While there are many organizations (including Ethics Committees and Institutional Review Boards) involved in the protection of human research subjects, the sponsors of clinical research studies also have a role and an obligation to participate in the protection of study participants. Relationships between these oversight committees and the biotech/ pharma industry have often been difficult, as there is little understanding or education about drug development in the IRB community, and little education about human subject protection in the biotech/pharma industry.The sponsors of research also have a role to play in the protection of human subjects, and this session is intended to explore and expand that role.
• Educate BIO members about the history, ethics and regulations of human subject protection
• Engage BIO members in discussion about the role of industry sponsors of research in subject protection efforts
• Propose concrete and realistic ideas for improving relationships between IRBs and industry research sponsors