NIH Form 2890-Request for Human Embryonic Stem Cell

Instructions for Completing NIH Form 2890
Request for Human Embryonic Stem Cell Line
to be Approved for Use in NIH Funded Research
OMB Approval 0925-0601
Expiration Date: October 31, 2022

Table of Contents
Introduction
Submission through the NIH Form 2890
Website
 eRA Commons Registration
 Signing Official Authority
 eRA Commons support
General Information about Submission
     Saving Data, FOIA, and Intent to
Submit
 Form 2890 support
Selection of Method of NIH Review
 NIH Administrative Review
 Working Group of the ACD Review

Completing Form 2890
 Administrative Information
 Stem Cell Line Information

 Adding Additional Related Cell Lines
 Uploading Supporting Information
       Supporting Information for NIH Administrative
Review
       Supporting Information for Working Group of the
ACD Review
     Assurance, Certification, Authority and Final
Submission
Final Submission and Email Confirmation
     Printing Your Submission
Notification of NIH Determination

Introduction
NIH Guidelines for Human Stem Cell Research, effective July 7, 2009, established an NIH Human
Embryonic Stem Cell Registry listing human embryonic stem cells (hESCs) eligible for use in NIH
funded research. Only hESCs that have been reviewed and deemed eligible by the NIH in accordance
with the Guidelines may be used in NIH supported research.
NIH Form 2890 is provided for the purposes of submitting information about hESC lines to the NIH,
along with assurances and supporting documentation of compliance with the NIH Guidelines. NIH will
conduct either an Administrative Review, or review by a Working Group of the Advisory Committee to
the [NIH] Director (ACD). The Working Group of the ACD will make recommendations to the ACD, which
will advise the NIH Director, who will make the final determination of whether a hESC line is approved
for use in NIH funded research.
All approved lines will be listed on the NIH Registry. The Registry will
also contain basic information about organizations intending to submit lines to the Registry, lines
pending NIH review and lines not approved for NIH funding eligibility.

Submission of hESC line through the NIH Form 2890 Web Site
NIH Form 2890 is a web-based form only, and must be submitted electronically through this web site:
http://hESCRegApp.od.nih.gov/Login/.
eRA Commons Registration: An organization wishing to submit a hESC line for review must be
registered in the eRA Commons. This is a one-time registration and is necessary for NIH validation
purposes. Organizations may verify their current registration status by accessing the List of Grantee
Organizations Registered in NIH eRA Commons at
http://era.nih.gov/commons/quick_queries/index.cfm#commons. To register an Organization in the eRA
Commons follow these instructions:
https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. Note that a DUNS
number must be included in the Institutional Profile. If your organization does not have a DUNS number
you may obtain one from: http://fedgov.dnb.com/webform/displayHomePage.do.
Signing Official Authority: Requests may be submitted by the individual with a Signing Official (SO)
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role for the organization. Requests may also be submitted by another appropriate individual within an
organization who has an eRA Commons UserID and password, provided that the SO approves the
submission and provides the necessary certification and assurance via a signed letter on institutional
letterhead, and attached as an uploaded document with the request. A sample letter (MS Word - 44 KB)
is provided for this purpose. To log into the system and complete NIH 2890, the individual must provide
his/her eRA Commons UserID and password. Once a Commons user enters a draft request, only that
individual has the rights to edit and submit the request. However, the system provides a way to email
copies of draft requests to the individuals of their choosing for review.
eRA Commons Support: For questions or problems concerning obtaining an eRA Commons account,
please contact Commons Support at 1-866-504-9552, or email [email protected] and a customer
service representative will be in contact with you.

General Information about Submission
Upon successful log-in to the NIH 2890 web site, you will be required to select the method of NIH review
of your request. The two methods of review are Administrative Review, or review by the Working Group
of the ACD. Your selection is based on a number of factors, including where and when the embryo from
which the stem cells were derived was donated, and whether you are able to provide supporting
documentation that the embryo was donated in accordance with Section II(A) of the NIH Guidelines.
Please use the Guidelines to determine the appropriate method of review. A cell line that meets the
requirements of Section II(A) should be reviewed by NIH Administrative Review. Review by the Working
Group of the ACD is only appropriate for:
cell lines donated prior to July 7, 2009 which do not meet the exact specifications of Section II(A)
but for which the embryos 1) were created using in vitro fertilization for reproductive purposes
and were no longer needed for this purpose; and 2) that were donated by donor(s) who gave
voluntary written consent for the human embryos to be used for research purposes, or
cell lines from embryos donated outside the US on or after July 7, 2009 that do not meet the
exact specifications of Section II(A) but for which the applicant believes the procedural standards
of the foreign country provide protections at least equivalent to Section II(A) and were followed.
NOTE: NIH encourages you to select NIH Administrative Review if you believe that your cell line meets
the Section II(A) requirements. If NIH determines that the line is not approvable under Section II(A), NIH
will then refer the submission for ACD review under Section II(B) if the line is eligible for such review.
It is important that you select the method of review carefully. Once you have made a selection you
cannot change your selection without exiting the system and logging in again. You may contact the NIH
Registry at: [email protected] and request that a submission be deleted.
Following your selection of method of review, you will be directed to complete the remaining sections of
Form 2890, where administrative and stem cell line information will be entered, and you will upload
supporting documentation for Administrative Review or review by the Working Group of the ACD.
Form 2890 provides the ability to submit multiple hESC lines in one submission, when all of the following
circumstances are present:
1. the same organization is submitting all of the hESC lines;
2. the method of review for all of the hESC lines is the same (either Administrative Review or
Working Group of the ACD review), and
3. the supporting information for all of the hESC lines included in the submission is exactly identical.
When multiple hESC lines are part of one submission, NIH will review the request as a single
submission. If the request is approved then each hESC line will receive a separate NIH approval
number and be listed separately on the NIH Registry. It is critical that the supporting information for all of
the hESCs included in a single submission is identical.
The last section of Form 2890 is the Assurance, Certification, Authority and Final Submission section. If
the Signing Official, who has direct or delegated authority to sign on behalf of the organization, is
submitting the request, the authority, certification and assurance is provided electronically. If selecting
review by the Working Group of the ACD, the SO will be required to indicate, by selection of the
appropriate assurance, whether requesting review by the Working Group under Section II(B) or II(C) of
the NIH Guidelines. If an individual other than a Signing Official is submitting the form, then the
necessary authority, certification and assurance are provided in a letter that is signed by the SO and
uploaded as part of the request.
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Saving Data, Public Information, and Intent to Submit
Users have the ability to save data to avoid a timeout of the session and potential data loss. When
saving a draft, the system does not check to see that all data meets required validations. All data
validations are performed when the "Submit FINAL Registry Request"; button is clicked. A session lasts
approximately one hour, but each time the user clicks the "Save DRAFT for Further Editing" button, the
session in restarted.
In addition, if you start a session and click the "Save DRAFT for Further Editing" button, then the
session will be saved on the NIH server as a draft. You may come back at a later time or date and
complete the submission.
All information submitted with regard to a request for approval of a human embryonic stem cell line must
be submitted in a form so that it may be made available by NIH to the public.  Do not submit any
financial, commercial, confidential or proprietary information.  Do not submit consent documents with the
personally identifying information/names of donor(s) of the embryos (the individual(s) who sought
reproductive treatment).  Proprietary and/or personal information may be redacted by the submitters. 
PLEASE NOTE:  NIH Intends to treat all information which is submitted, unless there is written
agreement to the contrary, as information which may be made available to the public.
In order to provide the community with information about plans to submit a particular cell line, if you do
not complete a session, and have clicked the "Save DRAFT for Further Editing" button, the name of the
applicant organization (item 3) and the name of any stem cell lines that have been entered (item 6), will
be posted on the NIH Registry under "Institutions Intending to Submit hESC Lines." If you decide not to
complete the submission, please contact [email protected] and request that the draft(s) be
purged and removed from this list. If you do not complete a submission within 6 months after the last
updated date, then the draft will automatically be purged and removed from the list of institutions
intending to submit hESC lines for review.
Form 2890 Support
Questions concerning the NIH Guidelines and use of Form 2890 should be addressed to the NIH
Registry at: [email protected]. In addition, a Sample Web Version of the form is available for
review; however, it is not an interactive form and you may not enter data into the sample.

Selection of Method of NIH Review
The two methods of NIH review, NIH administrative review and review by the working group of the
Advisory Committee to Director of NIH (ACD), and the criteria and supporting information required for
each are described below. A simplified decision tree (PDF - 15 KB) is also available to assist with your
selection.
NIH Administrative Review
NIH Administrative Review should be selected if the organization has documentation related to the
embryo donation that demonstrates compliance with all of the elements of Section II(A) of the NIH
Guidelines. Regardless of where or when the embryo was donated, this option is available for all hESC
lines for which there is supporting documentation. For embryos donated in the United States on or after
July 7, 2009, compliance with Section II(A) is mandatory and therefore the only method of review
available for such cell lines is NIH Administrative Review.
NOTE: NIH encourages you to select NIH Administrative Review if you believe that your cell line meets
the Section II(A) requirements. If NIH determines that the line is not approvable under Section IIA, NIH
will then refer the submission for ACD review under Section II(B) if the line is eligible for such review.
Supporting documents should be those that were used (such as a consent form) or in force (such as a
policy) at the time of the relevant activity, such as embryo donation or reproductive treatment.
Documents may include, for example, the consent for donation of embryos for research purposes; the
research protocol or other document(s) demonstrating the relative timing of reproductive treatment and
the donation of embryos for research purposes; the consent for reproductive treatment (including the
consent for cryopreservation of embryos, if applicable); relevant written policies; or other documents,
such as a copy of the Embryonic Stem Cell Research Oversight (ESCRO) or Institutional Review Board
(IRB) or ethics committee approval to derive or use the line, or documentation of a committee's
exemption from review. For consents, please submit the signed version (with any identifiers redacted),
or confirm that a unsigned document was the version signed by the donors. Aside from signatures on
consents, when possible, NIH would appreciate receiving typed documents (rather than handwritten
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information) in order to make documents more readily accessible (508-compliant). For scanned
documents, please scan at a minimum of 200 dots per inch (dpi).
The supporting information must provide evidence of compliance with each of the following elements of
Section II(A) of the NIH Guidelines:
Element 1. hESCs were derived from human embryos that were created using in vitro
fertilization for reproductive purposes and were no longer needed for this purpose.

Element 2. hESCs were derived from human embryos that were donated by individuals
who sought reproductive treatment (donor(s)) and who gave voluntary written consent for
the human embryos to be used for research purposes.

where treatment was sought
Element 3. All options available in the health care facility
pertaining to the embryos no longer needed for reproductive purposes were explained to
the individual(s) who sought reproductive treatment.

for the donated embryos.
Element 4. No payments, cash or in kind, were offered

Element 5. Policies and/or procedures were in place at the health care facility where
the
embryos were donated that neither consenting nor refusing to donate embryos for
research would affect the quality of care provided to potential donor(s).
There was a clear separation between the prospective donor(s)’s decision to create
human embryos for reproductive purposes and the prospective donor(s)’s decision to
donate human embryos for research purposes. Specifically:

Element
6. Decisions related to the creation of human embryos for reproductive purposes
should have been made free from the influence of researchers proposing to derive or
utilize hESCs in research. The attending physician responsible for reproductive clinical
care and the researcher deriving and/or proposing to utilize hESCs should not have been
the same person unless separation was not practicable.

Element 7. At the time of donation, consent for that donation
should have been obtained
from the individual(s) who had sought reproductive treatment. That is, even if potential
donor(s) had given prior indication of their intent to donate to research any embryos that
remained after reproductive treatment, consent for the donation for research purposes
should have been given at the time of the donation.
Element 8. Donor(s) should have been informed that
they retained the right to withdraw
consent until the embryos were actually used to derive embryonic stem cells or until
information that could identify the donor(s) was no longer retained by the researchers, if
applicable.
During the consent process, the donor(s) were informed of the following:
Element 9. The embryos would be used to derive hESCs for research.

Element 10.What would happen to the embryos in the derivation of hESCs
for research.
Element 11. hESCs derived from the embryos might be kept for many years.

Element 12. The donation was made without any restriction or direction regarding
the
individual(s) who may receive medical benefit from the use of the hESCs, such as who
may be the recipients of transplants of the cells.

Element 13. The research was not intended to provide
direct medical benefit to the
donor(s).
Element
14. The results of research using the hESCs may have commercial potential, and
that the donor(s) would not receive financial or any other benefits from any such
commercial development.

Element 15. Whether information
that could identify the donor(s) would be available to
researchers.
Working Group of the ACD Review
With the exception of embryos donated in the United States on or after July 7, 2009, review by the
Working Group of the ACD is possible. The Working Group will review the materials as described below,
and make recommendations regarding eligibility for NIH funding to its parent group, the Advisory
Committee to the Director (ACD) of NIH. The ACD will make recommendations to the NIH Director, who
will make the final determination of whether an hESC line is approved for use in NIH funding.
Embryos donated prior to July 7, 2009. Working Group of the ACD review is possible for embryos
donated prior to July 7, 2009, in any country, under Section II(B) of the NIH Guidelines. Supporting
information will be similar to that provided for Administrative Review (e.g., consent forms, written
policies, or other documents such as a copy of the Embryonic Stem Cell Research Oversight (ESCRO)
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or Institutional Review Board (IRB) or ethics committee approval to use the line, or documentation of a
committee's exemption from review).
Under Section II(B) of the NIH Guidelines, the supporting documentation must demonstrate that the
hESCs were derived from human embryos:
1. that were created using in vitro fertilization for reproductive purposes and were no longer needed
for this purpose; and
2. that were donated by donor(s) who gave voluntary written consent for the human embryos to be
used for research purposes.
The Working Group will consider the submitted materials taking into account the principles articulated in
Section II(A) of the Guidelines, HHS regulations for the Protection of Human Research Subjects
(45
CFR 46 Subpart A), and the following additional points to consider: during the informed consent
process, including written or oral communications, whether the donor(s) were:
1. informed of other available options pertaining to the use of the embryos;
2. offered any inducements for the donation of the embryos; and
3. informed about what would happen to the embryos after the donation for research.
Embryos donated outside of the United States on or after July 7, 2009. Working Group of the ACD
review is possible for embryos donated outside the United States on or after July 7, 2009, under Section
II(C) of the NIH Guidelines. Supporting documentation demonstrating that the alternative procedural
standards of the foreign country where the embryo was donated provide protections at least equivalent
to those provided by Section II(A) of the Guidelines will be required.

Completing NIH Form 2890
Please review the instructions below prior to completing the form, uploading supporting documentation,
and final submission.
Remember that if you click "Save DRAFT for Further Editing" and do not complete the submission, the
data entered thus far is saved on the NIH server as a draft and the name of the applicant organization
(item 3) and the name of any stem cell lines that have been entered (item 6), will be posted on the NIH
Registry under institutions intending to submit hESC lines for review.
Do not click the Back button to enter additional information or Refresh the screen. These actions can
result in data corruption or data loss. Please remember to save your data often (every 10-15 minutes).
Administrative Information
1. Signing Official. Enter the name, phone number and email address of the Signing Official (SO,
also known as the Authorized Organizational Representative). The SO must have designated or
delegated authority to sign on behalf of the organization.
2. Submitter of Request.   If submitted by anyone other than the Signing Official, please enter the
name, phone and email address of the submitter. In these cases, a copy of a letter signed by the
SO must be provided as one of the documents in the Supporting Information section of the
request form. See sample letter (MS Word - 44 KB) for appropriate language. In addition, users
have the ability to send the SO or other individuals a copy of the draft request upon saving draft
changes and from the main NIH Form 2890 selection screen in the "Edit Draft Request(s)"
section. NIH questions about the submission will be emailed to both the Signing Official and
submitter (if different).
3. Organization Name and DUNS Number. Enter the applicant organization name and DUNS
number. This information should match the information in the eRA Commons account. You may
verify the organization name and DUNS number at:
http://era.nih.gov/commons/quick_queries/index.cfm#commons
4. Organization Address. Enter the applicant organization's address.
5. NIH Grant or Application Number. If there is an NIH grant or pending NIH application that
would potentially use the stem cell line(s) that is(are) the subject of the request, please provide
the numbers, using the following format: HL123456, AI654321, AG345678. If you are requesting
approval for multiple stem cell lines, you may enter multiple application numbers. The response
to this question will have no bearing on the NIH review or approval of the submission.
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Stem Cell Line Information
6. Name of Stem Cell Line.  Enter the cell line's common or official name.
7. Cell Line Availability. Check yes or no to indicate whether the cell line will be available for use
by the research community if approved for use in NIH funded research. NIH strongly encourages
that hESC lines be made widely available to facilitate the advancement of new scientific
knowledge. NIH Principles and Guidelines for Recipients of NIH Research Grants and Contracts
on Obtaining and Disseminating Biomedical Research Resources stress the importance of
sharing unique research resources and dissemination of research tools to advance science and
further discovery. Similarly, NIH Best Practices for the Licensing of Genomic Inventions
encourage licensing policies and strategies that maximize access of genomic technologies.
If you answer "yes" to item 7 you must complete items 8 and 9A. If a hESC line is approved for
use in NIH funding, information entered into items 8 and 9 will appear on the NIH Registry.
If it is unknown at this time whether the cell line will be available for distribution, check "other" and
provide a brief explanation, e.g., unknown at this time, potentially available in the future, etc.
8. Restrictions (if any) on Use of Stem Cell Line. If there are any limitations on the use of the
hESC line (e.g., no commercial use, in-vitro research only, diabetes research only), please
describe those restrictions in the space available. If the line is approved this information will
appear on the NIH Registry. Enter "None" if there are no restrictions.
9. Provider of Stem Cell Line. Enter contact information for researchers wishing to obtain the
hESC line(s). You may provide the name of an individual, organization, or stem cell bank, and a
phone number, email address or URL. If the line is approved this information will appear on the
NIH Registry. If the answer to Question 7 is "Yes", answer to 9A is required: 9B-D are optional.
10. Embryo Donation.  Indicate whether the embryo was donated in the United States or outside the
United States, and the year in which the embryo was donated. If the embryo was donated in
2009, please also include the day and month of donation. This information is relevant to the NIH
review of the hESC line. The answers to item 10 will not appear on the NIH Registry.
Adding Additional Related Cell Lines
You may add additional hESC lines to your request. The method of review and the supporting
information (see next section Uploading Supporting Information) must be precisely identical to the
information for the hESC line identified in item 6.   If the method of review or any of the supporting
information for another hESC would differ in any way (even in a non-substantive way), you must
complete separate requests.
To add another cell line to your request, click “Add Another Cell Line with Identical Supporting
Information.” You will automatically be routed to a confirmation page that your submission thus far has
been saved. (Important Note: Be sure not to click the Back Button to enter additional data or to
Refresh the screen. These actions can result in data corruption or data loss.) Scroll to the bottom and
click “Continue to Edit Draft Request” and you will be directed to complete items 6-10 for another cell
line. The new cell line will not be saved until you click one of the "Save DRAFT for Further Editing"
buttons. You may repeat this process to add additional cell lines. When you have finished adding all the
cell lines to be included in the submission, you will have the opportunity to upload one set of supporting
documentation for all of the cell lines. When more than one cell line has been entered, you will have the
option of deleting the last line saved, by clicking "DELETE Cell Line #_."
Supporting Information (Document Attachments)
11. Supporting Information. All requests for NIH review require that you upload supporting
information. All supporting information must be in English. For materials presented to embryo
donors: please indicate the language in which the documents provided to the donors were
written. Please also address whether the donors received the information in their native/preferred
language or in a language in which they were sufficiently fluent.
All information submitted with regard to a request for approval of a human embryonic stem cell
line must be submitted in a form so that it may be made available by NIH to the public.  Do not
submit any financial, commercial, confidential or proprietary information.  Do not submit consent
documents with the personally identifying information/names of donor(s) of the embryos (the
individual(s) who sought reproductive treatment).  Proprietary and/or personal information may be
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redacted by the submitters.  PLEASE NOTE:  NIH Intends to treat all information which is
submitted, unless there is written agreement to the contrary, as information which may be
made available to the public.
In the event that you mistakenly upload an incorrect document, once you have uploaded
documents and clicked "Save DRAFT for Further Editing" you will have the opportunity to delete
any uploaded documents. Deleting a document removes the file from the NIH system. A copy will
not be retained.
If the individual submitting the request is not a Signing Official (SO) with direct or delegated
authority to sign on behalf of the organization, one of the attachments must be a letter signed by
the SO. See the sample letter (MS Word - 44 KB) for appropriate language. If you are requesting
NIH Administrative Review, check �other� in the Supporting Elements question for the letter
of the SO.
Supporting Information for NIH Administrative Review. (If you did not select NIH Administrative
Review, go to Supporting Information for Working Group of the ACD Review below.)
If you selected NIH Administrative Review, then you must provide information demonstrating compliance
with each element of Section II(A).
Supporting documents should be those that were used (such as a
consent form) or in force (such as a policy) at the time of the relevant activity, such as embryo donation
or reproductive treatment. Documents may include, for example, the consent for donation of embryos for
research purposes; the research protocol or other document(s) demonstrating the relative timing of
reproductive treatment and the donation of embryos for research purposes; the consent for reproductive
treatment (including the consent for cryopreservation of embryos, if applicable); relevant written policies;
or other documents, such as a copy of the Embryonic Stem Cell Research Oversight (ESCRO) or
Institutional Review Board (IRB) or ethics committee approval to derive or use the line, or
documentation of a committee's exemption from review. For consents, please submit the signed version
(with any identifiers redacted), or confirm that a unsigned document was the version signed by the
donors. Aside from signatures on consents, when possible, NIH would appreciate receiving typed
documents (rather than handwritten information) in order to make documents more readily accessible
(508-compliant). For scanned documents, please scan at a minimum of 200 dots per inch (dpi).
Failure to provide documentation for any element of Section II(A) will result in the cell line not being
approved for NIH funding under the NIH Administrative Review process.
To upload supporting information:
Click the "Browse" buttons below to select a file from your computer. Valid document file type
extensions are doc, xls, ppt, pdf, rtf, wpd, gif, jpg, txt or csv.
Provide a brief description (limit 100 characters) of the file (e.g., consent document, clinic policy,
SO letter, etc.) in the box provided.
For consents, please submit the signed version (with any identifiers redacted), or confirm that a
unsigned document was the version signed by the donors. Aside from signatures on consents,
when possible, NIH would appreciate receiving typed documents (rather than handwritten
information) in order to make documents more readily accessible (508-compliant). For scanned
documents, please scan at a minimum of 200 dots per inch (dpi).
Select which of the 15 element(s) of Section II(A) of the Guidelines are supported by the document. You
may choose multiple elements for each document. Up to 10 supporting documents may be attached. If
you fail to select each of the 15 elements at least once, you will receive an error message that at least
one of the elements is not checked and the system will not permit you to finalize your submission.
Supporting Information for Working Group of the ACD Review. Applicants are encouraged to
provide, as document 1, a summary document explaining how the attachments address the materials
that the Working Group will consider (see below).
If the embryos were donated prior to July 7, 2009, in any country, upload supporting information
demonstrating that the hESCs were derived from human embryos:
1. that were created using in vitro fertilization for reproductive purposes and were no longer needed
for this purpose; and
2. that were donated by donor(s) who gave voluntary written consent for the human embryos to be
used for research purposes.

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Additional information that will be relevant to the review of the Working Group includes documentation
addressing the principles articulated in Section II(A) of the NIH Guidelines, the HHS regulations for the
Protection of Human Research Subjects (45 CFR 46 Subpart A), and the following additional points to
consider: during the informed consent process, including written or oral communications, whether the
donor(s) were:
1. informed of other available options pertaining to the use of the embryos;
2. offered any inducements for the donation of the embryos; and
3. informed about what would happen to the embryos after the donation for research.
If the embryos were donated on or after July 7, 2009, in a country other than the United States, the
supporting documentation is expected to demonstrate that the alternative procedural standards of the
foreign country where the embryo was donated provide protections at least equivalent to those provided
by Section II(A) of the NIH Guidelines.
To upload supporting information:
Click the "Browse" buttons below to select a file from your computer. Valid document file type
extensions are doc, xls, ppt, pdf, rtf, wpd, gif, jpg, txt or csv.
Provide a brief description (limit 100 characters) of the file (e.g., consent document, clinic policy,
SO letter, etc.) in the box provided.
Up to 10 supporting documents may be attached.
Comments
12. Comments. If there is any additional information you wish to provide regarding the submission,
you may enter it here. If your comments exceed 1,000 characters and spaces, you may upload
additional information as one of the attachments above and, if you are requesting an
Administrative Review, please check "Other" for the supporting Elements question.
Assurance, Certification, Authority and Final Submission
The Signing Official (SO) registered in the eRA Commons is the only official with the authority to provide
the necessary Assurance and Certifications. If the individual submitting the form is not the SO, one of
the attached supporting documents must be a letter signed by the SO, which provides the required
Assurance and Certifications. If the SO submits the form and has selected review by the Working Group
of the ACD, there are two Assurance options; only one may be checked. If the individual submitting the
form is not the SO, no Assurance, Certification and Authority boxes on the form should be checked; this
information must be provided in the letter signed by the SO. The sample letter (MS Word - 44 KB)
provides three assurance options; only one may be checked.

Final Submission and Email Confirmation
After clicking "Submit FINAL Registry Request" button, all data validations will be invoked. If any
required data is missing, you will need to make any necessary corrections prior to it being accepted as
final. Note that only partial data validation is performed when saving drafts, which allows you to have
incomplete work-in-progress requests. Once all final validations are passed, you will receive an email
confirmation and an NIH assigned request number that pertains to the submission.  The email will go to
the Signing Official and to the submitter, if one is identified in item 2.
If you have questions concerning your submission, please contact the NIH Registry at
[email protected], and reference the assigned request number.
The name of the organization submitting the request (item 3), the name(s) of the hESC cell line(s)
provided in item 6, and the method of NIH review selected (Administrative Review or Working Group of
the ACD) will appear on the NIH Registry under Submitted hESC Lines Pending Review.
Printing Your Submission
The email confirmation will include the entire text of the request, with all data you have entered and the
names of the uploaded files. Print or save this email as a record of your submission.

Notification of NIH Determination

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The results of the NIH review of the submission will be emailed to the SO and to the submitter, if one is
identified in item 2.
NIH decisions are final and may not be appealed.  NIH will provide the reason(s) for non-approval.  If
NIH determines that the line is not approvable under Section II(A), NIH will then refer the submission for
ACD review under Section II(B) if the line is eligible.

Go to NIH Stem Cell Information Page

Note: For help accessing PDF or MS Word files, see Help Downloading Files.

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Selection of Method of Review of hESC Line for
Eligibility for NIH Funding under NIH Guidelines for
Human Stem Cell Research
Was the embryo donated in accord with
Section II(A) of the NIH Guidelines?

Yes

No

When was the
embryo donated?

Select NIH
administrative review
and provide
supporting
information required
under Section II (A)

Prior to
7-7-2009

On or after
7-7-2009

Select Working Group of the ACD
review and provide supporting
information required under
Section II(B)

Where was the embryo donated?

In the US

If the embryo donation does not
meet the standards of Section
II(A) of the Guidelines, the cell
line is not eligible for listing on
the NIH Registry.

Outside the US

Select Working Group of the
ACD review and provide
supporting information that
the alternative procedural
standards of the foreign
country where the embryo
was donated provide
protections equivalent to
Section II(A)