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ARCHIVED - OER Grants News Flashes - 1999

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News Archive Table Of Contents

Date News Flash Description
December 20 1999      NIH Principles and Guidelines for Sharing of Biomedical Research Resources finalized
December 14 1999 To NIH Grantees and Applicants: Notice Of Amendment To A-110
December 08 1999 NIH Regulatory Burden Working Group Established
November 23 1999 Important Information About NIH Requirements Regarding Gene Therapy Research
November 23 1999 Equity in Handling Research Facilities Costs is Achieved
October 19 1999 Revised A-110 Is Effective Soon
September 27 1999 Further Discussions Of A110
September 14 1999 Near-term Efforts to Reduce Regulatory Burden
September 08 1999 NIH Responds to OMB's Clarifications to A-110; All comments Due by Sept. 10
August 18 1999 New Web Sites For Funding and Research Training Information
August 17 1999 Problems Remain Even After Major Improvements In Modification To A110
June 21 1999 Guidance On Reporting Adverse Events To Institutional Review Boards For NIH-supported Multicenter Clinical Trials
June 02 1999 Forum On Intellectual Property Restrictions To Research Tools
May 10 1999 Proposal for Electronic Publications in the Biomedical Sciences
April 20 1999 Monoclonal Antibody Report Available for Review and Comment
April 19 1999 NIH Position On Human Pluripotent Stem Cell Research
April 16 1999 DHHS/NIH Comments On The Implications of Proposed Rule Making, OMB Circular A-110
March 11 1999 Research Involving Individuals with Questionable Capacity to Consent: Points to Consider
March 10 1999 NIH Project To Reduce Regulatory Burden - Report Released
February 26 1999 Implications of Notice of Proposed Rule Making, OMB Circular A-110
February 17 1999 1999 SBIR Phase 1 Update
February 12 1999 Electronic Request For Forms Available
February 5 1999 Proposed Revision of Circular A-110 Regarding Access to Data Developed Under Federal Grants
February 5 1999 Biomedical Engineering Summer Internship Program Being Offered At The NIH
January 25 1999 NIH Position On Human Pluripotent Stem Cell Research
January 15 1999 NIH Establishes Trans-NIH Mouse Initiative


News Flash Items
December 20 1999:     NIH Principles and Guidelines for Sharing of Biomedical Research Resources finalized

On May 25, 1999 the National Institutes of Health published for public comment in the Federal Register a proposed policy entitled SHARING BIOMEDICAL RESEARCH RESOURCES: Principles and Guidelines for Recipients of NIH Research Grants and Contracts [64 FR 28205]. This policy is designed to provide recipients of NIH funding with guidance concerning appropriate terms for disseminating and acquiring unique research resources developed with federal funds and is intended to assist recipients in complying with their obligations under the Bayh-Dole Act and NIH funding policy. Comments on the Principles and Guidelines were requested by August 23, 1999. This Notice presents the final Principles and Guidelines together with NIH's response to the public comments received.

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December 14 1999:     To NIH Grantees and Applicants: Notice Of Amendment To A-110

The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access under some circumstances to research data through the Freedom of Information Act (FOIA). The effective date of the revised Circular is November 8, 1999; the guidance that NIH will impose on grantees will be effective pending publication of revised 45 CFT 74, which is expected in early 2000. Amended A-110 is applicable to new and competing continuation awards made after that date. It is important for grantees to understand the basic scope of this amendment and to plan for implementation. NIH encourages sharing of research data. Nothing in the A110 amendment should affect ongoing data sharing plans.

The guidance presented explains how access would be achieved when a request is made under this amendment.

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December 08 1999:     NIH Regulatory Burden Working Group Established

Among the recommendations in the report NIH Initiative to Reduce Regulatory Burden - Identification of Issues and Potential Solutions was the establishment of an advisory group of community representatives to take part in the overall NIH effort to reduce regulatory burdens on the research community. A working group has now been established to assist in identifying and resolving unnecessary burden. Its membership is listed below.

  • Melanie Dreher, Dean and Professor, College of Nursing, University of Iowa
  • Geoffrey Grant, Associate Vice President for Research Administration, Stanford University
  • Janet Greger, Professor, Department of Nutritional Sciences, University of Wisconsin-Madison Medical School
  • Joyce Jentoft, Associate Provost and Dean, Graduate School of Medicine, Case Western Reserve University
  • Cora B. Marrett, Provost and Vice Chancellor for Academic Affairs, University of Massachusetts-Amherst
  • Linda G. Martin, President, Population Council
  • Robert R. Rich, Executive Associate Dean, Emory University School of Medicine
  • Ada Sue Selwitz, Director, Sponsored Program Development, University of Kentucky
  • Peter Theran, Vice President, Health and Hospitals, Massachusetts Society for the Prevention of Cruelty to Animals
  • John L. VandeBerg, Director, Southwest Regional Primate Research Center, Southwest Foundation for Biomedical Research

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November 23 1999:     Important Information About NIH Requirements Regarding Gene Therapy Research

The NIH Guidelines for Research Involving Recombinant DNA Molecules require the immediate reporting of serious adverse events associated with human gene transfer clinical research. The purpose of this memorandum is to request that you conduct a review to ensure that your institution is in compliance with these requirements.

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November 23 1999:     Equity in Handling Research Facilities Costs is Achieved

The Office of Management and Budget (OMB) and Department of Health and Human Services (HHS) budget staff — in consultation with the National Institutes of Health (NIH) — have taken a significant step toward equity in charging procedures for laboratory and animal-based research. This change to circular A-21 (which guides NIH awards to universities and colleges) ensures that research facilities costs will generally be included in indirect costs (or facilities and administrative --F/A--costs) rather than placing animal facility costs into the per diem for animals used in research.

    "This change is important since it reflects the current practice of close proximity of research laboratories with the animal facilities," said Wendy Baldwin, Ph.D., Deputy Director for Extramural Research at NIH. "Animal research has become more complex and animal facilities are, in reality, extensions of scientists' research space. This change in accounting will bring equity to laboratory and animal-based research."

The facility costs that will become part of the F/A rate include costs for procedure rooms, operating and recovery rooms, and isolation and quarantine rooms, as well as rooms that house animals involved in research that are not generally removed from the facility for conducting research.

    "This will not change the overall cost of research, but ensure a clearer, more appropriate accounting of the direct costs as well as the indirect costs," Baldwin said. "The NIH is pleased that the Department has implemented these changes, which should result in many benefits, including enhanced animal care."

For further information, please contact Don Ralbovsky: (301) 496-5787.

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October 19 1999:     Revised A-110 Is Effective Soon

OMB has published its final revision of Circular A-110. See Federal Register, Volume 64(195) at
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1999_register&docid=99-26264-filed

While it is important to read the full announcement, we note the following items from the final revision:

  • The final revision applies to research data used in developing "an agency action that has the force and effect of law". This is broader than the scope set by earlier language, which restricted it to research used in developing "a regulation".
  • In addition, language restricting the scope to actions with an impact in excess of $100 million was not included in the final revision.
  • The revised Circular applies to all Federally-funded research, regardless of the level of funding or whether the award recipient is also using non-Federal funds.
  • The revised Circular is effective for awards issued after the effective date and those continuing awards which are renewed after the effective date.

The comment period is over. The effective date for the revised Circular A-110 is dependent on the revision of 45 CFR 74.36. NIH is now working on the implementation plan.

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September 27 1999:     Further Discussions Of A110

The case study found here is based on an actual, ongoing request for data. It highlights some very negative aspects of uncontrolled data sharing.

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September 14 1999:     Near-term Efforts to Reduce Regulatory Burden

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 have been identified from the report that the NIH can readily commit to pursuing in the immediate future. These activities lend themselves to immediate action, and in addition, are selected because their promise in reducing regulatory burden for the research community, while continuing to provide the intended protections, is significant.

As these activities get underway, it is expected that additional ones will be identified from the report and considered for pursuit.

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September 08 1999:     NIH Responds to OMB's Clarifications to A-110; All comments Due by Sept. 10

On August 11, 1999, the Office of Management and Budget (OMB) issued clarifying changes to the proposed amendment to Circular A-110 regarding data sharing. The NIH's current, final response is attached. Also attached is a "case study" that illustrates some of the issues of concern to the NIH.

The public comment period for the clarifying changes closes on September 10. Interested parties are invited to share their comments with OMB by email (grants@omb.eop.gov). The clarifying language issued by OMB and background information on the latest draft can be found in the August 11 edition of the Federal Register.

By way of background, the NIH recently posted a list of concerns about clarifying changes to Circular A-110. NIH comments prepared in response to the earlier OMB draft of the amendment can be seen at http://grants.nih.gov/grants/policy/a110/a110implications.htm and at http://grants.nih.gov/grants/policy/a110/nih-memo.htm. These documents, as well as the attachments found above, may be useful in considering the implications of this amendment to NIH-supported research.

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August 18 1999:     New Web Sites For Funding and Research Training Information

The NIH Office of Extramural Research welcomes you to the new web sites for Funding Opportunities and Research Training information. In addition, these locations also house the NIH Guide and the Human and Animal Protection areas.

The purpose for the change in locations is to provide the highest level of customer service. Although intially the web sites will not appear any different from what they were previously, in the future the following enhancements will be phased in:

  • A new "look and feel" - The web sites will be redesigned to provide an improved "look". Along with this redesign will come improved ways of locating needed information.
  • Multimedia - Streaming multimedia presentations (audio and video) will be provided for both training and policy purposes. In addition, session presentations from important NIH scientific conferences will be available "on demand".
  • Discussion forums - As the need arises, discussion groups on specific topics of interest will be made available to the general public. Within these forums (accessable via standard web browsers), the public will be able to interact with the NIH and with interested parties from around the world on topics of interest to the biomedical research community.
  • Database access - Database enabled applications of various types will be developed to provide the public with access to enhanced levels of information.

Feedback is welcome. Any comments should be forwarded to the OER Webmaster.

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August 17 1999:     Problems Remain Even After Major Improvements In Modification To A110

The Office of Management and Budget (OMB) has issued clarifying changes to the proposed amendment to Circular A-110, which would require that Federally funded research data be made available through the Freedom of Information Act (FOIA). See August 11 Federal Register.

The 30-day comment period for these revisions will end on September 10. This is your opportunity to make known your thoughts and concerns about a rule that is likely to have a pervasive effect on the conduct of research. Your comments should be directed to F. James Charney, Policy Analyst/OMB, grants@omb.eop.gov. The NIH will be submitting formal comments as well.

We would like to draw your attention to several points related to the revised language.

First, OMB has definitely heard many of the concerns of the scientific community. They have gone to great effort to clearly define terms that were largely undefined in the earlier language. For example, the term "data" has been changed to "research data" . Research data is defined as "the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues." The term also excludes physical objects, such as laboratory samples, as well as trade secrets and commercial information. Similarly "published" research findings are now defined as "either when (A) research findings are published in a peer-reviewed scientific or technical journal, or (B) a Federal agency publicly and officially cites to the research findings in support of an agency action."

Second, OMB is actively seeking comments on revised language that would focus the applicability of the amendment on regulations. They propose replacing the phrase "used by the Federal Government in developing policy or rules" with "used by the Federal Government in developing a regulation." This would provide access to only those data involved in Federally-funded research findings that are used to support the agency's issuance of a regulation, a matter on which the agency is relying publicly, officially, and with the force and effect of law on the basis of those findings. This is a very useful clarification.

Third, OMB is also seeking comments on further limiting requests to only those data used on regulations having substantial impact on society, with substantial impact being defined as meeting a $100 million impact threshold. This is a very useful clarification.

However, several definitions and procedures for implementing the amendment remain ambiguous and require further attention. For example, the current language clearly protects the privacy of individuals, but it is unclear about protecting the privacy of "entities," such as clinics and communities that might be the subject of research. The new language does not specify if the amendment will address Federally-supported research regardless of level of funding. It is not clear that the conditions stated in most informed consent documents, including the use of data for research purposes only or unauthorized recontacting of subjects, will be protected once the data are shared. Procedurally, it is unclear how disagreements about data redaction and timeliness of data delivery will be adjudicated. It is similarly unclear how Agencies and institutions will be reimbursed for "incremental costs" associated with providing the data.

By way of background, these issues were discussed in the NIH comments prepared in response to the earlier OMB draft of the amendment. See the discussion of the implications of A-110 at http://grants.nih.gov/grants/policy/a110/a110implications.htm.

In addition, Dr. Varmus' comments can be found at http://grants.nih.gov/grants/policy/a110/nih-memo.htm

OMB is specifically seeking comments on estimates of potential incremental costs incurred in carrying out the proposed revision as well as on mechanisms available to recipients to charge costs incurred.

Finally, the regulation continues to rely on FOIA as the data sharing mechanism, and NIH remains convinced that this is the wrong mechanism for making research data available. During the comment period, NIH will be developing data and information to address the questions raised in the NPRM and addressing the fundamental mechanism used to implement research data sharing. Updates will be posted at this site.

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June 21 1999:     Guidance On Reporting Adverse Events To Institutional Review Boards For NIH-supported Multicenter Clinical Trials

Effective July 1, all multi-site trials with data safety monitoring boards are expected to forward summary reports of adverse events to each IRB involved in the study. This action in no way reduces the responsibilities of individual IRBs to address such reports coming to them from the site over which they have responsibility.

This NIH document provides guidance to investigators engaged in NIH-supported multi-center clinical trials to promote effective reporting of adverse events to the appropriate IRBs.

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June 02 1999:     Forum On Intellectual Property Restrictions To Research Tools

The NIH is seeking comments on a proposed policy entitled SHARING BIOMEDICAL RESEARCH RESOURCES: Principles and Guidelines for Recipients of NIH Research Grants and Contracts. This policy represents part of the overall implementation of recommendations made by the Advisory Committee to the Director (ACD) to Dr. Harold Varmus, Director, NIH. Dr. Varmus requested that a Working Group of the ACD look into problems encountered in the dissemination and use of proprietary research tools, the competing interests of intellectual property owners and research users underlying these problems, and possible NIH responses. One of the recommendations in the Report was that NIH issue guidance to the recipients of NIH funding.

A Web Site has been established to invite people with an interest in this issue to participate in the process.

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May 10 1999:     Proposal for Electronic Publications in the Biomedical Sciences

Electronic communication is making dramatic changes in the way information is exchanged among scientists, including biomedical scientists. The NIH is proposing a system for electronic publication of new results and ideas in the biomedical sciences. Comments concerning this proposal may be sent to NIH at execsec1@od.nih.gov.

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April 20 1999:     Monoclonal Antibody Report Available for Review and Comment

A Report of the Committee on Methods of Producing Monoclonal Antibodies (PDF), prepared by the Institute for Laboratory Animal Research, National Research Council, for NIH, is open for comment for 60 days.

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April 19 1999:     NIH Position On Human Pluripotent Stem Cell Research

Update: See August 23, 2000 OER News Flash for the New NIH Procedures for Stem Cell Research and the related NIH Guide Notice.

NIH funds (including equipment, facilities, and supplies purchased on currently funded grants) must not be used to conduct research using human pluripotent stem cells derived from human fetal tissue or human embryos until further notice.

Recent advances have indicated important research opportunities using human pluripotent stem cells that have been derived from fetal primordial gonadal tissue or from the inner cell mass cells of a human embryo at the blastocyst stage. While the NIH proposes to support research utilizing these human pluripotent stem cells, it will not do so until public consultation has occurred, guidelines are issued, and an oversight committee has ensured that each project is in accord with these guidelines.

As a first step, the NIH Director has commissioned a subcommittee of the Advisory Council to the Director with developing guidelines for the use of pluripotent stem cells in NIH-funded research. That group held an initial meeting on April 8, 1999, heard initial public comments, and began drafting guidelines which will be published in the Federal Register, with a 60-day public comment period, before being finalized.

Research on human stem cells derived from sources other than human embryos or fetal tissue will not be subject to these guidelines and oversight: this research will continue to be funded under existing policies and procedures.

For additional information, please consult:

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April 16 1999:     DHHS/NIH Comments On The Implications of Proposed Rule Making, OMB Circular A-110

On February 4, 1999, the Office of Management and Budget published a Request For Comments on the implications of proposed changes to OMB Circular A-110 (Federal Register, Volume 64, Number 23). These changes would extend mandatory disclosure requirements under Freedom of Information Act (FOIA) procedures to data produced under Federal grants and used by the Federal Governmentn developing policy or rules, which would have significant implications for the scientific research community. In response, the NIH convened a working group to evaluate the proposed rule changes, and initially published a document that presented some of the issues that needed to be clarified.

The DHHS has provided OMB with consolidated comments as to the implications of Proposed Rule Making, OMB Circular A-110. In addition, NIH director Dr. Harold Varmus has also provided comments.

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March 11 1999:     Research Involving Individuals with Questionable Capacity to Consent: Points to Consider

The National Institutes of Health (NIH) offers the following Points to Consider when involving in research individuals, from a wide variety of circumstances, who (may) have impaired decisionmaking capacity. Including useful strategies and practical guidance that are within existing regulations, this document is designed to maximize the potential opportunities and benefits of research while minimizing harms and discomforts to individuals who may be vulnerable. Comments on this document may be e-mailed to DDER@NIH.GOV.

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March 10 1999:    NIH Project To Reduce Regulatory Burden - Report Released

The NIH Initiative To Reduce Regulatory Burden report, provided to the NIH by a consultant, Mr. John Mahoney, was originally posted on March 10, 1999, for a public comment period of 60 days.

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February 26 1999:     Implications of Notice of Proposed Rule Making, OMB Circular A-110

We are now in the public comment period on a Notice of Proposed Rule Making (NPRM) which has significant implications for the scientific research community. The Omnibus 1999 Appropriations bill directed the Office of Management and Budget (OMB) to amend Circular A-110 to extend the Freedom of Information Act (FOIA) to "require Federal awarding agencies to ensure that all data produced under an award will be made available to the public under the [FOIA]. …If the agency obtaining the data does so solely at the request of a private party, the agency may authorize a reasonable user fee equaling the incremental cost of obtaining the data."

The NIH is developing a response to the NPRM issued by the OMB regarding the release of grantee data under FOIA. In order to seek clarification from the OMB during the comment period, the NIH is working with the scientific community to address some areas of concern. This document lays out some areas of concern and, in some cases, addresses the implications of the use of FOIA for data release, and will form the basis of the NIH response.

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February 17 1999:     1999 SBIR Phase 1 Update

The 1999 SBIR Phase 1 application forms and instructions are now available.

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February 12 1999:     Electronic Request For Forms Available

There is now an electronic form for use by Offices of Sponsored Research to request publications and materials from the NIH Grants Information office. The new order form which is accessible from http://grants.nih.gov/grants/forms.htm may be filled out electronically. The edited order form enumerating the quantity of items requested may be sent as an email attachment back to grantsinfo@nih.gov in order to obtain a supply of the printed items for local distribution. Researchers and other individuals who do not have access to an Office of Sponsored Research or its equivalent are encouraged to access forms, program guidelines and other materials directly from the Internet at the website http://grants.nih.gov/grants/forms.htm or if unable to obtain forms from the sources described above, call 301-435-0714.

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February 5 1999:     Proposed Revision of Circular A-110 Regarding Access to Data Developed Under Federal Grants

As anticipated, the Office of Management and Budget has published a Notice of Proposed Rule Making (NPRM) for revision of Circular A-110, having to do with FOIA access to data developed under Federal Grants. This NPRM can be found in the February 4 issue of the Federal Register, available on the World Wide Web at the following address: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1999_register&docid=99-2220-filed. This Notice is posted for a 60-day period of public comment. In the near future the NIH will post, on this web site, issues related to this topic and observations regarding this proposed rule.

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February 5 1999:     Biomedical Engineering Summer Internship Program Being Offered At The NIH

In a partnership of the National Institutes of Health, the Foundation for the National Institutes of Health, and The Whitaker Foundation, a Biomedical Engineering Summer Internship Program is being offered at the NIH. This structured 10-week summer program will sponsor 10 undergraduate biomedical engineering students in cutting-edge biomedical research projects in NIH laboratories in Bethesda, Maryland, under the mentorship of world-class scientists.

The students will be selected by a nationwide competition, and participants will have the opportunity to indicate preferences of projects from an extensive list. For more details, and elegibility requirements, please visit the Biomedical Engineering Summer Internship Program page.

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January 25 1999:     NIH Position On Human Pluripotent Stem Cell Research

Update: See August 23, 2000 OER News Flash for the New NIH Procedures for Stem Cell Research and the related NIH Guide Notice.

NIH funds (including equipment, facilities, and supplies purchased on currently funded grants) should not be used to conduct research using human pluripotent stem cells derived from human fetal tissue or human embryos until further notice.

Recent advances have indicated important research opportunities using human pluripotent stem cells that have been derived from fetal primordial gonadal tissue or from the inner cell mass cells of a human embryo at the blastocyst stage. While the NIH proposes to support research utilizing these human pluripotent stem cells, it will not do so until public consultation has occurred, guidelines are issued, and an oversight committee has ensured that each project is in accord with these guidelines.

Research on human stem cells derived from sources other than human embryos or fetal tissue will not be subject to these guidelines and oversight: this research will continue to be funded under existing policies and procedures.

For additional information, please consult:

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January 15 1999:     NIH Establishes Trans-NIH Mouse Initiative

In March 1998, the NIH convened a group of scientists to develop priorities for mouse genomics and genetics resources. In response to the community's recommendations, the NIH has created a Trans NIH Mouse Genomics and Genetics Resources Coordinating Group and a strategic implementation plan. For the convenience of all interested investigators, we have established the Trans-NIH Mouse Initiative Web site as a central information resource. It will contain all relevant information from all parts of the NIH.

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