University Policies
Policy Contact
Office of Research Integrity Email 401-863-3050

Policy on the Use of Human Embryonic Stem Cells in Research

Policy No. Issue Date Effective Date

1.0 Policy Purpose

The purpose of this policy is to ensure that all human embryonic stem cell (hESC) research conducted at or funded by Brown University (“Brown” or “University”) is conducted in an ethical manner. The Embryonic Stem Cell Research Oversight (ESCRO) Committee shall have the authority to review and approve, disapprove, or require modifications to any project involving the derivation or use of hESCs. 

2.0 To Whom the Policy Applies

This policy applies to the ESCRO Committee and to all members of the Brown community including, but not limited to, faculty, staff, students, visiting scholars, and postdoctoral fellows, and any other persons at Brown involved in hESC research.

3.0 Policy Statement

3.1 Membership of ESCRO Committee

3.1.1 Composition and Selection

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.

3.1.2 Responsibilities

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

3.2 Advisors

The ESCRO Committee may request the advice of certain internal or external advisors as necessary for completion of the Committee’s duties (i.e., clinicians or scientists with expertise in the area of a project under review; ethicists with experience/insights relevant to the issues under consideration; a representative from Brown’s Office of General Counsel). These advisors may attend Committee meetings or consult with the ESCRO Committee Chair, among other tasks requested by the Committee. ESCRO Committee members can work with Brown University’s Office of General Counsel to obtain a confidentiality agreement for any outside advisor prior to sharing non-public information regarding Brown University projects or processes or other information proprietary to Brown University or the Committee’s duties. Outside advisors do not have authority to vote on matters under review by the Committee. 

3.3 Ancillary Committee Reviews

It is recommended that Principal Investigators (PIs) submit projects to the ESCRO Committee prior to submission to the Institutional Animal Care and Use Committee (IACUC), Institutional Review Board (IRB), and Institutional Biosafety Committee (IBC). However, submission may be performed in any order to expedite review timelines, so long as all required approvals are obtained prior to initiation of the research.

3.3.1 Role of ESCRO Committee in Animal Studies

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.

3.3.2 Role of ESCRO Committee in Informed Consent Process for Embryo, Gamete or Somatic Cell Donors

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.

3.3.3 Role of ESCRO Committee in Human Clinical Research

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.

3.4 Review of Provenance of Lines

3.4.1 Lines Listed on the NIH Human Embryonic Stem Cell Registry

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.

3.4.2 Other Lines

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.

4.0 Definitions

For the purpose of this policy, the terms below have the following definitions:

Human embryonic stem cell (hESC):

Cells that are derived from the inner cell mass of blastocyst stage human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers


5.0 Responsibilities

All individuals to whom this policy applies are responsible for becoming familiar with and following this policy. University supervisors are responsible for promoting the understanding of this policy and for taking appropriate steps to help ensure compliance with it.

6.0 Consequences for Violating this Policy

Failure to comply with this and related policies is subject to disciplinary action, up to and including suspension without pay, or termination of employment or association with the University, in accordance with applicable (e.g., staff, faculty, student) disciplinary procedures. 

7.0 Related Information

These policies and procedures as well as any revisions thereto must be approved by the Vice President for Research, and a majority of the ESCRO Committee membership, to be effective.

Brown University is a community in which employees are encouraged to share workplace concerns with University leadership. Additionally, Brown’s Anonymous Reporting Hotline allows anonymous and confidential reporting on matters of concern online or by phone (877-318-9184).

The following information complements and supplements this document. The information is intended to help explain this policy and is not an all-inclusive list of policies, procedures, laws and requirements.

7.1 Related Policies:

  • N/A

7.2 Related Procedures:

  • Embryonic Stem Cell Research Oversight (ESCRO) Committee Standard Operating Procedure

7.3 Related Forms:


7.4 Frequently Asked Questions (FAQs):

  • N/A

Policy Owner and Contact(s)

Policy Owner: Vice President for Research

Policy Approved by: Vice President for Research

Contact Information:

Office of Research Integrity Email 401-863-3050

Policy History

Policy Issue Date:

Policy Effective Date:

Policy Update/Review Summary:

  • Policy updated to transfer procedural information to a new SOP.  Added the definition for human embryonic stem cells (hESCs).