UW Research

ESCRO Committee

OFFICE OF RESEARCH

ESCRO Committee

  1. Introduction
  2. Membership
  3. Responsibilities
  4. Review Standards
  5. Conflicts of Interest
  6. Coordination with UW IRB

Introduction

The ESCRO Committee’s review shall be specific to the scientific and ethical issues presented by proposals of covered research. The UW’s Vice Provost for Research establishes the ESCRO Committee, which shall have general authority to review, conditionally approve, require modifications of, or disapprove all human embryo and human embryonic stem cell (hESC) research proposals at the UW requiring review under GIM 36. The ESCRO Committee may from time to time advise and make recommendations to the Vice Provost for Research with respect to legal, ethical and policy issues regarding hESC research. The UW Office of Research will provide necessary administrative support for the ESCRO Committee.

The ESCRO Committee review and approval shall be deemed to be separate from and in addition to any other reviews or approvals otherwise required at the UW for such research, including but not limited to, committees or administrative offices having responsibility for review and approvals of human subject’s research, animal research, biological safety, radioactive materials, and environmental safety.

Membership

The Committee is composed of members with scientific education, background, and experience relevant to subject matter described as covered research. Additionally, the Committee contains members from the public unaffiliated to the University of Washington, who provide input on public concerns relevant to the research.

Responsibilities

The ESCRO Committee’s review shall be specific for the scientific and ethical issues presented by proposals to use human embryo and hESC research in particular research projects. The Committee shall provide, in accordance with GIM 36, scientific and ethical review of proposed human embryo and hESC research including compliance with applicable regulatory requirements and UW policies. Committee responsibilities include:

  • Review and approve or disapprove all human embryo and hESC at the UW or involving UW personnel requiring institutional review (subject to any other UW approvals that may also be required);
  • Provide continuing review and approval of all human embryo and hESC research requiring institutional review, including review of progress and similar reports that may be submitted to the UW by investigators conducting human embryo and hESC research.
  • Confirm that the provenance of relevant tissues and stem cell lines are used in research at the UW or involving UW personnel is adequately demonstrated, and when appropriate, confirm that there is IRB approval of the process for acquisition of tissues and stem cell lines to verify adherence to basic ethical and legal principles of informed consent and protection of confidentiality;
  • Refer to, and require review of research proposals by other oversight offices or committees as required by UW policies, including but not limited to those relating to human subjects research (IRB), animal research, biological safety, and conflicts of interest;
  • Prescribe, establish and maintain a registry of hESC lines maintained at the UW;
  • Prescribe, establish and maintain a database of ongoing human embryo and hESC research at the UW, including information regarding key personnel, the type of human embryo and hESC research, and the tissues and cell lines in use;
  • Monitor national, state and local ethical, regulatory and policy discussions regarding human embryo and hESC research and from time to time propose modifications to UW policy as needed.
  • Adopt, implement, and publish rules of procedures that are consistent with GIM 36 and other UW policies governing the conduct of ESCRO Committee affairs and interactions by investigators with the ESCRO Committee, including but not limited to rules covering: quorum requirements; conflict of interest disclosures by members; meeting format, schedules and length; workload assignments; content of minutes; applications and other forms; criteria for evaluating human embryo and hESC research proposals; and communication of decisions; and
  • Facilitate education and training of investigators in the policy, ethical, legal, regulatory, and compliance issues involved in human embryo and human embryonic stem cell research, including recommending minimum compliance training requirements as a condition for participating in human embryo and hESC research.

Review Standards

The ESCRO Committee review shall be primarily directed to determining whether proposed human embryo and hESC research is scientifically meritorious and ethically acceptable. The ESCRO Committee shall only approve human embryo and hESC research proposals whose goals are judged to be scientifically worthy and whose methods demonstrate sound research design, such that it can be reasonably expected that the study is likely to answer the proposed questions and to achieve the stated goals of the research. In so doing, the ESCRO Committee shall take into account the inherent uncertainty of the outcome of scientific research while also assessing the overall importance or significance of the proposed research. In carrying out its review, the ESCRO Committee shall give substantial consideration to any ethical or social aspects of the proposed research and shall not approve any proposal that is inconsistent with the prohibitions outlined in the Research and Review Categories table or otherwise fails to meet generally accepted ethical principles for the conduct of human embryo and hESC research and other research. In accordance with the ESCRO Committee’s rules of procedure, an investigator proposing to conduct human embryo and hESC research will be required to provide the ESCRO Committee no less than a detailed description of the proposed research, adequate documentation demonstrating the provenance of human embryo and hESC lines to be used in the research, and evidence of compliance with other required reviews. In cases where a proposal fails to meet the requirements of GIM 36, the ESCRO Committee Chairperson may disapprove the application without review by the full ESCRO Committee. In making determinations, the ESCRO Committee shall have authority to grant full conditional approval (subject to obtaining all other required UW approvals), conditional approval (such to specific conditions, limitations, or changes) or disapprove proposed human embryo and hESC research. The ESCRO Committee may also establish rules and procedures by which applications may be reconsidered or resubmitted with substantial revisions.

  1. Conflicts of Interest
  2. Researcher Significant Financial Interests. All investigators participating in human embryo and hESC research shall disclose personal financial interests in accordance with the UW’s Significant Financial Interest Disclosure Policy, GIM 10. The ESCRO Committee research proposal application shall include questions, comparable to those on the UW’s human subjects research application, representing and affirming compliance with GIM 10 by investigators proposing to participate in hESC research.
  3. ESCRO Committee Member Conflicts of Interest. It shall be the responsibility of each ESCRO Committee member to disclose all personal, financial, and other competing interests, in accordance with the UW’s Significant Financial Interest Disclosure Policy, GIM 10, that could reasonably be seen as affecting the ability of the committee member to impartially discharge the committee member’s duties. Potential conflicts include but are not limited to personal financial interests, professional interests, or personal relationships having a significant connection to a matter under consideration by the ESCRO Committee. The ESCRO Committee as a whole shall determine whether and the extent to which a disclosure disqualifies the committee member from participating in the review of a particular matter under consideration.

Coordination with UW Institutional Review Board

To ensure consistent and efficient processing of human embryo and hESC research proposals requiring IRB review, the UW Human Subjects Division shall designate a single IRB committee as having exclusive jurisdiction to review all human embryo and hESC research proposals requiring IRB approval. In carrying out their reviews, the IRB and ESCRO Committee shall strive to coordinate their activities to avoid unnecessary overlap and duplication of reviews and shall cooperate in the sharing and interchange of information to the extent permitted by applicable rules and regulations.