APPENDIX A-2, Section E

Contract Policy Statements and Conditions

E. Human Embryonic Stem Cell Research

Scope. The following types of research (“Human Stem Cell Research” or “HSC Research”) are subject to the requirements of this section. Research involving:

a) human embryonic stem cells;

b) human totipotent or pluripotent cells;

c) human pluripotent stem cell lines;

d) human neural and gonadal progenitor stem cells; or

e) other human somatic tissues for stem cell research (excluding cells that remain restricted in tissue potential and are not known to possess totipotent or pluripotent potential).
National Academy of Science (NAS) and International Society of Stem Cell Research (ISSCR) Guidelines. HSC Research must comply with either NAS or ISSCR Guidelines to the extent applicable, and must also comply with any additional or conflicting requirements of this Contract.
Embryonic Stem Cell Research Oversight (ESCRO) Committees.

a) HSC Research must be approved by an Embryonic Stem Cell Research Oversight (ESCRO) Committee that meets the standards set forth in the NAS or ISSCR Guidelines and in paragraph (d) below. However, research permissible without ESCRO Committee review under Category 1 of the ISSCR Guidelines or Section 1.2 (a) of the NAS Guidelines shall not require ESCRO review if notification is provided to the ESCRO Committee.²

b) The ESCRO Committee shall be responsible for the initial and ongoing review and oversight of the research at the institution where the research is being conducted.

c) The ESCRO Committee shall ensure that research complies with either NAS or ISSCR Guidelines to the extent such Guidelines are applicable, and also complies with any additional or conflicting requirements of this Contract.

d) The ESCRO Committee shall create and follow written policies that include the following standards:

i) Committee Membership: The membership of the ESCRO Committee responsible for oversight for the contracting institution should have sufficient diversity among its members, including consideration of race, gender and background, and should be sensitive to such issues as community attitudes, to promote respect for its advice and counsel. The ESCRO Committee should be composed of qualified persons of both sexes. The members present at a meeting in which research funded under this contract is approved by the ESCRO Committee must include at least one scientist with relevant expertise and one ethicist. The purpose of diverse membership on the ESCRO Committee is to ensure that different perspectives are given a voice; the ESCRO Committee should encourage different perspectives and voices in its discussion of protocols and in its minutes.

ii) Conflict of Interest Policies: The policies shall address conflicts of interest in a manner that is in alignment with other institutional conflict of interest policies, including, but not limited to, those governing the activities of the IRB. Such policies shall preclude a member from participating in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the ESCRO Committee.

iii) Recordkeeping: The policies shall address recordkeeping requirements for the activities of the ESCRO Committee and for research reviewed by the Committee that are in alignment with the policies developed by the institution’s IRB in accordance with the requirements of 45 CFR Part 46 and guidance issued by the Office for Human Research Protections. In addition, the ESCRO Committee shall develop and adhere to policies for maintaining records relating to the provenance of all stem cell lines used in funded research, consent of gamete donors, applicable ethical research standards, and reports of adverse or unexpected outcomes that pose a threat to the health or safety of any individual or raise new ethical issues. Records relating to the activities and review of the ESCRO Committee and to the research conducted shall be retained for at least six years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the Department of Health at reasonable times and in a reasonable manner.
Consent to Donation: Consent to donate gametes or embryos to research must be obtained prior to donation. With respect to obtaining re-consent from gamete or embryo donors immediately prior to donation to research, the ESCRO Committee should apply the standards set forth in ISSCR Guidelines 11.2, but may choose to use the stricter NAS Guidelines.
Payment: The ESCRO Committee should review information, where available, regarding the payment of donors who produced gametes originally for reproductive purposes to ensure compliance with the ISSCR Guidelines 11.5(a). Where no such information is reasonably available, the ESCRO Committee need not ensure that payment history complies with either NAS or ISSCR Guidelines.

² Category 1 of the ISSCR Guidelines (section 10.1) provides: “Experiments that are permissible after review under existing mandates and by existing local committees, and are determined to be exempt from full SCRO review. These will include experiments with pre-existing human embryonic stem cell lines that are confined to cell culture or involve routine and standard research practice, such as assays of teratoma formation in immune-deficient mice. We recommend that all institutions pursuing such research establish a mechanism capable of determining that a) these projects can be adequately reviewed by committees with jurisdiction over research on human tissues, animals, biosafety, radiation, etc. and b) that full review by a SCRO mechanism or body is not required. This mechanism should include a determination that the provenance of the human embryonic stem cell lines to be used has been scrutinized and deemed acceptable according to the principles outlined in this document, and that such research is in compliance with scientific, legal and ethical norms.”

Section 1.2(a) of the NAS Guidelines provides: “Purely in vitro hES cell research that uses previously derived hES cell lines is permissible provided that the ESCRO committee or equivalent body designated by the investigator’s institution (see Section 2.0) receives documentation of the provenance of the cell lines including (i) documentation of the use of an acceptable informed consent process that was approved by an Institutional Review Board (IRB) or foreign equivalent for their derivation (consistent with Section 3.6); and (ii) documentation of compliance with any additional required review by an Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), or other institutionally mandated review.”