- What are the NIH information quality guidelines?
- Why did NIH develop these guidelines?
- When did the information quality guidelines go into effect?
- How is information quality maintained?
- What information is subject to the quality guidelines?
- Are there quality control procedures for information NOT subject to the quality guidelines?
- Who is responsible for the information quality guidelines at NIH?
- What are the procedures for seeking corrections to information provided by NIH?
- How will NIH respond to requests for correction?
- How long will NIH take to respond?
- What is the process for appeal?
1. What are the NIH information quality guidelines?
The National Institutes of Health (NIH) has developed information
quality guidelines in order to maintain the high quality of the
information it provides to the public. These guidelines include administrative
mechanisms for affected parties to seek corrections to noncompliant information
provided by the agency.
2. Why did NIH develop these guidelines?
The NIH guidelines were developed in response to the Government-wide
guidelines issued by the Office of Management and Budget (OMB), which
are directed at ensuring and maximizing the quality, objectivity, utility,
and integrity of information disseminated by Federal agencies. Each Federal
agency is responsible for developing its own guidelines.
The OMB information quality guidelines require that "influential" scientific,
financial, or statistical information in Government documents be based
on studies that can be substantially reproduced if the original or supporting
data were to be independently reanalyzed using the same methods. "Influential"
means that the information has a clear and substantial impact on important
public policies or important private sector decisions, or has important
consequences for specific health practices, technologies, substances,
products, or firms.
Final OMB guidelines were published in the Federal Register on September
28, 2001, and supplemental information was published in corrected form on February 22, 2002, but effective as of January 3, 2002.
3. When did the information quality guidelines
go into effect?
The OMB guidelines apply to official information (with the NIH
imprimatur) that is released on or after October 1, 2002, regardless of
when first released.
4. How is information quality maintained?
NIH is committed to applying rigorous scientific standards to
ensure the accuracy and reliability of research results. For scientific
and technical documents, the scientific community recognizes peer review
as the primary means of quality control. NIH routinely seeks the input
of highly qualified peer reviewers on the propriety, accuracy, completeness,
and quality (including objectivity, utility, and integrity) of its materials.
Since the influence and implications of disseminated information cannot
always be fully anticipated, all NIH scientific reports are expected
to state clearly and specifically how the results are generated-data
used, various assumptions, analytic methods, statistical procedures,
sources of error-so that the original analysis is sufficiently transparent.
5. What information is subject to the quality
guidelines?
The guidelines apply to information in all forms-print, electronic,
audiovisual, verbal, etc. The guidelines focus primarily on the dissemination
of substantive information (e.g., reports, studies, summaries) rather
than information pertaining to basic agency operations. Information that
is disseminated at the request of NIH or with specific NIH approval through
a contract or a grant is subject to these guidelines. The guidelines apply
to preliminary information and are not limited to information used in
agency rulemaking.
Information that is subject to the guidelines includes:
- Scientific research papers, books, journal articles, and similar
authoritative materials unless they have disclaimers alerting the
audience that they do not represent official views of NIH
- Official reports, brochures, documents, newsletters, electronic
documents, and audiovisual productions
- Editorials, commentaries, and letters to the editor, but only if
they are provided by NIH staff representing official NIH viewpoints
- Verbal information, including speeches, interviews, and expert opinions,
but only if it represents NIH viewpoints, official positions, or policies
- Statistical information, including statistical analyses and aggregated
information by program, institute, or center or for NIH, including
funding information and histories (by disease, funding mechanism,
dollars, and other criteria)
- Consensus panel reports and open meetings' proceedings and minutes
6. Are there quality control procedures
for information NOT subject to the quality guidelines?
Although information that is not covered by the OMB guidelines
is not subject to the new administrative correction procedures, the information
is still subject to the usual NIH internal review procedures for accuracy
and high quality. This information includes:
- National Library of Medicine (NLM) databases or other archival records,
CRISP, and similar databases
- Documents not authored by the agency and not representing the agency's
views, including information authored and distributed by NIH grantees
- Information that is limited in dissemination to Government employees
or agency contractors or grantees
- Information pertaining to basic agency operations, including information
about agency authorities, activities, and programs; contact information
for the public; organizational charts; NIH or institute or center
directors' status reports; solicitations [program announcements (PAs)/requests
for applications (RFAs)]; and receipt and review materials (e.g.,
summary statements, information for advisory councils or advisory
committee members)
- Information intended solely for intra- or interagency use
- Responses to requests for agency records under the Freedom of Information
Act, the Privacy Act, the Federal Advisory Committee Act, or other
similar laws
- Information relating solely to correspondence with individuals
- Press releases that support the announcement or give public notice
of information that NIH has disseminated elsewhere
- Information for public filings, subpoenas, or adjudicative processes
- Opinions where the agency's presentation makes it clear that what
is being offered is personal opinion rather than fact or the agency's
viewpoints.
7. Who is responsible for the information
quality guidelines at NIH?
The Director of the Office
of Communications and Public Liaison (OCPL) in the Office of the
Director is responsible for implementing the NIH information quality guidelines
and works collaboratively with the institutes and centers to ensure the
quality of NIH materials and to resolve requests for corrections.
8. What are the procedures for seeking
corrections to information provided by NIH?
To seek a correction, an individual should submit the request
by electronic mail (email) to InfoQuality@od.nih.gov or should submit or mail the request to
the office that disseminated the information.The mailing
address for each of the NIH institutes and centers is posted elsewhere
on this Web site. Correction requests that are specific and provide supporting
evidence, such as comparable data or research results on the same topic,
will enable NIH to provide a satisfactory response. The request should
state that an information quality request for correction is being submitted,
and should provide the following information:
- Requestor contact information: Name, mailing address, telephone
number, e-mail address, and organizational affiliation, if any. This
information is needed to respond to your request and initiate follow-up
contact with you if required.
- Description of the specific material that is proposed for correction,
including where the material is located [i.e., publication title,
date, and number, if any; Web site and Web page address (URL); or
the presentation, presenter, date, and mode of delivery].
- Reasons for believing that the information is in error, and supporting
documentation, if any.
- Suggested recommendations for what corrective action(s) should be
taken.
- A description of how the requestor is affected by the information
error.
9. How will NIH respond to requests for correction?
Based on a review of the information provided, NIH staff will
determine whether a correction is warranted, and if so, what action to
take. Any corrective action will be determined by the nature and timeliness
of the information involved, the significance of the correction on the
use of the information, and the magnitude of the correction. NIH will
respond to the requestor by letter or email. The response will explain
the findings of the review and the actions NIH will take. NIH may reject
claims made in bad faith or without justification.
Requests for correction of information are handled primarily by the
director or designee (e.g., scientific director, laboratory or branch
chief) of the institute or center where the information originated.
A request for correction regarding information originating from a division
or office within the Office of the Director at NIH should be handled
by the director of the division or office. If more than one institute
or center was involved in releasing the information, the institute or
center of the lead NIH author should take primary responsibility for
coordinating a response.
10. How long will NIH take to respond?
NIH will respond to all requests for correction within 60 calendar
days of receipt. If more than 60 days are needed, NIH will inform the
requestor that more time is required and will state the reason why and
an estimated decision date.
11. What is the process for appeal?
If NIH denies a request for correction, the requestor may send
within 30 days of receipt of the agency's decision a written request for
reconsideration. The request should state the reasons for the appeal and
may be sent as hard copy or electronically to InfoQuality@od.nih.gov.
Requestors should reference the NIH tracking number provided in the NIH
response to the original request. If sent by hard copy, requestors should
also clearly mark the appeal and the outside envelope with "Information
Quality Appeal," and send the appeal to the following address:
Tom Johnson, Ph.D.
Office of Science Policy Analysis
Office of the Director
National Institutes of Health
Building 1, Room 218
9000 Rockville Pike
Bethesda, MD 20892
If the information in dispute was originally disseminated by the OCPL/NIH,
then an appeal should be addressed to the NIH Director at the same address
above, or sent electronically to InfoQuality@od.nih.gov.
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