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NIH POLICY MANUAL
1184 - Scientific, Technical, and Other
Professional Information Presented by NIH Employees: Review,
Approval, and Distribution
Issuing Office: OD/OCPL 301-496-4143
Release Date: 3/10/2008
1. Explanation of Material Transmitted:
The purpose of this chapter is to provide information on the NIH policy
and procedures for the review, approval, and distribution of scientific,
technical, and other professional information by individual employees
(including intramural, extramural, and OD staff). This chapter provides
guidelines for written, electronic, or oral presentations, and
reiterates the many quality control measures embedded in the scientific
process, and at NIH, to ensure that the information disseminated by NIH
employees is of the highest quality. Scientific and professional
information presented by NIH employees must be considered differently
from information presented in other professional settings (such as when
scientists from universities or industry labs present information in
public forums.) A clear distinction must be made between the
presentation of scientific data and the presentation of opinion that may
be construed as the position of the agency. It is important to follow
the review, approval, and distribution guidelines with your supervisors
in order to ensure compliance. This issuance covers only official
distribution of scientific, technical and professional information
presentation clearance, and other products such as letters to the
editor. Employees writing, presenting or otherwise distributing
materials in their personal capacities are instructed to consult their
ethics officials for applicable rules and restrictions, including those
requiring prior approval and limiting the use of title or NIH
affiliation.
2. Filing Instructions:
Remove: NIH Manual Chapter 1184, dated 2/27/02
Insert: NIH Manual Chapter 1184 dated 3/10/2008
PLEASE NOTE: For information on:
- Content of this chapter, contact the issuing office listed above.
- NIH Manual System, contact the Office of Management Assessment, OM, on
301-496-4606.
- Online information, enter this URL: http://www1.od.nih.gov/oma/manualchapters/
A. Purpose: The purpose
of this chapter is to provide information on the policy and procedures
for the review, approval, and distribution of scientific, technical,
and other professional information by NIH employees. The policy
covers intramural, extramural, and OD staff. This chapter
provides guidelines for written, electronic, or oral presentation
of scientific and professional information by individual employees.
Information is required to be consistent with the framework of applicable
guidance which may include the OMB and HHS Guidelines for Ensuring
and Maximizing the Quality, Objectivity, Utility, and Integrity
of Information Disseminated by Federal Agencies, and the NIH Guidelines
for Ensuring the Quality of Information Disseminated to the Public,
hereinafter referred to as Information Quality Guidelines. See http://ospp.od.nih.gov/infoquality/
for further guidance.
B. Applicability: This chapter
applies to the review, approval, and release of any scientific,
technical, or other professional information related to the official
duties of NIH employees to the public regardless of the medium used
for dissemination, e.g., Web, print, audio or video broadcast, etc.
These materials include:
- written or electronic reports, lectures, books, chapters, editorials,
reviews, proceedings, or abstracts;
- broadcast scripts, audio or video tapes;
- prepared (i.e., not extemporaneous) formal speeches, oral
presentations, interviews or commentaries for publication or broadcast;
- official letters-to-the-editor, and
- official correspondence submitted for publication.
Materials are related to the employee's official duties if they:
- Report on or describe work performed as an official duty;
- Draw conclusions, advocate or oppose professional practices or
stances on subjects related to NIH activities or mission;
- Evaluate, summarize, or review work by others in an area related to a
position or official duty at NIH; or
- State or comment on Federal or agency policies or practices or might
be construed as reflecting an official position of the Federal
government.
C. Policy: NIH encourages public
dissemination of scientific research and other information on public health
matters by its employees. Scholarly writing, lecturing, editing, and
publishing are an essential part of research. These activities are in the
public interest and bring credit and distinction to both the NIH and to the
employees themselves. In assisting employees to share information about
their official and professional activities, NIH seeks to advance scientific
knowledge and contribute to professional education. Ordinarily first report
of any scientific research results or other professional findings is made
by:
- publication in a scientific or professional journal; or
- presentation at a meeting of a professional organization.
The choice of the journal or meeting to which reports are offered is
generally the prerogative of the author(s).
Sometimes the NIH provides "breaking news" to the public on research
findings prior to publication in scientific journals and prior to peer
review by journals. This is usually the result of an important public
health finding, such as publication of the results of a clinical trial
result that has immediate health implications. In such cases, there are
applicable internal review processes devised to ensure that information
disseminated to the public summarizes the facts as NIH currently knows them,
and that appropriate disclaimers are attached, if necessary.
There are many quality control measures embedded in the scientific process
to ensure that the information disseminated by NIH employees is of the
highest quality. NIH expects publications or presentations by NIH employees
to meet high standards of quality, make a substantial contribution to the
field, and contain sufficient information for the informed audience to
assess its validity.
Any non-extemporaneous presentation (written or electronic) by an NIH
employee on a subject related to the employee's NIH duties must be reviewed
and approved through an internal NIH process. This review process must
precede the author submitting material for publication consideration. Formal
oral presentations on health policy or practice must also be cleared in
advance. (See Section E for review and approval procedures and Section F
[“Clearance Not Required”] for exemptions.) All of these procedures are
designed to ensure the highest quality of information is made public.
Individual Institutes and Centers (IC), because they vary in structure,
size, and mission, have the flexibility to implement the quality and
accountability requirements of Federal and NIH guidelines in the most
sensible manner for their organization, as long as they ensure appropriate
review.
D. Preparation: In preparing a document or
presentation for publication, an employee should give particular attention
to the following:
1. Propriety, Accuracy, and Quality. Each publication
or presentation must be of high quality (including objectivity,
utility, and integrity) and accurate both in specific details
and in general impressions. It should demonstrate the highest
professional and ethical standards, as well as generally accepted
standards of good taste. General principles governing the
conduct of good science, including data management, publication
practices, and authorship can be found in "Guidelines for the
Conduct of Research in the Intramural Research Programs at NIH,"
(http://www.nih.gov/news/irnews/guidelines.htm).
2. Sufficient Detail for Reproducibility .
Where appropriate, supporting data should have full, accurate,
transparent documentation. The NIH supports and encourages the
timely release and public sharing of final data from NIH-supported
studies for use by other researchers and others whenever feasible.
Investigators should retain research data long enough to allow
others to repeat and analyze the studies. At a minimum data
must be retained consistent with applicable record retention requirements.
Refer to NIH
Manual Chapter 1743 "Keeping and Destroying Records," Appendix
1 for specific guidance. Publication of the data and methods
in peer-reviewed journals, or making data available through data
archives, are two accepted mechanisms for making results available.
3. Disclaimers. Normally, the need for a disclaimer in relation
to official materials, presentations, or publications is eliminated
through the clearance process. However, a disclaimer may still be needed
even after official clearance to make clear that the presentation should
not be construed as necessarily representing the NIH view.
Investigators may also need to use disclaimers to distinguish the status
of information, e.g., preliminary data or incomplete data. Where
appropriate, potential error sources affecting the quality of the data
should be identified and disclosed.
4. Use of Name, Logo or Marks Associated with DHHS,
NIH or the IC. Any use of DHHS, NIH or IC or other
subdivisions names, logos, marks, etc., must be consistent with
the provisions of NIH Manual 1186, “Use of the NIH Names
and Logos” (pending release, contact 301-496-5787 for information),
which provides NIH policy and procedures for the review and approval
of ANY materials that bear the logos and/or names of NIH or any
of its entities or programs.
E. Review and Approval Procedures:
In general, any writing by an NIH employee on a work-related subject,
whether intended for electronic or print publication, or for oral delivery,
must be prepared according to accepted NIH standards, reviewed for
substantive content, and administratively approved. This process both
protects the public and the employee.
IC Directors (or their delegates) are responsible
for establishing and maintaining controls to ensure competent and
timely clearance of materials covered by this chapter by developing
procedures appropriate to each type of information. Individual IC's
may determine how best to meet these requirements. IC Directors
should ensure that senior staff are knowledgeable about their IC’s
internal clearance procedures and are also responsible for maintaining
files of requests for approval and actions taken. IC Directors
should ensure that senior staff are knowledgeable about their IC’s
internal clearance procedures and are also responsible for maintaining
files (See the NIH Manual Chapter 1743, "Keeping and Destroying
Records”;
http://www1.od.nih.gov/oma/manualchapters/management/1743/)
of requests for approval and actions taken.
Intramural Scientists: Materials produced by
intramural scientists are generally reviewed and approved by Lab/Branch
Chiefs and sometimes Scientific Directors. The intramural approval
process helps to assure that applicable animal, human subjects,
and/or technology transfer issues have been considered, that major
press and policy implications are noted, and that at least one supervisory
scientist finds the work to be of merit. (See the Intramural
Research Sourcebook.) In the case of materials having
press implications, the lab chief or scientific director will inform
the communication director of the Institute or Center, and in the
case of policy implications, the director of the IC’s policy
office.
Fellows: Each NIH Fellow must follow publication
review rules set by the NIH and his/her IC. Fellows may not
personally profit from any publication associated with his or her
official duties at NIH. Ordinarily publications related to
work done at the NIH and with NIH resources are in the public domain,
It is highly recommended that both the Fellow and the Fellow’s
assigned Institute/Office refer to the HHS/NIH publication rules/guidelines
of this Chapter.
All Others: Written presentations by extramural
scientists or office of the director staff will be reviewed and
approved according to the policy established by the applicable IC
and any applicable policies issued by the Office of Extramural Research.
1. Policy Material. Information prepared for dissemination by an
employee that includes any discussion of Federal policy, has policy
implications, or makes public health practice recommendations must be
approved in the Office of the Director, NIH.
2. Official NIH Publications and Audiovisuals. All official
publications and audiovisuals by organizational components of
NIH must comply with the provisions of NIH
Manual Chapter 1183 even though some or all of the contents
may have been approved under the provisions of this Chapter.
3. Non-policy Material.
a. OD/NIH Staff. Non-policy material or professional
statements/correspondence prepared by staff within the Office of the
Director, NIH, shall be cleared by the director of the employee's division
or office for content and appropriate disclaimers. Materials or statements
prepared by the director of a division or office in the Office of the
Director, NIH, should be cleared by an NIH Associate Director or Deputy
Director.
b. IC Associate Director Level and Above. Professional
statements/correspondence or materials on a subject related to the official
duties of an employee at or above the Associate Director level requires
approval by that IC’s Director (or designee). Employees should follow
specific instructions for publication and speech clearance developed by
their IC. If there is any question about whether the material has policy
implications, it should also be reviewed by the Office of the Director,
NIH. See section 4.a. below for guidance on OD/NIH clearance procedures.
c. All Other Staff. Professional
statements/correspondence or material on a subject related to the official
duties of an employee below the Associate Director level must be approved by
the IC Director or designee (e.g., Scientific Director, Laboratory or Branch
Chief). In the case of joint authorship, each author must receive approval
from his or her respective IC Director or designee, unless IC internal
policies direct otherwise.
4. Clearance Procedures: Requests for clearance must be resubmitted if information has changed substantially.
a. OD/NIH Approval. Professional statements/correspondence
or materials requiring clearance from the Office of the Director,
NIH, must be approved by a designated officer within the originating
IC, and by the author's supervisor, prior to submission to the
Office of the Director, NIH. No such preliminary review is required
for writing or presentation by an IC Director, however. For
each manuscript, speech text, or other material requiring approval
in the Office of the Director, NIH, the originator must submit
to the Editorial Operations Branch, PIO/OCPL/OD, Bldg 31, Room
5B52 one copy of a completed Request for Publication and Speech
Clearance (NIH Form 1616-1) signed by both the Director and
Communications Director of the employee's IC. NIH Form 1616-1
is available at
http://forms.nih.gov/adobe/procurement/NH1616_1.pdf).
b. Institute/Center (IC) Approval. Professional
statements/correspondence or materials requiring clearance at
the IC level must be approved by the Director (or designee)
of the employee's IC. Employees should follow specific instructions
for publication and speech clearance developed by their IC.
IC's may use a variation of NIH Form 1616-1 (Request for Publication
and Speech Clearance) or the clearance form described in the
Intramural Sourcebook: http://www1.od.nih.gov/oir/sourcebook/oversight/pub-clear.htm.
5. Appeals. An employee whose presentation or material has
been disapproved may ask for review of the decision. The Deputy Director for
Extramural Research, NIH, reviews requests by extramural staff. The Deputy
Director for Intramural Research, NIH, reviews requests by intramural staff.
The Director, NIH, has responsibility for reviewing all other requests for
materials disapproved for publication or presentation.
F. Clearance Not Required:
1. Routine Oral Presentations. Oral scientific
presentations that do not discuss Federal policies and do not have policy
implications (e.g., usual intramural scientific oral presentations), and
routine presentations on existing NIH or IC procedures for information
purposes (e.g., to describe NIH grant application or management procedures
or to publicize priority areas for the purpose of soliciting grant
applications), do not typically require official clearance. Individual IC's
may implement their own procedures for requiring IC clearance of these
materials prior to presentation.
2. Answers to Inquiries and Informal Presentations.
Except when disallowed by Institute, Center, or Department policy, an NIH
employee may respond orally to questions and requests for information from
any source, including the news media. Similarly, an employee may appear as a
member of a discussion panel or seminar and on radio and television
broadcasts without prior approval if the appearance does not require a
manuscript or written text or statement and is in keeping with NIH policies
for responsible presentation of information as described above. Speakers
should limit their statements and responses to subjects within their field
of expertise and should present only official DHHS and NIH positions in
discussion of policy matters. For news media interviews, responses or
appearances, employees are encouraged to seek advice from the relevant IC
communications office or, for OD employees--from the NIH Office of
Communications and Public Liaison.
3. Unofficial Activities. Employees writing, presenting
or otherwise distributing materials, as defined in section 2.B. of this
manual chapter, in their personal capacities are instructed to consult their
ethics officials for applicable rules and restrictions, including those
requiring prior approval and limiting the use of title or NIH affiliation.
G. Employee Responsibility and Identification:
NIH employees are responsible for the statements they make, regardless of
whether they have been cleared. Employees who present material that requires
clearance but material that has not been cleared prior to presentation, must
inform the audience that the material represents the individual's views. An
example of an appropriate disclaimer follows:
"This material is presented from my own
perspective, and should not be taken as representing the viewpoint of
the Department, NIH, or [IC]."
H. NIH Staff (Co-)Authorship of Publications
from NIH Extramural Awards: Responsibilities of program
officials and project officers include providing suggestions and
critiques to awardee investigators and other staff -- for example,
developing or negotiating acceptable project direction or budget;
monitoring extramural awards; or commenting on research design or
conduct, draft manuscripts and other awardee presentations. 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, such as contributing
intellectually to the concept, design, conduct and/or analysis of
the results of the research.
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. NIH staff should work with supervisors when seeking approval
of activities as official duties. Review and clearance according to
applicable IC procedures is required.
I. Copyrights and Electronic Access:
Papers authored by government employees as part of official duties
are not subject to copyright in the United States. This
applies to the version submitted to the publication and not always
what appears in the publication as the publication may claim copyright
for its formatting or other enhancements. The citation to
the publication may be listed on an IC Website. The version submitted
to a journal or publication may be scanned and posted on the IC
Website. To the extent possible, the scanned document should
be compliant with Section 508 standards (http://www.section508.gov)
that ensure accessibility to people with disabilities.
J. Records Retention and Disposal: All
records (e-mail and non-e-mail) pertaining to this chapter must
be retained and disposed of under the authority of the NIH
Manual Chapter 1743, "Keeping and Destroying Records," Appendix
1, NIH Records Control Schedule, Section 1100 - General Administration,
Item 1100-B-1, "Policy Files” and all other sections that
apply.
NIH e-mail messages: NIH e-mail messages (messages, including
attachments, that are created on the NIH computer systems or transmitted
over the NIH networks) that are evidence of the activities of the agency or
have informational value are considered Federal records. These records must
be maintained in accordance with current NIH Records Management guidelines.
Contact your IC Records Officer for additional information.
All e-mail messages are considered Government property, and if requested
for a legitimate Government purpose, must be provided to the requester.
Employees' supervisors, the NIH staff conducting official reviews or
investigations, and the Office of Inspector General may request access to or
copies of the e-mail messages.
E-mail messages must also be provided to the Congressional Oversight
Committees, if requested, and are subject to the Freedom of Information Act
requests. Since most e-mail systems have back-up files that are retained for
significant periods of time, e-mail messages and attachments are likely to
be retrievable from a back-up file after they have been deleted from an
individual's computer. The back-up files are subject to the same requests as
the original messages.
K. Management Controls: The purpose of this Manual
issuance is to ensure that information disseminated to the public by the NIH
is of maximum quality, objectivity, utility, and integrity. This is achieved
through review and approved through an internal NIH process outlined in this
chapter. The use of appropriate disclaimers is addressed in Section D3.
1. Office Responsible for Reviewing Management Controls Relative to this Chapter:
The NIH Office of Communications and Public Liaison (OCPL) is accountable
for the method used to ensure that management controls are implemented and
working.
2. Frequency of Reviews: Ongoing
3. Method of Review: On an ongoing basis, OCPL evaluates input
concerning this policy from users based on e-mail, telephone calls, meetings
and memoranda, and makes appropriate changes as needed. Formal review of
this policy is conducted annually by the Associate Director for
Communications and Public Liaison and the Deputy Associate Director for
Communications and Public Liaison. Comments concerning this policy,
including agency controls, compliance, and reporting requirements, may be
addressed to John T. Burklow, Associate Director for Communications and
Public Liaison, NIH, and Marin P. Allen, Ph.D., Deputy Associate Director
for Communications and Public Liaison, NIH, both at 1 Center Drive, Room
344, Bethesda, Maryland 20892, 301-496-5787, fax 301-496-0017.
4. Review of Reports: are sent to DDM, DDER, and DDIR upon
request. Reports should indicate that controls are in place and working
well or indicate any internal management control issues that should be
brought to the attention of the report recipient(s).
L. References:
1. OMB and HHS Guidelines for Ensuring and Maximizing the Quality,
Objectivity, Utility, and Integrity of Information Disseminated
by Federal Agencies and NIH Guidelines for Ensuring the Quality
of Information Disseminated to the Public. See http://ospp.od.nih.gov/infoquality.
2. NIH Manual Chapter 1130 Delegation of Authority, Program:
General No. 3, Publish Articles and Results of Scientific Research,
and Program: General No. 4, Availability of Records for Examination
or Copying, both dated January 11, 1985. See
http://www1.od.nih.gov/oma/manualchapters.
3. NIH Manual Chapter 1183, NIH Publications and Audiovisuals:
Preparation, Review, Approval, and Distribution,
http://www1.od.nih.gov/oma/manualchapters/management/1183/
.
4. NIH Manual Chapter 1185 (in development), Complaints about
NIH Information Quality.
5. "Guidelines for the Conduct of Research in the Intramural
Research Programs at NIH," http://www.nih.gov/science/irnews.htm
.
6. The Intramural Research Sourcebook:
http://www1.od.nih.gov/oir/sourcebook/oversight/pub-clear.htm.
7. NIH Manual Chapter 1743, "Keeping and Destroying Records,"
Appendix 1, NIH Records Control Schedule: http://www1.od.nih.gov/oma/manualchapters/management/1743/
.
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