PA 08-80—sSB 464

Public Health Committee

AN ACT CONCERNING STEM CELL RESEARCH

SUMMARY: This act makes changes in Connecticut's stem cell research law to reflect the acknowledgment of, and compliance with, the “National Academies' Guidelines for Human Embryonic Stem Cell Research” (see BACKGROUND). The act (1) amends the consent requirements for prospective embryo donors; (2) establishes standards to allow the use of human embryonic stem cell lines derived outside Connecticut; (3) requires that all human embryonic stem cell research conducted in the state be overseen by embryonic stem cell review oversight committees, rather than by “institutional review committees; ” and (4) requires the state's Stem Cell Research Peer Review Committee members to use the guidelines when evaluating grant applications.

EFFECTIVE DATE: October 1, 2008

COMPLIANCE WITH NATIONAL ACADEMIES' GUIDELINES

Consent for Donation

By law, a person choosing to donate for stem cell research purposes any human embryos or embryonic stem cells remaining after undergoing fertility treatment or unfertilized human eggs or human sperm must give written consent, and cannot receive any direct or indirect payment, for the donation.

The act requires that consent for such donations conform to the National Academies' guidelines.

Under the guidelines, consent should be obtained from each donor at the time of donation. Even those who have previously indicated their intent to donate to research any embryos remaining after clinical care should nonetheless give informed consent at the time of donation. Donors should be informed that they retain the right to withdraw consent until the embryos are actually used in cell line derivation.

Research on Stem Cells Derived Outside Connecticut

The act allows human embryonic stem cell research on stem cells that have been derived outside Connecticut and have been acceptably derived as provided in the guidelines. This would have the effect of allowing the use in Connecticut of human embryonic stem cells lines derived elsewhere (e. g. , the United Kingdom, Canada, the California Institute for Regenerative Medicine). Under the guidelines, (1) the donation protocol for the cell lines must be reviewed by an oversight body, (2) there must be informed and voluntary consent, (3) there must have been no payment for donation, and (4) the donation must be legal in the relevant jurisdiction.

Embryonic Stem Cell Research Oversight Committees (ESCROs)

The act requires that all human embryonic stem cell research performed in Connecticut be overseen by an ESCRO rather than by an institutional review committee. The act defines such an ESCRO as one established according to the National Academies' guidelines.

Under existing law, such research must be reviewed and approved by an institutional review committee. Such a committee is defined as (1) the local institutional review committee established according to federal law to supervise the clinical testing of devices in facilities where clinical testing is to be conducted and (2) where applicable, an “institutional review board” (IRB), which, under federal law, is responsible for ensuring that human subjects engaged in research are treated with dignity, are protected from harm, and have given informed consent to participate in research. An IRB reviews and approves research protocols before any work is started and periodically reviews ongoing research to ensure the protection of subjects.

The act deletes references to “institutional review committee,” and instead requires that the research be overseen by an ESCRO.

The academics' guidelines make clear that activities related to human embryonic stem cell research should be overseen by an ESCRO. Such committees, according to the guidelines, can be internal to a single institution or established jointly with one or more other institutions. The guidelines give ESCROs the following responsibilities:

1. provide oversight over all issues related to derivation and use of human embryonic stem cell lines,

2. review and approve the scientific merit of research protocols,

3. review compliance of all in-house human embryonic stem cell research with all relevant regulations and the guidelines,

4. maintain registries of human embryonic stem cell research conducted at the institution and cell lines derived or imported by institutional investigators, and

5. facilitate education of investigators involved in human embryonic stem cell research.

Although an ESCRO may overlap with other oversight committees, it should not be a subcommittee of an IRB according to the guidelines.

Stem Cell Research Peer Review Committee

Under existing law, the Department of Public Health (DPH) commissioner appoints a Stem Cell Research Peer Review Committee of up to 15 members. The committee reviews all applications for grants and makes recommendations to DPH and the existing Stem Cell Research Advisory Committee concerning the ethical and scientific merit of each application. Peer review committee members must be aware of the National Academies' guidelines.

The act specifies that the peer review committee must use the guidelines to evaluate each grant application.

BACKGROUND

National Academies

The National Academies is an independent organization that Congress chartered to advise the government on scientific, engineering, and health matters. In April 2005, it released guidelines and recommendations for human embryonic stem cell research. These guidelines are intended for use by the scientific community, including researchers in academic, industry, or other private sector organizations.

The guidelines are amended from time to time. The National Academies called for the establishment of ESCROs in its 2005 guidelines. The guidelines committee believes that all research institutions engaged in human embryonic stem cell research should create and maintain these committees at the local level. The composition and responsibilities of ESCRO committees was further clarified in the February 2007 amendments to the guidelines.

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