The University at Buffalo is committed to maintaining the highest ethical standards while permitting qualified investigators to engage in research using pluripotent human stem cells (pHSC). To assist with the process, UB and Roswell Park Cancer Institute (RPCI) created a Stem Cell Research Oversight (SCRO) Committee.
The committee reviews and approves research and training materials related to the derivation and use of pHSCs, including human embryonic stem cells (hESC) and pluripotent stem cells produced from non-embryonic human sources.
If you plan to use or derive pHSCs, including induced pluripotent stem cells, please contact the SCRO office.
These guidelines apply to any research or training use of pHSC. Pluripotent Human Stem Cell research is research involving any culture-derived, human pluripotent stem cell population that can:
This definition includes both embryonic and non-embryonic human stem cell lines regardless of the tissue of origin.
It does NOT include accepted medical treatment practices using adult stem cells, human cord blood or transplantation of non-pluripotential stem cells.
No UB/RPCI personnel shall engage in nor use UB/RPCI facilities, equipment for any of the following activities:
The following research activities are exempt from review by the SCRO Committee:
This type of research is permitted if the SCRO office receives a completed application form that documents the provenance of the cell lines including:
Listing of the pHSC line on the NIH-approved list is acceptable for (i) and (ii). For non-listed cell lines other documentation must be presented.
Your pHSC proposals might be eligible for expedited review with a SCRO Committee designated reviewer
pHSC proposals to be reviewed by the full SCRO Committee, unless otherwise noted, include:
The SCRO Committee is a joint UB/RPCI advisory body reporting to the UB vice president for research and economic development, and the RPCI deputy director. The committee reviews research and training materials related to the derivation and use of pHSC. Every three years, an ad hoc panel–appointed by UB's president and RPCI's CEO–will audit the committee's actions and operations. Both UB and RPCI will receive the audit results.
The Institutional Review Boards (IRBs) at the respective institutions operate under the auspices of the federal Office of Human Research Protections (OHRP) and are responsible for review and approval of clinical research protocols including those where pHSC are administered to human subjects.
The Institutional Animal Care and Use Committees (IACUC) at the respective institutions operate under the auspices of the federal Office of Laboratory Animal Welfare (OLAW). They will review and approve research protocols involving animal subjects, including those using stem cells (pHSC).
The Institutional Biosafety Committees (IBC) at the respective institutions operate under the auspices of the NIH Recombinant DNA Advisory Committee and will review and approve research protocols involving hazardous biological agents, gene therapy and/or recombinant DNA, including protocols utilizing pHSC.
All investigators using pHSC must comply with applicable regulations, federal funding restrictions and relevant institutional policies and procedures. Our pHSC research policies are based on the best available information, including embryonic stem cell research guidelines from the National Academies of Science (NAS), the International Society for Stem Cell Research (ISSCR) and the Empire State Stem Cell Board Strategic Plan.
The SCRO Committee must review and approved all proposals using pHSC (both federally and non-federally funded) for research or educational purposes before the projects can proceed. The committee may request additional documentation during the review, which must be completed prior to review by other committees.
Approved laboratory research and educational proposals that do not involve administration of pHSC into human or animal subjects may proceed when procurement and material transfer requirements are met. Approved proposals requiring administration of pHSC into humans or animals will be returned to the principal investigator for development and submission of IRB or IACUC protocols. If the PI has submitted IRB or IACUC protocols with the SCRO application, the approved proposals will be forwarded directly to those committees.
You must obtain IRB approval before beginning studies involving human subjects, including but not limited to:
The appropriate IACUC must approve pHSC research involving animal subjects prior to initiating the study.
The institutional biosafety committee must review pHSC research involving recombinant DNA technologies as well as those involving hazardous biological or infectious agents.
You must comply with institutional environmental, health and safety requirements when receiving, using and disposing of pHSC.
When receiving pHSC materials, you must secure Material Transfer Agreements (MTA) or other authorizations in compliance with the respective research administrative offices (UB Sponsored Projects Services or RPCI Office of General Counsel). When purchasing materials, rely on the institutional purchasing policies. You also may need documentation proving that the cell lines have been acceptably derived (e.g. IRB approved), with appropriate consent and in compliance with the legal requirements of the relevant jurisdiction.
Transfer of pHSC materials out of the respective institutions as follows:
Everyone involved with research using pHSC will receive information and be trained in stem cell research, policy and ethics. Following training, you will need to sign a form stating that you have read and understood the National Academy of Sciences Guidelines for Human Embryonic Stem Cell research.
The SCRO Committee consists of eight faculty/staff members–four per institution–appointed jointly by the UB Vice President for Research and Economic Development serve renewable three-year terms. In addition, the committee includes at least one community member having no employment or business relationship with either institution. Collectively the committee must incorporate expertise in stem cell research, ethics and community perspective and input. Committee membership may be adjusted as necessary to meet changes in federal regulations and other nationally accepted guidelines. Committee distribution as follows:
The SCRO Committee:
UB/RPCI SCRO Committee policy prohibits committee members from reviewing, discussing or voting on any research protocol for which he/she serves as principal investigator or co-investigator, or which is sponsored by a company in which the committee member holds a financial interest.
They define this as anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). Uncompensated relationships giving rise to a conflict of interest, such as board of directors or other executive service, would similarly disqualify a member. Additional conflicts may include:
SCRO committee members with a conflict of interest may provide information about the protocol as requested by the SCRO Committee, then shall recuse themselves from the meeting during the discussion and vote on all such studies.
For proposals supported by extramural grants, UB's Sponsored Projects Services or RPCI's Grants Office will verify that the SCRO Committee and all other required committees have approved the proposal prior to acceptance of the award.
For UB projects with other funding sources, the department and investigator must obtain SCRO Committee and IRB review/approval before beginning the project.
The SCRO Committee determines the following for the proposed pHSC project:
The SCRO Committee can grant full approval (subject to obtaining other review committee approvals), conditional approval (subject to specific conditions, limitations or changes) or disapproval.
The UB office of the Vice President for Research and Economic Development maintains all records related to SCRO applications submitted by UB investigators for all active projects and for three years after the project ends. The RPCI office of Corporate Ethics and Research Subjects Protection maintains all similar records for RPCI investigators in the same manner.
The records include SCRO applications, meeting minutes, approval and disapproval letters, correspondence with funding agencies, regulatory compliance documents, training documents and current state, national and international guidance on the ethical conduct of stem cell research.
UB, 516 Capen Hall
Buffalo, NY 14260
Office Hours: 8:30am–5:00pm; Monday-Friday
Please allow two months for your documents to be reviewed and approved, so submit accordingly.
Many federal and institutional compliance regulations require training, both in person and/or online, often before you are allowed to begin your research.