Sample Web Version
NIH Form 2890
(08/09/2011)
(Note: This is not an interactive form.
Active system is at http://hescregapp.od.nih.gov/)
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: April 30, 2013
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). 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 indentifying 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. 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 organization name and the name of the stem cell line for institutions intending to submit hESC lines for review (those submissions begun and saved but not submitted), lines pending review, and lines not approved for NIH funding eligibility. 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). IntroductionNIH 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 not approved for NIH funding eligibility. Submission of hESC line through the NIH Form 2890 Web SiteeRA 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. eRA Commons Support: For questions or problems concerning obtaining an eRA Commons account, please contact Commons Support at 1-866-504-9552, or email commons@od.nih.gov 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
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NIH Security Login Page:
(eRA Commons UserID and Password Required)
Secured
Request
Selection Page: Request for Human Embryonic Stem Cell Line
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: 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 hescregistry@mail.nih.gov and request that a submission be deleted
or to answer questions about this system. Enter New Request: Edit Draft Request(s):
Go Back to NIH Form 2890 Login Page Go to NIH Stem Cell Information Page
(Add New or Edit Draft
Requests)
to be Approved for Use in NIH Funded Research
NIH Form 2890
OMB Approval 0925-0601
Expiration Date: April 30, 2013
Select Draft Request to Edit:
Draft
NumberLast Updated
DateEmail Copy
of Draft
2009-DRAFT-017
09/21/2009
Email
2009-DRAFT-017
09/22/2009
Email
Note: Draft Requests not submitted
within 6 months after the Last
Updated Date, will be deleted.
All Draft Requests are posted on the
Draft Requests in Process page.
Login: Commons\smithj
Date: 08/13/2009
Secured Request Form for NIH Administrative Review:
Secured Request Form for ACD Review: