Carle Connect - Research Policies and Procedures


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Research Policies and Procedures

Research Institute

Updated August 2010

Research Institute Links

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	07/10
Review of External Resident, Fellow, Nursing and Student Case Presentations Using Carle Foundation Hospital Patient Data	107	03/10
Disclosure of Research Resources by Principal Investigators	108	12/09

Billing Compliance for Research Studies	110	12/09
Good Clinical Practices in Research	111	04/10

IRB

Policy Type	Section	Revision Date
General Administration	100
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
IRB Organization	200
Management of IRB	201	04/10
Duties of IRB Members	202	06/09
Jurisdiction of the IRB	203	06/09
Functions & Operations	300
Research Submission Requirements	301	12/09
IRB Meeting Administration	302	12/09
Documentation and Document Management	303	10/09
Ensuring Regulatory Compliance: State and Local Laws	304	07/09
Review of Research	400
Expedited Review	401	07/10
Initial Review - Criteria for IRB Approval	402	06/09
Ongoing Oversight	403	06/09
Continuing Review	404	07/10
Project Closure or Transfer	405	04/10
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
Reviews Requiring Special Consideration	500
Vulnerable Populations	501	06/09
Emergency Use and Other Special Situations in Research	502	12/09
IRB Communication and Notification	600
Notice of IRB Decisions to Investigators	601	06/09
IRB Communication with Other Entities	602	06/09
Informed Consent	700
General Requirements and Documentation of Informed Consent	701	03/10
Waiver of Informed Consent or Waiver of Documentation of Informed Consent	702	06/09
Assent	703	06/09
Reporting Responsibilities of Investigators & Sponsors	800
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	900
Quality Assurance/Quality Control	901	06/09
Audits by Regulatory Agencies	902	06/09
Scientific Misconduct and Investigations	903	06/09
Waiver of Authorization	1000
Statement of Authority	1001	06/09
Miscellaneous	1100
Clinical Trials Registration	1101	06/09
Recruitment Materials for Human Subject Research	1102	04/10

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