Human Subjects Special Terms
Special Terms and Conditions
Applicable Regulations and Guidelines
All parties are responsible for compliance with all applicable laws, regulations, and standards of local, state and Federal government agencies.
Sponsor agrees to be responsible for the charges incurred for reasonable and customary medical treatment of any Research Injury caused by or derived from Sponsor’s investigative product or the protocols agreed upon for its use and administration, provided that: (1) the Project was administered or performed in accordance with the approved protocol and all written instructions from Sponsor regarding the administration of the investigative product or performance of required procedures; and (2) the Research Injury is not attributable to any negligence or misconduct in attending to the project participants.
“Research Injury” means physical injury or illness caused by treatment or procedures required by the protocol that a project participant would not have received if he or she had not participated in the study.
University agrees to provide or arrange for prompt diagnosis and medical treatment of any Research Injury experienced by a project participant as soon as University becomes aware of the Research Injury. University further agrees to promptly notify Sponsor of any Research Injury upon becoming aware of such injury. Sponsor will assist in the notification of subjects of this information as necessary.
Notification of Unanticipated Problems
During and for a period of at least two years after the completion of the Project, Sponsor shall promptly (generally 30 days, or in a timely manner appropriate to the level of risk involved) report to the Principal Investigator any information that could directly affect the health or safety of past or current project participants or influence the conduct of the Project, including but not limited to the Project results and information in site monitoring reports and data safety monitoring committee reports as required by the protocol. In each case, the Principal Investigator and University shall be free to communicate these findings to each study subject and the IRB.