Stem Cell Research Oversight

No UB/Roswell Park personnel shall engage in nor use UB/Roswell Park facilities, equipment for any of the following activities:

• Human reproductive cloning
• Research in which pHSCs are introduced into non-human primate blastocysts, or in which any embryonic stem cells are introduced into human blastocysts.
• In vitro culture of an intact human embryo for more than 14 days of development or until formation of the primitive streak, whichever occurs first;
• The breeding of animals into which pHSC’s have been introduced at any stage of development;
• Payment to a donor, beyond reimbursement for direct costs incurred as a result of the procedure, for the purpose of creating a human embryo to be used in pHSC research;
• Using federal funds to engage in human stem cells (pHSC) research deemed ineligible by the NIH.

The following research activities are exempt from review by the SCRO Committee:

• Research involving the use of adult stem cells; (may still require IRB review)
• Use of human cord blood; (may still require IRB review)
• Research involving transplantation of non-pluripotent stem cells as part of a recognized and accepted medical treatment

• Research involving the use of pHSCs, including iPSCs, in purely in vitro experiments as long as the experiments are not designed or expected to yield gametes. 

This type of research is permitted if the SCRO office receives a completed application form that documents the provenance of the cell lines including:

1. Use of an acceptable informed consent process that was approved by an IRB for their derivation, and
2. Compliance with any additional review required by committees with jurisdiction over biosafety, radiation, etc.

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

• After you have documented provenance of the pHSC including IRB approval for the derivation:
  • Research involving transplantation of pHSC into postnatal animals with no likelihood of contributing to the central nervous system or germ line including transplantation of pHSC lines for the purpose of raising antibodies or validation of pluripotency (requires IACUC review).

pHSC proposals to be reviewed by the full SCRO Committee, unless otherwise noted, include:

• Human Subject research using pHSC;
• Research in which personally identifiable information about the donor of pHSC is readily ascertainable or may become known;
• Research involving creation of new pHSC lines derived from human blastocysts (hESC), somatic cell nuclear transfer (SCNT) or altered nuclear transfer (ANT).
• Introduction of pHSC into non-human animals for purposes other than raising antibodies or validation of pluripotency.

The SCRO Committee is a joint UB/Roswell Park advisory body reporting to the UB vice president for research and economic development, and the Roswell Park 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 Roswell Park's CEO–will audit the committee's actions and operations. Both UB and Roswell Park 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:

• Research that involves the derivation of new pHSC cell lines by any means;
• Research in which the identity of the donors from which the pHSC are derived is readily ascertainable or might become known to the investigator.

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 Roswell Park 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:

1. For UB: Work with the Science, Technology Transfer, and Economic Outreach (STOR) office for an MTA or license agreement when generating or modifying pHSC materials to be transferred off campus for others to use.
2. For Roswell Park: Work with the Office of Technology Transfer for an MTA or license agreement re Roswell Park generated or modified pHSC materials to be transferred off site for use by others. 
3. These offices will comply with SCRO requirements for prior approval and tracking of such transactions.

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:

• Co-Chairpersons (one from UB, one from Roswell Park);
• Public member(s) not employed by or having a business relationship with UB or Roswell Park;
• Administrator or researcher experienced in the regulation and/or oversight of human subjects research;
• Expert in medical ethics and/or legal matters; and
• Research faculty with terminal degrees and expertise related to pHSC research drawn from such disciplines as developmental biology, stem cell research, molecular biology, regenerative medicine and assisted reproduction.

The SCRO Committee:

• Provides initial review and approval of the ethical acceptability and scientific merit of pHSC research protocols;
• Records, tracks and verifies compliance for ongoing pHSC research;
• Refers unresolved issues to the appropriate individual or committee for resolution;
• Maintains a public registry of pHSC lines maintained at UB and Roswell Park;
• Develops policies, procedures and guidelines for the vice president for research and economic deveopment / deputy director to ensure that pHSC research and training at both institutions comply with regulations and meet ethical guidelines;
• Facilitates education regarding stem cell research policies/regulations and provides ethics training for investigators involved in human stem cell research.

UB/Roswell Park 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:

• Involvement in the design, conduct or reporting of the research
• Involvement of immediate family members in the design, conduct or reporting of the research

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.

1. The investigator initiates a review by completing a proposal application.
   1. The SCRO Committee review precedes all others by required standing committees such as SRC, IRB and the IACUC.
   2. Proposals exempt from full or expedited review still need SCRO office notification.
2. Approval letters are valid for three years. However, investigators must complete and submit an annual continuation form for each project.
3. Investigators also must reapply for project approval at least 60 days prior to the expiration of the initial three-year period by using the proposal application form.

For proposals supported by extramural grants, UB's Sponsored Projects Services or Roswell Park'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:

• scientifically meritorious;
• of sound design; and
• ethically acceptable.

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.

References: National Academies’ Guidelines for Human Embryonic Stem cell Research

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 Roswell Park office of Corporate Ethics and Research Subjects Protection maintains all similar records for Roswell Park 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.