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Research Policies and Procedures

Research Institute

Updated February 2010

   

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Foundation  
Research IRB
Carle Tissue Repository Research Operations

 

 

Foundation
 

Policy Title

 Number Revision
Date
Medical Research/Clinical Trials/Other Research Activities 135 02/10

 

Research
 

Policy Title

 Number Revision
Date
Research Policies Table Of Contents    
Intellectual Property 100 01/08
Protocol Processing Fee 101 07/09
Education Requirements for Investigators and Key Personnel Involved in Research 102 12/09
Securing Permission To Use and Disclose Individuals Photographs, Written Accounts and Transcriptions, Video/Audio Recordings and Transmissions For Research Purposes 103 08/09
Carle Scientific Review Committee 104 08/09
Research Misconduct & Failures of Research Integrity 105 08/09
Electronic Signatures for IRBNet Users 106 08/09
Review of External Poster/Oral Presentations Single Case Studies 107 02/10
Disclosure of Research Resources by Principal Investigators 108 12/09
     
Billing Compliance for Research Studies 110 12/09

 

IRB
 

Policy Title

 Number Revision
Date
IRB Policies Table of Contents    
Overview, Introduction, & Statement of Authority and Purpose for Carle Foundation IRB Policies 100 06/09
Compliance with Policies and Procedures Mandate 101 06/09
Policies and Procedures Maintenance 102 06/09
Training and Education 103 06/09
IRB Resources and Management of IRB Personnel 104 06/09
Signatory Authority 105 06/09
Conflict of Interest 106 06/09
Management of IRB 201 06/09
Duties of IRB Members 202 06/09
Jurisdiction of the IRB 203 06/09
Research Submission Requirements 301 12/09
IRB Meeting Administration 302 12/09
Documentation and Document Management 303 12/09
Ensuring Regulatory Compliance: State and Local Laws 304 07/09
Expedited Review 401 06/09
Initial Review - Criteria for IRB Approval 402 06/09
Ongoing Oversight 403 06/09
Continuing Review 404 06/09
Project Closure or Transfer 405 06/09
Categories of Action 406 06/09
Certificates of Confidentiality 407 06/09
Research Defined 408 06/09
Clinical Investigations Involving Drugs, Devices, and Biological Products 409 06/09
Research in Emergency Settings 410 06/09
Humanitarian Use Device 411 06/09
IRB Requirements for Non-Carle Research Subject who Receives Medical Care Through Carle Foundation Hospital 412 06/09
"Exempt" Status Review of a Research Study 413 12/09
Vulnerable Populations 501 06/09
Special Categories of Research 502 12/09
Notice of IRB Decisions to Investigators 601 06/09
IRB Communication with Other Entities 602 06/09
General Requirements and Documentation 701 06/09
Waiver of Informed Consent or Waiver of Documentation of Informed Consent 702 06/09
Assent 703 06/09
Unanticipated Problems and Other Events Requiring Prompt Reporting 801 06/09
Sponsor Responsibilities 802 06/09
Storage, Handling, and Dispensing of Investigational Agents 803 06/09
Quality Assurance/Quality Control 901 06/09
Audits by Regulatory Agencies 902 06/09
Scientific Misconduct and Investigations 903 06/09
Statement of Authority 1001 06/09
Clinical Trials Registration 1101 06/09
Recruitment Materials for Human Subject Research 1102 06/09

 

Carle Tissue Repository (CTR)
 

Policy Title

 Number Revision
Date
Carle Tissue Repository Policies Table Of Contents    
Educational Requirements for Carle Tissue Repository (CTR) Staff 100 01/10
Consenting of Donors 105 01/10
Utilization of the Honest Broker Concept for the Carle Tissue Repository (CTR) 106 01/10
Collection, Processing, Quality Control & Storage of FF Specimen 110 01/10
Quality Control 120 01/10
Request & Release of Specimen/Data 130 01/10
CTR (Carle Tissue Repository) Lab Safety 140 01/10
Cost Recovery 150 01/10

 

Research Operations
 

Policy Title

 Number Revision
Date
Research Operations Policies Table Of Contents    
Overview of Research Operations 100 01/10
Request for Changes/Renovations to Laboratory Space 105 01/10

 
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