A Guide to Policies, Practices and Resources
for the Conduct of Research at Yale University
Introduction
This Guide is designed to assist new and established investigators in their conduct
of research at Yale University and in complying with research-related regulations.
It is University policy to encourage and assist research, and we hope this Guide
will provide a convenient reference for investigators in answering general questions
and providing information about the various University offices that can help
investigators meet their many research-related responsibilities. The guide provides
an introduction to important research-related topics and contains links to relevant
websites and policies for easy access to the most current information.
The guide is not an official statement of University policy. The definitive statements
of University policies are found in the Yale University Faculty Handbook, the
Yale University Department of Human Resources Manual, the Provost's website,
and in various school and department/office policies. To the extent possible,
links are provided to the source of the policies referenced in this guide.
The Guide has three main goals:
· To support the University's research effort by providing guidance regarding
the development and administration of sponsored research projects.
· To inform Principal Investigators/Project Directors of their roles and
responsibilities in research administration and compliance and to indicate the
roles of staff in supporting the research effort.
· To collect and organize all information pertinent to sponsored projects
administration in a single document and make that information accessible to all
interested parties.
This Guide addresses standards for the conduct of research; sponsored project
administration at Yale from proposal development through post-award administration;
financial and other compliance responsibilities; and other research-related policies,
issues, and resources. You may go directly to your area of interest through the
links below, or locate subjects of interest through the table of contents (click
on the topic), or by using the find in page function in your browser.
This guide is intended to be an evolving reference work and may be updated
frequently. Please check back often to make sure that you have the latest information.
In addition, your suggestions for changes and improvement are welcome and encouraged.
Table of Contents
Quick Contact List
Chapter
1. Standards for Conduct of Research at Yale University
1.1 Yale University Standards of Business Conduct
1.2 Sexual Harassment
1.3 Non-Discrimination
1.4 Openness in Research
1.5 Scientific Misconduct
1.6 Responsible Conduct of Research
1.6.1 Authorship
1.6.2 Mentorship/Supervision of Research Trainee
1.7 Outside Interest and Employment
1.7.1 Conflict of Interest and Conflict of Commitment
1.7.2 Protocol-Specific Conflict of Interest
1.8 Data Gathering, Retention, and Storage
Chapter
2. Overview of Sponsored Projects Administration at Yale University
2.1 The Offices of Grant and Contract Administration
2.2 What is a Sponsored Project
2.3 The Principal Investigator/Program Director (PI/PD)
2.4 Overview of PI/PD Responsibilities
Chapter
3. Proposal Development
3.1 Funding Opportunities: Identifying a Sponsor
3.2 Types of Proposals
3.2.1 Preliminary proposals
3.2.2 New Proposals
3.2.2.1 RFPs, RFQs, RFQs
3.2.2.2 Unsolicited proposals
3.2.3 Continuation or Non-Competing proposals
3.2.4 Renewal or competing proposals
3.2.5 Revised proposals
3.2.6 Supplemental proposals
3.2.7 Consortium/Joint Proposals and Subcontracts
3.3 Limitations on Proposal Submissions
3.4 Procedures for the Submission of Proposals
3.5 Initial Contact with the Sponsor
3.6 Proposal development
3.7 Components of a Proposal
3.7.1 Title Page
3.7.2 Abstract of Proposal Summary
3.7.3 Introduction
3.7.4 Research Plan
3.7.5 Bibliography
3.7.6 CV/Biographical Sketch
3.7.7 Required Reviews
3.7.8 Budget and Budget Justification
3.7.9 Current and Pending Support
3.7.10 Facilities and Resources
3.7.11 Transmittal Letter
3.8 Helpful Hints and Resources
Chapter
4. Budget Development
4.1 Principles of Sponsored Project Support
4.1.1 Reasonableness
4.1.2 Allocability
4.1.3 Consistency
4.1.4 Allowability
4.2 Developing a Proposal Budget
4.3 Major Budget Categories
4.3.1 Direct Costs
4.3.1.1 Personnel Costs
4.3.1.2 Fringe Benefits
4.3.1.3 Consultants
4.3.1.4 Equipment
4.3.1.5 Materials and Supplies
4.3.1.6 Travel
4.3.1.7 Patient Care Costs
4.3.1.8 Alterations, Renovations and Construction Costs
4.3.1.9 Other Direct Costs
4.3.1.10 Subcontracts/Subawards
Chapter
5. Proposal Review, Approval, and Processing
5.1 PI/PD Review and Approval Responsibilities
5.2 Departmental Business Office Review and Approval Responsibilities
5.3 Department Chair/Dean Review and Approval Responsibilities
5.4 GCA Review and Approval Responsibilities
5.5 Proposal Routing Forms
5.5.1 The Central Proposal Transmittal Sheet
5.5.2 The YSM Proposal Summary Form
5.6 Materials required for review
5.7 Proposal and Award Tracking
5.8 Required Review and Signatures
5.9 Sending the Proposal to a Sponsor
5.10 Deadlines
5.11 Pre-Award Audit/Additional Information
5.12 Site Visits
5.13 Protection of Confidential or Sensitive Proposal Information
Chapter
6. Award Acceptance
6.1 Types of Awards
6.1.1 Grants
6.1.2 Contracts
6.1.3 Subcontracts or subgrants
6.1.4 Cooperative Agreements
6.2 Receipt of Award
6.3 Negotiation/Acceptance
6.4 Signature Authority
6.5 Account Set-Up
6.6 Pre-Award/Late Award Account Set-Up
Chapter
7. Post-Award Administration
7.1 Role of the PI/PD in Post-Award Administration
7.2 Role of the Business Office in Post-Award Administration
7.3 Role of GCA and GCFA in Post-Award Administration
7.4 Financial Management
7.5 Post-Award Changes and Aprrovals
7.6 Changes Requiring Prior Approval
7.7 Cost Transfers
7.8 Effort Reporting
7.9 Other Financial Management Issues
7.10 Reporting Responsibility
7.11 Project Management Reports
7.11.1 Interim Progress Reports
7.11.2 Final Technical Reports
7.12 Records Retention
Chapter
8. Other Awards and Agreements
8.1 Research Agreements Sponsored by Industry
8.1.1 Costs
8.1.2 No Warranties and Guarantees
8.1.3 Conflict of Interest
8.1.4 Publication
8.1.5 Termination
8.1.6 Proprietary Information and Patents
8.2 Industry Supported Clinical Trials
8.2.1 Indemnification
8.2.2 Payment for Injuries
8.2.3 Confidentiality of Patient Records
8.2.4 Patents/Intellectual Property
8.3 Startup-Sponsored Agreements
8.4 Collaborative Agreements
8.5 Service Agreements
8.5.1 Publication
8.5.2 Financial Considerations
8.5.3 Insurance
8.5.4 Indemnification
8.6 Material Transfer Agreements
8.7 Industrial Affiliates Programs
8.8 Intergovernmental Personnel Act Agreements (IPAs)
8.9 Confidential Disclosure Agreements (CDAs)
8.10 Consulting Agreements
Chapter
9. Transfer Issues in Grant Administration
9.1 Policies and Procedures for when a PI/PD Leaves Yale University
9.1.1 NIH Awards
9.1.2 NSF Awards
9.1.3 Other Sponsors
9.2 Transfer and Disposition of Equipment
9.3 Safety Issues in Leaving Yale University
Chapter
10. Required Assurances; Research-Related Regulations, Policies and Procedures
10.1 Use of Human Subjects in Research
10.1.1 Determining Whether Research Involves Human Subjects
10.1.2 IRB Training Requirement
10.1.3 Who to Contact if Research Involves Human Subjects
10.1.4 HIPAA Privacy and Security
10.2 Use of Animals in Research and Testing
10.3 Safety
10.4 Emergency Response
10.5 Biological Safety
10.6 Radiation Safety
10.7 Chemical Safety
10.8 Select Agents
10.9 Controlled Substances
10.10 Purchasing Hazardous Materials and Other Restricted Items
10.11 Conflict of Interest and Conflict of Commitment
10.11.1 Protocol-Specific Conflict of Interest
10.12 Patents, Copyrights, and the Office of Cooperative Research
10.13 Export Controls
10.14 Minors in Labs
Chapter
11. Research-Related Resources at Yale University
11.1 Yale Libraries
11.2 Animal Resources
11.3 Training/TMS
11.4 Shop Facilities/Fabrication
11.5 Other Facilities Available to the Yale Community
Chapter
12. Other Issues in the Conduct of Research
12.1 Personnel
12.1.1 Faculty
12.1.2 Visiting Teaching Faculty
12.1.3 Visiting Research Faculty
12.1.4 Clerical and Technical Staff
12.1.5 Managerial and Professional Staff
12.1.6 Postdoctoral Appointees
12.1.7 Visiting Fellows
12.1.8 Research Affiliates
12.1.9 Temporary Replacement Personnel
12.1.10 Special Personnel Issues
12.1.10.1 Foreign Scholars
12.1.10.2 Minors
12.1.11 Personnel-Related Training
12.2 Purchasing
12.3 Shipping of Hazardous Material
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