1. 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.
2. 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.
3. 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 Erica.Grant@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.
4. 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.
5. 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.
6. 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
7. 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.
8. 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.
9. 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 Erica.Grant@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:
Marina Volkov, Ph.D.
Office of Evaluation, Performance and Reporting
Office of the Director
National Institutes of Health
6011 Executive Blvd., Suite 206, 2nd Floor
Rockville, MD 20852
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 Erica.Grant@nih.gov.
10. 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.
11. 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.