Human Embryo and Embryonic Stem Cell Research Oversight

GIM-36

• GIM-36

ESCRO Changes

What is UW’s Embryo and Embryonic Stem Cell Research Oversight?

Why does ESCRO exist – what makes it unique?

ESCRO addresses unique ethical issues specific to stem cell research, such as the use of human embryonic stem cell lines created from the destruction of a human embryo.

In late 2007, GIM 36 was born: UW’s policy and guidelines on human embryonic stem cell research.

Then-President Bush allowed very limited federal funding for research on a set of established hESC lines. UW responded by creating GIM 36 in anticipation of further regulation and protection of UW interests:

• Use of equipment, supplies, buildings for research involving hESCs ineligible for federal funding;
• Types of research that could occur at the UW;
  • ESCRO Committee composition and review;
  • Establishment of registry of hESC lines at UW.

President Obama allowed more federal funding for research using established hESCs and the creation of an NIH human embryonic stem cell registry still in effect today.

ESCRO Committee

A. 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.

B. 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.

C. 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:

1. 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);
2. 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.
3. 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;
4. 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;
5. Prescribe, establish and maintain a registry of hESC lines maintained at the UW;
6. 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;
7. 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.
8. 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
9. 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.

D. 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.

E. CONFLICTS OF INTEREST

1. 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.

1. 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.

F. 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.

ESCRO Intellectual Property and Technology Transfer Guidelines

Inventions and Discoveries. Intellectual property and or materials of commercial value created by UW investigators in the course of hESC research will be disclosed to UW CoMotion in accordance with the UW Patent, Invention, and Copyright Policy. All intellectual property arising from human embryo and hESC research shall be managed in accordance with the foregoing policy and the rules and procedures of UW CoMotion Consistent with the foregoing, the UW recognizes that there may be instances in which it will be in the public interest to place intellectual property arising from human embryo and hESC research in the public domain for broad no-cost dissemination . Provided it does not conflict with any other agreements including funding or internal UW agreements, and is not already under management by UW CoMotion, decisions in such cases shall be made by UW inventors, creators, and/or authors after appropriate consultations with the principal investigator and co-creators on the research.

Material Transfer Agreements. Incoming and outgoing transfers of human embryo and hESC, hESC lines, hESC derived cell lines, hESC derivatives, and other materials where UW wishes to control downstream usage and further distribution shall be documented through material transfer agreements approved by the UW CoMotion MTA Group.

Funding and Facilities Guidelines

Cost-Allocation Guidelines:

1. Introduction
2. Financial Definitions
3. General Cost Allocation Principles
4. Application of Federal Cost Principles to Specific Resources
5. Further Questions and Information

1. Introduction

2. Financial Definitions

3. General Cost Allocation Principles

a. Direct Costs

b. Indirect Costs

4. Application of Federal Cost Principles to Specific Resources

a. Facilities

1. Responsibility for Seeking Approval.  The PI retains primary responsibility for seeking approval for facilities to be used in the conduct of hESC research.
2. Tracking Usage of Facilities.  UW’s existing policies and procedures for tracking and confirming the usage of facilities for federally funded research, and the direct and indirect costs associated with that usage, will apply so that only allowable costs are charged to federal grants, and so that the costs of using facilities for other activities, including  hESC research, are not supported by federal funds.
3. Limitations on the Usage of Facilities.  UW facilities may be used for  hESC research, subject to approval on appropriate conditions.  Such conditions may include, for example, limitation on time, allocation of space, or percentage of use and will in any event take into account other commitments for the facilities, if any, to federally sponsored projects and to other UW activities, including non-federally sponsored research.
4. Use of Multiple Facilities.  As part of the approval process, the PI must disclose all locations, both on-campus and off-campus, where any hESC research, will be conducted.
5. Approval of Changes in Usage of Facilities.  Any change in space usage where hESC research is conducted, whether addition or deletion of existing space, or changes in time or percentage of hESC research or usage, is also subject to these guidelines.  Changes must be reviewed and approved by the school or college in accordance with usual and customary procedures.

b. Equipment

• Responsibility for Seeking Approval.  The PI retains primary responsibility for seeking approval for equipment, whether existing or proposed for acquisition, to be used in the conduct of hESC research.
• Tracking Usage of Equipment.  UW’s existing policies and procedures for tracking and confirming the acquisition and usage of equipment for federally funded research, and the direct and indirect costs associated with acquiring and using equipment, will apply so that only allowable costs are charged to federal grants, and so that the costs of acquiring or using equipment for other activities, including  hESC research, are not supported by federal funds.
• Use of Equipment.  The school or college will issue approval as follows:
  • Equipment owned by UW. Equipment owned by UW may be used to conduct  hESC research if the following conditions are satisfied:
    • Acquisition of the equipment was not supported by federal funds, and
    • Use of the equipment is not subject to any other restrictions, including restrictions imposed by non-federal sponsors.
    • Equipment owned by the Federal Government.  Equipment owned by the federal government may be used in conducting  hESC research only in the following circumstances:
    • Use of the equipment is expressly permitted pursuant to the terms of the federal award under which the equipment was obtained, the terms of an equipment rental agreement, or the approval of the appropriate federal agency; or
    • UW purchases the equipment from the federal government and has documentation of such transaction, including title transfer.
  • Equipment owned by UW but Purchased with Federal Support.  Equipment owned by UW but acquired, in whole or in part, with federal funds may be used in conducting hESC research only in the following circumstances:
  • All competitive segments of the federal grant or contract supporting the equipment purchase have been completed and UW retains title to the equipment without restriction, observing any preferences for federal usage; or
  • Use of the equipment for  hESC research is permitted pursuant to the terms of the federal grant or the approval of the appropriate federal agency; or
  • UW purchases the equipment in full, without federal restriction, and has documentation of such a transaction.
  • Approval in changes in Usage of Equipment.  Any anticipated changes in usage of equipment are also subject to these guidelines.  Changes must be reviewed and approved by the schools, and sponsor approval obtained, if required by the sponsor per the terms of the award.

c. Personnel

• ascertain that any required approvals have been obtained from the ESCRO Committee,
• have an approved  eGC-1 on file, if funded by an external entity,
• and obtain the agreement of all UW personnel participating in the hESC research to follow all UW rules and procedures regarding hESC research, including GIM 36 and these hESC cost-allocation guidelines.  In addition to the foregoing, the following rules apply to the approval of personnel to participate in hESC research, regardless of funding source:
  • Responsibility for Seeking Approval.  The PI shall have primary responsibility for ensuring that approvals are sought and obtained for all personnel participating in hESC research.
  • Tracking Effort.  UW’s existing policies and procedures for tracking and confirming work effort, both direct charged and cost shared, on federally funded research  will apply so that appropriate effort is devoted to commitments under federal grants, and so that other activities including  hESC research, are not supported by federal funds (See GIM 35 – Effort Reporting Policy for Sponsored Agreements
  • Support and Cost Sharing.  Non-federal funds may be used to support all hESC research. Efforts expended on  hESC research cannot be used to meet cost share commitments to federal projects.
  • Individuals Holding Multiple Appointments.  Many UW personnel have appointments or relationships elsewhere, including with affiliated hospitals and other institutions.  The process for approving UW personnel to engage in hESC research will consider in the usual and customary fashion other appointments, relationships, and commitments of such personnel.
  • Work Benefiting Multiple Research Aims.  From time to time certain research activities may require further analysis to determine whether they may be supported in whole, part, or not at all by federal funds.  Research activities on approved hESC lines may be supported by federal funds to the extent permitted by the particular grant.  On occasion, certain types of activities may be directed to research aims with respect to approved hESC lines and hESC lines not listed on the NIH hESC registry, for example, the development of a reagent of assay that can be used on both types of hESC lines.  In such instances, time and effort performing such activities should be allocated in proportion to the benefit each receives.

d. Materials, Supplies, Non-Capitalized Equipment, and Purchased Services

• Consumable Materials and Purchased Services.
• Specific Purchases.  If purchased services, such as the services of consultants, laborers, or maintenance/repair technicians, or purchase materials are used to carry out  hESC research, neither the direct costs of those items nor the indirect costs associated with their acquisition may be charged to the federal government.
• Use of Materials from General Supply.  Materials withdrawn from general supply should be charged at their actual costs “under any recognized method of pricing inventory withdrawals, consistently applied.” (Uniform Guidance (2 CFR 200).  Transportation charges may be included.  The PI must track usage and apply a written plan for allocating costs among different projects.  In such cases, the indirect cost must be transferred as well.  For example, if the PI of a project desires to consume one-half of the cost of existing materials initially purchased with federal funds for $100, then the $50 of the Materials plus the associated indirect costs must be transferred to non-federal sources prior to using or consuming the materials.
• Non-Capitalized Equipment.  The cost of non-capitalized equipment must be allocated among the projects for which they are used, under a reasonable allocation plan consistent with UW policies.

e. Data, Information and Intellectual Property Obtained from hESC Research

5. Further Questions and Information

ESCRO Application Form

ESCRO Application Form (for new and amendments)

Amendments to approved applications

Amendments must be submitted by the Principal Investigator. Amendments to approved ESCRO applications include the changes below:

• Changes in scientific experiments
• Changes to the Principal Investigator
• Addition of research ineligible for federal funding
• Addition of hESC or hESC like lines
• Changes to intended research

Use the ESCRO Application Form (for new and amendments) to report any changes meeting the above criteria.

Annual Updates & Closed Studies

Annual updates must be submitted by the Principal Investigators within a month of the annual anniversary of approved ESCRO applications.

Use the Annual Update Form to inform the ESCRO office of the types and sources of cells used in approved embryo and stem cell research.

Closed studies are those that have concluded and where the cell lines and/or tissue will no longer be used.

The Principal Investigator must send an email to escro@uw.edu to report a closure to an existing application.

Example of Research and Review Categories

Research-examples-and-Review-categories

Financial Supplement Form

• Financial Supplement

Frequently Asked Questions

• Frequently Asked Questions

Terms & Conditions

• Terms and Definitions