Common use of RESPONSIBILITIES OF THE INSTITUTION Clause in Contracts

RESPONSIBILITIES OF THE INSTITUTION. The Institution agrees to the following: a. The Institution shall require investigator compliance with IRB determinations and requirements, applicable federal regulations, state and local laws, and, institutional requirements relating to the research. Further, the Institution shall identify the requirements of applicable state or local laws, regulations, institutional policies, and communicate such requirements to Advarra. This policy does not affect any state or local laws or regulations (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that may otherwise be applicable and that provide additional protections for human subjects. b. The Institution shall require the applicable Principal Investigator to provide all information reasonably required by Advarra to conduct its reviews. The Institution may not approve any research study that has been disapproved by Advarra. The Institution may, however, disapprove any study that is approved by Advarra. The Institution agrees to abide by the decisions of Advarra, including the use of the Advarra-approved informed consent document, and shall use its best efforts to ensure that the human subject research performed by the Institution shall be conducted in accordance with those decisions. c. The Institution shall require that investigators and other study personnel at the Institution are qualified and have appropriate resources to conduct the research, including but not limited to education and training in human research protection regulations. The Institution shall provide documentation of training and education as reasonably requested by Advarra. d. The Institution shall maintain an institutional process by which complaints about the study can be made by local study participants or others. Complaints that meet criteria as potential unanticipated problems involving risks to subjects or others, or which may be evidence of serious or continuing noncompliance shall be reported to Advarra in accordance with the timeframes specified by Advarra. e. The Institution shall cooperate with any Advarra investigation regarding noncompliance or unanticipated problem(s) involving risks to subjects or others related to the studies conducted under this Agreement at the Institution. Nothing in this Agreement shall prevent either party from conducting its own investigation; however, Advarra shall have the authority to determine whether serious or continuing noncompliance or unanticipated problems involving risks to subjects or others have occurred. f. The Institution shall notify Advarra’s Responsible Official promptly in the event of the following:  Any suspension or restriction of the Institution’s authorization or ability to conduct studies  Any Institutional policy decisions or regulatory matters that might affect Advarra’s ability to review the Institution’s research;  Any unanticipated problems involving injury or risks to subjects or others in a study reviewed by Advarra;  Any serious or continuing non-compliance the Institution believes has occurred in a study reviewed by Advarra and any steps the Institution has deemed necessary for remediation of non-compliance;  Any suspension or termination of Institutional approval;  Any communication with the FDA, OHRP or any funding agency relating to the Institution’s studies being reviewed by Advarra; and  Any changes in the accreditation status of the Institution’s Human Research Protection Program. g. The Institution will maintain a current, approved Federalwide Assurance (FWA) with OHRP for the duration of this Agreement. The Institution will notify Advarra promptly in writing if the status of the FWA is no longer in good standing with OHRP, including a terminated or expired status for any reason.

RESPONSIBILITIES OF THE INSTITUTION. The Institution agrees to the following: a. : The Institution shall require investigator compliance with IRB determinations and requirements, applicable federal regulations, state and local laws, and, institutional requirements relating to the research. Further, the Institution shall identify the requirements of applicable state or local laws, regulations, institutional policies, and communicate such requirements to Advarra. This policy does not affect any state or local laws or regulations (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that may otherwise be applicable and that provide additional protections for human subjects. b. . The Institution shall require the applicable Principal Investigator to investigator/research staff provide all information reasonably required by Advarra to conduct its reviews. The Institution may not approve any research study that has been disapproved by AdvarraXxxxxxx. The Institution may, however, disapprove any study that is approved by AdvarraXxxxxxx. The Institution agrees to abide by the decisions of AdvarraXxxxxxx, including the use of the Advarra-approved informed consent document, and shall use its best efforts to ensure that the human subject research performed by the Institution shall be conducted in accordance with those decisions. c. . The Institution shall require that investigators and other study personnel at the Institution are qualified and have appropriate resources to conduct the research, including but not limited to education and training in human research protection regulations. The Institution shall provide documentation of training and education as reasonably requested by Advarra. d. Xxxxxxx. The Institution shall maintain an institutional process by which complaints about the study can be made by local study participants or others. Complaints that meet criteria as potential unanticipated problems involving risks to subjects or others, or which may be evidence of serious or continuing noncompliance shall be reported to Advarra in accordance with the timeframes specified by Advarra. e. . The Institution shall cooperate with any Advarra investigation regarding noncompliance or unanticipated problem(s) involving risks to subjects or others related to the studies conducted under this Agreement at the Institution. Nothing in this Agreement shall prevent either party from conducting its own investigation; however, Advarra Xxxxxxx shall have the authority to determine whether serious or continuing noncompliance or unanticipated problems involving risks to subjects or others have occurred. f. . The Institution shall notify AdvarraXxxxxxx’s Responsible Official promptly in the event of the following:  Any suspension or restriction of the Institution’s authorization or ability to conduct studies  Any Institutional policy decisions or regulatory matters that might affect AdvarraXxxxxxx’s ability to review the Institution’s research;  Any unanticipated problems involving injury or risks to subjects or others in a study reviewed by AdvarraXxxxxxx;  Any serious or continuing non-compliance the Institution believes has occurred in a study reviewed by Advarra Xxxxxxx and any steps the Institution has deemed necessary for remediation of non-compliance;  Any suspension or termination of Institutional approval;  Any communication with the FDA, OHRP or any funding agency relating to the Institution’s studies being reviewed by AdvarraXxxxxxx; and  Any changes in the accreditation status of the Institution’s Human Research Protection Program. g. . The Institution will maintain a current, approved Federalwide Assurance (FWA) with OHRP for the duration of this Agreement. The Institution will notify Advarra promptly in writing if the status of the FWA is no longer in good standing with OHRP, including a terminated or expired status for any reason.

RESPONSIBILITIES OF THE INSTITUTION. The Institution agrees to the following: a. : The Institution shall require investigator compliance with IRB determinations and requirements, applicable federal regulations, state and local laws, and, institutional requirements relating to the research. Further, the Institution shall identify the requirements of applicable state or local laws, regulations, institutional policies, and communicate such requirements to Advarra. This policy does not affect any state or local laws or regulations (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that may otherwise be applicable and that provide additional protections for human subjects. b. . The Institution shall require the applicable Principal Investigator to investigator/research staff provide all information reasonably required by Advarra to conduct its reviews. The Institution may not approve any research study that has been disapproved by Advarra. The Institution may, however, disapprove any study that is approved by Advarra. The Institution agrees to abide by the decisions of Advarra, including the use of the Advarra-approved informed consent document, and shall use its best efforts to ensure that the human subject research performed by the Institution shall be conducted in accordance with those decisions. c. . The Institution shall require that investigators and other study personnel at the Institution are qualified and have appropriate resources to conduct the research, including but not limited to education and training in human research protection regulations. The Institution shall provide documentation of training and education as reasonably requested by Advarra. d. . The Institution shall maintain an institutional process by which complaints about the study can be made by local study participants or others. Complaints that meet criteria as potential unanticipated problems involving risks to subjects or others, or which may be evidence of serious or continuing noncompliance shall be reported to Advarra in accordance with the timeframes specified by Advarra. e. . The Institution shall cooperate with any Advarra investigation regarding noncompliance or unanticipated problem(s) involving risks to subjects or others related to the studies conducted under this Agreement at the Institution. Nothing in this Agreement shall prevent either party from conducting its own investigation; however, Advarra shall have the authority to determine whether serious or continuing noncompliance or unanticipated problems involving risks to subjects or others have occurred. f. . The Institution shall notify Advarra’s Responsible Official promptly in the event of the following:  Any suspension or restriction of the Institution’s authorization or ability to conduct studies  Any Institutional policy decisions or regulatory matters that might affect Advarra’s ability to review the Institution’s research;  Any unanticipated problems involving injury or risks to subjects or others in a study reviewed by Advarra;  Any serious or continuing non-compliance the Institution believes has occurred in a study reviewed by Advarra and any steps the Institution has deemed necessary for remediation of non-compliance;  Any suspension or termination of Institutional approval;  Any communication with the FDA, OHRP or any funding agency relating to the Institution’s studies being reviewed by Advarra; and  Any changes in the accreditation status of the Institution’s Human Research Protection Program. g. . The Institution will maintain a current, approved Federalwide Assurance (FWA) with OHRP for the duration of this Agreement. The Institution will notify Advarra promptly in writing if the status of the FWA is no longer in good standing with OHRP, including a terminated or expired status for any reason.