The NIH budget has been signed and grant awards for noncompeting awards (Type 5) will be made at their approved FY2001 levels. Awards that were issued at the FY 2000 level will be revised if reductions were made. Detailed instructions regarding the salary cap and funding plans for new and competing awards will be issued shortly. Happy Holidays to all our research partners!

The OER Grants and Research Training Opportunities Web sites have been redesigned in an effort to provide for easier user interface, updated navigation techniques and overall site accessibility. The basic look and feel of the new site is based on the recent NIH Home page redesign (see URL http://www.nih.gov/). Page names and organization of OER sites remains the same as in previous sites. Some of the major changes in the redesigned sites include the following:

• All pages now have a selection for Text Only. Once activated, all subsequent pages will be in text format;
• Likewise, when graphical format is selected, all subsequent pages will show standard site graphics.
• The Home page now has links to virtually all primary site pages;
• There is a new Rolling News Flash section on the Home page with clickable links to News Flash Items;
• There is a new Search Box on Home Page and link to Advanced Search page;
• Advanced Search page now provides ability to search All OER pages simultaneously, or selected pages individually;
• A search feature has been added for searching of the Research Training site and the News Archives;
• Standard Headers and Footers have been developed for all site pages;
• Top level site pages have a new side navigation bar to go quickly to primary site pages and resources;
• Side navigation bars can be shown or hidden, at the user's choice. Once a choice is made, it applies for all subsequent pages;
• Pages with a side navigation bar also have a section for links "On This Page" or "Quick Links" to page resources;
• A new Contacts Page provides site users with e-mail addresses of Content Managers for all top-level pages with instruction on who to contact for specific issues;
• OER now uses "cookies" to track user preferences on Text vs. Graphical format and whether to Show or Hide the navigation bar;
• A New site Privacy Notice with a discussion on "cookies" used on this site, Disclaimer and Accessibility page have been added.

The redesigned OER Web sites also provide a significant level of behind-the-scenes automation. This will allow for quicker response to users needs as it pertains to future redesigns and reorganization of site resources. If you have any questions or comments about the redesign or OER sites in general, please send them to the OER Webmaster.

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The Office for Human Research Protections (OHRP) has released a Web site with Procedures for Registering Institutional Review Boards IRBs and Filing Federalwide Assurances of Protection for Human Subjects (FWAs). This website introduces a process through which Institutional Review Boards (IRBs) and (international) Independent Ethics Committees (IECs) can register with HHS and thereby receive timely information from HHS about the protection of human subjects. The website also introduces a simplified process for filing Institutional Assurances of Protection for Human Subjects with the HHS Office for Human Research Protections (OHRP). Assurances approved under this process will cover all of the institution's Federally-supported human subject research. Each legally separate institution will need its own Federalwide Assurance (FWA). After February 28, 2001, OHRP will no longer routinely accept Assurances that are limited to HHS-supported research, to special categories of research, or to individual research projects. OHRP invites your comments and suggestions about these processes during their initial phase of implementation, which will last approximately 3 months. During this initial phase, completed materials must be sent to OHRP for processing (for IRB Registration) or approval (for FWAs). Based on feedback and experience during the first phase, OHRP will make necessary modifications and launch an interactive, on-line version that will permit direct submission and updating of most IRB Registration and Institutional Federalwide Assurance (FWA) materials.

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NIH typically makes grant awards starting December 1 of each fiscal year. NIH is currently funded through a Continuing Resolution at the FY 2000 level. Therefore, continuing (type 5) awards will be made at the FY2000 level, or their committed FY2001 level, whichever is less. If the NIH budget changes during the year, restorations will be made. For competing awards (types 1 and 2) Institutes and Centers will be making reductions to keep the average cost of competing grants at the level experienced in FY2000. These reductions will vary by IC and are in addition to any routine adjustments made to budgets as part of the award process.

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The International Human Genome Sequencing Consortium recently described a number of electronic sites where the public working draft version of the human sequence can be found in its most useable forms (see letter published in the Sept. 1 issue of Science and a news brief published in the Aug. 31 issue of Nature). NIH is interested in making the entire scientific community aware of this valuable resource, by distributing the attached information describing three sites that display the entire working draft sequence and provide tools for its use. The following links will take investigators directly to three different (but complementary) assembled views of the human genome, together with useful browsing tools that provide a wide variety of annotations of the sequence. These sites are updated very frequently:

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Videotape clips of the announcements, plenary talks, and NIH-101 session have been posted on the Symposia page of the NIH's Biomedical Engineering Web site. These clips can be accessed through the "Previous Symposia" section of the SYMPOSIA page or at url http://www.nibib.nih.gov/becon/becon2000_video.cfm. This posting includes a menu of available clips with appropriate links so specific talks can be accessed without starting at the beginning of the symposium.

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NIDDK research dollars may be easier to obtain now that funding information from NIDDK itself is easier to find. With the overhaul of the Research Funding Opportunities section on the NIDDK home page, current and future grantees will find a complete and intuitive organization of the current RFAs, PAs, and notices. More cross links and better contact information on program staff have been added, as well as more guidance for first-time applicants. NIDDK web and extramural staff welcome comments and suggestions for continued improvement to the site. (Use the email form on the NIDDK site.)

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This is to clarify the June 5, 2000 NIH Guide announcement on Required Education in the Protection of Human Research Participants. The NIH has received a large number of inquires regarding the recent announcement requiring investigators to document their education in the protection of human subjects. This notice is intended to clarify two issues: (1) what constitutes documentation and (2) when documentation should be submitted to the NIH.

With respect to the type of documentation, the NIH requires a letter that includes the names of the key personnel who are responsible for the design and conduct of the study; the title of the education program completed by each named personnel plus a one sentence description of the program. This letter must be signed by the principal investigator and co-signed by an institution official.  (Note: In accordance with the September 5, 2001 NIH Guide Notice, only the signature of an institution offical is now required.)

The timing of submission of documentation is in keeping with just-in-time procedures. Thus, the NIH will request this letter documenting education before an award is issued.

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The Office of Extramural Research (OER) is requesting comments/suggestions on the upcoming revisions of the PHS 398 and 2590 Grant Applications (see NIH Guide Notice of September 5, 2000).

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The National Academy of Science's Committee on National Needs for Biomedical and Behavioral Scientists, chaired by Dr. Howard Hiatt, has released the eleventh edition of the congressionally mandated study on the NIH extramural research training programs. The report, Addressing the Nation's Changing Needs for Biomedical and Behavioral Scientists, calls for a gradual expansion of the National Research Service Award (NRSA) program coupled with a corresponding reduction in the number of graduate students and postdoctorates supported by NIH research grants. The report also includes a number of other recommendations related to the quality of training, the racial and ethnic diversity of the research work force, and the declining participation of clinicians in biomedical research. The report is available on the NIH Research Training Web site's Outcome and Administration Information page at URL http://grants.nih.gov/training/nas_report/index.htm (in PDF format) and on the National Academy Press website at http://www.nap.edu/books/0309069815/html/ (in HTML format).

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The NIH Computer Based Training (CBT) on Protection of Human Subjects can be accessed on the web site of the NIH Office of Human Subjects Research at http://ohsr.od.nih.gov/. While this training module was developed for NIH staff, it can be used by other institutions seeking to meet training requirements in this area. Please see NIH Guide Notice for further information.

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On August 23, the NIH announced a new requirement for all NIH-funded research involving human pluripotent stem cells (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-050.html). Effective immediately, all research involving human stem cells must follow the new NIH procedures for assessing compliance with guidelines related to the derivation of those cells. This requirement applies to both intramural and extramural investigators. It also applies to stem cell research to be supported with existing NIH funds as well as research proposed in new applications, including competing and administrative supplements.

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NIH has published a Notice in the NIH Guide for Grants and Contracts that describes: 1) a modification of the instructions for the budget narrative page to now include ALL personnel, 2) the consequences of submission of non-compliant modular applications, 3) an update on the peer review of modular applications, 4) clarification of the instructions for completing the Checklist, and 5) some general reminders for modular grant applications.

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On July 13, 2000, President Clinton signed Public Law 106-246, which includes a provision to repeal the delayed obligations in our original FY 2000 appropriation (please see FY 2000 DELAYED OBLIGATIONS, published on May 17, 2000). NIH is developing a plan to promptly issue the remaining funds on partial awards, and will announce this plan shortly in the NIH Guide.

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We have developed a set of Frequently Asked Questions regarding the new NIH requirement for education in the protection of human participants. Beginning on October 1, 2000, the NIH will require this education for all investigators submitting NIH applications for grants or contracts or receiving new or non-competing awards for research involving human subjects. Also see the June 5, 2000 NIH Guide Notice, Required Education in the Protection of Human Research Participants.

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DHHS has elevated the Office for Protection from Research Risks (OPRR) to become the Office of Human Research Protections (OHRP) within OPHS, DHHS. Based on this change, a new OHRP Web site has been established at URL http://www.hhs.gov/ohrp. Accordingly, links on this site to previous OPRR resources have been changed to point to the same resources on the new OHRP site.

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HHS will hold public discussions on August 15-16, 2000 at the Natcher Center, National Institutes of Health, Bethesda, Maryland. The purpose of the conference is to find new ways to manage financial conflicts of interest so that research subjects are appropriately informed, and to further ensure that research results are analyzed and presented objectively. Information about the conference maybe found at http://aspe.hhs.gov/sp/coi/index.htm.

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A new NIH Guide for Grants and Contracts repository is now available from the NIH Guide Home Page. Enhancements include comprehensive indexes of published NIH Guide announcements by category (Notices, Program Announcements and Requests for Applications). In addition, all files now follow a standard naming convention. As a result of this reorganization, links and bookmarks to NIH Guide Files for Notices posted prior to February 6, 1998, and for PAs and RFAs posted prior to October 17, 1997, have been broken. Detailed information on finding new links and repairing old links may be found in the May 17, 2000 NIH Guide Notice.

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As part of the DHHS initiative to strengthen IRBs and the protection of human subjects, NIH has issued three Guide Notices. The first announcement requires clinical investigators to be educated in the fundamentals of the protection of human subjects. Starting on October 1, 2000, NIH will review the educational experiences of such investigators. There are many ways to satisfy this requirement, and some examples are provided in the announcement. The second announcement clarifies existing policies for data and safety monitoring in clinical trials. NIH has a long standing policy requiring data and safety monitoring for all clinical trials. This new policy requires investigators to submit to the NIH monitoring plan for Phase I and II trials. The third announcement clarifies existing PHS regulations regarding financial conflicts of interest for clinical investigators. DHHS will hold a meeting on financial conflicts of interest in August, 2000.

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In assessing the various suggestions and recommendations presented in the report entitled “NIH Initiative to Reduce Regulatory Burden” and after consideration of public comment on the report, a number of activities were identified from the report that the NIH could readily commit to pursuing in the immediate future. These activities lent themselves to immediate action and in addition, were selected because their promise in reducing regulatory burden for the research community, while continuing to provide the intended protections, was significant. A near-term plan was posted on September 14, 1999. At that time, we indicated that as these activities got underway, it was expected that additional ones would be identified from the report and considered for implementation. The attached update details our continuing progress.

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The FY 2000 Appropriations Bill for the National Institutes of Health (NIH) contains a provision that will result in the modification of our grant award process for a portion of NIH awards. While most of our appropriation is available for grant awards throughout the entire fiscal year, $3 billion of the appropriation is not available for award by NIH until September 29, 2000. While appropriations language states that such funds delayed by this requirement will be available for obligation until October 15, 2000, NIH will issue delayed obligation awards on September 29, 2000. Please see the May 17, 2000 Guide Notice for details.

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Bioinformatics or biomedical computing is the application of computer science and technology to address problems in biology and medicine. To realize the potential benefits that the fusion of biomedicine and computer technology offers, the Biomedical Information Science and Technology Initiative (BISTI) has been launched at the NIH. A BISTI Consortium (BISTIC) is being developed to serve as a focus for biomedical computing activities at the NIH. The BISTIC will be modeled after but separate from the BECON and will consist of senior-level representatives from each of the NIH institutes and centers plus representatives of other Federal agencies. A NIH Bioinformatics Web site has been developed to communicate information on the BISTIC, bioinformatics news, a calendar of related events, biomedical computing symposia, funding opportunities, and general information about the field. The new site is linked from the side bar of the OER Grants Web site at http://grants.nih.gov/grants/oer.htm. The direct url for this Web site is http://grants.nih.govhttp://www.bisti.nih.gov/bistic.cfm.

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Update on A-110: The amendment to OMB Circular A-110 that provides public access under some circumstances to research data through the Freedom of Information Act became effective on November 8, 1999. The implementing regulations for the NIH and other Federal agencies and organizations had to be revised to reflect this amendment. A joint agency notice was published in the March 16, 2000 Federal Register (PDF) to announce an interim final rule with an effective date of April 17, 2000. Thus, the guidance that NIH will impose on grantees became effective on April 17, 2000.

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On April 5, 2000, Dr. Ruth Kirschstein, Acting Director of the National Institutes of Health (NIH), approved the establishment of an Office of Bioengineering and Bioimaging (OBB) at the NIH. The OBB was established in response to conference report language accompanying the FY2000 Appropriations Bill (P.L. 106-113) and will exist within the Office of the Director at the NIH. The purposes of the OBB are to serve as a focus for efforts in bioengineering and bioimaging at the NIH institutes and centers and to provide a mechanism for enhanced interagency activities. Since 1997, these activities have been coordinated by the Bioengineering Consortium (BECON) which will transition into the OBB. A search for an office director and staff is in progress.

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It has been NIH grants policy that applications submitted to NIH, which include research involving human participation, are required to have IRB approval at the time of submission or within 60 days after application receipt date. Since fewer than half of all applications submitted to NIH are funded, and in order to reduce burden on applicants and IRBs, the NIH is modifying this policy to provide greater flexibility in the timing of IRB review. See attached document.

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Following consultation with the Office of General Counsel, a decision has been made to accept IRB meetings conducted via telephone conference call. OPRR will continue to recommend strongly that IRB meetings take place with members physically present wherever possible. Recognition by OPRR of IRB meetings convened via telephone conference call is consistent with longstanding FDA policy. See attached memorandum from OPRR (PDF).

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The Office for Protection from Research Risks' Division of Animal Welfare has been renamed the Office of Laboratory Animal Welfare (OLAW) effective March 2, 2000. The Director, Dr. Nelson Garnett, will report to the NIH Deputy Director for Extramural Research, Dr. Wendy Baldwin. OLAW will be responsible for all of the animal-related functions of the OPRR, including implementing and interpreting the Public Health Service Policy on Humane Care and Use of Laboratory Animals, administering an educational program for PHS-supported institutions and investigators, negotiating Animal Welfare Assurances, and evaluating compliance with the PHS Policy.

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The following announcement was made in the March 6, 2000 NIH Guide for Grants and Contracts (Notice OD-00-026):

Scientific and ethical challenges associated with research utilizing human fetal tissues make it imperative that researchers and their institutions be clearly aware of the 1993 statute concerning such research as published in http://grants.nih.gov/grants/guide/notice-files/not93-235.html. This statute, section 498B of the Public Health Service Act, 42 U.S.C. 289g-2 prohibits the knowing acquisition, receipt or transfer of any human fetal tissue for "valuable consideration" (e.g. profit). Violation of this statute carries criminal penalties.

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Calendar year 1999 was an exciting year for reinvention initiatives. NIH implemented modular grant applications, received its first electronic non-competing applications, streamlined Council reviews, continued to push towards a fully electronic grant life cycle, and more. The NIH Reinvention Status Report for January 2000 provides an update on reinvention and ERA efforts that the NIH Office of Extramural Research (OER) is coordinating in partnership with the NIH Institutes and Centers (ICs).

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On January 19, 2000, the National Institutes of Health (NIH) and E.I. DuPont (DuPont) signed an agreement on the use of DuPont's proprietary OncoMouse® transgenic animal technology covered by the Harvard "Leder" patents. The technology relates to animal models that develop tumors as a consequence of containing a recombinant activated oncogene sequence, and is useful in basic medical research for the study of cancer. The Memorandum of Understanding (MOU) resolves long-standing issues of access by academics to the technology, originally developed through DuPont funding by Dr. Philip Leder at Harvard University and licensed exclusively to DuPont. This agreement reinforces the partnership between NIH and DuPont first established over a year ago with the signing of the landmark agreement on Cre-lox technology.

Under the MOU, DuPont will continue to provide, at no cost, the OncoMouse® transgenic animal technology to academic laboratories for research uses and will allow unencumbered use and transfer of this technology among researchers at not-for-profit institutions. The MOU imposes no limitations on scientific publications or so-called "reach-through" rights. Discoveries made within the academic realm through use of this technology will not be subject to any payments to DuPont as long as the discovery is made outside of any direct benefit accruing to a commercial entity. Transfer of the OncoMouse® transgenic animal technology to commercial entities requires the commercial entity to obtain a commercial research license from DuPont.

The agreement was negotiated by the NIH Office of Technology Transfer, under the leadership of Dr. Maria C. Freire. The full text of the agreement is available at http://ott.od.nih.gov/.

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A new Web site aimed at providing information and interactive opportunities on biomedical engineering for bioengineering researchers, biomedical program staff and managers, Bioengineering Consortium (BECON) members, and the general public was released on January 31, 2000. This site is a redesigned version of the current "Biomedical Engineering" Web page linked from the OER Home Page at http://grants.nih.gov/grants/oer.htm. The new self-contained site contains information on the BECON, news and events concerning biomedical engineering, bioengineering symposia, NIH-supported funding opportunities in bioengineering, and general information about the field. Questions or comments related to biomedical engineering at the NIH, BECON, or the Web site can be submitted using a "Feedback" option. The url for this site is http://www.becon.nih.gov/becon.htm. Please access the site and take advantage of the information features and interactive options.

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The Calendar Year 2000 Omnibus Solicitation of the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) for Phase I Small Business Innovation Research (SBIR) and Phase I Small Business Technology Transfer (STTR) Grant Applications (PHS 2000-2) for coincident receipt dates of April 1, August 1 and December 1, 2000 is now available. In the past, NIH has issued separate SBIR and STTR Grant Solicitations. Because of the similarities between the two solicitations, both in research topics that may be of interest to small businesses and in application instructions, a single Omnibus Solicitation of the NIH, CDC, and FDA for SBIR/STTR Grant Applications will be issued for CY 2000 grant application receipt dates.

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