Skip to content →

Stem Cells & ESCRO Policy

Policy Contacts

Melissa Lopes, J.D.
ESCRO Director; Senior Research Compliance Officer, OVPR

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.

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 by the due dates noted below. 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, unless otherwise indicated.  For new protocols, researchers should ensure that a representative of the lab is available to present and/or answer any questions.

Due Date

Meeting Date

2021 Reviews

1/22/21

2/9/21

4/9/21

4/27/21

8/27/21

9/14/21

11/26/21

12/14/21

 

1Date subject to change. Please check this page when preparing a submission for a meeting.
2The due date is usually two weeks prior to the meeting date; however, if the due date falls on or during a Harvard holiday, submissions will be due one week earlier.

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)

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 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.

Published in Uncategorized

Skip to toolbar