Common use of Consent Forms Clause in Contracts

Consent Forms. Provide to each Relying Institution and Site Investigator(s) informed consent forms to use for the Research where the Reviewing IRB has determined that such a consent form(s) is required. The Reviewing IRB will permit a Relying Institution/Site Investigator(s) to customize limited site-specific sections of the form, generally the sections on the availability of treatment and compensation for research-related injury; payment or reimbursement of research costs incurred by subjects; and local contacts. Any such modifications will be subject to approval by the Reviewing IRB, which will then provide a final approved consent form(s) to the Relying Institution(s)/Site Investigator(s) for use. Conflicts of Interest. Consider any applicable conflict of interest assurances received from federal Relying Institutions or conflict of interest determinations and associated management plans provided by non-federal Relying Institutions pursuant to Section 6.6 hereof with respect to the Overall PI, Site Investigator(s), and other Research Personnel in connection with the Research. The Reviewing IRB will ensure that any management plan is incorporated into its initial or continuing review or other deliberations, as applicable, and without limiting the foregoing, that any disclosures to subjects required by the plan and that are approvable by the Reviewing IRB are included in the approved informed consent form(s) for the relevant Relying Institution. The Reviewing IRB retains the authority to impose additional prohibitions or conflict management requirements more stringent or restrictive than proposed by a non-federal Relying Institution if necessary to approve the Research, provided, however, the Reviewing IRB will not modify or change any management plan or mandated disclosure to subjects without discussion with and acceptance by the Relying Institution. In the extraordinary circumstance that the Reviewing IRB is unable to implement/approve a non-federal Relying Institution’s prohibitions or management plans, the Reviewing IRB will so inform such Relying Institution or, if the non-federal Relying Institution fails to accept any additional prohibitions or requirements, the non-federal Relying Institution will so inform the Reviewing IRB. If the institutions are not able to identify a mutually agreeable approach, the Research will be withdrawn from Ceded Review (without an IRB approval or disapproval) with respect to that non-federal Relying Institution. If the Reviewing IRB concludes that it cannot rely upon the assurances from a federal Relying Institution, the Reviewing IRB will so inform the federal Relying Institution, and the Research will be withdrawn from Ceded Review (without an IRB approval or disapproval) with respect to that federal Relying Institution. Notification of IRB Decisions, Changes, Lapses in Approval. Promptly notify the Overall PI, Site Investigator(s), and the Relying Institution(s) of its determinations (e.g., exemption) or review decisions regarding the Research (e.g., approval, disapproval, required modifications); of changes in the Research reviewed and approved by the Reviewing IRB after initial approval; and of lapses in IRB approval and any applicable corrective action plans. Such notification may be made through the Reviewing IRB’s designee, as determined by the Participating Institutions in connection with the specific Research.

Consent Forms. Provide to each Relying Institution and Site Investigator(s) informed consent forms to use for the Research where the Reviewing IRB has determined that such a consent form(s) is required. The Reviewing IRB will permit a Relying Institution/Site Investigator(s) to customize limited site-specific sections of the form, generally the sections on the availability of treatment and compensation for research-related injury; payment or reimbursement of research costs incurred by subjects; and local contacts. Any such modifications will be subject to approval by the Reviewing IRB, which will then provide a final approved consent form(s) to the Relying Institution(s)/Site Investigator(s) for use. Conflicts of Interest. Consider any applicable conflict of interest assurances received from federal Relying Institutions or conflict of interest and/or determinations and associated management plans provided by non-federal Relying Institutions pursuant to Section 6.6 hereof with respect to the Overall PI, Site Investigator(s), and other Research Personnel in connection with the Research. The Reviewing IRB will ensure that any management plan is incorporated into its initial or continuing review or other deliberations, as applicable, and without limiting the foregoing, that any disclosures to subjects required by the plan and that are approvable by the Reviewing IRB are included in the approved informed consent form(s) for the relevant Relying Institution. The Reviewing IRB retains the authority to impose additional prohibitions or conflict management requirements more stringent or restrictive than proposed by a non-federal Relying Institution if necessary to approve the Research, provided, however, the Reviewing IRB will not modify or change any management plan or mandated disclosure to subjects without discussion with and acceptance by the Relying Institution. In the extraordinary circumstance that the Reviewing IRB is unable to implement/approve a non-federal Relying Institution’s prohibitions or management plans, the Reviewing IRB will so inform such Relying Institution or, if the non-federal Relying Institution fails to accept any additional prohibitions or requirements, the non-federal Relying Institution will so inform the Reviewing IRB. If the institutions are not able to identify a mutually agreeable approach, the Research will be withdrawn from Ceded Review (without an IRB approval or disapproval) with respect to that non-federal Relying Institution. If the Reviewing IRB concludes that it cannot rely upon the assurances from a federal Relying Institution, the Reviewing IRB will so inform the federal Relying Institution, and the Research will be withdrawn from Ceded Review (without an IRB approval or disapproval) with respect to that federal Relying Institution. Notification of IRB Decisions, Changes, Lapses in Approval. Promptly notify the Overall PI, Site Investigator(s), and the Relying Institution(s) of its determinations (e.g., exemption) or review decisions regarding the Research (e.g., approval, disapproval, required modifications); of changes in the Research reviewed and approved by the Reviewing IRB after initial approval; and of lapses in IRB approval and any applicable corrective action plans. Such notification may be made through the Reviewing IRB’s designee, as determined by the Participating Institutions in connection with the specific Research. Notification of Unanticipated Problems, Injuries, Complaints. Promptly notify the Overall PI, Site Investigator(s), and Relying Institution(s) of applicable review decisions as well as of any findings and actions (including any suspension or termination of IRB approval of the Research and required corrective actions), with respect to: (i) any unanticipated problems involving risks to human subjects or others, subject injuries related to Research participation, or significant subject complaints (e.g., those that could affect the conduct of the Research) that occurred at the Relying Institution, and (ii) such events or actions that occurred at any institution if such events or actions relate to or may affect the conduct of the Research or the safety, rights or welfare of human subjects participating in the Research at the Relying Institution(s). Such notification may be made through the Reviewing IRB’s designee, as determined by the Participating Institutions in connection with the specific Research. Notification of Serious and/or Continuing Noncompliance. Promptly notify the Overall PI, Site Investigator(s), and Relying Institution(s) of any findings of serious and/or continuing noncompliance with applicable human subjects protection regulations or with the requirements or determinations of the Reviewing IRB, or of apparent serious and/or continuing noncompliance with such regulations or requirements, pertaining to the Relying Institution or its Research Personnel as well as any actions taken (including any suspension or termination of IRB approval of the Research) and the steps the Reviewing IRB deems necessary for remediation of the noncompliance at the Relying Institution. The Reviewing IRB will also notify the Overall PI, Site Investigator(s), and Relying Institution(s) of any suspension or termination of IRB approval and any remediation actions pertaining to findings of serious and/or continuing noncompliance at any other institution if such finding or actions relate to or may affect the conduct of the Research or the safety, rights, or welfare of human subjects participating in the Research at the Relying Institution(s). If the Reviewing IRB determines that the facts of a noncompliance matter or any other matter under this Section 5.11 or under Sections 5.9 or 5.10 hereof raise issues apart from or in addition to noncompliance with human subjects protection requirements (such as a potential allegation of research misconduct), the Reviewing IRB shall notify and refer those issues to the Relying Institution for review. Any of the notifications required in this section may be made through the Reviewing IRB’s designee, as determined by the Participating Institutions in connection with the specific Research.