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Compliance - Research with Animals

 

 

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Animal Care Quality Assurance Policies

 

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Office of Animal Resources Standard Operating Procedures

 

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Compliance - Research with Humans

 

 

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2876.1 Federal Wide Assurance

PDF

Last update: January, 2008

2876.2 Applicability of State and Local Laws

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Last update: January, 2008

2876.3 Authority

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Last update: January, 2008

2876.4 Campus IRB Purpose and Function

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Last update: January, 2008

2876.5 Board Membership

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Last update: March, 2008

2876.6 Board Chair's Roles and Responsibilities

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Last update: January, 2008

2876.7 Administrative Staff

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Last update: January, 2008

2876.9 Board Meeting Procedures

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Last update: March, 2008

2876.11 Minutes

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Last update: March, 2008

2876.12 INVITEES Requesting Information From Consultants or Guests

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Last update: January, 2008

2876.13 Record Keeping Process

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Last update: January, 2008

2876.15 Conflicts of Interest

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Last update: January, 2008

2876.16 Training Requirement for Key Personnel

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Last update: January, 2008

2876.17 Investigator or Key Personnel Responsibilities

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Last update: January, 2008

2876.18 Priority Reviews

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Last update: January, 2008

2876.19 Application Submission Process

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Last update: January, 2008

2876.20 CIRB Review Process

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Last update: March, 2008

2876.21 Recruitment Process

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Last update: January, 2008

2876.23 Informed Consent Process

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Last update: March, 2008

2876.24 Privacy and Confidentiality

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Last update: January, 2008

2876.25 Certificates of Confidentiality

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Last update: January, 2008

2876.26 Assessment Scientific Merit

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Last update: January, 2008

2876.27 Assessing the Level of Risk

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Last update: January, 2008

2876.29 Continuing Review Process

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Last update: March, 2008

2876.30 Amendment Review Process

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Last update: March, 2008

2876.31 Deviation Review Process

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Last update: January, 2008

2876.32 Unanticipated Problems or Adverse Events Involving Risks to Participants and Others

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Last update: March, 2008

2876.33 Research Involving Collaborative Institutions

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Last update: January, 2008

2876.34 Noncompliance with Campus IRB Policies and Procedures

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Last update: January, 2008

2876.35 Suspensions and Termination of IRB Approval

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Last update: January, 2008

2876.36 CIRB Reporting Requirements

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Last update: March, 2008

2876.37 Complaint Procedures

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Last update: January, 2008

2876.38 Policy Development

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Last update: January, 2008

2876.39 Annual Departmental Certification

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Last update: January, 2008

2876.40 Quality Assessment and Improvement

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Last update: January, 2008

2876.41 Activities Requiring Campus IRB Review

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Last update: January, 2008

2876.42 Community Outreach

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Last update: April, 2008

2876.43 Recruiting Vulnerable Populations

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Last update: January, 2008

45 C.F.R. 46 (The Common Rule)

 

Link

Last update: March, 2006

HIPAA Standards of Privacy of Individually Identifiable Health Information

 

Link

Last update: January, 2008

Forum Selection (Guidelines for Applying to the Campus IRB or the Health Sciences IRB)

 

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Amendments

 

Link

Last update: May, 2008

Board Purpose and Function

 

Link

Last update: May, 2008

Community Outreach

 

Link

Last update: May, 2008

Conflict of Interest

 

Link

Last update: May, 2008

Continuing Review Reports

 

Link

Last update: May, 2008

Emergency Use of a Test Article

 

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Last update: May, 2008

Exempt Applications

 

Link

Last update: May, 2008

Informed Consent - Process & Issues

 

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Last update: April, 2008

Initial Review

 

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Last update: April, 2008

Investigational or Unlicensed Test Articles

 

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Last update: May, 2008

IRB Membership

 

Link

Last update: April, 2008

Meeting Procedure

 

Link

Last update: April, 2008

Minutes

 

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Last update: April, 2008

Non-Compliance

 

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Last update: May, 2008

Record Retention

 

Link

Last update: April, 2008

Recruitment of Special Subject Populations

 

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Last update: April, 2008

Unanticipated Problems

 

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Last update: April, 2008

Unanticipated Problems Flowchart

 

Link

Last update: April, 2008

Department of Health and Human Services Regulations

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Basic DHHS Policy for Protection of Human Subjects

 

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Last update: December, 2005

Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved In Research

 

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Last update: December, 2005

Categories of Research That May Be Reviewed by the IRB through an Expedited Review Procedure

 

Link

Last update: December, 2005

Research Which May Be Exempt from Subsequent Review

 

Link

Last update: December, 2005

Human Subject Regulations Decision Charts

 

Link

Last update: December, 2005

NIH Guidance Involving Human Embryonic Stem Cells

 

Link

Last update: December, 2005

OHRP Guidance Involving Human Embryonic Stem Cells

 

PDF

Last update: December, 2005

Food & Drug Administration Regulations

 

 

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FDA Protection of Human Subjects

 

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Last update:

Institutional Review Boards

 

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Last update:

Investigational New Drug Application

 

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Last update:

Investigational Device Exemptions

 

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Last update:

National Institutes of Health

 

 

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Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications

 

Link

Last update: December, 2000

Inclusion of Women and Minorities as Participants in Research Involving Human Subjects

 

Link

Last update: September, 2003

Inclusion of Children as Participants in Research Involving Human Subjects

 

Link

Last update: March, 1998

Funding

 

 

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Research Council Principles and Standards of Conduct

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Last updated: August 2001

Grant Fact Sheet

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Last updated: January, 2008

Pre-award Standard Operating Procedures

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Last updated: June 1, 2008

Post-award Standard Operating Procedures

 

Word

Last updated: September 21, 2007

A-21 Exclusion Account Detail

 

Excel

Last updated: March 2004

A-21 Exclusion

 

Word

Last updated: March, 2004

NIH Salary Limitation on Grants, Cooperative Agreements and Contracts

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Word

Last updated: September 6, 2006

Proposal Processing Overview

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Last updated:

Criteria for Processing External Funding

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Last updated:

Guidelines for Processing Interdisciplinary Proposals

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Last updated: February 25, 2008

Agreements with Industry

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Facilities & Administrative Costs

 

PPT

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F&A Cost Recovery Policy

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Last updated: February 14, 2008

F&A Rate Agreement

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Last updated: May 16, 2006

NIH Public Access Policy

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Last updated: November 2006

Technology Transfer

 

 

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Purpose of Regulations

 

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Last updated:

Application of Regulations

 

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Last updated:

Definitions

 

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Last updated:

Inventions by Employees of the University

 

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The Patent Committee

 

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Last updated:

The Patent Administrator

 

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Last updated:

Notification of Abandonment

 

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Last updated:

Use of Funds Received by University Relating to Inventions, Patents and Plant Varieties

 

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Last updated: