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NEW INVESTIGATORS: A QUICK GUIDE TO STARTING YOUR RESEARCH AT UCSF Obtaining Regulatory Committee Approvals
- Other Topics: OBTAINING REGULATORY COMMITTEE APPROVALS Involving human subjects in your research
• Does my study require human subject research review and approval? 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. 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 Subjects Protection Program (HSPP) in the Office of Research. The CHR is UCSF’s federally mandated Institutional Review Board (IRB). The main number for the CHR is (415) 476-1814. The CHR 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 CHR web site. 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:
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. (Renewal 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 Research Supplement 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. Investigators who will work with human subjects must complete the UCSF Research Online Human Subjects Training before the CHR gives final approval. The CHR tracks this online training to document compliance with Federal training requirements. UCSF also requires completion of an online HIPAA research training module. For other clinical training and links to useful clinical services see What Research Services are Available at UCSF? in this Quick Guide. 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:
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:
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:
What are my additional responsibilities for clinical research? Additional institutional requirements that may apply are described at the following sites:
Top Tips to speed up approval and prevent problems:
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 HSPP 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 Subjects Protection Program website.
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