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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

3. OBTAINING REGULATORY COMMITTEE APPROVALS

3.9 Involving human subjects in your research

• Does my study require human subject research review and approval?
• Who do I contact?
• What types of approvals do I need to work with human subjects?
• What training is required?
• Is auditing or monitoring required?
• What are my additional responsibilities for clinical research?
• Top Tips to speed up approval and prevent problems
• Relevant polices, procedures, and ethical statements


Does my study require human subject research review and approval?

Any research that involves either the participation of human subjects or the use of human biological specimens, medical charts, or databases with information about humans is considered to be human subject research and requires review. Full information on when human subject protocol review is required is available at Applying and Reporting to the CHR.

The Committee on Human Research (CHR) reviews human subject research to ensure the ethical and equitable treatment of those subjects under federal and state laws. The CHR is part of the Human Research Protection Program (HRPP) in the Office of Research. The CHR is UCSF’s federally mandated Institutional Review Board (IRB).

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Who do I contact?

The main number for the CHR is (415) 476-1814. The HRPP front desk will answer routine questions. Complex questions are referred to an “analyst of the day”. See also the CHR Contact Information and the main HRPP web site.

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What types of approvals do I need to work with human subjects?

You need Committee on Human Research (CHR) approval. All research on human subjects (including the use of biospecimens, medical charts, and data) must be submitted to the CHR for review and approval prior to any contact with human subjects or any use of their specimens, records, or data. Depending on the nature of your research, you may need additional approvals.

There are three types of CHR review, with separate application formats. The type of application needed depends on the degree of risk to subjects:

•  Full Committee: more than minimal risks to subjects, reviewed by one of four full CHR committees
•  Expedited: no more than minimal risks, reviewed by a subcommittee of the CHR
• 
Exempt Certification: technically exempt from the need for CHR review, but requires submission and review of a form for certification of exempt status

Approval turnaround time: Full Committee and Expedited approvals usually take from 2 weeks to 8 weeks depending on the type of human research, the level of risk, and the complexity of ethical or technical questions that arise during review. Exempt certifications usually can be issued within a week. You should allow extra time during holiday and vacation periods.

Expiration date: Most human research projects are given approval for one-year but some may receive a shorter term of approval based on the CHR’s perception of the need for more frequent review. The expiration date is absolute, and by federal law, the CHR cannot grant an extension. You must obtain approval of your renewal before the expiration date. (Continuing Review Application)

If your approval expires, you must stop your research until you receive a new CHR approval. However, if it would jeopardize subjects to suspend ongoing treatment or follow-up tests, you must continue activities needed to ensure the safety of the subjects

Modifications: You cannot modify CHR approved procedures without prior review and additional approval from the CHR. You need CHR approval for additions, deletions, or substitutions to your research protocol, informed consent documents, recruitment procedures, questionnaires, or other previously approved documents. Failing to follow your approved protocol or using documents altered without approval is a serious violation of federal regulations. ( CHR Modifications)

Additional approvals: Authorizations or approvals may also be required from the Technical Committees: biologicals ( BUA), radioisotopes ( RUA, RUA for Humans) and/or controlled substances ( CSP). If human stem cells, either embryonic or adult, will be used in the study, then the Human Stem Cell Application must be submitted with the CHR application. Human stem cell research is carefully regulated and may require additional approvals. See the Human Stem Cell web site for UCSF guidance and policies. The Comprehensive Cancer Center, Clinical Research Centers: GCRC and PCRC, and the Veterans Affairs Medical Center also have review requirements.

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What training is required?

Investigators who will work with human subjects must complete the CITI On-line Human Subjects Protection Training before the CHR gives final approval. The CHR tracks this online training to document compliance with Federal training requirements.

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Is auditing or monitoring required?

All human subjects studies at UCSF are subject to auditing or monitoring.

The UCSF Human Subjects Protection Program includes a Quality Improvement Unit (QIU) that provides quality assurance, quality improvement, and educational activities to:

•  monitor the conduct of clinical research to ensure the rights and welfare of human research subjects

optimize compliance with federal, state, and institutional regulations and policies.

Audit types include both for-cause audits and random quality improvement assessments (not-for-cause audits). Other groups internal to UCSF that may audit your research are:

•  UCSF Cancer Center (clinical audit)
•  General Clinical Research Centers (clinical audit)
•  Pediatric Clinical Research Center (clinical audit)
• 
Internal Audit

External audits also may be done as part of federal, university, or sponsor programs. If you receive adverse findings from an outside auditor, you should notify the CHR immediately. If needed, the CHR and UCSF Legal Counsel can assist in the preparation of a response. Failing to respond properly may jeopardize your and UCSF’s human research programs. External groups that may audit your research may include (but are not limited to) the following:

•  San Francisco Veterans Affairs Medical Center (federal)
•  National Institute of Health (federal)
•  Cooperative Research Groups (federally funded)
•  Research sponsors (public or private)
•  Food and Drug Administration (federal)
• 
Office for Human Research Protections (federal)

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What are my additional responsibilities for clinical research?

Additional institutional requirements that may apply are described at the following sites:

•  UCSF HRPP Guidance
•  Cancer research: All human research on cancer at UCSF must be approved by the Cancer Center before the CHR gives final approval. Special requirements of the Cancer Center include submission of a Data and Safety Monitoring Plan.
•  Data and Safety Monitoring Plans
• 
UCSF Stem Cell Research: There are specific federal and state restrictions and requirements on the use of human stem cells in research.

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Top Tips to speed up approval and prevent problems:

•  Use iMedRIS for human subject and human stem cell application.
•  Remember that chart reviews, studies of specimens (even anonymous ones), and use of information about humans from clinical or research databases all require CHR review or formal exemption.
•  Do not change your study procedures or documents without CHR approval.
•  Be sure that your protocol and consent form clearly explain how what happens to subjects in the study will be different from what happens to people who decline participation.
•  All documents and sections of the application should be consistent; in particular check the purpose, significance, procedures, benefits, and alternatives in both the protocol and the consent form; use the same name for the drugs throughout the protocol and consent form.
•  Use non-technical, everyday language in the consent form. Avoid all jargon.
•  Do not use acronyms in either the protocol or the consent form without first explaining them.
•  Keep track of the approval expiration date and submit your renewal application in time to receive a new approval before the study expires. Allow four to six weeks.
• 
Get separate CHR approval for each discrete study. Do not group related studies into a complicated application. You may have several CHR applications for a single grant.

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Relevant policies, procedures, and ethical statements:

Human subject research is regulated by federal, state, university, and affiliate regulations, guidance, policies, and practices. You are encouraged to follow the guidance found at UCSF’s HRPP web site, which consolidates the requirements into consistent guidelines. By following the web site’s guidance, a researcher will automatically comply with numerous regulations. For reference, major federal regulations and ethical statements are listed below. Additional links can be found at the UCSF Human Research Protection Program website.

•  21 CFR 50 and 21 CFR 56 (FDA Human Subjects Regulations)
•  21 CFR 312 (FDA Investigational Drug Regulation)
•  21 CFR 812 (FDA Investigational Device Regulation)
•  45 CFR 46 (DHHS Human Subjects Protection Regulation)
•  Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
•  Nuremberg Code
•  World Medical Association Declaration of Helsinki
• 
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)