Institutional Stem Cell Research Oversight (ISCRO)

Committee Mission

The Institutional Stem Cell Research Oversight (ISCRO) committee functions as Rensselaer Polytechnic Institute’s embryonic stem cell, pluripotent stem cell and adult stem cell research oversight committee. The committee reports to the Rensselaer Vice President for Research (VPR) on any issues that arise related to the conduct and use of human stems cells (embryonic, pluripotent or adult) in research, based on the National Academy of Science (NAS) and International Society of Stem Cell Research (ISSCR) standards for human embryonic stem cell research. The Rensselaer ISCRO committee is charged with:

1. Education of stem cell researchers at Rensselaer to include all primary investigators, technical staff and student trainees involved in stem cell research as well as the general public to understand Rensselaer’s role in basic and advanced medical research with stem cells.
2. Review of proposals for non-Presidential hESC lines and other newly derived pluripotent stem cell populations, including induced pluripotent stem cell (IPS) lines, to ensure that all research that uses or derives new lines or products are in compliance with NAS guidelines and with New York State ESSCB statutes. The ISCRO will confirm that procedures used in human pluripotent stem cell research meet ethical standards and are of scientific merit. In regard to the generation of new hESC lines using the inner cell mass of blastocysts, the ESSCB mandates that consent to donate gametes or embryos to research must be obtained prior to donation. To obtain re-consent from gamete or embryo donors immediately prior to research, the standards set forth in ISSCR 11.2 will be followed. In regard to payment for donors who produced gametes originally for reproductive purposes, the ISCRO will review information where available for compliance with ISSCR 11.5 (a). Where no such information is reasonably available, the ISCRO need not ensure that payments complied with ISSCR guidelines.
3. Review of proposals on Neuronal and Gonadal adult stem cells, which are still deemed sensitive in research. Other human adult stem cell lines and nonhuman (animal) stem cell research at Rensselaer need not be reviewed if it meets requirements of other Institutional regulating agencies as well as being in compliance with national and state standards for research with these cells.
4. Review of efficacy and protocols for the generation of chimeras by use of human stem cells into animal models.
5. Maintaining a record of all stem cell research at Rensselaer to ensure that review, when appropriate has been done. Review of proposals for hESC research with approved Presidential lines is not deemed necessary as long as requirements of other Institutional regulating agencies are met. Any research at Rensselaer that uses Presidential hESC lines must be in compliance with nationally established standards for research with these cells and in compliance with the New York state Empire State Stem Cell Board (ESSCB) regulations and guidelines.

The Rensselaer ISCRO Committee will meet quarterly or as necessary to review stem cell proposals and monitor grant compliance with committee standards and will retain written records of its meetings and activities. One half of the committee must be present to generate a quorum for meeting and have any decisions be binding. The ISCRO will coordinate its activities with other research oversight committees, Rensselaer offices, and regulatory and advisory Institutional bodies at Rensselaer, including:

1. IACUC (Institutional Animal Care and Use Committee)
2. IRB (Institutional Review Board)
3. IBC (Institutional Biosafety Committee)
4. Office of the General Counsel
5. Office of the Vice President for Research
6. Research Administration and Finance

Any violations of approved protocols after review may be reported to the Institute Official. The committee will review current policies and recommend any future changes to internal policies based on external regulations. Any changes to internal policy will be presented to the Institute Official for approval. Additional duties of the ISCRO committee may be assigned from the Institute Official to meet future needs or guidelines in stem cell research. Inter-Institutional use of this ISCRO is allowed but will be determined on a one by one basis so as not to overtax the committee and interfere with its functions.

Conflict of Interest

In accordance with the policies of Rensselaer Polytechnic Institute, no member of the ISCRO committee may be involved in ISCRO review of any stem cell proposal that he/she is a participant on nor may an individual of the ISCRO committee participate in review of a proposal if they report by employment to an investigator on the proposal.

Membership

Membership in the ISCRO committee is through appointment by the Institute Official with term of membership for 12 months and renewable. Calendar term of membership is February 1 to January 31. The committee will be composed of at least five primary members with expertise in the areas of hESCs, human adult stem cells, developmental biology, assisted reproduction and in biomedical ethics. Internal expertise must include at least one human stem cell expert, along with developmental biology expertise. Two external members of the committee must be maintained to include a biomedical ethicist and stem cell expert. It is recommended that an external patient advocate be added to the committee. Ex officio internal membership will include the VPR and General Council. Ex officio external membership can include an Administrative Officer from that Institution using the RPI ISCRO. When more specific expertise is demanded, nonmembers that may be faculty or others with appropriate expertise may attend a meeting, but only upon formal invitation by the ISCRO Chair. ISCRO meetings are otherwise closed to the public, although meeting notes will be made available upon request.

Reporting

The Rensselaer ISCRO committee will keep written meeting minutes and generate a semi-annual report to the VPR. Future requests for changes to ISCRO policies or recommendations on Institution policies on stem cell research will be made to the VPR as necessary.

The International Society for Stem Cell Research (ISSCR) is an independent, nonprofit organization formed in 2002 to foster the exchange of information on stem cell research.  The ISSCR Guidelines for the Conduct of Human Embryonic Stem Cell Research specify rigorous ethical standards for scientists working with human embryonic stem cells, and seek to promote responsible, transparent and uniform practices worldwide.