Common use of Human Subjects Protection Clause in Contracts

Human Subjects Protection. The Parties shall promptly notify each other upon identifying a serious unanticipated problem involving risks to subjects or others and/or an unanticipated serious adverse event which may be related to the Protocol. VA shall promptly notify the Collaborator of any Protocol deviations using the notification method and time frame described in the IRB-approved Protocol. Collaborator shall promptly notify VA in writing upon identifying an interim data-analysis result, or study-result finding that may adversely affect the safety or well-being of subjects. If study result findings are provided to VA for conveyance to subjects, such communication to subjects shall be subject to Federal law and regulations and VA policy. VA always reserves the right to communicate and notify any safety concerns to the subjects.

Human Subjects Protection. The Parties shall promptly notify each other upon identifying a serious unanticipated problem involving risks to subjects or others and/or an unanticipated serious adverse event which may be related to the Protocol. VA shall promptly notify the Collaborator of any Protocol deviations using the notification method and time frame described in the IRB-approved Protocol. Collaborator shall promptly notify VA in writing upon identifying an interim data-data analysis result, or study-study result finding that may adversely affect the safety or well-being of subjects. If study result findings are provided to VA for conveyance to subjects, such communication to subjects shall be subject to Federal law and regulations and VA policy. VA always reserves the right to communicate and notify any safety concerns to the subjects.

Human Subjects Protection. The Parties shall promptly notify each other upon identifying a serious unanticipated problem involving risks to subjects or others and/or an unanticipated serious adverse event Serious Adverse Event which may be related to the Protocol. VA shall promptly notify the Collaborator of any Protocol deviations deviation using the notification method and time frame described in the IRB-approved Protocol. protocol; Collaborator shall promptly notify VA in writing upon identifying an interim data-data analysis result, or study-study result finding that may adversely affect the safety or well-being of subjects. If study result findings are provided to VA for conveyance to subjects, such communication to subjects shall be subject to Federal law and regulations and VA policy. VA always reserves the right to communicate and notify any safety concerns to the subjects.