CIRB Annual Principal Investigator Worksheet About Local ...



|[pic] |Institutional Review Board |

| |Human Research Protections |

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| |Appendix U – Single IRB (sIRB) Review |

| |UCI is the IRB of Record |

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| |UPDATED! Version June 2021 |

|Instructions: |

|Appendix U is to be completed when a non-UCI researcher/site (entity) will cede review to UCI IRB (rely). |

|Do not include UCI site specific information. Appendix U relates to the non-UCI (Relying) entity only. |

|A separate Appendix U must be completed for each non-UCI entity requesting to cede review to UCI. |

|HRP Webpage: Human Research Activities Performed At Other Institutions. |

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|IMPORTANT! sIRB Mandate Effective January 20, 2020: |

|UCI will follow the single IRB requirement for new cooperative research studies that are: |

|Conducted or supported by an agency that has signed on to the 2018 Common Rule |

|Conducted in the USA |

|Non-exempt |

|HS#:       |

|(to be completed by the IRB) |

SECTION 1: SIRB VERIFICATION

|Review the flow chart below to confirm that the non-UCI entity’s research activities are eligible for the sIRB process. |

|[pic] |

|Confirm that this study is eligible for sIRB. Check only one. |

| Exempt Research & UCI Lead Researcher with dual affiliation at the relying non-UCI Entity |

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|Expedited or Full-Committee Research |

|Specify the name of the non-UCI entity requesting to cede IRB review (rely) to the UCI IRB. |

|Type Here OR sIRB request is for an Independent Researcher |

|Confirm that UCI is eligible to serve as the IRB of Record/Reviewing IRB for the non-UCI entity. |

| UCI is the prime awardee on the award/contract & the funding agency/Sponsor requires sIRB |

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|The non-UCI entity requests that UCI serve as the IRB of record; provide rationale: Type Here |

SECTION 2: NON-UCI STUDY TEAM

|Provide detail for the Lead Collaborating Researcher (LCR) below. |

| non-UCI LCR OR UCI LR has dual affiliation |

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|Name, Title, & Degrees: Type Here Department: Type Here Email: Type Here Phone: Type Here |

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|Duties: Screen/Recruit Subjects Finalize Informed Consent Translate Consent |

|Access/Analyze Identifiable Information Access/Analyze Identifiable Biospecimens |

|Research Procedures; specify: Type Here |

|List the research activities/procedures to be performed and the individual’s relevant qualifications (training, experience): Type Here |

|How is the LCR provided with a copy of the UCI IRB approved study documentation (i.e. protocol, recruitment, consent, etc.) throughout the duration of the study? |

|Type Here OR Not Applicable: UCI LR has dual affiliation at non-UCI entity |

|Will additional researchers at the non-UCI entity be engaged in human subjects research (i.e. interact with subjects or access identifiable private |

|information/biospecimens)? |

| Not Applicable: No additional researchers beyond the LCR will be engaged |

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|Yes: Additional researchers will be engaged |

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|Check here to confirm the LCR will verify that all trainings have been completed by their study |

|team prior to their engagement with human subjects |

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|No: Additional research will not be engaged with human subjects |

|Has the LCR or any of their research team reported a financial conflict of interest related to this study that has resulted in a management plan? |

| No |

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|Yes: LCR and/or their research team reported a financial conflict of interest. The non-UCI entity’s |

|conflict of interest management plan is required. |

SECTION 3: RESEARCH ACTIVITIES (INCLUDING STORAGE/ANALYSIS OF PRIVATE IDENTIFIABLE

INFO/SPECIMENS) PERFORMED AT NON-UCI LOCATIONS (NOT UCI OWNED/LEASED

SPACE)

Not Applicable: Research performed at UCI locations only.

OR Address the following:

|Will research activities be performed outside of California? |

| No: Research will be performed in California |

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|Yes: Specify if there are any applicable state or local laws, regulations, policies, or ancillary review |

|processes as are relevant to the research: None OR Type Here |

|Pharmacy: How will the drugs/agents used in the study be managed? |

| Not Applicable: Study does not involve drugs/agents |

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|Managed by (check only one): Pharmacist Non-Pharmacist |

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|Specify name and title of the pharmacist/responsible person for the drugs/agents at the non-UCI location: Type Here |

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|Specify how this individual is provided with a current copy of the protocol: Type Here |

|Emergency Resources: What resources available at the non-UCI location to treat emergencies resulting from study-related procedures? Check all that apply. |

| Not applicable: Study does not require emergency resources. |

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|Advanced Cardiovascular Life Support (ACLS) Trained Personnel and crash cart |

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|Basic Cardiac Life Support (BCLS) trained personnel |

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|Emergency response team within facility |

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|Emergency drugs and supplies to stabilize study subject until emergency personnel arrive |

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|Staff available to call 911 |

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|Other (specify): Type Here |

|Radiation Safety Committee (RSC): Does this study involve the human use of radioactive materials (e.g., PET scans, radioimmunotherapy, nuclear medicine procedures,|

|lymphoscintigraphy) and/or radiation-producing equipment (e.g., CT scans, X-rays, fluoroscopy, but not MRI or laser procedures)? |

| Not applicable: Study does not require RSC review |

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|Yes: Study requires RSC review. The non-UCI entity’s RSC approval is required. |

|Institutional Biosafety Committee (IBC): Do research procedures involve recombinant and synthetic nucleic acids, materials or microorganisms modified using |

|recombinant and synthetic nucleic acids or infectious agents and human materials including cells into human subjects? |

| Not applicable: Study does not require IBC review |

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|Yes: Study requires IBC review. The non-UCI entity’s IBC approval is required. |

SECTION 4: sIRB AGREEMENT

|The UCI IRB will consider serving as the HIPAA Privacy Board when the non-UCI entity is within California and it does not have a privacy board. Exceptions may be |

|considered. |

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|Is the non-UCI entity requesting that the UCI IRB also serve as their HIPAA Privacy Board? |

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|IMPORTANT! The UCI IRB determines whether participants should sign an "Authorization" or if a Waiver of HIPAA Authorization may be granted. The non-UCI entity may|

|use the Relying Site HIPAA Research Authorization template. Each institution will retain their own Privacy reporting responsibilities should a breach of privacy |

|occur. |

| Not applicable: The research does not involve PHI from a non-UCI entity |

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|No: The non-UCI entity has their own HIPAA Privacy Board |

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|Yes: PHI from a non-UCI entity will be accessed for research purposes and the non-UCI entity does not |

|have a HIPAA Privacy Board. |

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|Yes: PHI from a non-UCI entity will be accessed for research purposes, the non-UCI entity has their own |

|HIPAA Privacy Board, but they are requesting that UCI serve as their HIPAA Privacy Board; |

|provide rationale: Type Here |

|Review the flow chart below to confirm which sIRB Agreement applies. |

|[pic] |

|Indicate which sIRB agreement applies. |

|Download the agreement document and obtain the signature of non-UCI Entity. |

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|IMPORTANT! UCI utilizes the SMART IRB, which is free resource that enables IRB reliance for multisite studies across the nation, regardless of funding status. When|

|UCI is the IRB of Record, it does not utilize the SMART IRB Online Reliance System. |

| SMART IRB – Letter of Acknowledgement (UCI is IRB of Record) |

|The non-UCI entity must be a Participating Institution or in the process of joining the SMART IRB. |

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|SMART IRB - Letter of Acknowledgement (UCI is IRB of Record & HIPAA Board) |

|The non-UCI entity must be a Participating Institution or in the process of joining the SMART IRB. |

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|Institutional Authorization Agreement (IAA) - (UCI is IRB of Record) |

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|Institutional Authorization Agreement (IAA) - (UCI is IRB of Record & HIPAA Board) |

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|Individual Investigator Agreement (IIA) |

A. sIRB Requirements

SECTION 5: LOCATION SPECIFIC REQUIREMENTS

Not Applicable: Research will not be performed at the locations below.

OR Address the following:

|Children’s Hospital of Orange County (CHOC): If research activities will be performed at CHOC Children's facilities, address the following: |

| Not Applicable: Research is not performed at CHOC Children’s facilities |

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|A letter from CHOC acknowledging their reliance on UCI is required. |

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|For additional information on how to obtain a letter, please contact CHOC Office of Research Compliance: orc@ |

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|If subjects will be consented/assented at CHOC, use of the CHOC Consent Template is required. |

|MemorialCare Health System (MHS): If research activities will be performed at MHS facilities, address the following. |

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|MHS facilities include: |

|Long Beach Memorial |

|Memorial Care Foundation |

|Memorial Care Medical Group |

|Memorial Care Regional |

|Miller Children’s Hospital |

|Nautilus Healthcare |

|Orange Coast Memorial |

|Saddleback Memorial Medical Center |

|Wave Imaging |

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|IMPORTANT! If a MemorialCare investigator, also wants to include private offices (PO) that are not covered under the MemorialCare FWA, a separate Appendix U is |

|required for each PO. |

| Not Applicable: Research is not performed at MHS facilities |

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|An email from MHS acknowledging their reliance on UCI is required. |

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|For additional information on how to obtain an email confirmation, please contact: |

|MemorialCare Human Research Protections: MHSIRB@ and |

|Sharon Denham: SDenham@ and/or Teri Cilurso: TCilurso@ |

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|If subjects will be consented at MHS, revise the UCI consent template with the MHS Consent Language inserted where applicable. The consent must be submitted to MHS|

|for approval prior to submitting to UCI. |

SECTION 6: SUBMISSION REQUIREMENT CHECKLIST

|The following documents (as applicable) must be uploaded as part of a modification application. Check all that apply. |

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|IMPORTANT! |

|Failure to submit the requisite documentation will delay the sIRB review process. |

|Be sure to download and revise (as applicable) the most current, UCI IRB approved documents from the Document Depot. |

| Appendix U for each non-UCI entity requesting to cede review to UCI. |

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|sIRB agreement signed by each non-UCI entity (see Section 4 above). |

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|Revised Protocol Narrative that accounts for the research activities of the non-UCI entity as |

|follows; check all that apply: |

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|Subject Population: Revised to account for the subject enrollments at the non-UCI entity. |

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|Recruitment: Revised to account for any recruitment methods that are specific to the non-UCI |

|entity. |

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|Consent Process: Revised to account for any consent methods that are specific to the non-UCI |

|entity. |

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|Procedures: Revised to account for the non-UCI entity's role in the research and for any |

|alterations in the research procedures that are specific to the non-UCI entity. |

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|Compensation: Revised to account for any compensation that is specific to the non-UCI entity. |

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|Confidentiality of Research Data: Revised to account for any data storage methods that are |

|specific to the non-UCI entity. |

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|Revised UCI Consent / Assent Form that includes any non-UCI entity specific information in context of |

|the research. |

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|UCI prefers that only the Lead Collaborating Researchers (LCRs) from each non-UCI entity be listed at the top of the UCI consent form. Do not list other non-UCI |

|researchers from the non-UCI entity on the consent form. |

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|MHS approved UCI consent with the MHS Consent Language inserted. |

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|CHOC Consent Template. |

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|Relying Site HIPAA Research Authorization. |

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|Non-UCI entity’s conflict of interest management plan. |

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|Non-UCI entity’s RSC approval. |

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|Non-UCI entity’s IBC approval. |

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