The IRB is charged with the responsibility of reviewing, prior to its initiation, all research involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.
Check out these helpful resources for more information about clinical trials and the development process:
The Center for Information & Study on Clinical Research Participation (CISCRP) Education Center provides helpful information about clinical research and what it means to be a clinical research volunteer.
ClinicalTrials.gov is a database of privately and publicly funded clinical trials conducted around the world. You can search for trials as well as find other helpful information about the clinical trial process.
- EU Clinical Trials Register
The EU Clinical Trials Register provides a search tool for clinical trials in European Union member states and the European Economic Area.
- FDA Clinical Trials Information
The U.S. Food & Drug Administration (FDA) provides helpful information about clinical trials, including the different types, what informed consent means, and so on.
- NCATS Toolkit for Patient-Focused Therapy Development
The National Center for Advancing Translational Sciences (NCATS) Toolkit explains how investigational products are developed, why it is important for patients to be a part of the process, and how to go about doing so.
- Rare University – Understanding Drug Development
Rare University is an online course developed by Global Genes that is designed specifically for rare disease patients and advocates.