China’s Personal Information Protection Law (PIPL) China’s PIPL applies to the processing of personal information of individuals living in mainland China on or after November 1, 2021.  Per Article 4 of PIPL: “Personal information” refers to various information related to an identified or identifiable natural person recorded electronically or by other means, but does not include…

HRP Policies and Procedures Download All These Policies In a Single, Searchable File! Get the File I. IRB Authority & Institutional Commitment 01 Institutional Oversight of Assurance02 Activities Subject to IRB Jurisdiction II. Conducting Research 03 Research Involving Performance Sites04 Offsite Research, Cooperative Research and Research at UCI-affiliated Institutions15 Research with Human Specimens and Data;…

IRB Forms Checklists Protocol Preparation Checklist Checklist – Transition 2018 Common Rule Checklist – Continuing Review (Long CPA) Checklist – Continuing Review (Short CPA) Checklist – Emergency Use of a Test Article Checklist – Exempt Research Checklist – Informed Consent Checklist – IRB Committee Quorum and Expertise Checklist – Modification Checklist – New Expedited or…

Lead Researcher Eligibility Differences Between Lead Researcher and Principal Investigator Principal Investigator eligibility for a Contract or Grant is separate from Lead Researcher eligibility for conducting research with human subjects or animals. In making this distinction, UCI recognizes both the added responsibility associated with research involving humans or animals, and the research contributions of all…

National Cancer Institute Central IRB (CIRB) Independent Review Process Overview of the CIRB Initiative The Central Institutional Review Board (CIRB) Initiative is sponsored by the National Cancer Institute (NCI).  The Adult NCI CIRB reviews Cooperative Group trials from the ACOSOG, CALGB, ECOG, GOG, NCCTG, NCIC, NSABP, RTOG, and SWOG, as well as any other studies…

Expanded Access to Unapproved Devices There are two options for treating patients with an unapproved medical device outside of a clinical trial. One option is Expanded Access. The other is Right to Try. Wrencha and Screw Driver Icon (Decorative) FDA Expanded Access eRequestA web-based tool that enables physicians to complete, sign, and submit non-emergency Expanded…

Drugs and  Biologics Used in Clinical Research Per FDA, Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements…

What is ClinicalTrials.gov? ClinicalTrials.gov is a resource that provides access to information on clinical trials studying a wide range of diseases, conditions and interventions. Studies listed in the database are conducted in all 50 States and worldwide. Each ClinicalTrials.gov record includes summary information about studies. Want a quick start guide to CT.gov? Download a PDF…

Department of Defense Research Requirements Background The Department of Defense (DOD) IS a signatory to the Revised Common Rule, which took effect January 21, 2019.   To determine additional applicability and requirements when conducting DoD supported research, view the DoD Instruction 3216.02. The IRB Application in Kuali Research Protocols addresses DoD requirements. Specific branches of the…