The ESCRO chair must be a Brown University employee, appointed by the Vice President of Research.

The ESCRO Committee shall include at least five members, to be appointed by the Vice President for Research. At least one voting member of the ESCRO Committee shall be an external member who is not employed by Brown University.

The chair will be responsible for, or delegate to an appropriate party, the following:

• Scheduling meetings and planning meeting agendas
• Taking meeting minutes
• Identifying and nominating potential members for Committee approval
• Maintaining the registry on ongoing hESC research
• Reviewing and categorizing submitted projects

Responsibilities of all ESCRO Committee members include the following:

• Attending convened ESCRO Committee meetings
• Serving as the primary reviewer of submitted proposals as requested by the chair
• Participating in Committee deliberations regarding provenance of cell lines
• Reviewing circulated proposals and raising any concerns with the chair
• Deliberating and voting on the ethical and scientific merit of proposals
• Recommending improvements to ESCRO Committee policies and procedures as appropriate
• Reporting any conflicts of interest

For projects involving the transplantation of hESCs or derivatives into non-human animals, the ESCRO Committee is responsible for consideration of matters relating to the scientific and ethical merits of the proposed experiments. Matters of particular consideration include, but are not limited to, the likelihood of contribution to the transplanted cell population to brain or reproductive function and the rationale for use of hESCs versus another cell type. Matters relating to animal welfare shall be deferred to the IACUC for consideration in accordance with normal IACUC procedures.

For projects contemplating the donation of human-sourced materials for hESC derivation, the ESCRO Committee will review and approve the informed consent document to ensure it is consistent with the National Academy of Sciences (NAS) guidelines and 2010 Amendments (“NAS Guidelines”). Such review shall be in addition to IRB review and approval of the informed consent process. The IRB will have final approval authority. The ESCRO chair or another member designated by the chair may serve in an advisory capacity to an IRB with respect to hESC-specific considerations for the informed consent process as requested by the IRB.

For projects involving the transplantation of hESCs or derivatives into humans, the ESCRO Committee shall review the proposed clinical protocol for its scientific and ethical merits, especially as it relates to the use of hESCs versus another cell type, and the appropriate mention of hESC-specific items in the informed consent document. The IRB will have final approval authority with respect to the clinical protocol and informed consent process. Similarly, the ESCRO Committee will have no responsibility for the review of patient safety considerations.

Presence of a cell line on the NIH Human Embryonic Stem Cell Registry (“the NIH registry”) will be considered by the ESCRO Committee to be adequate documentation of the cell line’s provenance as an anonymous cell line.

For lines not listed on the NIH Human Embryonic Stem Cell Registry, the ESCRO Committee shall determine whether provenance of the line was sufficiently documented in accordance with the criteria of the NAS Guidelines. The ESCRO Committee reserves the right to set policy that varies from NAS Guidelines when doing so is determined to be advisable by a majority of Committee members.

Considerations relevant to determining whether provenance of the line was sufficiently documented include:

• The procurement process was IRB approved.
• Informed consent was obtained from all gamete donors and addressed all elements listed in the NAS Guidelines.
• The anonymity of donors was suitably protected or appropriate authorizations were obtained from donors with respect to the transmission of their confidential health information.
• Decisions relating to the production of embryos for infertility treatment were free from influence by researchers planning to derive hESC lines from excess embryos.
• No cash or in-kind payments were provided for donation of blastocysts, oocytes, or gametes (oocyte donors may be reimbursed for direct expenses relating to donation).
• Informed consent was obtained at the time of donation and donors were given the opportunity to withdraw consent at any time up to destruction of the embryo.
• Appropriate steps were taken to ensure that consent or refusal to donate did not affect quality of care.
• Clinical personnel having a conscientious objection were not required to participate in the donation process.

The ESCRO Committee shall vote with respect to whether provenance of an hESC line not on the NIH registry is sufficiently documented. Approval of a line for use at Brown shall require approval by a majority of ESCRO Committee members. Approved lines shall be further categorized by the ESCRO Committee into “anonymous lines” and “non-anonymous lines.” The review and approval process shall be documented through completion of the “provenance review form” in Appendix B.