The following general principles of research ethics are followed when human subjects are involved in clinical trials:
- Autonomy: respect for persons and protecting those with diminished autonomy
- Beneficence and non-maleficence: do no harm
- Informed consent
- Confidentiality and data protection
Lannett (LCI) Clinical controls/requirements to ensure compliance with these principles:
- Internal SOPs (Standard Operating Procedures) are established for clinical studies that define our strict requirements and controls
- Protocols are prepared in advance that dictate study conduct such as the inclusion and exclusion criteria for the subjects and any safety precautions. Protocol requirements evolve based on current requirements and information. For instance, all protocols have recently been updated to include precautions for COVID
- All clinics utilized by Lannett must use an IRB (Institutional Review Board) that has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects
- All clinics used by Lannett must be FDA inspected
- Lannett’s clinical studies are conducted and are managed within compliance of national and international guidelines (FDA and WHO)
- We send a clinical monitor to LCI sponsored studies to check informed consent documents, adherence to protocols, and whether SOP’s are followed