May also use information provided by appropriate collaborating UCSD affiliated committees

Transcript

1 University of California, San Diego Human Research Protections Program Institutional Review Board Standard Operating Policies and Procedures Section 3.19 Collaboration with other UCSD Committees Policy The University of California, San Diego IRBs function independently but in coordination with other UCSD Committees to protect human subjects in research. The IRB makes its independent determination whether to approve or disapprove a protocol based upon whether human subjects are adequately protected. ould be noted that IRB approval does not constitute funding or other institutional required It sh approvals. Should the study involve other review committees, it is the researchers responsibility to ensure that all approvals are in place prior to conducting research involving human subjects or their related specimens. In compliance with 45 CFR 46.112 , research “approved by the IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.” The following provides examples of IRB collaborating UCSD Committees. The PRMC The Moores Cancer Center Protocol Review and Monitoring Committee (PRMC) and the -related Biomedical Research IRBs share oversight responsibilities for the review of cancer human subjects research that is conducted at UCSD, affiliate sites, such as RCHSD, and satellite facilities including UCSD San Diego Cancer Center, and North County Sites. The reviews by the PRMC and IRB are complementary with the PRMC focusing mainly on scientific integrity of proposed translational and clinical trials and the IRB focusing mainly on the core ethical principles as outlined in the Belmont Report and regulatory criteria for approval as outlined in 45 CFR 46 and 21 CFR Part 50 and 56. In addition, the PRMC is responsible largely for administrative oversight issues related to feasibility, prioritization, and scientific progress; whereas, the IRB is responsible largely for local context including recruitment and consent procedures, indemnification for research-related injury and informed consent language and documentation. The PRMC and IRB reviews may necessarily overlap in some areas, such as in evaluating the safety of a proposed investigational drug use, the appropriateness of eligibility criteria and safety monitoring, the rationale and ethical ailable standard -of-care treatments (i.e., justification for experimental interventions vs. av equipoise), and in a global risk/benefit assessment. -related human research Procedures for review of cancer The IRB Biomedical Research Application Facesheets include resources to indicate 1. whether the proposed pr oject will recruit patients with cancer or at a high risk of UCSD Human Research Protections Program IRB Standard Operating Policies and Procedures 11/6/2015 3.19 Version Date: Collaboration with other UCSD Committees. Section Page 1 of 6

2 developing cancer during the study. The Biomedical Application Research Plan related studies includes an item that provides supplemental instructions for cancer- including that appropriate documents for cancer -related studies should be uploaded to the ePRMC website when the study is submitted to the HRPP. 2. Studies that are eligible for expedited IRB review are typically not required to undergo PRMC review. However, once the review process begins, information provided in response to HRPP queries may indicate that the study requires review by the convened IRB. In this case, the study would then require submission to PRMC for their determination regarding the study. 3. Upon notification from the PRMC or the PI that a PRMC -reviewed study that requires review by a convened IRB has received a PRMC determination of “Approved Pending,” “Approved,” or “Exempt,” the study will be assigned by the HRPP Office to the next appropriate IRB meeting agenda. Assignment is contingent upon availability of required expertise and other factors. The project is assigned related approximately eight working days before the date of the IRB meeting. Cancer- studies may be assigned to an IRB agenda after this date with the approval of the oncology IRB Chair. Studies that have received a PRMC determination of “Deferred” will not be scheduled for IRB review until the study has received a PRMC determination of “Approved Pending,” “Approved,” or “Exempt.” The application will be reviewed s eparately and independently by the PRMC and the 4. IRB. The IRB may request document versions that have been revised in response to PRMC in order to ensure version control. 5. The PRMC comments/determinations will be provided to the PI from the PRMC in the form of a PRMC determination letter. This PI is responsible for notifying the HRPP of the PRMC determination by submitting the PRMC determination letter to the relevant project file using e -IRB services. 6. order to access PRMC An HRPP analyst will have access to the ePRMC database in meeting minutes and to generally facilitate communication between PRMC and HRPP staff for operations purposes. As the PRMC minutes for new IRB applications include a record of PRMC questions and PI responses discussed during the PRMC meeting that are not included in the PRMC determination letter, they will be provided to the IRB as supplementary information for the IRB to consider. The HRPP analyst will provide a copy of the appropriate entry from the PRMC minutes for each new project amongst the administrative notes in the relevant entry on the IRB agenda. 7. The IRB may disapprove, defer, approve with conditions, or approve protocols that are approved by the PRMC. he PI’s Final IRB approval is contingent upon final PRMC approval, provided that t 8. efforts to secure PRMC approval do not change or otherwise affect the IRB application under consideration. Should changes be made at the behest of PRMC in order to secure their approval, all revised documents should be submitted to IRB for review. The IRB will make the final determination regarding approval of a study. 9. The HERC The Human Exposure Review Committee (HERC) is a subcommittee of the Radiation Safety Committee that reviews all uses of radioactive materials or radiation producing equipment UCSD Human Research Protections Program IRB Standard Operating Policies and Procedures 11/6/2015 3.19 Version Date: Collaboration with other UCSD Committees. Section Page 2 of 6

3 that result in exposure to human subjects. The Human Exposure Review Committee provides a parallel review of research protocols that include human radiation exposure to the review by the IRB. Procedures for review of research protocols that include human radiation exposure 1. The IRB Biomedical Application Facesheets include resources to indicate whether the proposed project is associated with radiation or radioactivity exposure to study subjects and what the sources of radiation are. If the Facesheets indicate such an mail notification that includes association, the HERC is provided with an automatic e- a project has indicated such an exposure and the project number and project title. 2. The application instructions include various items to describe the use, risks, risk management procedures, etc. radiation/radioactivity related to the study. 3. The Research Plan and consent(s) and other study documents, as appropriate, will be reviewed independently by the HERC and the IRB. The review documentation provided b y the HERC to the IRB will be incorporated into the archival project file and may at the discretion of the IRB be provided to the PI in association with the IRB’s comments and requests if the HERC review comments have been provided at the time of the conve ned IRB review. 4. Interactions between the HERC and the IRB are facilitated by a HERC status field and HERC review notes field maintained in the IRB project tracking system. These data can be updated online via a web interface provided to the HERC. The outline interface also provides the HERC copies of all correspondence issued by the IRB relevant to a research project. 5. Should the PI receive information directly from the HERC that affects the study, the clude a study amendment to revise PI will provide this information to the IRB and in study documents for review by a convened IRB or using expedited review, as appropriate. More information about the procedures associated with the review of research protocols that include human radiation exposure are outlined in the SOPP, section 3.15, Radiation Exposure and Radioisotopes. — The Conflict of Interest Office) The IRC (The Independent Review Committee antive review committee The Independent Review Committee is “UCSD’s independent subst appointed by the Chancellor to review financial disclosure statements and relevant features of a research project. They function as the principal advisory committee to eth Chancellor for specific conflicts of interest and determines if a potential, perceived, or real conflict of interest exists by virtue of the investigator’s financial interests.” The Conflict of Interest Office “assists all employees in assessing situations under which their outside financial onal considerations may compromise or have the appearance of interests or other pers compromising their actions or judgments in the administration, management, or performance of their professional activities at UCSD.” The Conflict of Interest Office provides a parallel review of human research protocols to the review by the IRB. UCSD Human Research Protections Program IRB Standard Operating Policies and Procedures 11/6/2015 3.19 Version Date: Collaboration with other UCSD Committees. Section Page 3 of 6

4 Procedures for review of possible conflict of interest 1. The IRB application Facesheets include resources to indicate whether the proposed project discloses financial interests. If the Facesheets indicate such a disclosure, the mail notification that Conflict of Interest Office is provided with an automatic e- includes a project has indicated a disclosure of financial interest(s) and the project number and project title. 2. The application instructions include an item requiring a description as to whether the PI or any key personnel associated with this study have any financial interests or other “conflicts” related to the study. The application instructions also note that if a conflict is disclosed, appropriate forms must be provided to the Conflict of Interest Office. 3. The Research Plan and consent(s) will be reviewed independently by the Conflict of Interest Office and the IRB. The review documentation provided by the Conflict of Interest Office to the IRB will be incorporated into the archival project file and may at the discretion of the IRB be provided to the PI in association with a convened IRB’s comments and requests including an assessment of any disclosure or t provided to the PI such as revision to the management of any conflict of interes consent(s) to provide appropriate disclosure of conflict of interest to subjects. Interactions between the Conflict of Interest Office and the IRB are facilitated by a 4. Conflict of Interest status field and Conflict of Interest Office review notes field maintained in the IRB project tracking system. These data can be updated online via a web interface provided to the Conflict of Interest Office. The outline interface also provides the Conflict of Interest Office copies of all correspondence issued by the IRB relevant to a research project. 5. The Conflict of Interest Office may provide to the IRB a copy of the concurrence letter submitted to the PI from the Independent Review Committee. The PI may be asked to confirm that the procedures outlined in the concurrence letter are being followed and submit revised study documents, as appropriate. 6. Should the PI receive information directly from the Conflict of Interest Office that affects the study, the PI will provide this information to the IRB and include a study amendment to revise study documents for review by a convened IRB or using expedited review, as appropriate. Institutional Biosafety Committee The UCSD Institutional Biosafety Committee (IBC) responsibilities include “establishing, monitoring, and enforcing policies and procedures for biohazardous materials and/or recombinant DNA including gene transfer clinical trials” and “reviewing and approving use of biohazardous materials and/or recombinant DNA.” The IBC provides a parallel review of human research protocols associated with biohazardous materials and recombinant DNA to the review by the IRB. Procedures for review of projects that may require Institutional Biosafety Committee Review al Research Application Facesheets include resources to indicate The IRB Biomedic 1. whether the proposed project is associated with gene therapy, recombinant DNA and/or gene transfer. If the Facesheets indicate such an association, the IBC is UCSD Human Research Protections Program IRB Standard Operating Policies and Procedures 11/6/2015 3.19 Version Date: Collaboration with other UCSD Committees. Section Page 4 of 6

5 provided with an automatic e- mai l notification that includes that a project has indicated such an association and the project number and project title. 2. The application instructions include various items to describe the use, risks, risk mbinant DNA and/or gene transfer management procedures, etc. of gene therapy, reco related to the study. 3. The Research Plan and consent(s) and other study documents, as appropriate, will be reviewed independently by the IBC and the IRB. The review documentation provided by the IBC to the IRB will be incorporated into the archival project file and may at the discretion of the IRB be provided to the PI in association with the convened IRB’s comments and requests including revision to the consent(s), as appropriate. RB are facilitated by an IBC status field and 4. Interactions between the IBC and the I IBC review notes field maintained in the IRB project tracking system. These data can be updated online via a web interface provided to the IBC. The outline interface also provides the IBC copies of all correspondence issued by the IRB relevant to a research project. 5. The IBC may provide a copy of the Biohazard Use Authorization associated with the study or other appropriate documents to the IRB for inclusion in the study file. ion directly from the IBC that affects the study, the PI 6. Should the PI receive informat will provide this information to the IRB and include a study amendment to revise study documents for review by a convened IRB or using expedited review, as appropriate. The ESCRO Committee The Embry onic Stem Cell Research Oversight (ESCRO) Committee is “responsible for ethical and scientific review, approval, and disapproval of human embryonic stem cell research projects. The ESCRO Committee provides a parallel review of human research he review by the IRB. protocols to t Procedures for review of studies that involve human embryonic stem cells at UCSD 1. The IRB application Facesheets include resources to indicate whether the proposed project involves human embryonic stem cells, iPS cells, or other pluripotent cells. If the Facesheets indicate such cells are involved, a representative of the ESCRO -mail notification that includes a project Committee is provided with an automatic e her has indicated involvement of human embryonic stem cells, iPS cells, or ot pluripotent cell and the project number and project title. 2. The Research Plan and consent(s) will be reviewed independently by the ESCRO Committee and the IRB. The ESCRO Committee members have similar access and g their comments into the HRPP database as follow the same procedures for enterin IRB members. The ESCRO Committee currently includes members that are also members of the 3. IRB. These members are able to provide additional information regarding the ESCRO Committee review of the project, as nee ded. 4. The review documentation provided by the ESCRO Committee to the IRB will be incorporated into the archival project file and may at the discretion of the IRB be provided to the PI in association with the IRB’s comments and requests. UCSD Human Research Protections Program IRB Standard Operating Policies and Procedures 11/6/2015 3.19 Version Date: Collaboration with other UCSD Committees. Section Page 5 of 6

6 Applicable Regulations and Standard Operating Policies and Procedures 21 CFR Part 50 UCSD SOPP, Section 3.15, Radiation Exposure and Radioisotopes 21 CFR Part 56 UCSD SOPP, Section 4.2, Categories of 45 CFR 46 on Acti 45 CFR 46.112 UCSD SOPP, Section 1.5, UCSD Institutional Policies Links The Moores Cancer Center Protocol Review and Monitoring Committee (PRMC) The Human Exposure Review Committee (HERC) The Independent Review Committee (IRC — The Conflict of Interest Office) The Institutional Biosafety Committee (IBC) The Embryonic Stem Cell Research Oversight (ESCRO) Committee UCSD Human Research Protections Program IRB Standard Operating Policies and Procedures 11/6/2015 3.19 Version Date: Collaboration with other UCSD Committees. Section Page 6 of 6

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