Carle Connect - Research Policies and Procedures

Research Policies and Procedures

Research Institute

Updated January 13, 2012

General Pertaining To Research	Research	IRB
Biomedical Research Center	Tissue Procurement Services	Research Operations

General Carle Pertaining to Research

Policy Title	Number

Research

Policy Title	Number	Review Date
Research Policies Table Of Contents
Medical Research/Clinical Trials/Other Research Activity Supersedes CF135 effective 02/11	100	02/11
Responding to Allegations of Research Misconduct	101	02/10
Education Requirements for Investigators and Key Personnel Involved in Research	102	12/09
Conflict of Interest in Research	103	02/11
Scientific, Feasibility, and Local Context Review of Human Subjects Research	104	04/11
Designation of Institutional Review Board Supersedes CCA5306 and IRB203 effective 02/11	106	02/11
Federalwide Assurance Supersedes CCA5307 effective 11/10	107	11/10
Reporting Adverse Events, Unanticipated Problems Involving Risks to Subjects or Others, and Noncompliance Supersedes CCA5308 and CCA5309 effective 02/11	108	02/11
Billing Compliance for Research Studies Supersedes CCA5310 and RES110 effective 02/11	110	02/11
Definition of Human Subject Research Supersedes CCA5311 and IRB408 effective 02/11	111	06/11
Investigator Responsibilities Supersedes CCA5312, CCA5316, CCA5317, CCA5318, and CCA5320 effective 02/11	112	02/11
Developing and Obtaining Informed Consent for Human Subject Research Supersedes CCA5313 effective 02/11	113	06/11
Research Related Contracts Supersedes CCA5314 effective 02/11	114	02/11
Preparing and Negotiating the Study Budget Supersedes CCA5315 effective 02/11	115	02/11
Affiliate Requirements	119	03/11
Verification from Sources Other Than the Principal Investigator That No Material Changes Have Occurred to IRB-Approved Research Supersedes CCA5321 effective 02/11	121	02/11
Research Monitoring and Auditing Program	122	04/11
Investigational Drug and Device Accountability	123	03/11
Intellectual Property	124	02/11
Protocol Processing Fee Replaces RES101 effective 11/10	125	06/11
Electronic Signatures for IRBNet Users Replaces RES106 effective 10/10	126	02/11
Photo Use In Research Replaces RES103 effective 10/10	127	02/11
Disclosure of Research Resources by Principal Investigators Replaces RES108 effective 10/10	129	10/10

IRB

Policy Title
Number Review Date

IRB Policies Table Of Contents

General Administration

100

Overview, Introduction, & Statement of Authority and Purpose for Carle Foundation IRB Policies 100 11/10

Compliance with Policies and Procedures Mandate 101 09/10

Policies and Procedures Maintenance 102 02/11

Training and Education 103 09/10

IRB Resources and Management of IRB Personnel 104 09/10

Signatory Authority 105 09/10

Conflict of Interest 106 09/10

IRB Organization

200

Management of IRB 201 09/10

Duties of IRB Members 202 09/10

Functions & Operations

300

Research Submission Requirements 301 04/11

IRB Meeting Administration 302 09/10

Documentation and Document Management 303 09/10

Ensuring Regulatory Compliance: State and Local Laws 304 09/10

Review of Research

400

Expedited Review 401 04/11

Initial Review - Criteria for IRB Approval 402 04/11

Modifications to Previously Approved Research 403 04/11

Continuing Review 404 04/11

Project Closure or Transfer 405 04/11

Categories of Action 406 04/11

Certificates of Confidentiality 407 09/10

Research Defined 408 04/11

Clinical Investigations Involving Drugs, Devices, and Biological Products 409 09/10

Research in Emergency Settings 410 09/10

Humanitarian Use Device 411 09/10

IRB Requirements for Non-Carle Research Subject who Receives Medical Care Through Carle Foundation Hospital 412 09/10

"Exempt" Status Review of a Research Study 413 09/10

Facilitated Review of NCI CIRB-approved Cooperative Group Trials 414 08/29/2011

Reviews Requiring Special Consideration

500

Vulnerable Populations 501 09/10

Emergency Use and Other Special Situations in Research 502 09/10

IRB Communication and Notification

600

Informed Consent

700

General Requirements and Documentation of Informed Consent 701 09/10

Waiver of Informed Consent or Waiver of Documentation of Informed Consent 702 09/10

Assent 703 09/10

Reporting Responsibilities of Investigators & Sponsors

800

Unanticipated Problems and Other Events Requiring Prompt Reporting 801 08/29/2011

Sponsor Responsibilities 802 09/10

Quality Assurance

900

Quality Assurance/Quality Control 901 09/10

Audits by Regulatory Agencies 902 09/10

Scientific Misconduct and Investigations 903 09/10

Waiver of Authorization

1000

Statement of Authority 1001 09/10

Miscellaneous

1100

Clinical Trials Registration 1101 09/10

Recruitment Materials for Human Subject Research 1102 09/10

Biomedical Research Center (BRC)

Policy Title
Number Review Date

Biomedical Research Center Policies Table of Contents

Policy and Procedures: Creation and Maintenance
101 02/11

Compliance Structure for the Biomedical Research Center
102 02/11

Obtaining Initial Access to the Biomedical Research Center
103 02/11

Space Utilization
104 02/11

Building Modifications to the Biomedical Research Center
105 02/11

Carle Tissue Procurement Services

Policy Title
Number Review Date

Research Operations

Policy Title
Number Review Date

Research Operations Policies Table Of Contents

Overview of Research Operations 100 01/10

Request for Changes/Renovations to Laboratory Space 105 09/10