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1. Introduction  
2. Setting up Office and Research Space
2.1 What should I do before I get to UCSF?
2.2 What should I do once I arrive at UCSF?
2.3 What Research Support Services are available?
3. Obtaining Regulatory Committee Approvals
3.1 Making Sense of Regulations
3.2 What is Research Online
3.3 Working with Biologicals
3.4 Working with Chemicals
3.5 Working with Radioactive Materials
3.6 Working with Radioactive Materials in Humans
3.7 Working with Controlled Substances
3.8 Working with Animals
3.9 Involving Human Subjects in Research
3.10 Serving on Committees
3.11 Working with Affiliates
4. Finding, Obtaining, and Managing Money
4.1 Fiscal Responsibility
4.2 Pre-award: How do I find and ask for funds?
4.3 Post-award: How do I manage funding awards?
4.4 Working with Industry
4.5 Minimizing Financial Conflicts of Interest
4.6 Intellectual Property
5. Being Responsible
5.1 Ethical Conduct of Research
5.2 Authorship and Publication
5.3 Confidentiality and Privacy
5.4 Data Management: Research Records
5.5 Training in Responsible Conduct of Research
5.6 Guidelines for Lab Notebooks
6. Leaving or Transferring Funds/Specimens Out of UCSF
 
Appendices
I. UCSF Acronyms
II. UCSF Research Links
III. Whistleblower Policies & Procedures
 
School of Medicine Clinical and Translational Research

THE OFFICE OF RESEARCH

RESEARCH INVESTIGATOR HANDBOOK

5. BEING RESPONSIBLE

5.1 ETHICAL CONDUCT OF RESEARCH

What are Principal Investigators responsible for?
• How do I fulfill these responsibilities?
• Are there areas of special concern for investigators?
• How do I report a concern?
• Relevant Policies and Procedures


What are Principal Investigators responsible for?

UCSF is committed to creating and maintaining an environment for research that conforms to the highest ethical principles, fosters intellectual honesty and integrity, and encourages scientific advances of the highest quality. All researchers are obligated to uphold the highest ethical standards by:

  1. Committing to research integrity, excellence, accountability and respect.
  2. Promoting open exchange of scientific findings by a thorough description of methods and data in published reports;
  3.  Enabling other investigators to reproduce and expand on published findings by making unique research materials, such as cells, DNA clones, or monoclonal antibodies, available when feasible to any interested academic;
4.  Maintaining accurate and detailed records of research procedures and results;
  5. Safeguarding intellectual property rights by fairly and honestly assigning authorship or acknowledgement and by appropriate attribution of credit in research publications to the originators of ideas, methods, and findings; and
  6. Fulfilling all departmental and University research and publication standards. Fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community are unethical. They are also, by definition of the United States Public Health Service, scientific misconduct, and constitute grounds for disciplinary action by the University and the Public Health Service.

How do I fulfill these responsibilities?

  1. Conducting yourself in adherence to UCSF Code of Conduct and UC Faculty Code of Conduct.
  1. Orienting your laboratory and collaborating personnel to University standards, policies and procedures;
  2.  Overseeing all work performed by your students, research fellows, residents, co-investigators and staff to ensure that each has the knowledge, information, skills and support necessary to meet these standards;
  3. Complying fully with all policies, regulations, and University guidelines governing the use of human or animal subjects and hazardous materials; and
4. Verifying the validity and quality of data and manuscripts generated in your laboratories.
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Are there areas of special concern for investigators?

Yes. Questions can arise about integrity of the research in the areas of authorship, conflict of interest, and finances. Some simple guidance to avoid problems would include reading and understanding the appropriate sections in this Quick Guide as well as understanding the following:

  •  Authorship:
    •  Co-authorship must reflect scientific involvement in the project. By agreeing to submit a manuscript for publication, each author assumes responsibility for all work reported within his or her area of expertise.
    •  Experimental data, reports and manuscripts should be reviewed by all co-authors as well as by the senior member of the research team.
  •  Conflict of Interest:
    •  In order to protect the objectivity of research and reduce opportunity for bias in the interpretation and reporting of results, investigators are required to disclose financial interests in private sponsors of their research or related to their PHS- and NSF- funded research.

Disclosures are reviewed and when it is determined that the financial interests could have a direct and significant affect on the research the University will take steps to eliminate, mitigate, or manage these conflicts.

  Financial:
   

Costs of clinical studies performed primarily for investigational purposes should not be borne by patients or third party payers.

    Unauthorized or undisclosed use of public funds to support industry-funded studies is unethical.

How do I report a concern?

Integrity of Research Notice: Reporting Allegations of Research Misconduct

 

Relevant Policies and Procedures

  UCSF and UC policies:
  UCSF Administrative Policies: (Academic Administration, Academic and Staff Personnel, and Audit policies)
    •  Policy 150-23 Reporting Improper Governmental Activities and Protection Against Retaliation ("Whistleblowing")
    •  Policy 100-29 Integrity of Research
    Policy 350-13 Defalcations and Fraud
    UCSF Code of Conduct
  •  UC policies:
    •  UC Code of Conduct
    Research Integrity (Policy 90-01S1)
    UC Policy for Investigating Allegations of Suspected Improper Governmental Activities
    UC Whistleblowers Policies
  Federal:
  Food and Drug Administration (FDA):
      Good Laboratory Practices for nonclinical laboratory studies (GLP)
      Good Clinical Practices (GCP) Program
      GCP Guidelines for Industry
    NIH Web Resources for Bioethics :
      Research Resources (humans, animals, conflict of interest, others)
      Other Federal Resources (agencies, genetics, human research)
Office of Research Integrity