HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public. Endnotes

10/01/2002

1 In general, grantees own the data generated by or resulting from a grant-supported project. Special terms and conditions of the award may specify alternative rights, e.g., under a cooperative agreement or if there are shared rights to data. Except as otherwise provided in the terms and conditions of the award, the grantee is free to copyright without NIH approval when publications, data, or other copyrightable works are developed under, or in the course of, work under an NIH grant. For this purpose, "data" means recorded information, regardless of the form or media on which it may be recorded, and includes writings, films, sound recordings, pictorial reproductions, drawings, designs, or other graphic representations, procedural manuals, forms, diagrams, work flow charts, equipment descriptions, data files, data processing or computer programs (software), statistical records, and other research data. Grantees are required to place an acknowledgment of NIH grant support and a disclaimer, as appropriate, on any publication written or published with such support and, if feasible, on any publication reporting the results of, or describing, a grant-supported activity. An acknowledgment shall be to the effect that: "This publication was made possible by Grant Number ________ from _________" or "The project described was supported by Grant Number ________ from ________" and "Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the (name of awarding office or NIH)." For more details, see the NIH Grants Policy Statement.

2 RePORTER is a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other research institutions. The database, maintained by the Office of Extramural Research at NIH, includes projects funded by NIH, Substance Abuse and Mental Health Services (SAMHSA), Health Resources and Services Administration (HRSA), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Agency for Healthcare Research and Quality (AHRQ), and Office of Assistant Secretary of Health (OASH). Users, including the public, can use the RePORTER interface to search for scientific concepts, emerging trends and techniques, or identify specific projects and/or investigators.

3 Excluded from this discussion are non-work-related and private writing, speaking, and publishing by an NIH employee, unless the employee's NIH responsibilities are likely to be regarded as influencing the content.

4 NIH Manual Chapter 6308 (Acquisition of Printing Requirements at the NIH) sets forth guidelines on how requirements for printing are to be handled by ICs at the NIH, in compliance with Federal printing rules and procedures. Manual Issuance 6308 covers direct acquisition for printing, as well as printing that is a peripheral deliverable in a contract for a larger purpose (e.g., an R&D contract for a study, the results of which are to be published).

5 To merit approval for (co-)authorships on publications from extramural awards (including grants, contracts, and other award mechanisms), NIH staff must have played a substantial role beyond normal program officer duties, including the following:
 

  • Originating the specific ideas that led to the research activity and manuscript,
  • Performing significant portions of the activity, and
  • Participating actively in preparing manuscripts.

The conditions allowing NIH staff to be (co-)authors of publications under NIH extramural awards ordinarily arise only from contracts and cooperative agreements, where, by definition, there is substantial programmatic, i.e., scientific-technical, staff involvement. Deviations from these provisions must be approved by IC directors, and only when justified under special circumstances. The Office of Extramural Research, OD, can provide further information and advice on this subject.

6 The National Toxicology Program (NTP) was established in 1978 by the Department of Health and Human Services (HHS) to coordinate toxicological testing programs within the Department, strengthen the science base in toxicology; develop and validate improved testing methods; and provide information about potentially toxic chemicals to health regulatory and research agencies, the scientific and medical communities, and the public. NTP's mission is to evaluate agents of public health concern by developing and applying tools of modern toxicology and molecular biology. The NTP is an interagency program consisting of relevant toxicology activities of the National Institutes of Health's National Institute of Environmental Health Sciences (NIH/NIEHS), the Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health (CDC/NIOSH), and the Food and Drug Administration's National Center for Toxicological Research (FDA/NCTR). The NIH's National Cancer Institute (NIH/NCI) was a charter agency; however, the NCI Carcinogenesis Bioassay Program was transferred to the NIEHS in 1981. The NCI remains active in the Program through membership on the NTP Executive Committee.