Stem Cells & ESCRO Policy

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Stem cell research holds much promise for a greater understanding of basic biology, human development, and disease progression and for the potential creation of therapies that rebuild or replace damaged cells.  Harvard University has a strong commitment to advancing, supporting and overseeing the ethical conduct of this research through the Harvard Stem Cell Institute, the Department of Stem Cell and Regenerative Biology and the Harvard University Embryonic Stem Cell Research Oversight (“ESCRO”) Committee.

Policy Contacts

Melissa Lopes
ESCRO Director; Senior Research Compliance Officer, OVPR

The ESCRO Committee performs ethical and scientific reviews of all research involving the derivation and research use of embryos, human embryonic stem cells and certain activities involving non-embryonic stem cells, human neural stem cells, and human gametes.  Its scope includes use of anonymous materials that may not require consideration by an Institutional Review Board (“IRB”).

What is Essential

Applications are reviewed by the ESCRO Committee on an on-going basis.  For applications requiring full-committee review, the Committee meets four times per year.  For more information on the submission process, please review the Submission Process Page.  For information on deadlines, please review the Submission Deadlines Page.

Submission Process

Submit the following materials with a new protocol:

  • ESCRO Application, available on the Forms Page
  • Research Plan
  • If human subjects or identifiable human material:
    • IRB approval
    • consent form(s) that include all the ESCRO-required items (or an explanation for any that are missing)
    • any other materials used in the course of the study, e.g., recruiting materials, letters to subjects, protocol forms
  • If animal subjects:
    • IACUC approval (e.g., signed protocol face page)

Note: IACUC materials are not required if all you are doing is generating teratomas to test for pluripotency.

  • ESCRO, IRB, and IACUC applications and approvals (including approved consent form) from all collaborating schools/institutions
  • COMS Approval Letter

Annual Renewals

Submit the following materials with an annual renewal:

  • Progress Report Form, available on the Forms Page
  • Any new materials not previously reviewed
  • Any materials that have changed, including the Research Description, recruiting materials, consent forms, etc.
  • Documentation of any approvals that have expired or will expire in the near future, including IRB, IACUC, or collaborator approvals (Note: Documentation of COMS approval is only required if changes were made.)
  • Any other materials, as directed by the Progress Report Form

 

Submission Deadlines

Materials submitted for consideration at an ESCRO meeting must be submitted a minimum of two weeks prior to the meeting. Please contact Melissa Lopes, ESCRO Director; Senior Research Officer, OVPR for upcoming meeting dates. When submitting protocol renewals, please be sure to check the expiration date. A protocol renewal must be submitted for review prior to the expiration month, regardless of the date of the next meeting.  All meetings are scheduled for 8-10 AM in Smith Center 869.  For new protocols, researchers should ensure that a representative of the lab is available to present and/or answer any questions.

How to Comply

Harvard Policies

The Harvard ESCRO Committee’s policies are based on the National Academies of Sciences (“NAS”) Guidelines for Human Embryonic Stem Cell Research and the International Society for Stem Cell Research (“ISSCR”) Guidelines for the Conduct of Human Embryonic Stem Cell Research  and are consistent with Massachusetts law 111L.

ESCRO Policy (P-001)
ESCRO Scope (P-005)
Provenance Policy (P-002)
hESC Registry Policy (P-003)
Amendments Policy (P-004)

Harvard Embryo and hESC Statement on Cost Allocation
Harvard Genomic Data Sharing Policy

ESCRO SOPs (Standard Operating Procedures)

For investigators/investigational staff:
Registration of hESC Lines and Protocols
Protocol Review

For administrative ESCRO SOPs:
ESCRO Membership (S-002)
ESCRO Meetings (S-003)

Law, Regulation and Guidance

Federal:
NIH Funding Guidelines

State:
MA Biotechnology Law

Other Guidance:
Harvard University Human Embryo and hESC Cost Allocation Guidance
NAS Guidelines for Human Embryonic Stem Cell Research
ISSCR Guidelines for the Conduct of Human Embryonic Stem Cell Research

Forms & Applications

The forms below are for use by Harvard investigators. If you are a non-Harvard investigator looking for forms to submit in order to obtain documentation of ESCRO approval for the use of HUES lines you are ordering, please contact your own ESCRO.

ESCRO New Protocol Application
ESCRO Progress Report Form (for renewals)
hESC Registration Form

Why It’s Important

Funders and publications often require evidence of ethical review of research involving human embryos, oocytes or pluripotent stem cells. The Embryonic Stem Cell Research Oversight (“ESCRO”) Committee performs ethical and scientific reviews of all research involving the derivation and research use of embryos, human embryonic stem cells and certain activities involving non-embryonic stem cells, human neural stem cells, and human gametes.  Its scope includes the use of anonymous materials that may not require consideration by an IRB.  The Committee reports to the Office of the Vice Provost for Research and is comprised of a diverse group of faculty members and other subject-matter experts in the areas of biology, stem cell research, genetics, bioethics and law.

Helpful Resources

The following lines have been registered with the Harvard University ESCRO. Harvard investigators who wish to use any of the lines listed below do not need to re-register them with the ESCRO; however, they do need to obtain ESCRO protocol approval for the specific use of the line(s). Work may not commence until the ESCRO has approved the stem cell use protocol.

As lines are sometimes in the process of being registered, you may want to contact the ESCRO Administrator to determine whether a line you wish to register has already been submitted for consideration. Use the hESC Registration Form, available on the Forms page to register lines not listed below.

Note: Lines listed below may not be available for distribution to other investigators. Please contact the distributor (linked below in Source column) for information.

Line IDSourceEligible for Federal Funding?*
CHB4Children’s Hospital BostonYes (see NIH Registry)
CHB5Children’s Hospital BostonYes (see NIH Registry)
CHB6Children’s Hospital BostonYes (see NIH Registry)
CHB8Children’s Hospital BostonYes (see NIH Registry)
CHB9Children’s Hospital BostonYes (see NIH Registry)
CHB10Children’s Hospital BostonYes (see NIH Registry)
CHB11Children’s Hospital BostonYes (see NIH Registry)
CHB12Children’s Hospital BostonYes (see NIH Registry)
GENEA002GENEAYes (see NIH Registry)
GENEA048GENEAYes (see NIH Registry)
GENEA015GENEAYes (see NIH Registry)
GENEA016GENEAYes (see NIH Registry)
GENEA047GENEAYes (see NIH Registry)
GENEA042GENEAYes (see NIH Registry)
GENEA043GENEAYes (see NIH Registry)
GENEA057GENEAYes (see NIH Registry)
GENEA052GENEAYes (see NIH Registry)
H1 (WA01)WiCell Research InstituteYes (see NIH Registry)
H7 (WA07)WiCell Research InstituteYes (see NIH Registry)
H9 (WA09)WiCell Research InstituteYes
H13 (WA13)WiCell Research InstituteYes
H14 (WA14)WiCell Research InstituteYes
HUES 1-24Harvard (HUES lab)Yes, with restrictions (see NIH Registry)
HUES 25Harvard (HUES lab)No
HUES 26-28Harvard (HUES lab)Yes, with restrictions (see NIH Registry)
HUES 29Harvard (HUES lab)No (submitted for future NIH consideration)
HUES 31-41Harvard (HUES lab)No (submitted for future NIH consideration)
HUES 42Harvard (HUES lab)Yes (see NIH Registry)
HUES 43Harvard (HUES lab)No (submitted for future NIH consideration)
HUES 44-45Harvard (HUES lab)Yes (see NIH Registry)
HUES 46-47Harvard (HUES lab)No (submitted for future NIH consideration)
HUES 48Harvard (HUES lab)Yes (see NIH Registry)
HUES 49Harvard (HUES lab)Yes (see NIH Registry)
HUES 50-52Harvard (HUES lab)No (submitted for future NIH consideration)
HUES 53Harvard (HUES lab)Yes (see NIH Registry)
HUES 54-61Harvard (HUES lab)No (submitted for future NIH consideration)
HUES 62-66Harvard (HUES lab)Yes (see NIH Registry)
HUES 67Harvard (HUES lab)No (submitted for future NIH consideration)
HUES 68-70Harvard (HUES lab)Yes (see NIH Registry)
HUES PGD 1Harvard (HUES lab)No (submitted for future NIH consideration)
HUES PGD 2Harvard (HUES lab)No (submitted for future NIH consideration)
HUES PGD 3Harvard (HUES lab)Yes (see NIH Registry)
HUES PGD 4-9Harvard (HUES lab)No (submitted for future NIH consideration)
HUES PGD 10-12Harvard (HUES lab)Yes (see NIH Registry)
HUES PGD 13Harvard (HUES lab) Yes (see NIH Registry)
HUES PGD 14Harvard (HUES lab) Yes (see NIH Registry)
HUES PGD 15Harvard (HUES lab) Yes (see NIH Registry)
HUES PGD 16Harvard (HUES lab) Yes (see NIH Registry)
SA01Cellartis ABYes (see NIH Registry)
SA02Cellartis ABYes (see NIH Registry)
TE03TechnionYes (see NIH Registry)
RUES1The Rockefeller UniversityYes (see NIH Registry)
RUES2The Rockefeller UniversityYes (see NIH Registry)
RUES3The Rockefeller UniversityYes, with restrictions (see NIH Registry)
HES-3Stanley Lab at Monash UniversityNo
BJNhem19Jawharlal Nehru Centre for Advanced Scientific ResearchYes (see NIH Registry)
BJNhem20Jawharlal Nehru Centre for Advanced Scientific ResearchYes (see NIH Registry)
HS346Karolinska InstituteYes (see NIH Registry)
HS401Karolinska InstituteYes (see NIH Registry)
HS420Karolinska InstituteYes (see NIH Registry)
UCSF4University of California at San FranciscoYes (see NIH Registry)
CT1University of Connecticut School of MED/DNTYes (see NIH Registry)
CT2University of Connecticut School of MED/DNTYes (see NIH Registry)
CT3University of Connecticut School of MED/DNTYes (see NIH Registry)
CT4University of Connecticut School of MED/DNTYes (see NIH Registry)
UM4-6University of MichiganYes (see NIH Registry)
UM14-1University of MichiganYes (see NIH Registry)
UM14-2University of MichiganYes (see NIH Registry)
UM22-2University of MichiganYes (see NIH Registry)
Shef3University of SheffieldYes (see NIH Registry)
Shef6Unversity of SheffieldYes (see NIH Registry)
WIBR1Whitehead Institutie for Biomedical ResearchYes (see NIH Registry)
WIBR2Whitehead Institutie for Biomedical ResearchYes (see NIH Registry)
WIBR3Whitehead Institutie for Biomedical ResearchYes (see NIH Registry)
WIBR4Whitehead Institutie for Biomedical ResearchYes (see NIH Registry)
WIBR5Whitehead Institutie for Biomedical ResearchYes (see NIH Registry)
WIBR6Whitehead Institutie for Biomedical ResearchYes (see NIH Registry)
WA15WicCell Research InstituteYes (see NIH Registry)
WA17WicCell Research InstituteYes (see NIH Registry)
WA18WicCell Research InstituteYes (see NIH Registry)
WA19WicCell Research InstituteYes (see NIH Registry)
WA20WicCell Research InstituteYes (see NIH Registry)
WA21WicCell Research InstituteYes (see NIH Registry)
WA22WicCell Research InstituteYes (see NIH Registry)
WA23WicCell Research InstituteYes (see NIH Registry)
WA24WicCell Research InstituteYes (see NIH Registry)
WA25WicCell Research InstituteYes (see NIH Registry)
WA26WicCell Research InstituteYes (see NIH Registry)
WA27WicCell Research InstituteYes (see NIH Registry)
MEL-1University of QueenslandYes (see NIH Registry)
MEL-2University of QueenslandYes (see NIH Registry)
MEL-3University of QueenslandYes (see NIH Registry)
MEL-4University of QueenslandYes (see NIH Registry)
ESI-014BioTime, Inc.Yes (see NIH Registry)
ESI-017BioTime, Inc.Yes (see NIH Registry)
ESI-035BioTime, Inc.Yes (see NIH Registry)
ESI-049BioTime, Inc.Yes (see NIH Registry)
ESI-053BioTime, Inc.Yes (see NIH Registry)
CSES2Cedars-Sinai Medical CenterYes (see NIH Registry)
CSES4Cedars-Sinai Medical CenterYes (see NIH Registry)
CSES7Cedars-Sinai Medical CenterYes (see NIH Registry)
CSES11Cedars-Sinai Medical CenterYes (see NIH Registry)
CSES12Cedars-Sinai Medical CenterYes (see NIH Registry)
CSES15Cedars-Sinai Medical CenterYes (see NIH Registry)
CSES17Cedars-Sinai Medical CenterYes (see NIH Registry)
CSES19Cedars-Sinai Medical CenterYes (see NIH Registry)
CSES25Cedars-Sinai Medical CenterYes (see NIH Registry)
CSES5Cedars-Sinai Medical CenterYes (see NIH Registry)
CSES6Cedars-Sinai Medical CenterYes (see NIH Registry)
CSES18Cedars-Sinai Medical CenterYes (see NIH Registry)
HAD-C 100Hadassah Hebrew University Medical CenterYes (see NIH Registry)
HAD-C 102Hadassah Hebrew University Medical CenterYes (see NIH Registry)
HAD-C 106Hadassah Hebrew University Medical CenterYes (see NIH Registry)
I3Technion R&D FoundationYes (see NIH Registry)
I4Technion R&D FoundationYes (see NIH Registry)
I6Technion R&D FoundationYes (see NIH Registry)
NMR-1University of Texas Health Sciences Center at HoustonYes (see NIH Registry)
CR-4University of Texas Health Sciences Center at HoustonYes (see NIH Registry)
Elf1University of WashingtonYes (see NIH Registry)
UM63-1University of MichiganYes (see NIH Registry)
UM77-2University of MichiganYes (see NIH Registry)
UM33-4University of MichiganYes (see NIH Registry)
UM25-2University of MichiganYes (see NIH Registry)
UM121-7University of MichiganYes (see NIH Registry)
UM114-10University of MichiganYes (see NIH Registry)
UM78-2University of MichiganYes (see NIH Registry)
UCLA 1University of California Los AnegelesYes (see NIH Registry)
UCLA 2University of California Los AnegelesYes (see NIH Registry)
UCLA 3University of California Los AngelesYes (see NIH Registry)
UCLA 4University of California Los AngelesYes (see NIH Registry)
UCLA 5University of California Los AngelesYes (see NIH Registry)
UCLA 6University of California Los AngelesYes (see NIH Registry)
UCLA 7University of California Los AngelesYes (see NIH Registry)
UCLA 8University of California Los AngelesYes (see NIH Registry)
UCLA 9University of California Los AngelesYes (see NIH Registry)
UCLA 10University of California Los AngelesYes (see NIH Registry)
UCLA 11University of California Los AngelesYes (see NIH Registry)
UCLA 12University of California Los AngelesYes (see NIH Registry)
UCLA 13University of California Los AngelesYes (see NIH Registry)
UCLA 14University of California Los AngelesYes (see NIH Registry)
UCLA 15University of California Los AngelesYes (see NIH Registry)
UCLA 16University of California Los AngelesYes (see NIH Registry)
UCLA 17University of California Los AngelesYes (see NIH Registry)
UCLA 18University of California Los AngelesYes (see NIH Registry)

*See NIH Registry for most up-to-date list of funding-eligible lines. Lines not eligible for federal funding may still be used at Harvard with private funding provided ESCRO and other required approvals are obtained.


Training: Stem Cell and ESCRO Training