Stem Cells & ESCRO Policy

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.

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

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.

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 ID	Source	Eligible for Federal Funding?*
CHB4	Children’s Hospital Boston	Yes (see NIH Registry)
CHB5	Children’s Hospital Boston	Yes (see NIH Registry)
CHB6	Children’s Hospital Boston	Yes (see NIH Registry)
CHB8	Children’s Hospital Boston	Yes (see NIH Registry)
CHB9	Children’s Hospital Boston	Yes (see NIH Registry)
CHB10	Children’s Hospital Boston	Yes (see NIH Registry)
CHB11	Children’s Hospital Boston	Yes (see NIH Registry)
CHB12	Children’s Hospital Boston	Yes (see NIH Registry)
GENEA002	GENEA	Yes (see NIH Registry)
GENEA048	GENEA	Yes (see NIH Registry)
GENEA015	GENEA	Yes (see NIH Registry)
GENEA016	GENEA	Yes (see NIH Registry)
GENEA047	GENEA	Yes (see NIH Registry)
GENEA042	GENEA	Yes (see NIH Registry)
GENEA043	GENEA	Yes (see NIH Registry)
GENEA057	GENEA	Yes (see NIH Registry)
GENEA052	GENEA	Yes (see NIH Registry)
H1 (WA01)	WiCell Research Institute	Yes (see NIH Registry)
H7 (WA07)	WiCell Research Institute	Yes (see NIH Registry)
H9 (WA09)	WiCell Research Institute	Yes
H13 (WA13)	WiCell Research Institute	Yes
H14 (WA14)	WiCell Research Institute	Yes
HUES 1-24	Harvard (HUES lab)	Yes, with restrictions (see NIH Registry)
HUES 25	Harvard (HUES lab)	No
HUES 26-28	Harvard (HUES lab)	Yes, with restrictions (see NIH Registry)
HUES 29	Harvard (HUES lab)	No (submitted for future NIH consideration)
HUES 31-41	Harvard (HUES lab)	No (submitted for future NIH consideration)
HUES 42	Harvard (HUES lab)	Yes (see NIH Registry)
HUES 43	Harvard (HUES lab)	No (submitted for future NIH consideration)
HUES 44-45	Harvard (HUES lab)	Yes (see NIH Registry)
HUES 46-47	Harvard (HUES lab)	No (submitted for future NIH consideration)
HUES 48	Harvard (HUES lab)	Yes (see NIH Registry)
HUES 49	Harvard (HUES lab)	Yes (see NIH Registry)
HUES 50-52	Harvard (HUES lab)	No (submitted for future NIH consideration)
HUES 53	Harvard (HUES lab)	Yes (see NIH Registry)
HUES 54-61	Harvard (HUES lab)	No (submitted for future NIH consideration)
HUES 62-66	Harvard (HUES lab)	Yes (see NIH Registry)
HUES 67	Harvard (HUES lab)	No (submitted for future NIH consideration)
HUES 68-70	Harvard (HUES lab)	Yes (see NIH Registry)
HUES PGD 1	Harvard (HUES lab)	No (submitted for future NIH consideration)
HUES PGD 2	Harvard (HUES lab)	No (submitted for future NIH consideration)
HUES PGD 3	Harvard (HUES lab)	Yes (see NIH Registry)
HUES PGD 4-9	Harvard (HUES lab)	No (submitted for future NIH consideration)
HUES PGD 10-12	Harvard (HUES lab)	Yes (see NIH Registry)
HUES PGD 13	Harvard (HUES lab)	Yes (see NIH Registry)
HUES PGD 14	Harvard (HUES lab)	Yes (see NIH Registry)
HUES PGD 15	Harvard (HUES lab)	Yes (see NIH Registry)
HUES PGD 16	Harvard (HUES lab)	Yes (see NIH Registry)
SA01	Cellartis AB	Yes (see NIH Registry)
SA02	Cellartis AB	Yes (see NIH Registry)
TE03	Technion	Yes (see NIH Registry)
RUES1	The Rockefeller University	Yes (see NIH Registry)
RUES2	The Rockefeller University	Yes (see NIH Registry)
RUES3	The Rockefeller University	Yes, with restrictions (see NIH Registry)
HES-3	Stanley Lab at Monash University	No
BJNhem19	Jawharlal Nehru Centre for Advanced Scientific Research	Yes (see NIH Registry)
BJNhem20	Jawharlal Nehru Centre for Advanced Scientific Research	Yes (see NIH Registry)
HS346	Karolinska Institute	Yes (see NIH Registry)
HS401	Karolinska Institute	Yes (see NIH Registry)
HS420	Karolinska Institute	Yes (see NIH Registry)
UCSF4	University of California at San Francisco	Yes (see NIH Registry)
CT1	University of Connecticut School of MED/DNT	Yes (see NIH Registry)
CT2	University of Connecticut School of MED/DNT	Yes (see NIH Registry)
CT3	University of Connecticut School of MED/DNT	Yes (see NIH Registry)
CT4	University of Connecticut School of MED/DNT	Yes (see NIH Registry)
UM4-6	University of Michigan	Yes (see NIH Registry)
UM14-1	University of Michigan	Yes (see NIH Registry)
UM14-2	University of Michigan	Yes (see NIH Registry)
UM22-2	University of Michigan	Yes (see NIH Registry)
Shef3	University of Sheffield	Yes (see NIH Registry)
Shef6	Unversity of Sheffield	Yes (see NIH Registry)
WIBR1	Whitehead Institutie for Biomedical Research	Yes (see NIH Registry)
WIBR2	Whitehead Institutie for Biomedical Research	Yes (see NIH Registry)
WIBR3	Whitehead Institutie for Biomedical Research	Yes (see NIH Registry)
WIBR4	Whitehead Institutie for Biomedical Research	Yes (see NIH Registry)
WIBR5	Whitehead Institutie for Biomedical Research	Yes (see NIH Registry)
WIBR6	Whitehead Institutie for Biomedical Research	Yes (see NIH Registry)
WA15	WicCell Research Institute	Yes (see NIH Registry)
WA17	WicCell Research Institute	Yes (see NIH Registry)
WA18	WicCell Research Institute	Yes (see NIH Registry)
WA19	WicCell Research Institute	Yes (see NIH Registry)
WA20	WicCell Research Institute	Yes (see NIH Registry)
WA21	WicCell Research Institute	Yes (see NIH Registry)
WA22	WicCell Research Institute	Yes (see NIH Registry)
WA23	WicCell Research Institute	Yes (see NIH Registry)
WA24	WicCell Research Institute	Yes (see NIH Registry)
WA25	WicCell Research Institute	Yes (see NIH Registry)
WA26	WicCell Research Institute	Yes (see NIH Registry)
WA27	WicCell Research Institute	Yes (see NIH Registry)
MEL-1	University of Queensland	Yes (see NIH Registry)
MEL-2	University of Queensland	Yes (see NIH Registry)
MEL-3	University of Queensland	Yes (see NIH Registry)
MEL-4	University of Queensland	Yes (see NIH Registry)
ESI-014	BioTime, Inc.	Yes (see NIH Registry)
ESI-017	BioTime, Inc.	Yes (see NIH Registry)
ESI-035	BioTime, Inc.	Yes (see NIH Registry)
ESI-049	BioTime, Inc.	Yes (see NIH Registry)
ESI-053	BioTime, Inc.	Yes (see NIH Registry)
CSES2	Cedars-Sinai Medical Center	Yes (see NIH Registry)
CSES4	Cedars-Sinai Medical Center	Yes (see NIH Registry)
CSES7	Cedars-Sinai Medical Center	Yes (see NIH Registry)
CSES11	Cedars-Sinai Medical Center	Yes (see NIH Registry)
CSES12	Cedars-Sinai Medical Center	Yes (see NIH Registry)
CSES15	Cedars-Sinai Medical Center	Yes (see NIH Registry)
CSES17	Cedars-Sinai Medical Center	Yes (see NIH Registry)
CSES19	Cedars-Sinai Medical Center	Yes (see NIH Registry)
CSES25	Cedars-Sinai Medical Center	Yes (see NIH Registry)
CSES5	Cedars-Sinai Medical Center	Yes (see NIH Registry)
CSES6	Cedars-Sinai Medical Center	Yes (see NIH Registry)
CSES18	Cedars-Sinai Medical Center	Yes (see NIH Registry)
HAD-C 100	Hadassah Hebrew University Medical Center	Yes (see NIH Registry)
HAD-C 102	Hadassah Hebrew University Medical Center	Yes (see NIH Registry)
HAD-C 106	Hadassah Hebrew University Medical Center	Yes (see NIH Registry)
I3	Technion R&D Foundation	Yes (see NIH Registry)
I4	Technion R&D Foundation	Yes (see NIH Registry)
I6	Technion R&D Foundation	Yes (see NIH Registry)
NMR-1	University of Texas Health Sciences Center at Houston	Yes (see NIH Registry)
CR-4	University of Texas Health Sciences Center at Houston	Yes (see NIH Registry)
Elf1	University of Washington	Yes (see NIH Registry)
UM63-1	University of Michigan	Yes (see NIH Registry)
UM77-2	University of Michigan	Yes (see NIH Registry)
UM33-4	University of Michigan	Yes (see NIH Registry)
UM25-2	University of Michigan	Yes (see NIH Registry)
UM121-7	University of Michigan	Yes (see NIH Registry)
UM114-10	University of Michigan	Yes (see NIH Registry)
UM78-2	University of Michigan	Yes (see NIH Registry)
UCLA 1	University of California Los Anegeles	Yes (see NIH Registry)
UCLA 2	University of California Los Anegeles	Yes (see NIH Registry)
UCLA 3	University of California Los Angeles	Yes (see NIH Registry)
UCLA 4	University of California Los Angeles	Yes (see NIH Registry)
UCLA 5	University of California Los Angeles	Yes (see NIH Registry)
UCLA 6	University of California Los Angeles	Yes (see NIH Registry)
UCLA 7	University of California Los Angeles	Yes (see NIH Registry)
UCLA 8	University of California Los Angeles	Yes (see NIH Registry)
UCLA 9	University of California Los Angeles	Yes (see NIH Registry)
UCLA 10	University of California Los Angeles	Yes (see NIH Registry)
UCLA 11	University of California Los Angeles	Yes (see NIH Registry)
UCLA 12	University of California Los Angeles	Yes (see NIH Registry)
UCLA 13	University of California Los Angeles	Yes (see NIH Registry)
UCLA 14	University of California Los Angeles	Yes (see NIH Registry)
UCLA 15	University of California Los Angeles	Yes (see NIH Registry)
UCLA 16	University of California Los Angeles	Yes (see NIH Registry)
UCLA 17	University of California Los Angeles	Yes (see NIH Registry)
UCLA 18	University of California Los Angeles	Yes (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.