December 19, 2001: NEW - Implementation Issues for Human Embryonic Stem Cell Research

A new web page is available for grant applicants and research institutions interested in human embryonic stem cell research. This serves as a one-stop shopping portal for updated NIH Guide announcements, the Stem Cell Registry, archives of Frequently Asked Questions, and pertinent grants policy statements - http://grants.nih.gov/grants/stem_cells.htm. (Note added on 5/29/2003: See http://stemcells.nih.gov/index.asp for current NIH Stem Cell Information page.)

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December 13, 2001: Reminder for Applicants Requesting Direct Costs of $500,000 or More

On October 19, 2001, the NIH updated its policy on the acceptance of unsolicited applications requesting direct costs of $500,000 or more for any year of the grant. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html) Effective January 1, 2002, applicants must obtain agreement to accept assignment from Institute/Center staff at least 6 weeks prior to the submission date for any such application. Please note that the 6-week deadline for the February 1 receipt date is December 21.

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December 7, 2001: NEW - Human Embryonic Stem Cell Research - Frequently Asked Questions and Relevant Information for Researchers

The FAQ has been updated with additional information. Please see the following page: http://grants.nih.gov/grants/stem_cell_faqs.htm. (Note added on 5/29/2003: See http://stemcells.nih.gov/index.asp for current NIH Stem Cell Information page.)

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November 27, 2001: Mail Addressed to the National Institutes of Health

All applications and other deliveries to the Center for Scientific Review must either come via courier delivery or the USPS. Applications delivered by individuals to the Center for Scientific Review will no longer be accepted. For additional information, see the NIH Guide Notice (Nov. 13, 2001) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

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November 23, 2001: NEW - Human Embryonic Stem Cell Research - Frequently Asked Questions and Relevant Information for Researchers

The FAQ has been updated with additional information. Please see the following page: http://grants.nih.gov/grants/stem_cell_faqs.htm. (Note added on 5/29/2003: See http://stemcells.nih.gov/index.asp for current NIH Stem Cell Information page.)

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November 16, 2001: Human Embryonic Stem Cell Research - Frequently Asked Questions and Relevant Information for Researchers

In response to inquiries about the recent NIH guide notices pertaining to policies on human embryonic stem cell research, NIH will be posting periodically additional information to assist investigators and research administrators. This information will be provided in the form of frequently asked questions and the answers to these questions. The first installment of these are at URL http://grants.nih.gov/grants/stem_cell_faqs.htm. Monitor this site frequently for additional information. This was also announced in the NIH Guide Notice of November 16, 2001. (Note added on 5/29/2003: See http://stemcells.nih.gov/index.asp for current NIH Stem Cell Information page.)

Additional information about the clearances required for the receipt of human embryonic stem cells developed outside of the U.S. is provided in the NIH Guide announcement Federal Government Clearances for Receipt of International Shipment of Human Embryonic Stem Cells at URL: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-013.html.

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August 17, 2001 (updated August 27, 2001):  NIH Funding of Research Using Specified Existing Human Embryonic Stem Cells

In accordance with the President's announcement of August 9, 2001, (http://www.nih.gov/news/pr/aug2001/od-09.htm), the National Institutes of Health is initiating a process to enable researchers to use Federal funds to conduct research using human embryonic stem cells as long as the derivation process (which begins with the destruction of the embryo) was initiated prior to 9:00 p.m. EDT on August 9, and the following criteria are met: the stem cells must have been derived from an embryo that was created for reproductive purposes and was no longer needed; informed consent must have been obtained for donation of the embryo; and that donation must not have involved financial inducements. The President's complete remarks and related information are available at http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html.

Investigators may not conduct research on any human embryonic stem cells until the NIH issues the policies and the procedures that will enable researchers and their institutions to document adherence to the criteria established by the President for use of these cells with Federal funds (direct and F&A). NIH has issued an update on existing human embryonic stem cells that can be found at http://stemcells.nih.gov/policy/statements/082701list.asp.

In order to facilitate research using human embryonic stem cells, the NIH is creating a Human Embryonic Stem Cell Registry that will list the human embryonic stem cells that meet the eligibility criteria. Specifically, the laboratories or companies that derived the cells listed on the Registry will have provided a signed assurance that the derivation process was initiated prior to 9:00 p.m. EDT on August 9, 2001; the stem cells were derived from an embryo that was created for reproductive purposes and was no longer needed; informed consent was obtained for donation of the embryo; and that donation did not involve financial inducements. The Registry will be accessible to investigators on the NIH Home Page http://www.nih.gov.

Initially, the Registry will contain basic information about the cells. This information will include a unique identifier; the name of the company or laboratory that derived the cells; contact information for the company/laboratory; and an assurance that the cells meet the President's criteria. In the future, to further assist researchers, additional information may also be included in the Registry, such as details about the derivation of the cells, the number of passages, culture conditions, and growth characteristics; a description of efforts to characterize the cells, including molecular markers and evidence of pluripotency; relevant publications; DNA fingerprinting data; and quality assurance data, such as the results of tests for Mycoplasma and standard human pathogens.

The NIH is working expeditiously to ensure that the Registry will be operational as soon as possible. General questions or comments about the Registry should be addressed to stemcellregistry@od.nih.gov. Researchers who are interested in studying or using particular human embryonic stem cells in their research will be expected to contact the company/laboratory directly to arrange for access to these cells. Investigators should be aware that, in some cases, existing cells need to be expanded in culture to reach larger numbers for the purposes of distribution, and that, in other cases, the derivations are still in the early stages of characterization and, thus, may not be immediately available.

With regard to the funding of research on both embryonic stem cells and adult stem cells in humans and animals, the NIH welcomes investigator-initiated grant applications proposing research using such stem cells, including requests to use existing funds or for supplements to existing grants to conduct such research. The NIH is also exploring a number of initiatives to facilitate research on all forms of stem cells. To hasten the development of a program of research and to stimulate submission of grant applications in this arena, some Institutes and Centers will be issuing Program Announcements to describe new, continuing, or expanded interests relevant to stem cell research, such as new approaches to the characterization of stem cells or the development of methods to differentiate cells into specific somatic cells for study. Other Institutes and Centers may issue specific Requests for Applications, which invite grant applications, include a special receipt date, and a set-aside of funds. Another possibility may be provision of resources (using contract or other mechanisms), in order to ensure adequate production of cells, means for their distribution, and adequate training of researchers as to how to maintain the cells. As usual, further updates and all solicitations will appear in the NIH Guide for Grants and Contracts that is available online at http://grants.nih.gov/grants/guide/index.html.

This was also announced in the NIH Guide Notice of August 27, 2001.

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July 25, 2001:  Proactive Compliance Site Visits FY 2001 Schedule

The Division of Grants Compliance and Oversight in the Office of Policy for Extramural Research Administration (OPERA) has posted the FY2001 Proactive Compliance Site Visit Schedule on the Grants Compliance and Oversight Page. Institutions participating in the site visits were selected based on the level and nature of NIH support, geographic diversity, and type of institution; these institutions also are not engaged in an active compliance case with OPERA. The eight FY2001 site visit participants include five educational institutions, 2 AIRI (Association of Independent Research Institutes) member institutes, and 1 hospital. Please refer to "Proactive Compliance Site Visits 2000: A Compendium of Findings and Observations" for further information about the NIH Proactive Compliance Site Visits.

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July 10, 2001:  Revised PHS 398 and PHS 2590 Now Available

The new PHS 398 application and PHS 2590 progress report instructions and forms are available on the NIH Grants Web site at http://grants.nih.gov/grants/forms.htm, and may now be used by applicants. Beginning January 10, 2002, use of the revised forms are required. The forms available on our website are now fillable using Adobe Acrobat Reader Software. Applicants are encouraged to access the instructions and forms via the Internet because they contain valuable links to policy documents as well as links for navigating the instructions easily. For further information, contact GrantsInfo@NIH.GOV. See NIH Guide Notice of July 10, 2001 for more details or contact heffernj@od.nih.gov.

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June 29, 2001:  NIH On-Line Education Module on the Protection of Human Research Participants

This is a reminder that the NIH provides an online education module on the protection of human research participants that is specifically designed for extramural investigators. Completing this module fulfills the NIH education requirement in the protection of human research participants for key personnel (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html). This education module was initiated in January 2001 and can be accessed at the following URL: http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp. Before developing this module specifically for extramural scientists, the NIH made available an on-line course that was designed for our intramural investigators. At this time, however, we strongly encourage extramural investigators to use the extramural module if they choose to complete an NIH course.

Also see the September 5, 2001 NIH Guide Notice for additional information.

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June 20, 2001:  Follow-up Announcement on Delay of Applications Due to Tropical Storm Allison

This is a Follow-up announcement to the June 13, 2001 edition of the NIH Guide to Grants and Contracts on delay of applications due to Tropical Storm Allison. NIH will consider requests for administrative supplements for extensions in time that include personnel costs, and replacement of equipment, supplies and unique resources damaged or lost as a result of the storm. These requests should be submitted using the PHS-398 face page, budget page, and budget justification page. The application should state that the requested support does not represent a duplication of benefits, e.g., from insurance. The request should be sent to the Grants Management Officer at the funding Institute or Center that is responsible for that grant. (The supplemental package should not be sent to the Center for Scientific Review.) NIH will also continue to accept applications that were intended for the July 1 receipt date. Applications delayed due to flooding should include a cover letter noting the reason for the delay. It is not necessary to get advance permission for a delayed submission. This has also been announced in the 06/22/2001 NIH Guide Notice.

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June 20, 2001:  Tropical Storm Allison Disaster Relief

The National Institutes of Health wishes to inform institutions in the Houston area who suffered damage or destruction to facilities, equipment, and/or supplies as a result of Tropical Storm Allison, of the procedure to follow to seek assistance to repair the damage. The Federal Emergency Management Agency (FEMA) is working with the Texas Division of Emergency Management's (DEM), State Public Assistance Office to provide support and assistance to public and private non-profit organizations. Requests must be submitted by organizational officials (not individual investigators) following the instructions that will be provided by the Texas State Public Assistance Office Public and private non-profit institutions are advised to contact:

Mr. Ben Patterson State Public Assistance Officer (832)513-4102

Mr. Richard Boltz State Coordinating Officer (832)513-4123

The main switchboard for the Disaster Field Office is (832)513-4000. For-profit institutions are advised to contact FEMA at 1(800)462-9029. Also, individuals who have already notified NIH staff of their damages are urged to make sure their institutional officials have initiated contact with the State and/or the Federal Emergency Management Agency, as appropriate. This has also been announced in the 06/21/2001 NIH Guide Notice.

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