Form 2890 Application

NIH Form 2890 - Request for Human Embryonic Stem Cell Line to be Ap...

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http://hescregapp.od.nih.gov/NIH_Form_2890_Sample.htm

Sample Web Version
NIH Form 2890
(10/28/2009)
(Note: This is not an interactive form.
Active system is at http://hescregapp.od.nih.gov/)

Entry Page for Submitting NIH Form 2890:

Request for Human Embryonic Stem Cell Line
to be Approved for Use in NIH Funded Research
NIH Form 2890
OMB Approval 0925-0601
Expiration Date: 02/28/2010
Privacy Notice: This collection of information is authorized by Executive Order 13505, Removing Barriers to Responsible
Scientific Research Involving Human Stem Cells (3/9/09) and 42 CFR 52.4, pertaining to documentation and assurances
that must accompany requests for NIH funding. Information submitted through this web site about human embryonic stem
cell (hESC) lines is wholly voluntary, and will be reviewed by NIH to determine eligibility of lines for use in NIH funded
research in accord with the NIH Guidelines on Human Stem Cell Research (74 FR 32170). If hESC lines are approved for
use in NIH funded research, the stem cell lines, and provider information if the lines are available for distribution, will be
posted on the NIH Human Embryonic Stem Cell Registry. NIH will also post the following information about institutions
intending to submit hESC lines for review (those submissions begun and saved but not submitted), lines pending review,
and lines reviewed by NIH: organization name, name of the stem cell line, and the method of NIH review (Administrative
Review or review by the Working Group of the Advisory Committee to the Director). Final, but incomplete submissions of
information may obviate NIH’s ability to conduct a review to determine eligibility for use in NIH funded research.
Burden Disclosure Statement: The NIH estimates that the average time to complete this form is 3 hours, including 2.5
hours to collect and prepare supporting information and 30 minutes to physically complete the form and upload all
supporting information. An agency may not conduct or sponsor the collection of information unless it displays a currently
valid OMB control number. Nor is a person required to respond to requests for the collection of information without this
control number. Send comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden, to: NIH, Project Clearance Office, 6705 Rockledge Drive MSC 7974,
Bethesda, MD 20892-7974, ATT: PRA (0925-0001).

Introduction
NIH Guidelines on Human Stem Cell Research, effective July 7, 2009, establish a new 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 that have been reviewed.

Submission of hESC line through the NIH Form 2890 Web Site
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/userreports/ipf_com_org_list.cfm. 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) 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

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and assurance via a signed letter on institutional letterhead, and attached as an uploaded document with the request. A
sample letter (MS Word - 41 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.
NIH Form 2890 hESC Request Support: Questions about this system may be emailed to the hESC Registry Help Desk
. In addition, Instructions for Completing NIH Form 2890 and a Sample Web Version of the form are available for review.
Note that the sample is not an interactive form and you may not enter data into the sample.

Login

eRA Commons UserID and Password Required:

Go to NIH Stem Cell Information Page

NIH Security Login Page:
(eRA Commons UserID and Password Required)

Secured Request Selection Page:
(Add New or Edit Draft Requests)

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Request for Human Embryonic Stem Cell Line
to be Approved for Use in NIH Funded Research
NIH Form 2890
OMB Approval 0925-0601
Expiration Date: 02/28/2010
Edit Draft Request(s)
You have successfully logged in to complete NIH Form 2890 Request for Human Embryonic Stem Cell Line to be
Approved for Use in NIH Funded Research
The NIH Guidelines on Human Stem Cell Research and the Instructions for Completing NIH Form 2890 should be read
prior to beginning the submission process. They include important information about submitting cell lines to the NIH
Registry, saving data during the submission process, NIH handling of draft submissions, uploading supporting information
and other considerations (e.g., assurances, authority to submit, and information that will appear on the NIH Registry).
Before entering any information you must select the appropriate method of NIH review of your request. The two methods
of review are Administrative Review and review by the Working Group of the Advisory Committee to the Director (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 individuals who sought reproductive treatment ("donor(s)") who gave
voluntary written consent for the human embryos to be used for research purposes, and
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.
It is important that you make the selection of 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 or to answer questions about this system.

Enter New Request:

Select Either Administrative or ACD Review:
NIH Administrative Review (ADM)
Working Group of the ACD Review
Enter New Request

Edit Draft Request(s):

Select Draft Request to Edit:
Draft
Number

Review
Type

Initial
Entry
Date

Email
Copy
of Draft

2009-DRAFT-017

ADM

09/21/2009

Email

2009-DRAFT-017

ACD

09/22/2009

Email

Note: Draft Requests not submitted
within 6 months after the Initial
Entry Date, will be deleted.
All Draft Requests are posted on the
Draft Requests in Process page.
Login: Commons\smithj
Date: 08/13/2009

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Go Back to NIH Form 2890 Login Page
Go to NIH Stem Cell Information Page

Secured Request Form for NIH Administrative Review:
Add New hESC Registry Request for NIH Administrative Review
Request for Human Embryonic Stem Cell Line to be Approved for Use in
NIH Funded Research Under Section II(A) of the Guidelines
The instructions for completing this form should be read prior to entering any information.
* Required fields are marked with a red asterisk.
Login Information: Commons\smithj (09/212009)

Administrative Information
* 1. Signing Official (SO):

2. Submitter of Request:
(* Required, if different
from Signing Official)

A. SO Name:
B. SO Phone Number:
C. SO Email Address:
A. Submitter Name:
B. Submitter Phone Number:
C. Submitter Email Address:
(Important Note: If submitted by anyone other than the Signing Official, a copy of a letter signed by
the SO must be provided as one of the documents in the Supporting Information section below.
See the sample letter (MS Word - 41 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.)

* 3. Organization Name:
DUNS Number:
* 4. Organization Address:

5. NIH Grant or Application
Number(s): (if applicable)

(Please use this format: HL123456, AI654321, AG345678)

(To avoid potential timeout and loss of data, be sure to save data often - Every 10-15 minutes)

Stem Cell Line Information
* 6. Name of Stem Cell Line:

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* 7. Cell Line Availability:

http://hescregapp.od.nih.gov/NIH_Form_2890_Sample.htm

If the cell line is approved for use with NIH funding, will it be available for
distribution to the research community?
Yes
No
Other
If Other, Please Specify:
(Please limit to 250 Characters and Spaces)

If the answer to Question 7 is "Yes", please complete Questions 8 and 9 below for posting on the NIH Registry.
8. Restrictions (if any)
on Use of Stem Cell Line:

(* If the answer to Question 7 is "Yes", an answer to Question 8 is required.
Enter "None" if there are no restrictions.
Please limit comments to 500 Characters and Spaces.)

9. Provider of Stem Cell Line:

A.
B.
C.
D.

Name of
Provider
Provider
Provider

Individual or Company:
Phone Number:
Email Address:
URL:

(* If the answer to Question 7 is "Yes", answer to 9A is required: 9B-D are optional.)

10. Embryo Donation:

A. Was the embryo from which the stem cell line was derived donated in
the United States?
Yes
No
Don't Know
B. If known, in what year was the embryo donated?

(e.g., 2001)

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. You will be required to complete items 6-10, as
appropriate, for any additional cell lines that are added to this request.

(To avoid potential timeout and loss of data, be sure to save data often - Every 10-15 minutes)

Supporting Information (Document Attachments)
* 11. Supporting Information:
You are expected to provide adequate documentation to support each element of II(A) of the NIH Guidelines. Failure to provide
documentation of any one element of II(A) will result in the cell line not being approved for NIH funding under the NIH
Administrative Review process.
All supporting information must be in English.
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. Please convert MS Office 2007 documents (e.g., .docx, xlsx, .pptx) to MS Office
2003 format (e.g., .doc, xls, .ppt), prior to uploading.

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Provide a brief description (limit 100 characters) of the file (e.g., consent document, clinic policy, SO letter, etc.) in the
box provided.
Select which element(s) of Section II(A) of the Guidelines are supported by the document from the list provided. You may
choose multiple elements for each document. Select "Other" if the document includes additional information not
necessarily associated with specific elements.
Note: All information submitted will be subject to the United States Freedom of Information Act. Do not submit any financial,
commercial, confidential, or proprietary information. Do not submit consent documents with personally identifying information of
the donor(s) of the embryos (the individuals who sought reproductive treatment).
Document 1:
Content Description:
Select which Element(s) Document 1 supports:
1
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Other

Document 2:
Content Description:
Select which Element(s) Document 2 supports:
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Other

Document 3:
Content Description:
Select which Element(s) Document 3 supports:
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Document 4:
Content Description:
Select which Element(s) Document 4 supports:
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Document 5:
Content Description:
Select which Element(s) Document 5 supports:
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Document 6:
Content Description:
Select which Element(s) Document 6 supports:
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Document 7:
Content Description:
Select which Element(s) Document 7 supports:
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Document 8:
Content Description:

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Select which Element(s) Document 8 supports:
1
9

2
10

3
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4
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5
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6
14

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15

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Other

Document 9:
Content Description:
Select which Element(s) Document 9 supports:
1
9

2
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Other

Document 10:
Content Description:
Select which Element(s) Document 10 supports:
1
9

2
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3
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4
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6
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7
15

8
Other

(To avoid potential timeout and loss of data, be sure to save data often - Every 10-15 minutes)

Comments
12. Comments:

If there is any additional information you wish to provide regarding this 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 check "Other"
for the supporting Elements question.

Please limit comments to 1,000 Characters and Spaces.

(To avoid potential timeout and loss of data, be sure to save data often - Every 10-15 minutes)

Assurance, Certification, Authority and Final Submission
Note: If you are a Signing Official with formal designated or delegated authority to sign on behalf of the organization,
check the Assurance, Certification, and Authority boxes to provide the required certifications. If you are not a Signing
Official with formal designated or delegated authority to sign on behalf of the organization, do not check the boxes,
but provide, as one of the attached supporting documents, a letter signed by the SO that provides the required
certifications (see Sample Letter (MS Word - 41 KB)).
Assurance (* Required, if submitted by SO. To be completed by SO only)
The applicant organization identified above hereby assures that the donation of the embryo from which the cell line
identified in item 6 was derived was in accordance with the elements of Section II(A) of the NIH Guidelines on Human
Stem Cell Research.

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Certification (* Required, if submitted by SO. To be completed by SO only)
By submitting this request, I certify that the statements and Assurance herein are true, complete and accurate to the
best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to
criminal, civil, or administrative penalties. (U.S. Code, Title 18, Section 1001).

Authority (* Required, if submitted by SO. To be completed by SO only)
I hereby confirm that I have the authority and/or rights pertaining to the human embryonic stem cell line identified in
item 6 to make this request for NIH review and determination of eligibility for use in NIH funded research (e.g., I am
the owner, deriver or licensee or have written permission of the same to submit). I have clearly and completely
identified any and all restrictions on the use of the stem cell line in item 8.

Final Request Submission and Subsequent Changes:
After clicking "Submit FINAL Registry Request", all data validations will be invoked. If any required data is missing, you will need
to make any necessary corrections prior to the submission 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 number that pertains to the submission. Once a request is
submitted, NIH will not change your selection of the method of review or any data or supporting documents. If changes are
necessary, you may send an email to the hESC Registry Help Desk requesting that the request be deleted, and then begin the
submission process again, as appropriate.
Acknowledgement:
By submitting this request (clicking the "Submit FINAL Registry Request" button below) you acknowledge that you have read,
understood, and agreed to the information provided on this form, including the Instructions for completing the form and the
Assurance, Certification, Authority and Final Submission information above.

Questions about this system may be emailed to the hESC Registry Help Desk.

Secured Request Form for ACD Review:
Add New hESC Registry Request for Advisory Committee to the Director (ACD) Review
Request for Human Embryonic Stem Cell Line to be Approved for Use in
NIH Funded Research - Working Group of the ACD Review
The instructions for completing this form should be read prior to entering any information.
* Required fields are marked with a red asterisk.
Login Information: Commons\smithj (09/21/2009)

Administrative Information
* 1. Signing Official (SO):

A. SO Name:
B. SO Phone Number:
C. SO Email Address:

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2. Submitter of Request:
(* Required, if different
from Signing Official)

http://hescregapp.od.nih.gov/NIH_Form_2890_Sample.htm

A. Submitter Name:
B. Submitter Phone Number:
C. Submitter Email Address:
(Important Note: If submitted by anyone other than the Signing Official, a copy of a letter signed by
the SO must be provided as one of the documents in the Supporting Information section below.
See the sample letter (MS Word - 41 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.)

* 3. Organization Name:
DUNS Number:
* 4. Organization Address:

5. NIH Grant or Application
Number(s): (if applicable)

(Please use this format: HL123456, AI654321, AG345678)

(To avoid potential timeout and loss of data, be sure to save data often - Every 10-15 minutes)

Stem Cell Line Information
* 6. Name of Stem Cell Line:
* 7. Cell Line Availability:

If the cell line is approved for use with NIH funding, will it be available for
distribution to the research community?
Yes
No
Other
If Other, Please Specify:
(Please limit to 250 Characters and Spaces)

If the answer to Question 7 is "Yes", please complete Questions 8 and 9 below for posting on the NIH Registry.
8. Restrictions (if any)
on Use of Stem Cell Line:

(* If the answer to Question 7 is "Yes", an answer to Question 8 is required.
Enter "None" if there are no restrictions.
Please limit comments to 500 Characters and Spaces.)

9. Provider of Stem Cell Line:

A.
B.
C.
D.

Name of
Provider
Provider
Provider

Individual or Company:
Phone Number:
Email Address:
URL:

(* If the answer to Question 7 is "Yes", answer to 9A is required: 9B-D are optional.)

10. Embryo Donation:

A. Was the embryo from which the stem cell line was derived donated in
the United States?
Yes
No
Don't Know
B. If known, in what year was the embryo donated?

(e.g., 2001)

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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. You will be required to complete items 6-10, as appropriate, for any additional cell lines that
are added to this request.

(To avoid potential timeout and loss of data, be sure to save data often - Every 10-15 minutes)

Supporting Information (Document Attachments)
* 11. Supporting Information:
Applicants are encouraged to provide, as document 1, a summary document explaining how the remaining attachments address the
materials that the Working Group will consider (as described in the Assurances below).
All supporting information must be in English.
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. Please convert MS Office 2007 documents (e.g., .docx, xlsx, .pptx) to MS Office 2003 format (e.g., .doc,
xls, .ppt), prior to uploading.
Provide a brief description (limit 100 characters) of the file (e.g., consent document, clinic policy, SO letter, etc.) in the box provided.
Note: All information submitted will be subject to the United States Freedom of Information Act. Do not submit any financial, commercial,
confidential, or proprietary information. Do not submit consent documents with personally identifying information of the donor(s) of the
embryos (the individuals who sought reproductive treatment).
Document 1:
Content Description:
Document 2:
Content Description:
Document 3:
Content Description:
Document 4:
Content Description:
Document 5:
Content Description:
Document 6:
Content Description:
Document 7:
Content Description:
Document 8:
Content Description:
Document 9:
Content Description:

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Document 10:
Content Description:

(To avoid potential timeout and loss of data, be sure to save data often - Every 10-15 minutes)

Comments
12. Comments:

If there is any additional information you wish to provide regarding this 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.

Please limit comments to 1,000 Characters and Spaces.

(To avoid potential timeout and loss of data, be sure to save data often - Every 10-15 minutes)

Assurance, Certification, Authority and Final Submission
Note: If you are a Signing Official with formal designated or delegated authority to sign on behalf of the organization, check the
Assurance, Certification, and Authority boxes to provide the required certifications. If you are not a Signing Official with formal
designated or delegated authority to sign on behalf of the organization, do not check the boxes, but provide, as one of the
attached supporting documents, a letter signed by the SO that provides the required certifications (see Sample Letter (MS Word
- 41 KB)).
Select the appropriate Assurance Statement from the two options below:
(* Required, if submitted by SO. To be completed by SO only)

Assurance in accord with Section II(B) of the NIH Guidelines:
The applicant organization identified above assures that the embryo from which the cell line identified in item 6 was derived
was donated prior to July 7, 2009, and the embryo : 1) was created using in vitro fertilization for reproductive purposes and
was no longer needed for this purpose; and 2) was donated by individuals who sought reproductive treatment ("donor(s)") who
gave voluntary written consent for the human embryo to be used for research purposes. The applicant is advised that the
Working Group of the Advisory Committee to the NIH Director will consider submitted materials taking into account the
principles articulated in Section II(A) of the NIH Guidelines for Human for Human Stem Cell Research, 45 CFR 46 Subpart A,
and the following points to consider: during the informed consent process, including written and oral communications, whether
the donor(s) were: (1) informed of other available options pertaining to the use of the embryo ; (2) offered any inducements for
the donation of the embryo ; and (3) informed about what would happen to the embryo after the donation for research.
OR
Assurance in accord with Section II(C) of the NIH Guidelines:
The applicant organization identified above assures that the embryo from which the cell line identified in item 6 was derived
was donated outside the United States on or after July 7, 2009, and 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
on Human Stem Cell Research.

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Certification (* Required, if submitted by SO. To be completed by SO only)
By submitting this request, I certify that the statements and Assurance herein are true, complete and accurate to the best of my
knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or
administrative penalties. (U.S. Code, Title 18, Section 1001).

Authority (* Required, if submitted by SO. To be completed by SO only)
I hereby confirm that I have the authority and/or rights pertaining to the human embryonic stem cell line identified in item 6 to
make this request for NIH review and determination of eligibility for use in NIH funded research (e.g., I am the owner, deriver or
licensee or have written permission of the same to submit). I have clearly and completely identified any and all restrictions on the
use of the stem cell line in item 8.

Final Request Submission and Subsequent Changes:
After clicking "Submit FINAL Registry Request", all data validations will be invoked. If any required data is missing, you will need to make
any necessary corrections prior to the submission 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 number that pertains to the submission. Once a request is submitted, NIH will not change your selection
of the method of review or any data or supporting documents. If changes are necessary, you may send an email to the hESC Registry Help
Desk requesting that the request be deleted, and then begin the submission process again, as appropriate.
Acknowledgement:
By submitting this request (clicking the "Submit FINAL Registry Request" button below) you acknowledge that you have read, understood,
and agreed to the information provided on this form, including the Instructions for completing the form and the Assurance, Certification,
Authority and Final Submission information above.

Questions about this system may be emailed to the hESC Registry Help Desk.

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