Responsibilities and Authority of the SCRO Committee
- – Review and approve the ethical and scientific merit of human pluripotent stem cell research projects in coordination with other appropriate committees;
- – Review and approve all issues related to derivation, use, procurement and disposal of covered cells.
- – Ensure that the conditions under which cells are maintained and stored meet current scientific standards.
- – Invite consultants with expertise in special areas to assist in the review of proposals that involve areas beyond the expertise of the committee members. Consultant may not vote on proposals.
- – Ensure that the primary cells or resulting cell lines were obtained ethically and with informed consent as required by law or WesternU policy.
- – Disapprove a protocol or require modifications in a protocol in order to obtain approval.
Investigators shall be notified, in writing, in a timely fashion of a decision to disapprove or require modifications in a protocol along with the reasons for the decision. The investigator shall be given an opportunity to respond, in writing or in person, during a convened meeting of the SCRO Committee.
- – Perform expedited review and approval by the chair, or other qualified member(s) of the Committee appointed by the chair, of proposals or modifications/amendments to a protocol that do not substantively modify the currently approved research, without convening a quorum (50% of the voting members + 1), of the committee members. A proposal under expedited review may be referred for full committee review at the discretion of the reviewer(s).
- – Projects conducted by qualified investigators who request to use stem cell lines currently approved at WesternU and/or techniques for creating human pluripotent stem cells previously approved by the SCRO Committee are eligible for expedited review, as are requests to change personnel, other than the principal investigator, space and de-identified cell lines that are consistent with the aims of the approved protocol. Changes in the numbers of animals must also be approved by the IACUC.
An expedited reviewer may approve or request modifications to a proposal but cannot defer or disapprove a proposal. This action may only be taken at a convened meeting of a majority of the voting members of the committee. If the expedited reviewer is unable to approve a proposal, the proposal must be referred for full committee review.
Expedited reviews must be reported to the SCRO Committee at the next convened meeting.
- – The SCRO Committee may observe, monitor and audit research under its jurisdiction or or have a third party perform these activities.
- – Identify ongoing human embryonic stem cell research and confirming that such research is in compliance with local, state or federal regulations and guidelines and accepted University practices;
- – Maintain a registry of WesternU stem cell research and of covered cells and cell lines derived or obtained by investigators.
- – Recommend actions, guidelines, and policies as needed to the VP for Research and Biotechnology to ensure compliance and the ethical conduct of research involving human pluripotent stem cells including, but not limited to, derivation of new human stem cell lines, banking of human stem cell lines and registries of human pluripotent stem cell research conducted at the WesternU;
- – Suspend or terminate research not conducted in accordance with regulations and guidelines or WesternU policy or research that has been associated with unexpected serious harm to subjects or others. Suspension or termination will be promptly reported to the investigator, other applicable compliance committees and to the VP for Research and Biotechnology.
- – Advise investigators regarding additional institutional reviews required for their projects (i.e., review by IRB, IACUC, Institutional Biosafety Committee (IBC), Radiation Safety Committee, etc.);
- – Maintain minutes of convened 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 the actions, including votes for, against and abstentions; d) the bases for requiring changes in or disapproving research; and e) a written summary of the discussion of controverted issues and their resolution.
- – Maintain copies of approved protocols, adverse events reports, progress reports, continuing reviews, correspondence with investigators, IRB and other applicable compliance committee approvals and a list of SCRO Committee members. These records shall be maintained for at least three years after the completion of the research.
- – Remind investigators of institutional requirements for education and ethics training of researchers involved in human pluripotent stem cell research;
- – Disseminate any changes in WesternU guidelines for human embryonic and human pluripotent stem cell Research to WesternU investigators and other personnel.