IRBchoice Master Agreement (IMA)

Transcription

1 IRBchoice Master Agreement (IMA) The purpose of this IRBchoice Master Agreement (IMA) is to outline the responsibilities and obligations between and among the Participating Institutions utilizing IRBchoice to reduce duplicative Institutional Review Board (IRB) reviews and facilitate their compliance with all applicable federal, state and local regulations and guidance in the conduct of research with human subjects. IRBchoice is a mechanism by which a Participating Institution can, on a study-by-study basis, choose to conduct IRB review through: (i) the Ceded Model or (ii) the Shared Model. This IMA does not preclude any Participating Institution from using its own IRB for review of a research study covered by this IMA. In addition, this IMA does not preclude any Participating Institution from conducting research not covered by this IMA, or relying upon other IRBs for review of research not covered by this IMA. Participating IRBs may choose to function as the Lead IRB by providing IRB review for other Participating Institutions as the 1) IRB of Record using the Ceded Model, as described in Appendix A of this IMA, 2) Sharing IRB using the Shared Model, as described in Appendix B of this IMA, or 3) agreeing to serve in either role for a given study, allowing the Relying Institution(s) or Relying IRB(s) to select the most suitable reliance model for the given study. 1. DEFINITIONS A. Federal Human Research Protections Regulations: 45 CFR Part 46, including all subparts as applicable for a given study (and as adopted by other federal agencies) and 21 CFR Parts 50 and 56. B. Customized Action Plan (CAP): For a given study, the mutually agreed upon plan of action between an IRB of Record and a Relying Institution or Relying IRB with respect to the responsibilities outlined in Section 5 of Appendix A. These terms may be negotiated between an IRB of Record and a Relying Institution or Relying IRB on a study-by-study basis, if needed. Any specific requirements related to these responsibilities, as agreed upon by the Participating Institutions, must be accepted in the IRBchoice System by the IRBchoice Liaison for each Participating Institution. If an agreement cannot be reached on these terms, the Relying Institution or Relying IRB cannot cede review to that particular IRB of Record for the given study. C. Ceded Model: An IRB reliance option in which one or more Participating Institutions transfers IRB review and oversight responsibilities to and relies on another Participating IRB that accepts IRB review and oversight responsibility. D. Human Research Protections Program (HRPP): A HRPP includes multiple components of an institutional program to ensure that the rights and welfare of human research subjects are protected. HRPPs include IRBs as well as quality assurance programs that help to ensure appropriate conduct of human subjects research as well as compliance with all applicable laws, regulations, and policies. E. Institutional Profile: A form in the IRBchoice System that captures information including but not limited to the Participating Institution s FWA, including but not limited to whether or not the Participating Institution applies the federal regulations and its subparts to non-federal, non-exempt human subjects research (aka has checked the box ); the Participating Institution s HRPP; its Participating IRB, as applicable; and adequate local context information to allow another Participating IRB to assess its willingness to assume review responsibilities under the Ceded Model. In addition, the Institutional Profile will contain the Lead IRB s procedures when serving as the IRB of Record under the Ceded Model. F. Investigator Responsibilities and Submission Instructions Sheet: A document generated for investigators at Relying Institutions or Relying IRBs that outlines the initial and ongoing submission and Page 1of 14

2 review requirements and the expectations of the Lead IRB, if applicable, and the Relying Institution or Relying IRB. The document is generated through the IRBchoice System based on the Institutional Profiles of the 1) the Lead IRB and 2) the Relying Institution or Relying IRB. G. IRBchoice Liaison(s): An IRB staff member or institutional designee at a Participating Institution who serves as the primary contact to the IRBchoice Steering Committee (ISC), all other Participating Institutions, and members of its own Participating Institution. The IRBchoice Liaison will be an integral part of his/her Participating Institution s own oversight of human subjects research, and will be responsible for all reporting, as outlined in this IMA, to the ISC and other Participating Institutions. H. IRBchoice System: The electronic software developed for IRBchoice that serves as a platform for allowing Participating Institutions to communicate and coordinate IRB reliance, as well as facilitate the sharing of IRB approval documentation between Participating Institutions. I. IRB of Record: A Lead IRB that, under the Ceded Model, has agreed to assume full IRB review and oversight responsibilities for at least one other Relying Institution or Relying IRB for a specific study. J. IRBchoice Steering Committee (ISC): The IRBchoice Steering Committee will be composed of at least three IRBchoice Liaisons and tasks will include, but are not limited to, the verification of Participating Institutions qualifications to participate in this IMA; monitoring compliance with the terms of this IMA; and facilitating discussion between Participating Institutions when needed. K. Lead IRB: A Participating IRB that agrees to allow another Participating Institution to rely upon its review. A Lead IRB may choose to serve as either the IRB of Record or a Sharing IRB or both for a given research study. L. Local Research Context: Any item affecting research conducted at a Participating Institution and/or its other performance sites including, but not limited to, state and local law, institutional policy, and requirements for the conduct of research at such Participating Institution as identified by the Participating Institution and designated in the Institutional Profile of the IRBchoice System.. M. Participating Institution: Any U.S. institution that has signed this IMA and, at a minimum, meets the following qualifications: i. has and maintains a current Federalwide Assurance ( FWA ) filed with DHHS; ii. has and maintains an employment or contractual relationship with the principal investigators for the research projects that are being reviewed with data or information from the IRBchoice System; and iii. is not debarred, excluded or otherwise ineligible to participate in any state or federal government grants, contracts, or programs. N. Participating IRB: A Participating Institution s internal IRB that regularly reviews research with human subjects in the U.S. in compliance with all applicable regulations pertaining to human subjects research, including without limitation, the Federal Human Research Protections Regulations, and whose institution has signed this IMA. O. Relying IRB: The IRB of a Participating Institution that maintains an internal DHHS-registration in compliance with all applicable regulations pertaining to research involving human subjects, including without limitation, the Federal Human Research Protections Regulations and that has chosen to rely on the review of a Lead IRB under either the Ceded Model or Shared Model. Page 2 of 14

3 P. Relying Institution: A Participating Institution that has chosen to rely on the review of a Lead IRB under the Ceded Model, but does not, like a Relying IRB, maintain an internal DHHS-registered IRB. Q. Shared Review Documents: The minutes, which are redacted (all personal identifiers removed, including reviewers names), protocol, investigator s brochure/device manual, approved consent documents, and other documents relevant to the discussions and determinations of any Lead IRB s review and approval (e.g., vulnerable population criteria) and provided via the IRBchoice System. R. Shared Review Process: An IRB review model for review of multi-site studies whereby a sub-committee (i.e., at least one IRB member or a qualified designee of the Chair) review of a multi-site research project (typically for review of Local Research Context issues as required by the Federal Human Research Protections Regulations) is conducted by any Relying IRB in conjunction with and secondary to a review and approval of all 45 CFR and 21 CFR criteria of the same research project conducted by ONE single Lead IRB (e.g., initial review, continuing review, and/or amendment as applicable) such that the combined reviews and approvals of both IRBs satisfies the criteria of the Federal Human Research Protections Regulations. If, at the time of initiating the Shared Review Process, continuing reviews and/or amendments have already been provided with an initial review and approval by a Lead IRB, then the Relying IRB must utilize all such continuing reviews and amendments together with the initial review and approval so provided in order to complete the Shared Review Process. S. Sharing IRB: A Lead IRB that, under the Shared Model, has agreed to make its review documents available for other Participating IRBs to rely upon and utilize to approve a research study via the Shared Review Process. T. Shared Model: An IRB reliance option in which one or more Participating Institutions utilize the IRB review of a designated Lead IRB and, using a subcommittee at its own Participating Institution, completes the review of a given research study and maintains IRB oversight for the given research study. 2. SCOPE A. Each Participating Institution will independently decide how it utilizes IRBchoice for any research study. A Participating Institution is not required to submit or accept any given study onto the IRBchoice System. Furthermore, a Participating Institution is not required to use IRBchoice for any given study. B. Research studies involving human subjects that are eligible for IRBchoice consist of multi-site studies that are funded by US. Government agencies, institutes or departments, non-profit foundations, and for-profit entities. C. Notwithstanding anything to the contrary in this IMA, each Participating Institution shall be solely responsible for the operations and compliance of its respective HRPP, including its IRB(s), if applicable, and for safeguarding the health, safety, and welfare of any human research subjects participating in research projects at its respective institution. D. Each Participating Institution will independently determine which research studies that are a part of this IMA will be conducted at its institution and by an investigator who has an employment or contractual relationship at the Participating Institution. Nothing in this IMA shall be construed as a recommendation by any Participating Institution or Operator about the research studies identified or described in the data or information available via the IRBchoice System. Page 3 of 14

4 E. Each Participating Institution is free to enter into other IRB authorization agreements with other entities, including other Participating Institutions, for research studies other than the research studies covered under this IMA. However, reliance of one Participating Institution upon another Participating Institution for a research study utilizing IRBchoice must be governed by the terms of this IMA. 3. REQUIREMENTS OF ALL PARTICIPATING INSTITUTIONS A. Each Participating Institution must maintain an active Federal Wide Assurance (FWA) with the Department of Health and Human Services (DHHS) and its IRB(s), if applicable, must be registered with DHHS, and comply with the requirements of the Federal Human Research Protections Regulations at all times while a party to this IMA. B. Each Participating Institution will be fully responsible for the performance of research at its institution in compliance with applicable federal regulations and state and institutional requirements applicable to the activities undertaken pursuant to this IMA, including without limitation, the applicable requirements of the Federal Human Research Protections Regulations. In addition, each Participating Institution shall comply and shall cause its IRB, as applicable, and its IRBchoice Liaison(s) to comply with the policies and procedures of its IRB, as applicable, and its FWA, as applicable. Each Participating Institution shall also notify the Operator promptly if at any time it fails to satisfy the qualifications of a Participating Institution as defined herein. C. Each Participating Institution must complete and maintain on a yearly basis an Institutional Profile. The Operator and appropriate Participating Institutions must, via the IRBchoice System, be promptly notified in writing of substantive changes to the Institutional Profile that occur outside of the yearly required update. Substantive changes include, but are not limited to, a change in the applicability of the federal regulations and its subparts. D. Each Participating Institution will be responsible for ensuring that the qualifications of its research personnel who are conducting research covered under this IMA are consistent with the Participating Institution s standards for eligibility to conduct research. This includes, but is not limited to, having the required professional staff appointments, credentialing, education, and insurance coverage as applicable for their assigned role in any given research study. E. Each Participating Institution will be responsible for ensuring its site s compliance with the determinations of the designated Lead IRB, federal regulations, and all applicable state, local, and institutional requirements relating to human subjects research. F. Each Participating Institution shall be independently responsible for its own compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) obligations (e.g., minimum necessary requirements or accounting of disclosures made pursuant to a waiver of authorization) and compliance with all state and local laws, if applicable. Under the Ceded Model, as described in Appendix A, the process for review of HIPAA authorizations and waivers may be mutually negotiated and documented in the IRBchoice System between the Lead IRB and a Relying Institution or Relying IRB on a study-bystudy basis. G. Each Participating Institution must establish an IRBchoice Liaison to maintain open communication among Participating Institutions. Contact information for the IRBchoice Liaison(s) will be available in the IRBchoice System. Any changes to the IRBchoice Liaison(s) must be communicated promptly by the Participating Institution in the IRBchoice System. Page 4 of 14

5 H. Each Participating Institution shall treat and shall cause its IRBchoice Liaison(s) and IRB, as applicable, to treat all data and information that is accessed, received, used, disclosed, transmitted, maintained, or obtained by or on behalf of its institution or IRB, as applicable, from the IRBchoice System (collectively, Confidential Information ) as confidential and shall only use or disclose such data and other information for the limited purposes described herein and in accordance with the terms and conditions of this IMA or as required by applicable law. Notwithstanding the foregoing, this IMA imposes no such obligations of confidentiality on, and Confidential Information shall not include, data and information that the Participating Institution can establish: i. was in the Participating Institution's possession before it was available via the IRBchoice System; ii. is or becomes available to the public through no fault of the Participating Institution; iii. is received in good faith by the Participating Institution from a third party without any obligation of confidentiality; or iv. is independently developed by the Participating Institution without reference to any data or information available via the IRBchoice System. If a Participating Institution or Participating IRB is required pursuant to applicable law to disclose Confidential Information, then the Participating Institution shall notify Operator and any relevant Participating Institution promptly to enable Operator and any such Participating Institution to respond and take any action it deems necessary or appropriate. To the extent permitted by law, each Participating Institution shall reasonably cooperate with Operator and any such Participating Institution if it chooses to respond or challenge any such required disclosure, and Operator and any such Participating Institution shall be responsible for their respective costs and expenses associated therewith, including reasonable attorney fees and costs. I. Each Participating Institution shall employ and shall cause its IRBchoice Liaison(s) and its IRB, as applicable, to employ sufficient safeguards (such as technical, physical, administrative and procedural safeguards) to prevent any use or disclosure of data or information obtained from the IRBchoice System that is not authorized pursuant to this IMA. J. Each Participating Institution may choose to provide the IRBchoice System with copies of any Shared Review Documents from any review and approval of any multi-site research project by its IRB, subject to the Participating Institution obtaining any necessary consents. Furthermore, notwithstanding any other provision contained herein, each Participating Institution will not knowingly include or provide any personally or individually identifiable subject information onto the IRBchoice System. K. To the extent permitted by law, each Participating Institution shall notify any other potentially affected Participating Institution and/or Operator in writing promptly upon receipt of any request or subpoena for any portion of any data or information obtained from or pertaining to the IRBchoice System in order not to prejudice such other Participating Institution s and/or Operator s ability to respond and to take any appropriate action deemed necessary. To the extent that such other Participating Institutions and/or Operator decide to assume responsibility for challenging the applicability, scope, or validity of such request or subpoena, each Participating Institution and/or Operator will reasonably cooperate with them in any such challenge, as permitted by applicable law, and any such Participating Institution and/or Operator shall be responsible for their respective costs and expenses associated therewith, including reasonable attorney fees and costs. Any data or information disclosed as a result of any such request or subpoena in compliance with this IMA shall not be deemed an unauthorized disclosure of Confidential Information. Page 5 of 14

6 L. Each Participating Institution will be responsible for any third-party claim, cause of action, liability, damage, cost or expense (including, without limitation, reasonable attorney s fees and court costs related thereto) ( Losses ) incurred by any and all other Participating Institutions who have signed this IMA and their respective trustees, directors, agents, officers, servants, IRB members, representatives, and employees, and their respective successors, heirs, and assigns ( Participating Institutional Representatives ) to the extent such Losses arise out of the negligent acts and omissions made pursuant to this IMA by the Participating Institution, the Participating IRB, as applicable, and the Participating Institution s IRBchoice Liaison(s), or any trustee, director, officer, representative, employee, or other agent of the Participating Institution, including without limitation, negligent use or disclosure of any information from the IRBchoice System, negligent performance of the Shared Model or Ceded Model, negligent reliance upon another Participating IRB, or any negligence resulting in a breach of this IMA except to the extent that such Losses result from the negligence or willful misconduct of the other Participating Institution and/or Participating Institutional Representatives. The Participating Institution shall be liable to the other Participating Institution and/or any Participating Institutional Representatives for reimbursement for such Losses. If a Participating Institution is a state/federal public institution in that it is an instrumentality of a state/federal government, then the Participating Institution s obligations to the other Participating Institution and/or Participating Institutional Representatives pursuant to this paragraph shall be limited in substance by the applicable law of the state or federal jurisdiction in which each Participating Institution serves as an instrumentality to the extent that such applicable law is designed to protect and limit the liability of the Participating Institution as an instrumentality of such state/federal government. Notwithstanding any other terms or conditions of this IMA, no state agency or corporation deemed to be nonprofit under the laws of its jurisdiction shall be deemed to waive any privileges or immunities that might be available to it under applicable law. M. Each Participating Institution shall procure and maintain for the term of this IMA comprehensive general liability insurance, including broad form contractual, in a minimum amount of $1,000,000 per occurrence/ $3,000,000 per annual aggregate. Such coverage shall act as primary insurance and no coverage of any other Participating Institution shall be called upon to contribute to a loss. Each Participating Institution shall also procure and maintain for the term of this IMA professional liability insurance in a minimum amount of $1,000,000/$3,000,000 in coverage for all of its personnel who may participate in the performance of this IMA or access or use the IRBchoice System. Such coverage shall provide for a retroactive date no later than the inception date of this IMA. If any such insurance provided by the Participating Institution as required by this Section M is claims-made rather than occurrence-based, such insurance coverage must include an extended reporting endorsement (tail coverage) of not less than three (3) years after termination or expiration of this IMA. Notwithstanding any other terms or conditions of this IMA, no state/federal public institution that is an instrumentality of a state/federal government shall be required to comply with the insurance requirements of this Section M so long as such institution relies on the applicable law of its state/federal jurisdiction to protect and limit its liability as an instrumentality of such state/federal government. Insurance under the Department of Health and Human Services Federal Tort and Claims Act, where applicable, is acceptable. A program of self-insurance is also acceptable to address the requirements outlined in this Section M. N. Notwithstanding anything to the contrary contained herein, any institution may become a party to this IMA by executing and delivering a counterpart signature page hereto agreeing to be bound by and subject to the terms and conditions of this IMA including the Appendices attached hereto. By executing and delivering its counterpart signature page hereto, each Participating Institution shall thereby agree to all of the terms and conditions of this IMA including the Appendices as part thereof and shall thereafter be deemed a Participating Institution for all purposes under this IMA, provided that such institution continues to satisfy and comply with the criteria and qualifications of a Participating Institution as defined herein and otherwise comply with the terms and conditions of this IMA. Page 6 of 14

7 4. IRBCHOICE MODELS A Participating Institution may choose to utilize IRB review for a research study covered under this IMA through: (i) the Ceded Model or (ii) the Shared Model. Participating Institutions who choose options (i) or (ii) shall abide by the processes described herein including the terms and conditions in the Appendices attached hereto. A. THE CEDED MODEL In the Ceded Model, a Participating IRB shall agree to be the IRB of Record for review of all IRB submissions related to the specific research study for any other Participating Institution who chooses to rely on that IRB as mutually agreed upon and documented in the IRBchoice System. The IRB of Record shall perform IRB review and continuing oversight in compliance with applicable federal regulations and state and local requirements. The process for use of this model and the responsibilities of the IRB of Record and the Relying Institution or Relying IRB are described in Appendix A. B. THE SHARED MODEL An IRB review model for review of a research study whereby a sub-committee (i.e., at least one IRB member or a qualified designee of the Chair) review of a multi-site research project (typically for review of Local Research Context issues as required by the Federal Human Research Protections Regulations) is conducted by a Participating IRB in conjunction with, and secondary to, a review and approval of the same research study conducted by ONE single Lead IRB (e.g., initial review, continuing review, and/or amendment as applicable) such that the combined reviews and approvals of both IRBs satisfies the criteria of the Federal Human Research Protections Regulations. If, at the time of initiating the Shared Review Process, continuing reviews and/or amendments have already been provided with an initial review and approval by a Lead IRB, then the Relying IRB must utilize all such continuing reviews and amendments together with the initial review and approval so provided in order to complete the Shared Review Process. The process for use of this model and the responsibilities of the Sharing IRB and the Relying IRB are described in Appendix B. 5. TERM AND TERMINATION A. A Participating Institution and/or Operator may terminate this IMA with or without cause or reason by providing thirty (30) days written notice to the other relevant Participating Institutions and Operator. B. Upon receipt of written notification of a material breach of this IMA, Operator may terminate this IMA (for purposes of a Participating Institution s status as a party to this IMA and IRBchoice), provided that Operator shall inform such Participating Institution in writing of the breach and such Participating Institution shall have an opportunity to cure the breach within thirty (30) days of receipt of such notice to the Participating Institution s IRBchoice signatory and/or IRBchoice Liaison(s). If the Participating Institution fails to cure the breach within such thirty (30) day period, Operator may immediately terminate the Participating Institution s status as a party to this IMA, provided that such termination shall not relieve the Participating Institution from any liability for damages arising from any such breach. Operator will promptly notify all relevant Participating Institution via the IRBchoice System if another Participating Institution s IMA is terminated by the Operator. C. If a Participating Institution terminates participation in this IMA pursuant to this Article 5, that Participating Institution must inform the Operator who will promptly notify all Lead IRBs upon whom the Participating Institution is relying and/or any Participating Institution(s) that is relying on the Participating Institution as a Lead IRB of its termination. Page 7 of 14

8 6. MISCELLANEOUS A. Each Participating Institution agrees to take such action as is necessary to amend this IMA from time to time to comply with any applicable federal or state law pertaining to the protection of human research subjects, the IRBchoice System, or this IMA. B. Any obligations of the Participating Institution, its IRB, or its IRBchoice Liaison(s) with respect to maintaining the security, safeguards, and confidentiality of any and all data or information used, accessed, obtained, or disclosed from the IRBchoice System shall survive any termination or expiration of this IMA. Additionally, the liability (as described in Section 3.L.) and insurance obligations in this IMA (including without limitation the Operator Appendix) shall also survive termination of this IMA. C. Each Participating Institution who signs this IMA in accordance with Section 3.N. is an intended party to this IMA and therefore a party to all of the terms and conditions hereof for purposes of enforcement of the Participating Institution s obligations hereunder, including without limitation, the Participating Institution s liability (as described in Section 3.L.), insurance, and confidentiality obligations (including the Operator Appendix). There are no intended third party beneficiaries to this IMA. Without in any way limiting the foregoing, it is the parties specific intent that nothing contained in this IMA gives rise to any right or cause of action, contractual or otherwise, by or on behalf of any third party. Only parties who sign this IMA pursuant to Section 3.N. hereof can become parties to this IMA. D. No provision of this IMA may be waived except by an agreement in writing signed by the authorized representative of the waiving Participating Institutions and the Operator, as applicable. A waiver of any term or provision shall not be construed as a waiver of any other term or provision or as a subsequent waiver of the same provision. E. The person signing this IMA has the right and authority to execute this IMA, and no further approvals are necessary to create a binding agreement on behalf of the Participating Institution. F. This IMA (including without limitation the Appendices hereto) contains the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior negotiations and any other agreements including all prior versions of the IRBshare Master agreement, restrictions, representations, and understandings with respect to the subject matter hereof. G. Any amendment to this IMA must be in writing and signed by the authorized representatives of Operator and all Participating Institutions. H. No party shall assign, subcontract, or transfer any of its rights or obligations under this IMA to a third party without the prior written consent of Operator and all Participating Institutions. If there is a valid assignment, subcontract, or transfer, this IMA shall be binding upon and inure to the benefit of the parties hereto and their respective successors or assigns. I. Each party agrees not to use the names, marks, or logos of the Operator or any Participating Institution in any advertising, promotional material, press release, publication, public announcement, or through other media written or oral without the prior written consent of an authorized representative of the Operator or the other Participating Institution. J. NOTWITHSTANDING ANY OTHER PROVISION CONTAINED HEREIN, NO PARTICIPATING INSTITUTION MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, AS TO THE CONTENTS OF ANY DATA OR INFORMATION CONTAINED WITHIN THE IRBCHOICE SYSTEM. EACH PARTICIPATING INSTITUTION EXPRESSLY Page 8 of 14

9 DISCLAIMS ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. IN PARTICULAR, EACH PARTICIPATING INSTITUTION MAKES NO REPRESENTATIONS OR WARRANTIES THAT THE CONTENTS OF THE IRBCHOICE SYSTEM ARE VALID OR OTHERWISE COMPLY WITH THE REQUIREMENTS OF THE FEDERAL HUMAN RESEARCH PROTECTIONS REGULATIONS OR ANY OTHER APPLICABLE LAW. EACH PARTICIPATING INSTITUTION ACCEPTS THE DATA AND INFORMATION CONTAINED ON THE IRBCHOICE SYSTEM ON AN AS IS BASIS AND SHALL BE SOLELY RESPONSIBLE FOR THE COMPLIANCE OF ITS INSTITUTION, ITS IRBCHOICE LIAISON, AND ITS IRB, AS APPLICABLE, WITH ALL APPLICABLE LAWS, INCLUDING WITHOUT LIMITATION, LAWS PERTAINING TO THE HEALTH, SAFETY, AND WELFARE OF HUMAN RESEARCH SUBJECTS. FURTHERMORE, EACH PARTICIPATING INSTITUTION AGREES TO ASSUME THE RISK OF USING ANY MATERIALS CONTAINED ON THE IRBCHOICE SYSTEM AND TO ASSUME THE RISK OF RELYING UPON ANY REVIEW AND APPROVAL OF ANY PARTICIPATING INSTITUTION THAT PROVIDES ANY MATERIALS AS A LEAD IRB. ACCORDINGLY, NOTWITHSTANDING ANY OTHER PROVISION CONTAINED HEREIN AND TO THE EXTENT PERMITTED BY APPLICABLE LAW, EACH PARTICIPATING INSTITUTION HEREBY RELEASES, ACQUITS, WAIVES AND FOREVER DISCHARGES ANY AND ALL CLAIMS, LIABILITY, DAMAGES, AND LOSSES ("LOSSES") AND HEREBY AGREES NOT TO SUE, FILE, OR ASSERT ANY CLAIM, LAWSUIT, COUNTERCLAIM, OR ANY OTHER ACTIONS ("CLAIMS") AGAINST ANY SUCH LEAD IRB TO THE EXTENT THAT SUCH LOSSES OR CLAIMS ARISE FROM ANY REVIEW CONDUCTED BY SUCH LEAD IRB. TO THE EXTENT CERTAIN JURISDICATIONS RESTRICT ANY OF THE DISCLAIMERS, ASSUMPTIONS, RELEASES OR WAIVERS UNDER APPLICABLE LAW, SUCH LIMITATIONS SHALL NOT APPLY IN SUCH JURISDICTIONS TO THE EXTENT NOT PERMITTED BY APPLICABLE LAW. K. TO THE MAXIMUM EXTENT PERMITTED BY LAW, IN NO EVENT SHALL ANY PARTICIPATING INSTITUTION BE LIABLE FOR ANY SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO PERSONAL INJURY, WRONGFUL DEATH, LOSS OF USE, LOSS OF PROFITS, INTERRUPTION OF SERVICE OR LOSS OF DATA, WHETHER IN ANY ACTION IN WARRANTY, CONTRACT, TORT (INCLUDING BUT NOT LIMITED TO NEGLIGENCE OR FUNDAMENTAL BREACH), OR OTHERWISE ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE USE OF, OR THE INABILITY TO USE, IRBCHOICE OR ANY MATERIAL OR INFORMATION CONTAINED IN OR ACCESSED OR OBTAINED THROUGH IRBCHOICE, EVEN IF AN AUTHORIZED REPRESENTATIVE OF SUCH PARTICIPATING INSTITUTION IS ADVISED OF THE LIKLIHOOD OR POSSIBILITY OF THE SAME, EXCEPT FOR ANY DAMAGES OR LOSSES ARISING PURSUANT TO SECTION 3.L ABOVE. TO THE EXTENT CERTAIN JURISDICTIONS RESTRICT ANY OF THE LIMITATIONS OF LIABILITY IN THIS SECTION K, SUCH LIMITATIONS SHALL NOT APPLY IN SUCH JURISDICTIONS TO THE EXTENT OF SUCH RESTRICTIONS. IN ANY DISPUTE OR LEGAL PROCEEDING BETWEEN PARTICIPATING INSTITUTIONS, THIS IMA SHALL BE GOVERNED IN ALL RESPECTS BY, AND BE CONSTRUED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF THE PARTICIPATING INSTITUTION WHO IS THE DEFENDANT WITHOUT REGARD TO ITS CONFLICTS OF LAW PRINCIPLES. EACH PARTY WHO BRINGS ANY DISPUTE OR LEGAL PROCEEDING AGAINST ANOTHER PARTICIPATING INSTITUTION PURSUANT TO THIS IMA HEREBY CONSENTS TO THE JURISDICTION OF ALL STATE AND FEDERAL COURTS SITTING IN THE HOME STATE OF THE PARTICIPATING INSTITUTION WHO IS THE DEFENDANT OF SUCH DISPUTE OR LEGAL PROCEEDING AND AGREES THAT VENUE FOR ANY SUCH DISPUTE OR LEGAL PROCEEDING WITH RESPECT TO THIS IMA AND THE RELATIONSHIP BETWEEN THE PARTIES HEREUNDER SHALL LIE EXCLUSIVELY IN SUCH COURTS; PROVIDED HOWEVER, THAT ANY DISPUTE OR LEGAL PROCEEDING TO WHICH THE OPERATOR IS A PARTY SHALL BE SUBJECT TO THE TERMS AND CONDITIONS OF THE OPERATOR APPENDIX IN LIEU OF THIS PROVISION. NOT WITHSTANDING THE FOREGOING OR ANY OTHER LANGUAGE CONTAINED IN THIS IMA, NO STATE AGENCY THAT IS A PARTY HERETO SUBMITS TO THE LAWS, JURISDICTION OR VENUE OF ANY FOREIGN COURT, AND EXPRESSLY DOES NOT WAIVE ANY PRIVILEGES, IMMUNITIES OR OTHER RIGHTS THAT MIGHT BE AVAILABLE TO IT PURSUANT TO THE DOCTRINE OF SOVEREIGN IMMUNITY OR OTHER Page 9 of 14

10 APPLICABLE LAW, AND NO PARTICIPATING INSTITUTION HEREBY SUBMITS OR CONSENTS TO THE JURISDICTION OF ANY FOREIGN COURT EXCEPT AS EXPRESSLY SETFORTH HEREIN. Page 10 of 14

11 Name of Participating Institution: IRBchoice Master Agreement: Counterpart Signature Page By execution of this counterpart signature page to the IRBchoice Master Agreement (IMA), Participating Institution agrees to comply with the terms and conditions of this IMA (including the Operator Appendix, Appendix A, and Appendix B) as defined herein. IN WITNESS WHEREOF, the undersigned have signed this counterpart signature page effective as this day of, 20. Official(s) Signing for Participating Institution (the official responsible for signing Participating Institution s FWA or designee) Signature: Print Name: Title: Date: Any notice required or permitted by this IMA shall be given to Participating Institution s IRBchoice Liaison at the address(es) listed below: Name: Address: Phone: Fax: Page 11 of 14

12 OPERATOR APPENDIX By execution of this IRBchoice Master Agreement (IMA), each Participating Institution agrees to comply with the terms and conditions in this Operator Appendix as part of its obligations and responsibilities under the IMA. Capitalized terms used in this Operator Appendix shall have the same meanings as set forth in this IMA. Introduction: The IRBchoice Operator Appendix outlines the rights and responsibilities of the entity maintaining the IRBchoice System ( Operator ), which are separate from the responsibilities of Participating Institutions. Section 1: Operator agrees to authorize access to the IRBchoice System to each Participating Institution in accordance with the terms of this IMA solely for the purpose of utilizing the Ceded Model or Shared Model by each Participating Institution and its Participating IRB, as applicable; provided, however, that each Participating Institution maintains its eligibility as a Participating Institution as defined in this IMA, and each Participating IRB, as applicable, continues to meet the criteria and qualifications of a Participating IRB as defined in this IMA. Section 2: Each Participating Institution understands and agrees that Operator may remove any materials provided by any Participating Institution or Participating IRB, as applicable, to the IRBchoice System, as Operator determines in its sole discretion. Upon such action by Operator, Operator shall promptly notify such Participating Institution in writing but in no event more than ten (10) business days thereafter. Section 3: Each Participating Institution will be responsible for any third party claim, cause of action, liability, damage, cost or expense (including, without limitation, reasonable attorney s fees and court costs related thereto) ( Losses ) incurred by the Operator and/or its trustees, agents, officers, servants, IRB members, representatives, and employees, and their respective successors, heirs, and assigns ( Operator Representatives ) to the extent such Losses arise out of or in connection with any use of, access to, and/or disclosure of data or any other information from the IRBchoice System or any breach of this IMA by a Participating Institution, Participating Institution s IRBchoice Liaison(s), Participating IRB, as applicable, or any director, officer, representative, employee, or other agent of a Participating Institution except to the extent that such Losses result from the negligence or willful misconduct of the Operator Representatives. Each Participating Institution shall be liable to any Operator Representatives for reimbursement for such Losses. If any Participating Institution is a state/federal public institution in that it is an instrumentality of a state/federal government, then such Participating Institution s obligations to the Operator Representatives pursuant to this paragraph shall be limited in substance by the applicable law of the state or federal jurisdiction in which the Participating Institution serves as an instrumentality to the extent that such applicable law is designed to protect and limit the liability of the Participating Institution as an instrumentality of such state/federal government. Notwithstanding any other terms or conditions of this IMA, no state agency shall be deemed to waive any privileges or immunities that might be available to it under applicable law. Section 4: Each Participating Institution shall procure and maintain for the term of this IMA comprehensive general liability insurance, including broad form contractual, in a minimum amount of $1,000,000 per occurrence/$3,000,000 annual aggregate. Such coverage shall act as primary insurance and no coverage of the Operator shall be called upon to contribute to a loss. Each Participating Institution shall also procure and maintain for the term of this IMA professional liability insurance in a minimum amount of $1,000,000/$3,000,000 in coverage for all of its personnel who may participate in the performance of this IMA or access or use the IRBchoice System. Such coverage shall provide for a retroactive date no later than the inception date of this IMA. If any such Page 12 of 14

13 insurance provided by a Participating Institution as required by this Section 4 is claims-made rather than occurrence-based, such insurance coverage must include an extended reporting endorsement (tail coverage) of not less than three (3) years after termination or expiration of this IMA. Notwithstanding any other terms or conditions of this agreement, no state/federal public institution that is an instrumentality of a state/federal government shall be required to comply with the insurance requirements of this Operator Appendix so long as such institution relies on the applicable law of its state/federal jurisdiction to protect and limit its liability as an instrumentality of such state/federal government. Insurance under the Department of Health and Human Services Federal Tort and Claims Act, where applicable, is acceptable. A program of self-insurance is also acceptable to address the requirements outlined in this Section 4. Section 5: Each Participating Institution will not use any promotional materials with respect to its use of the IRBchoice System that have not been authorized by the Operator in advance in writing. Section 6: Each Participating Institution (via its IRBchoice Liaison(s)) shall report promptly in writing to Operator and any relevant Participating Institution any use of, access to, and/or disclosure of data or information from the IRBchoice System that was not authorized pursuant to this IMA or any other unanticipated problem with respect to the IRBchoice System of which the Participating Institution or Participating IRB, as applicable, becomes aware. Section 7: NOTWITHSTANDING ANY OTHER PROVISION CONTAINED HEREIN, OPERATOR DOES NOT MAKE ANY REPRESENTATIONS OR EXTEND ANY WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, AS TO THE USE AND/OR CONTENT OF ANY DATA OR INFORMATION CONTAINED WITHIN THE IRBCHOICE SYSTEM, INCLUDING ITS WEB PORTAL. OPERATOR EXPRESSLY DISCLAIMS ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, AND FREEDOM FROM COMPUTER VIRUS STRAINS. IN PARTICULAR, OPERATOR MAKES NO REPRESENTATIONS OR WARRANTIES THAT THE USE AND/OR CONTENTS OF THE IRBCHOICE SYSTEM ARE VALID OR OTHERWISE COMPLY WITH THE REQUIREMENTS OF ANY APPLICABLE LAW. EACH PARTICIPATING INSTITUTION ASSUMES THE RISK OF USE OF THE IRBCHOICE SYSTEM, INCLUDING WITHOUT LIMITATION ITS WEB PORTAL, AND ACCEPTS THE DATA AND INFORMATION CONTAINED IN THE IRBCHOICE SYSTEM ON AN AS IS BASIS AND SHALL BE SOLELY RESPONSIBLE FOR THE COMPLIANCE OF THE PARTICIPATING INSTITUTION AND PARTICIPATING INSTITUTION S IRB, AS APPLICABLE, WITH ALL APPLICABLE LAWS, INCLUDING WITHOUT LIMITATION, LAWS PERTAINING TO THE USE AND TRANSMISSION OF DATA AND INFORMATION ELECTRONICALLY. Section 8: IN NO EVENT SHALL THE OPERATOR BE LIABLE FOR ANY DAMAGES OR OTHER LIABILITY TO ANY OTHER PARTICIPATING INSTITUTION BEYOND $1,000 PER COMPUTER USER OF THE IRBCHOICE SYSTEM. TO THE MAXIMUM EXTENT PERMITTED BY LAW, IN NO EVENT SHALL THE OPERATOR BE LIABLE FOR ANY SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO PERSONAL INJURY, WRONGFUL DEATH, LOSS OF USE, LOSS OF PROFITS, INTERRUPTION OF SERVICE OR LOSS OF DATA, WHETHER IN ANY ACTION IN WARRANTY, CONTRACT, TORT (INCLUDING BUT NOT LIMITED TO NEGLIGENCE OR FUNDAMENTAL BREACH), OR OTHERWISE ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE USE OF, OR THE INABILITY TO USE, IRBCHOICE OR ANY MATERIAL OR INFORMATION CONTAINED IN OR ACCESSED OR OBTAINED THROUGH IRBCHOICE, EVEN IF AN AUTHORIZED REPRESENTATIVE OF THE OPERATOR IS ADVISED OF THE LIKLIHOOD OR POSSIBILITY OF THE SAME, EXCEPT FOR ANY DAMAGES OR LOSSES ARISING PURSUANT TO Page 13 of 14

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15 APPENDIX A CEDED MODEL 1. INTRODUCTION Utilization of the Ceded Model requires a partnership between Participating Institutions to share information and communicate effectively regarding studies that are reviewed using this model. IRBchoice allows for Participating Institutions interested in using the Ceded Model to establish their own processes, whether serving as the IRB of Record or the Relying Institution or Relying IRB, for incorporating the use of the Ceded Model into their existing IRB review structures, if applicable. A Participating Institution may cede IRB review to a Participating IRB, as mutually agreed upon and documented in the IRBchoice System, that will act as the IRB of Record with the understanding that once a given research study has been ceded to another Participating IRB, the given research study will remain under the authority of that Participating IRB. Notwithstanding the foregoing, a Participating Institution may determine in its sole discretion to withdraw the given research study from ceded review at any time. In such cases, the IRB of Record and the Relying Institution(s) will work together to facilitate the transfer of IRB review and oversight with the least potential disruption to the research study. Until IRB oversight is transferred, the IRB of Record will continue to assume oversight responsibility. 2. PROCESS FOR INITIATING USE OF THE CEDED MODEL A. Investigator Request to Use IRBchoice: An investigator (or designee) may make the request to use IRBchoice to a Participating Institution where the investigator has an employment or contractual relationship. The Participating Institution where the investigator has such employment or contractual relationship will make a determination about the appropriateness of the given research study for IRBchoice. B. Determining Appropriateness for IRBchoice: Determination of the appropriateness of the use of IRBchoice for a given research study is the decision of a Participating Institution. No Participating Institution is obligated to participate as a Lead IRB or a Relying Institution or Relying IRB. Should a Participating Institution decide to serve as the Lead IRB or a Relying Institution or Relying IRB, no individual authorization agreements are needed to complete the reliance. A Participating IRB shall communicate its willingness to serve as a Lead IRB for a given research study via the IRBchoice System. Nothing in this agreement precludes more than one Participating IRB from serving as a Lead IRB for a given study. C. Identifying the Lead IRB and Selecting the Reliance Model (ceded or shared): Upon receipt of a request to utilize IRBchoice for a given research study and agreeing to serve as the Lead IRB for a study, the Participating IRB(s) will indicate what type of Lead IRB they are willing to serve as in the IRBchoice System: IRB of Record, Sharing IRB, or both. If the Lead IRB selects both, a Relying Institution or Relying IRB can then select the reliance model it prefers (ceded or shared) for the given research study. However, under the Ceded Model, the Lead IRB must mutually agree to be the IRB of Record for another Participating Institution. D. Serving as an IRB of Record: Once a Participating IRB(s) has agreed to be an IRB of Record for a particular Relying Institution or Relying IRB for a given study, the IRB of Record will edit or confirm the preferred study-specific CAP in the IRBchoice System. IRBchoice Master Agreement: Appendix A: Dated November 11, 2015 Page 1 of 5

16 E. Confirming the CAP: A Participating Institution willing to use the Ceded Model as a Relying Institution or Relying IRB for a given research study shall communicate its request through the IRBchoice System. As part of this request the Relying Institution or Relying IRB shall either accept the CAP outlined by the IRB of Record or submit proposed revisions to the CAP for consideration by the IRB of Record. Once the CAP is mutually agreed upon, the IRB of Record and Relying Institution or Relying IRB shall indicate acceptance via the IRBchoice System. If agreement cannot be reached, the IRB of Record can reject the request to use the Ceded Model by the requesting Relying Institution or Relying IRB. F. IRB of Record Documentation of Initial Approval: The IRB of Record shall update the IRBchoice System with the date of its initial approval, once finalized. Shared Review Documents from this approval can be made available to the Relying Institution or Relying IRB routinely or upon request as indicated by the IRB of Record in its Institutional Profile in the IRBchoice System. G. Investigator Responsibilities and Communication: For all ongoing reviews, including continuing reviews, modifications and submission of any reports that meet the reporting criteria of the IRB of Record, the responsibilities of the investigator to both the IRB of Record and the Relying Institution or Relying IRB will be outlined in the Investigator Responsibilities and Submission Instructions Sheet. 3. RESPONSIBILITIES OF THE IRB OF RECORD A. An IRB of Record shall perform initial and continuing reviews and reviews of amendments; reviews of unanticipated problems; and reviews of potential serious and continuing noncompliance for a ceded study that may involve risks to subjects or others, and review of other documents or information related to the approval and continuing oversight of the given study, as applicable. B. An IRB of Record shall maintain and make accessible to the Relying Institution(s) or Relying IRB(s), upon reasonable request, the documents submitted to the IRB of Record related to the review of an IRBchoice study, including redacted (all personal identifiers removed, including reviewers names) portions of meeting minutes of the IRB of Record relevant to the given research study and the Relying Institution(s) or Relying IRB(s). C. The IRB of Record s submission instructions, as provided via the Institutional Profile and the IRBchoice System, will be provided to investigators at a Relying Institution(s) or Relying IRB(s) through the IRBchoice System. In addition, the IRB of Record shall provide the Relying Institution or Relying IRB a template informed consent form(s) to be tailored for site-specific use. Changes will generally be limited to the following areas: HIPAA authorizations, conflict of interest, payment for research related injury, differences in research costs to subjects and local study contacts. Any modifications will be subject to approval by the IRB of Record. D. The IRB of Record shall incorporate into its review the Local Research Context provided by a Relying Institution or Relying IRB via the site-specific consent form and local context information provided in the IRBchoice System. All Relying Institution or Relying IRB modifications related to local context requirements will be subject to approval of the IRB of Record prior to implementation. IRBchoice Master Agreement: Appendix A: Dated November 11, 2015 Page 2 of 5

17 E. The IRB of Record shall consider any relevant information about the conflict of interest of a Relying Institution s or Relying IRB s study personnel as necessary for a given study. The IRB of Record will ensure that any relevant conflict of interest information, processes, and outcomes are incorporated into its initial review, continuing review or other deliberations and that any mandated disclosures to subjects are included in the approved informed consent form as deemed applicable by the IRB of Record. The IRB of Record will not modify or change any conflict of interest information or mandated disclosure to subjects without discussion with and acceptance by the Relying Institution(s) or Relying IRB(s). If the IRB of Record is unable to implement the Relying Institution s or Relying IRB s management requirements, the research will not be eligible for the Ceded Model under this IMA. F. The IRB of Record shall ensure prompt notification to Relying Institution(s) or Relying IRB(s) of its findings and actions, that are study-wide or specific to that Relying Institution or Relying IRB with respect to any unanticipated problems involving risks to human subjects or others, subject injuries, or subject complaints that are related to or may affect the rights or welfare of human subjects participating in research at the Relying Institution s or Relying IRB s Participating Institution. G. The IRB of Record shall ensure prompt notification to Relying Institution(s) or Relying IRB(s) of any finding of serious and or/continuing noncompliance that are study-wide or specific to that Relying Institution or Relying IRB, and the steps the IRB of Record deems necessary for remediation of the noncompliance including but not limited to, any suspension, disapproval or termination of the study, or any sanctions or limitations imposed on research personnel at the Relying Institution s or Relying IRB s Participating Institution. The IRB of Record will notify the Relying Institution or Relying IRB if it is conducting an investigation and may request that the Relying Institution or Relying IRB conduct its own investigation and report back to the IRB of Record or the IRB of Record and Relying Institution or Relying IRB may work cooperatively to conduct an audit or investigation. IRB of Record and Relying Institution or Relying IRB may negotiate responsibilities for ongoing study oversight, including conduct of any for-cause or notfor-cause audits, through the study-specific CAP. H. If the IRB of Record determines that it must report to regulatory agencies (e.g., OHRP, FDA, OCR, etc.), federal funding agencies, sponsors, and/or other oversight authorities and the Relying Institution(s), any unanticipated problems involving risks to human subjects or others, serious and/or continuing noncompliance, and/or any suspensions or terminations of IRB approval, the IRB of Record will notify all applicable Relying Institutions or Relying IRBs in advance. Unless an alternate reporting arrangement has been agreed upon through the study-specific CAP, the Relying Institution or Relying IRB shall have the opportunity to review and comment upon such reports prior to being sent to the entities listed above. Furthermore, the IRB of Record and Relying Institutions or Relying IRBs are free to make a joint report, or delegate to the Relying Institution or Relying IRB the responsibility to report to these entities through the CAP. Nothing in this IMA shall prevent a Relying Institution or Relying IRB from making its own report or taking additional remediation steps at its own institution. I. The IRB of Record shall supply any information to the Relying Institution or Relying IRB to facilitate ongoing review and oversight as agreed upon through the study-specific CAP. 4. RESPONSIBILITIES OF THE RELYING INSTITUTION AND RELYING IRB IRBchoice Master Agreement: Appendix A: Dated November 11, 2015 Page 3 of 5

18 A. A Relying Institution or Relying IRB shall perform the given research study in compliance with applicable federal regulations and state and local requirements to meet the human subjects protection requirements of its FWA(s). B. A Relying Institution or Relying IRB shall either agree to the CAP of the IRB of Record or work with the IRB of Record to negotiate revisions to the CAP when submitting a request for reliance through the IRBchoice System. C. A Relying Institution or Relying IRB shall identify, interpret, and communicate to the IRB of Record its Local Research Context, as are relevant to the given research study. This information may be communicated via the Relying Institution s Institutional Profile and/or via direct submission to the IRB of Record, as applicable. D. A Relying Institution or Relying IRB shall ensure its investigators secure any necessary institutional reviews that do not fall under IRB purview under federal regulations (e.g., pharmacy, radiation safety, billing compliance, ancillary reviews ) as applicable and required by its policies. Applicable information will be provided to the IRB of Record as appropriate for considerations. E. A Relying Institution or Relying IRB shall ensure the consent template is updated to incorporate all site-specific language required to address any applicable state or local laws, regulations and/or policies as relevant to the given research study prior to its submission to the IRB of Record for final approval. Absent written approval of such changes by the IRB of Record, deletion of the IRB of Record s approved requirements in the protocol, informed consent form, and substantive changes that affect the meaning of IRB approved requirements shall not be permitted. F. A Relying Institution or Relying IRB shall document in its Institutional Profile the expectations for ongoing review and submission requirements when using the Ceded Model. This will be communicated to relevant study personnel via the Investigator Responsibilities and Submission Instructions Sheet via the IRBchoice System. G. A Relying Institution or Relying IRB shall notify the IRB of Record in writing if it becomes aware of any unanticipated problems or serious or continuing noncompliance not otherwise reported by the research team that is applicable for any study conducted under this IMA, as well as any suspension or restriction of any individuals, either employed by or in contractual relationship with the Participating Institution of the Relying Institution or Relying IRB, involved in the conduct of any study covered by this IMA. The Relying Institution or Relying IRB will notify the IRB of Record if it becomes aware of any communications regarding research covered by this IMA to/from the Relying Institution or Relying IRB and FDA, OHRP, and/or other regulatory agencies (e.g., in relation to cases of unanticipated problems or serious and/or continuing noncompliance), as applicable. H. A Relying Institution or Relying IRB shall be responsible for overseeing the disclosure, review, and management of any conflicts of interest related to a given research study conducted under this IMA and communicating any requirements related to reported interests to the IRB of Record. The Relying Institution or Relying IRB will ensure that it has a mechanism to comply with all management plans related to the given research study. IRBchoice Master Agreement: Appendix A: Dated November 11, 2015 Page 4 of 5

19 I. A Relying Institution or Relying IRB shall ensure that the provisions of the grant or contract that address research related injuries for research are consistent with the approved research protocol and consent form. J. A Relying Institution or Relying IRB shall ensure an institutional mechanism exists by which complaints about the research can be made by local research participants or others and promptly report substantive complaints to the IRB of Record to ensure the safe and appropriate performance of the research at the Relying Institution or Relying IRB. K. The Relying Institution or Relying IRB must work with the IRB of Record to ensure any sitespecific requirements related to the use of Protected Health Information are addressed. L. The Relying Institution or Relying IRB shall cooperate with any inquiry, including requests for for-cause and not-for-cause audits, by the IRB of Record for research conducted under this IMA as applicable. Such cooperation shall include, but is not limited to, providing research records and related information, meeting with representatives from the IRB of Record upon request, and helping to carry out all corrective action(s). The Relying Institution or Relying IRB may be asked to conduct its own investigation and report back to the IRB of Record or work cooperatively with the IRB of Record to conduct the investigation as negotiated through the CAP. Also, the Relying Institution or Relying IRB may request a for-cause or not-for-cause audit of the research conducted under this IMA. M. A Relying Institution or Relying IRB shall supply any information to the IRB of Record to facilitate ongoing review and oversight as agreed upon through the study-specific CAP. 5. RESPONSIBILITIES SUBJECT TO CONSIDERATION For a given study, an IRB of Record and a Relying Institution or Relying IRB may negotiate and document a CAP for addressing specific regulatory responsibilities in the IRBchoice System. Specific areas where a study-specific plan may be warranted can include but are not limited to: A. Review of potential uses of protected health information, either under direct subject authorization, in accordance with an alteration or waiver of authorization or as a limited data set. B. Handling of noncompliance including responsibilities such as external reporting, internal auditing, retraining and implementation of corrective action plans. C. Ongoing study oversight including provision of documentation related to ongoing approval to address institutional requirements for record-keeping. IRBchoice Master Agreement: Appendix A: Dated November 11, 2015 Page 5 of 5

20 APPENDIX B SHARED MODEL 1. INTRODUCTION A Participating IRB may use this model to review and approve a given research study in conjunction with and secondary to a review and approval of the same research project conducted by ONE single Sharing IRB (e.g., initial review, continuing review, and/or amendment as applicable) using the Shared Review Process without transferring regulatory oversight to the Sharing IRB. 2. PROCESS FOR INITIATING USE OF THE SHARED REVIEW A. Investigator Request to Use IRBchoice: An investigator (or designee) may make the request to use IRBchoice to a Participating Institution where the investigator has an employment or contractual relationship. The Participating Institution where the investigator has such employment or contractual relationship will make a determination about the appropriateness of the given research study for IRBchoice. B. Determining Appropriateness for IRBchoice: Determination of the appropriateness of the use of IRBchoice for a given research study is the decision of a Participating Institution. No Participating Institution is obligated to participate as a Lead IRB or a Relying IRB. Should a Participating Institution decide to serve as a Lead IRB or a Relying IRB, no individual authorization agreements are needed to complete the reliance. A Participating IRB shall communicate its willingness to serve as a Lead IRB for a given research study via the IRBchoice System. Nothing in this agreement precludes more than one Participating IRB from serving as a Lead IRB for a given study. C. Identifying the Lead IRB and Selecting the Reliance Model (ceded or shared): Upon receipt of a request to utilize IRBchoice for a given study, and agreeing to serve as the Lead IRB for a study, a Participating IRB will indicate what type of Lead IRB it is willing to serve as in the IRBchoice System: IRB of Record, Sharing IRB, or both. If the Lead IRB selects both, a Relying IRB can then select the reliance model it prefers (ceded or shared) for the given research study. D. Serving as a Sharing IRB and Documentation of Initial Approval: Once a Participating IRB(s) has agreed to be the Sharing IRB for a given study, the Sharing IRB shall provide the IRBchoice System with its Shared Review Documents, once available, and the date of its initial approval, once finalized. E. Deciding to be a Relying IRB: Upon receipt of a request to utilize IRBchoice and consideration of the Sharing IRB, a Participating IRB will document its intention to use the Shared Model in the IRBchoice System. F. Investigator Responsibilities and Communication: The Participating IRB s intention to be a Relying IRB under the Shared Model will be communicated to the Relying IRB s investigator via the IRBchoice System. Any specialized responsibilities of the investigator to the Relying IRB will be outlined in the Investigator Responsibilities and Submission Instructions Sheet, if any; otherwise investigators should submit to their local IRB according to their IRB s local policies and procedures. IRBchoice Master Agreement: Appendix B: Dated November 11, 2015 Page 1 of 3