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Research Policy Handbook

5

Human Subjects and Stem Cells in Research

Table of Contents

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1 Conduct of Research
1.1 Principles Concerning Research
1.2 Rights and Responsibilities in the Conduct of Research
1.3 Academic Freedom
1.4 Openness in Research
1.5 On Academic Authorship
1.6 Multi-Authored Research Papers
1.7 Research Misconduct: Policy on Allegations, Investigations, and Reporting
1.8 Nondiscrimination in Research Agreements
1.9 Retention of and Access to Research Data
1.10 Information Security
2 Principal Investigatorship
2.1 Principal Investigator Eligibility and Criteria for Exceptions
2.2 Acting Principal Investigatorship
3 Fiscal Responsibilities of Principal Investigators
3.1 Preparation and Submission of Proposal Budgets
3.2 Management of Project Expenditures
3.3 Sponsor Notifications and Prior Approvals
4 Conflicts of Commitment and Interest
4.1 Policy on Conflict of Interest and Conflict of Commitment
4.2 PHS and NSF Requirements Regarding Financial Disclosures and Agency Notifications
4.3 Consulting and Other Outside Professional Activities by Members of the Academic Council and University Medical Line Faculty
4.4 RESERVED
4.5 University Investments in Start-Up Companies Involving Stanford Faculty
4.6 Equity Acquisition in Technology Licensing and Distance Learning Agreements
4.7 Institutional Conflict of Interest in Research Involving Human Subjects
5 Human Subjects and Stem Cells in Research
5.1 Human Research Protection Program
5.2 Federalwide Assurance for Protection of Human Subjects
5.3 People of Childbearing Potential as Subjects in Research
5.4 Use of Human Subjects in Student Projects, Pilot Studies, Oral Histories and QA/QI Projects
5.5 Use of Employees or Laboratory Personnel as Research Subjects
5.6 Guidelines for Studies Involving Human Volunteers Receiving Potentially Addicting Drugs
5.7 Training in the Protection of Human Subjects in Research
5.8 Human Stem Cell Research
6 Laboratory Animals in Research
6.1 Animal Welfare Assurance of Compliance
6.2 Use of Vertebrate Animals in Teaching Activities
6.3 Responsibilities for the Humane Care and Use of Laboratory Animals
6.4 Transport, Care, and Use of Non-Stanford Owned Laboratory Animals on the Stanford Campus
6.5 Animal Care and Use Training and Education Program
7 Environmental Health and Safety
7.1 Charge to the University Committee on Health and Safety
7.2 Health and Safety: Principles, Responsibilities and Practices
7.3 Emergency and Non-Emergency Hazardous Material Release Response
7.4 University Laboratory Animal Occupational Health Program
7.5 Chemical Hygiene Plan and Chemical Hazard Communication
7.6 Radiological Hazards
7.7 Laser Safety
7.8 Biohazardous Agents and Recombinant DNA
7.9 Research Funded by the Department of Energy Through SLAC National Accelerator Laboratory
7.10 Operation of Unmanned Flying Vehicles
7.11 High Hazard Research
8 Export Controls
8.1 Applicability and Policy Background, and Regulatory Authority
8.2 Definitions
8.3 Export Licenses for International Transfers of Items, Software or Technical Information
8.4 Accepting a Third Party’s Export Controlled Items or Information
8.5 Export Controls and Stanford’s Openness in Research Policy
8.6 Export Controls and an Individual’s Eligibility as a Recipient of Export Controlled Items, Software Code, or Information
8.7 Recordkeeping Requirements
9 Intellectual Property
9.1 Inventions, Patents, and Licensing
9.2 Copyright Policy
9.3 Administration of Copyright Policy
9.4 Tangible Research Property
9.5 Other Intellectual Property: Trademarks, Patents and Proprietary Information
10 Non-Faculty Research Appointments
10.1 Policy and Procedures for Appointment and Promotion: Academic Staff - Research
10.2 Academic Staff Appeal Procedure
10.3 Postdoctoral Scholars
10.4 Retention of Consultants
10.5 Visiting Scholars
10.6 Relationships Between Students (Including Postdoctoral Scholars) and Outside Entities
10.7 Visiting Student Researchers
10.8 Graduate Student Research Assistantships
10.9 Visiting Postdoctoral Scholars
11 Establishing and Managing Independent Laboratories, Institutes and Centers
11.1 Establishing and Managing Independent Laboratories, Institutes and Centers
12 Skeletal Remains
12.1 Human Skeletal Remains
13 Definitions and Types of Agreements
13.1 Gift vs. Sponsored Projects and Distinctions from Other Forms of Funding
13.2 Categories of Sponsored Projects
13.3 Specialized Categories of Sponsored Projects
13.4 Establishment of Industrial Affiliates and Related Membership-Supported Programs
13.5 Research Participation Agreements
13.6 Memoranda of Understanding and Letters of Intent
13.7 Service Agreements
14 Sponsored Project Proposals
14.1 Preparation, Review, and Submission of Sponsored Project Proposals
14.2 Academic Policies Pertaining to Sponsored Project Proposals
14.3 University Commitments Pertaining to Sponsored Project Proposals
15 Financial Aspects of Sponsored Projects Administration
15.1 Facilities and Administrative (Indirect Cost) and Fringe Benefits Rates
15.2 Indirect (F&A) Cost Waivers
15.3 Cost Sharing Policy
15.4 Charging for Administrative and Technical Expenses
15.5 Salary Cap Administration
15.6 Tuition Allowance for Research Assistants
15.7 Undergraduate Student Salaries Charged to Sponsored Projects
15.8 Cost Transfer Policy for Sponsored Projects
15.9 Program Income
16 Subawards
16.1 Definitions and Classifications
16.2 Proposing a Subaward
16.3 Issuance of a Subaward
16.4 Subrecipient Monitoring
16.5 Closeout of Subawards
17 Property Management
17.1 Control of Property
18 Committees and Panels That Support Research
18.1 Committees, Councils and Governing Boards
18.2 Charge to the Committee on Research
18.3 Administrative Panels for Research Compliance
18.4 Confidentiality of Administrative Panel Proceedings

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