Common use of Communication Concerning Certain Events Affecting Research Participants Clause in Contracts

Communication Concerning Certain Events Affecting Research Participants. In furtherance of Stanford’s HRPP, Company agrees: to notify promptly the Principal Investigator and/ or the Stanford IRB directly, of (i) non-compliance with the Research Program in Exhibit A or applicable laws, particularly those laws related to human research subjects, that could affect the safety or welfare of participating subjects; (ii) serious adverse events that have been reported to the FDA or other governmental agency in relation to the Research Program at Stanford or any other site; (iii) unanticipated problems in the Research Program at Stanford or any other site that could relate to risks to participating subjects; and (iv) circumstances that could affect subjects’ willingness to continue to participate in the Research Program or the continued approval of Stanford’s IRB for the Research Program; and, to develop a plan of communication to subjects with Stanford’s Principal Investigator that is acceptable to Stanford’s IRB when new findings or results of the Research Program might affect the willingness of subjects to continue to participate in the Research Program or directly affect their current or future safety or medical care.

Communication Concerning Certain Events Affecting Research Participants. In furtherance of Stanford’s HRPP, Company agrees: to notify promptly the Principal Investigator and/ or the Stanford IRB directly, of (i) non-compliance with the Research Program in Exhibit A or applicable laws, particularly those laws related to human research subjects, that could affect the safety or welfare of participating subjects; (ii) serious adverse events that have been reported to the FDA or other governmental agency in relation to the Research Program at Stanford or any other site; (iii) unanticipated problems in the Research Program at Stanford or any other site that could relate to risks to participating subjects; and (iv) circumstances that could affect subjects’ willingness to continue to participate in the Research Program or the continued approval of Stanford’s IRB for the Research Program; and, and to develop a plan of communication to subjects with Stanford’s Principal Investigator that is acceptable to Stanford’s IRB when new findings or results of the Research Program might affect the willingness of subjects to continue to participate in the Research Program or directly affect their current or future safety or medical care.