-H

QI Evaluation Report

 

601-OS-I

Not Human Research Determination

 

601-OS-J

Human Research Determination

 

601-OS-U

Miscellaneous Approval

 

601-Q

Amendment Pending Withdrawal

 

601-T

Continuing Review Approval-Active & Closed Enrollment

 

601-V

Continuing Review Periodic Report Request

 

601-W

Protocol-Deviation

 

601-X

Unanticipated Problem Noted & Accepted

 

601-Y

Unanticipated Problem Noted, Action Required

 

602C-A

Contract Hold Notification Email

 

602C-B

Studies-Received Report

 

602C-C

Studies-Approved Report

 

602C-D

Studies-Inactivation Report

602F-A

Institutional Biosafety Approval Letter

 

602H-A

Cancer Center Scientific Review Committee Approval Letter

 

602-I-A

Radiation Safety Approval Letter

 

603A-A

VA R&D Approval Memorandum

 

603A-B

VA Form 10-1086 Consent Form Template

 

603A-C

VA Form 10-9012 Investigational Drug Information Record

 

603B-A

Federalwide Assurance-Oklahoma City Campus

 

603B-B

Affiliate List-Oklahoma City Campus IRB

 

603B-C

Federalwide Assurance-Norman Campus

 

603B-D

Affiliate List-Norman Campus

 

603B-E

Terms Of Federalwide Assurance

 

603E-A

Web-Based Site For Study Participants

 

701-A

Informed Consent Template

 

701-A-1

Informed Consent To Participate In A Research Study

 

701-A-5

ICF Template Information Sheet – Norman Campus

 

701-B

Child Assent Template

 

701-C

Tissue Consent Template

 

701-D

Patient Information Sheet-Tissue Banking

 

701-E

Template for Informed Consent Addendum

801-A

Investigator’s Manual

 

901-A

Quality Improvement Evaluation

 

901-B

Quality Improvement Self Assessment

 

901-C

Informed Consent Observation Checklist

 

1001-A

Research Privacy Form 1-Use Or Disclose PHI

 

1001-A-1

Research Privacy Form 1-Use Or Disclose PHI – Norman Campus

 

1001-B

Research Privacy Form 2-Psychotherapy Notes For Research

 

1001-C

Research Privacy Form 3-Use Or Disclose PHI For Repository

 

1001-D

Research Privacy Form 4-Use Or Disclose PHI And Repository

 

1001-E

Research Privacy Form 5-Waiver

 

1001-F

Research Privacy Form 6-Review Preparatory To Research

 

1001-G

Research Privacy Form 7-Decedent Information

 

1001-H

Research Privacy Form 8-De-Identified Information

 

1001-I

Research Privacy Form 9-Limited Data Sets

 

1001-J

Research Privacy Form 10-Use Agreement On Limited Data Sets

 

1001-K

University Of Oklahoma Notice Of Privacy Practices

 

1001-L

Authorization For Use/Disclosure Of Individual Protected Health Information For Research Purposes-Saint Francis Hospital

Office for Human Research Participant Protection
Evans Hall, Room 316
660 Parrington Oval, Norman OK
Phone: 405-325-8110
E-mail: irb@ou.edu

Federalwide Assurance: FWA00003191
IRB ID: IRB00000194

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