This page provides investigators and personnel involved in human subjects research links to key guidance and resources for conducting research, from study initiation to study closure.
The first step is to develop a plan for how you want to conduct your research. In addition to the IRB application, this plan could include the creation of documents such as a protocol, consent form(s), study data collection instruments, and instructions (e.g. standard operating procedures).
Informed Consent Development
Informed Consent Requirements (video)
Effective Consent Forms and the Process (video)
Strategies for Improving the Process (video)
OHRP: General Informed Consent Requirements (video)
Informed Consent Wizard
Combined Consent HIPAA Wizard
ICTR Clinical Research Toolkit (Before You Begin a Study tab)
Research with Vulnerable and Underrepresented Populations (panel discussion)
Practical Regulatory Issues in Human Subjects Research (video)
The next step is conducting the study as approved, periodically re-assessing and making changes when needed.
Screening and Recruitment
Changes of Protocol
Developing an Internal Quality Assurance (QA) Program Guidance
Post-Approval Monitoring Program Self-Assessment Tool
ICTR Clinical Research Toolkit (Self-Assessment & Audit Prep tab)
Post-Approval Monitoring Program
The final step is initiating the IRB closure process and ensuring proper retention of study records.