Compliance Statements
Click here for our Compliance Statements.
Investigator Manual
The UM HSRO created an Investigator Manual that outlines the duties and responsibilities of investigators engaged in human subject research at the University of Miami. The HSRO requires that all first time and current principal investigators review and comply with this manual before and during their research. The summary of changes for the latest version can be found here.
SOP's, Checklists, & Worksheets
The University of Miami IRB developed these SOP's, Checklists, and Worksheets for the IRB Administration staff, analysts, and committee reviewers as part of the IRB review process. These documents are made available to the research community as guidance. Please do not submit these documents with your IRB submissions.
Human Research Protection Program Plan
The Human Research Protection Program Plan details the criteria for reviewing for or relying on other institutions/organizations.
HIPAA
Health Information is among the most sensitive types of personal information. The Health Insurance Portability and Accountability Act of 1996 (also known as HIPAA) protects the privacy and security of patient health information. More information on the HIPAA Privacy Rules can be found HERE.
FDA Regulated Studies
For reference, the following regulations are applicable to IRB review of clinical trials subject to FDA regulations conducted by the University of Miami:
21 CFR Part 50 – Protection of Human Subjects
21 CFR Part 56 – Institutional Review Boards
21 CFR Part 312 – Investigational New Drug Application
21 CFR Part 812 – Investigational Device Exemptions
Federally Funded Studies
The Federal Policy for the Protection of Human Subjects or the "Common Rule" governs human subject research conducted or supported by each federal department/agency. The HHS regulations, 45 CFR part 46, include four subparts:
- Subpart A, also known as the Federal Policy or the "Common Rule"
- Subpart B, additional protections for pregnant women, human fetuses, and neonates;
- Subpart C, additional protections for prisoners
- Subpart D, additional protections for children.
Each funding agency's regulations include language and section numbers that are identical to those of the HHS regulation, 45 CFR part 46, Subpart A. For all participating departments and agencies the Common Rule outlines the provisions for IRBs and informed consent. Click HERE and scroll down the page to view a chart that lists the specific regulation citations for each funding agency or department.
