Human Pluripotent Stem Cell Research Oversight (hPSCRO) Committee: Policies and Procedures
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The purpose of the UCLA Human Pluripotent Stem Cell Research Oversight (hPSCRO) Committee is to provide oversight of human pluripotent stem cell (hPSC) research and other stem cell research covered by the California Institute for Regenerative Medicine (CIRM) and California Department of Public Health (CA DPH) regulations in order to ensure that UCLA research meets the highest scientific and ethical standards. hPSC includes human pluripotent cells from both embryonic and non-embryonic sources. The goals are achieved in collaboration with the UCLA administration, the UCLA Institutional Review Boards (IRBs), other applicable campus compliance committees, and the participation of the research community.
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UCLA policy and California law requires the creation of an hPSCRO Committee to oversee hPSC and research with other covered cells* (referred to in this document as "stem cells"). The policy is based in part on the recommendations of the National Bioethics Advisory Commission*, the National Academies of Science-Institute of Medicine guidelines*, and standards created by CIRM* and CA DPH.
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The hPSCRO Committee reviews new protocols, modifications to currently approved research, and continuing research, (a) using or creating human pluripotent stem cells or stem cell lines, (b) any proposed collection and use of germ or other cells designed to generate pluripotent stem cells, (c) the use of human neural progenitor cells in the brain of non-human animals at any state of embryonic, fetal, or postnatal development, and (d) any "covered cells" as required by State or Federal law.
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The hPSCRO Committee is one of several committees that may be required to review stem cell research. The other committees include but are not limited to the IRB http://ohrpp.research.ucla.edu/, the Chancellor’s Animal Research Committee (ARC) http://oaro.research.ucla.edu/applications, the Institutional Biosafety Committee (IBC) http://biosafety.ucla.edu, or other committees required by laws, regulations, or institutional policy.
4.1 Review Procedures
The hPSCRO Committee will assess protocols according to Standard Operating Procedures.
4.2 Scope of review and responsibilities
4.2.1 All issues related to derivation, use, procurement, and disposal of covered cells
4.2.2 Scientific merit, including whether the cells are well-characterized and screened for safety
4.2.3 Ensure the conditions under which cells are maintained and stored meet current scientific standards
4.2.4 Ensure that the primary cells or resulting cell lines were obtained ethically and with informed consent as required by law or policy
4.2.5 Compliance with relevant regulations and guidelines
4.2.6 Consultation and collaboration with the IRBs and other relevant compliance committees
4.2.7 Maintain a registry of covered cells and lines derived or obtained by investigators
4.2.8 Maintain a registry of UCLA stem cell research
4.2.9 Adverse Events
4.2.10 Monitoring
4.2.11 Suspension and Termination
4.2.12 Maintenance of records
4.2.13 Education
4.3 Continuing Review
The hPSCRO Committee will review on-going research at a minimum of once every year.
The Committee may provide a three (3) year approval for solely non-sensitive/non-controversial purely in-vitro research:
- using or creating materials from non-identifiable cells, or
- cell lines recognized by an "authorized authority" like NIH, or
- in which the provenance is approved by the UCLA hPSCRO Committee, and
- that includes non-human animals only for demonstrating pluripotency through teratoma formation.
Consistent with Section 4.4 below, investigators with a three year approval are still required to prospectively submit proposed modifications to the project as an amendment prior to making any changes within the approval period.
4.4 Modifications to Approved Protocols
All modifications to approved protocols must be submitted prospectively to the hPSCRO Committee. No modifications, except in an emergency, if necessary to safeguard the well-being of non-human animal or human subjects, may be implemented without prospective review and approval by the hPSCRO and other applicable committees.
4.5 Approval
The hPSCRO Committee has the authority to approve, require modifications in a protocol in order to approve, or disapprove submitted research. The hPSCRO Committee will notify investigators in writing in a timely fashion of its decision. An hPSCRO Committee decision to require modifications or disapprove a submission will include a written statement to the investigator of the reasons for its decision and give the investigator an opportunity to respond in writing and if requested, in-person during a convened meeting.
4.6 Appeals
Appeals of hPSCRO Committee decisions must return to the Committee for review. Investigators may request to present responses to Committee decisions during a convened meeting. Appeals must be in writing and submitted directly to the hPSCRO Committee prior to an investigator’s personal presentation to the Committee.
4.7 Expedited Review
Expedited review means the chair or other qualified member(s) of the Committee has the authority to review and approve a proposal or request modifications in order to approve a proposal without convening a quorum of the Committee. A proposal under expedited review may be referred to the hPSCRO Committee for review during a convened meeting at the discretion of the reviewer.
4.7.1 Eligibility for Expedited Review
The hPSCRO Committee may perform an expedited review of new research and renewals. Expedited review may also be conducted for amendments that do not substantively modify the currently approved research*.
4.7.2 Expedited Review of New and Continuing Research
New and renewal applications may undergo expedited review when the project is conducted by qualified investigators who request to utilize stem cell lines that are currently approved at UCLA and/or techniques for creating hPSC or other types of cells previously approved by the hPSCRO Committee. New and renewal protocols that include certain types of non-human animal or human research studies may require convened committee review.
4.7.3 Expedited Review of Amendments to Approved Research
Amendments requesting the addition and/or change of space, non-human animals, and cell lines previously approved by the Committee, consistent with the initially approved study aims and design may be eligible for expedited review. A convened Committee review may be required when new grants, etc., are added to an approved project and/or when the proposed aims or procedures are inconsistent with the previously approved research protocol.
4.7.4 Limits to Expedited Review Decisions
The hPSCRO Committee member(s) conducting expedited review only have the authority to approve or recommend modifications to the proposal in order to achieve approval. Expedited review may not be used to disapprove a proposal. Only the convened hPSCRO Committee may disapprove an application.
4.7.5 Reporting Expedited Review to the Committee
The hPSCRO Committee will be notified of all expedited approvals with a short description of the approved proposal.
4.8 Monitoring
The hPSCRO Committee has the authority to observe or have a third party observe the research, monitor, and audit research under its jurisdiction.
4.9 Adverse Events
Adverse events may occur with human subjects, employees, or cellular material. Any adverse events that occur with human subjects that by UCLA policy require reporting to the IRB must also be reported to the hPSCRO Committee.
4.9.1 Required Reporting of Events with Employees
Any adverse events to employees or others that would be reported to the IBC/Environmental, Health, and Safety, will also be reported to the hPSCRO Committee.
4.9.2 Required Reporting of Adverse Laboratory Events
The investigator is responsible for documenting and reporting laboratory events to the hPSCRO Committee, such as but not limited to, the inability to expand cells due to contamination or contamination with pathogens. Such reports should include the reason for the contamination, the disposition of the cells, and any corrective actions.
4.10 IRB Review
IRB review is required when the research meets the federal or state threshold for human subjects research*.
4.10.1 Collaboration with the IRBs
When IRB review is required, the hPSCRO Committee and the IRBs will collaborate in order to ensure approved research meets the highest scientific and ethical standards.
When IRB review is required:
4.10.2
Ultimate hPSCRO Committee approvals will be contingent upon IRB approval of proposed research.
4.10.3
hPSCRO Committee review will occur prior to IRB review and serve to inform the IRB review.
4.10.4
hPSCRO Committee members and staff are available to attend IRB meetings to discuss proposed research, as requested by the IRBs.
4.10.5
The IRBs and hPSCRO Committee will freely exchange information in order to facilitate and coordinate the review of proposed research.
4.11 Suspension and Termination of hPSCRO Committee Approval
The hPSCRO Committee has the authority to suspend or terminate its approval of research that is not being conducted in accordance with the Committee's requirements, regulatory agency requirements, or that has been associated with unexpected serious harm to subjects or others. Suspension or termination will be promptly reported to the investigator, other applicable campus compliance committees, the chair of the investigator’s department, and the hPSC Research Policy Board.
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The hPSCRO Committee shall consist of a minimum of 5 members including the Chair. Members are appointed by the Vice Chancellor-Research after broad consultation with the UCLA research community. A majority of the voting members must have expertise in relevant scientific and/or medical fields, e.g., molecular biology, developmental biology, stem cell research, assisted reproduction, legal and/or ethical issues in hPSC research as well as non-scientific members and patient advocates who are not affiliated with UCLA. There may be alternates and non-voting members.
5.1 Consultants
The hPSCRO Committee may, at its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the Committee. These individuals may not vote with the Committee.
5.2 Ad Hoc Committees
The hPSCRO Committee may, as necessary, create ad hoc subcommittees, composed of members of the parent Committee and, as appropriate, consultants with relevant expertise to perform specific functions within the hPSCRO Committee’s jurisdiction. Subcommittee members may serve as a voting member on more than one subcommittee.
5.3 Membership Terms
Members shall be invited to serve for overlapping terms of 2 years and contingent upon renewal by appropriate action.
5.4 hPSC Research Policy Board
The Vice Chancellor for Research will convene the hPSC Research Policy Board on an ad hoc basis and as necessary to discuss and promulgate campus policy for hPSC research. The hPSCRO Committee chair will also serve as a member on the UCLA hPSC Research Policy Board.
5.5 Support
Management and support services will be provided by the UCLA Broad Stem Cell Research Center.
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Meetings shall be held as often as necessary to provide timely review of submitted research. Meetings shall be conducted, and records of the proceedings kept, as indicated in other sections of this policy.
6.1 Quorum
The hPSCRO Committee may only review and act upon proposed research during a convened meeting with a majority of the members present, including at least one non-scientist, or in accordance with the above referenced expedited review policy. In order for the research to be approved at a convened meeting, it shall receive the approval of a majority of those members present at the meeting.
6.2 Conflict of Interest
No member may participate in the hPSCRO Committee's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the Committee. Members with a conflict of interest must be recused from the discussion and the vote of the protocol except to answer questions of the Committee about the proposed research.
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The hPSCRO Committee shall maintain documentation sufficient to meet the requirements of this policy.
7.1 Research and Cell Registries
The hPSCRO Committee will maintain an auditable database of:
a. stem cell research conducted by UCLA investigators
b. stem cells and cell lines derived or obtained by UCLA investigators.
7.2 Meeting Documentation
The hPSCRO Committee will maintain Minutes of the meetings and relevant correspondence with investigators, including approvals and disapprovals. The Minutes shall be in sufficient detail to document:
a. attendance at the meetings;
b. actions taken by the Committee;
c. the vote on these actions including the number of members voting for, against, and abstaining;
d. the basis for requiring changes in or disapproving research; and
e. a written summary of the discussion of controverted issues and their resolution.
7.3 Documentation Maintenance
The hPSCRO Committee will maintain copies of reviewed proposals, reports of adverse events, progress reports, continuing review applications, correspondence with investigators, IRB and other applicable compliance committee approvals, and a list of Committee members.
7.4 Documentation Retention
The hPSCRO Committee will maintain related stem cell records for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research.