ESCRO | Research at Brown | Brown University

Brown's Embryonic Stem Cell Research Oversight (ESCRO) Committee

Brown University's Embryonic Stem Cell Research Oversight (ESCRO) Committee was established to ensure that any Brown human embryonic stem cell (hESC) research is conducted only after full consideration is given to all relevant scientific, medical, regulatory, and ethical issues, including compliance with Rhode Island statutes. Brown's Committee:

Reviews the scientific and ethical merits of all Brown University research activities involving the derivation or use of hESCs;
Ensures that the provenance of hESC lines used by Brown University is documented;
Maintains a registry of Brown University's ongoing hESC research;
Educates Brown University's personnel regarding existing guidelines, laws, and procedures relating to the derivation and use of hESCs.

Given this is an ad hoc committee and not a standing committee that meets routinely, it is imperative that any investigator proposing to use hESCs in research contact Brown’s Office of Research Integrity ([email protected]) well in advance of requiring approval to begin such work to allow time for a committee meeting to be called. For an ESCRO committee application, please contact us at [email protected].

Project Review Categories
Category of Review	Type of Review	Type(s) of Qualified Projects
Category A Projects	Minimal ESCRO Committee Review Required	In vitro research on (i) cell lines on the NIH Registry, or (ii) cell lines that have been approved as “anonymous lines” by the Brown University ESCRO Committee.
Category B Projects	Additional ESCRO Committee Review Required	Projects involving (i) the derivation of new hESC lines, (ii) the introduction of hESCs or their derivatives into humans or non-human animals, and/or (iii) the use of hESC lines classified by the ESCRO Committee as “non-anonymous lines”.
Category B1	Expedited Review	Projects involving the introduction of hESCs or their derivatives into post-pubertal non-human animals are eligible if deemed to have limited potential to contribute to brain or reproductive function.
Category B2	Standard Review	Projects involving (i) the derivation of new hESC lines, (ii) the use of non-anonymous lines, or (iii) the introduction of hESCs or their derivatives to humans or pre-pubertal animals.
Category C Projects	NOT PERMITTED	Projects involving (i) the in vitro culture of an intact human embryo for more than 12 days or until the primitive streak begins, (ii) the introduction of hESCs into human or non-human primate blastocytes, or (iii) the breeding (or insufficient control to prevent breeding) of animals into which hESCs have been introduced.

Other Reviews and Approvals of hESC or iPSC Research

Review by the ESCRO Committee does not satisfy other regulatory review requirements by Brown University boards and committees. Institutional Review Board (IRB), Institutional Biosafety Committee (IBC) and/or Institutional Animal Care and Use Committee (IACUC) review is required in addition to ESCRO Committee review in the following situations:

Research involving hESCs where the donor may be identified by the Brown investigator, including cell lines that retain links (such as code) to identifiable information, is considered to be Human Subjects Research that requires IRB review.
Research involving hESCs where there is interaction or intervention with a living individual and information about such individual, or tissue from such individual, is obtained, is considered Human Subjects Research that requires IRB review.
Derivation of induced pluripotent stem cells (iPSCs) from identifiable patient, volunteer, or repository samples that meet the definition of human subjects must have prospective IRB Approval.
All hESC research involving the use of live vertebrate animals is subject to the approval of the Institutional Animal Care and Use Committee (IACUC).
All research involving the use of human blood, body fluids, tissues and/or cell lines is subject to the approval of the Institutional Biosafety Committee (IBC).

Review and approval by other Brown compliance committees may occur prior to or concurrently with ESCRO review.