HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public. VI. Agency Administrative Complaint Procedures


NIH has developed administrative procedures to allow affected persons to seek and obtain correction of disseminated information that does not comply with OMB, HHS, and NIH guidelines (See NIH Manual Chapter 1185). Additional guidance on appropriate responses can be obtained from the NIH website (http://ospa.od.nih.gov/infoquality.html), particularly if the complaint involves a policy statement or official position. NIH established this website to advise information consumers of the agency's information quality guidelines, the process to submit a request for correction, information needed by the requestor, and a description of the complaint adjudication process.

The resolution process addresses the valid needs of the complainant without disrupting NIH processes. Complainants should be aware that they bear the "burden of proof" with respect to the necessity for correction, as well as with respect to the type of correction they seek. In making a determination of whether or not to correct information, NIH may reject claims made in bad faith or without justification, and is required to undertake only the degree of correction that is appropriate for the nature and timeliness of the information involved.

  1. Responsibility of the Complainant

    To seek a correction of information disseminated by the NIH or its components, an individual should submit or mail the request to the disseminating office (contact information for individual ICs will be made available through the NIH Information Quality website), or submit the request by electronic mail (email) to InfoQuality@mail.nih.gov or InfoQuality@od.nih.gov or mail the complaint to:

    Office of the Director
    Office of Science Policy
    National Institutes of Health
    Building 1, Room 218
    9000 Rockville Pike
    Bethesda, MD 20892

    The request should state that an information quality request for correction is being submitted, and should provide the following information:

    • A detailed description of the specific material that is proposed for correction, including where the material is located, i.e., the publication title, date, and publication number, if any, or the website and web page address (URL), or the presentation, presenter, date and mode of delivery;
    • The specific reasons for believing that the information does not comply with OMB, HHS, or NIH guidelines and is in error, and supporting documentation, if any;
    • Suggested recommendations for what corrective action(s) should be taken;
    • A description of how the person requesting the correction is affected by the information error; and
    • Complete contact information for the requestor, including name, mailing address, telephone number, e-mail address, and organizational affiliation, if any.
  2. Determination of Appropriate Response

    Requests for correction should be handled primarily by the originating IC Director or designee (e.g., Scientific Director, Laboratory or Branch Chief). IC Directors are responsible for establishing and maintaining procedures to ensure that requests are properly addressed, that an objective and qualified review of the merits of the request is undertaken, and that an appropriate response is provided in a timely manner. The procedures may include forming a review committee or equivalent, and shall allow for response by the originating and contributing authors, as well as input from the IC Communications Director.

    A complaint about information originating from a division or office within the Office of the Director (OD), NIH, should be addressed by the director of the division or office, with input from the Office of Science Policy and Office of Communications and Public Liaison (OCPL), OD, NIH.

    If more than one IC was involved in releasing the information, the IC of the lead NIH author should take primary responsibility for coordinating a response.

  3. Appropriate Responses

    Based on a review of the information provided, the responding office should determine whether a correction or clarification is warranted and if so, what action to take. Agencies may choose not to change claimed defects that are frivolous or unlikely to have substantial future impact. If NIH determines that action is warranted, NIH may respond in any of the following ways:

    • Provide a clarification by personal contact via letter or telephone;
    • Issue a written retraction or clarification, which can be accomplished through a press release, mass mailing, or some other reasonable method that corrects a widely disseminated error or addresses a frequently raised complaint;

    Suspend further dissemination of the information in question;

    • Refer complainant to the underlying data if the data are available in a public archive;
    • Arrange for an independent reanalysis of the data by NIH or a mutually acceptable third party if the data are not publicly available, and the complaint involves "influential scientific or statistical information." Complainants must agree to pay the costs of reanalysis or the process terminates.
    • Work with the grantee institution to respond to the complaint, when it involves research from a grantee. Complaints must be about information derived from a project that is supported in whole or in part with Federal funds under a new or competing continuation grant awarded after April 17, 2000, and that is cited officially by a Federal agency in support of an action that has the force of law, such as a new regulation or administrative order. (If not available elsewhere, these types of data can be obtained from a FOIA Coordinator for the granting IC, see www.nih.gov/icd/od/foia/coord.htm. Additional information about NIH FOIA procedures, including requests, appeals, and fees, is available at www.nih.gov/icd/od/foia/. For NIH guidance on OMB Circular A-110 see grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm).

    The response to the complainant will be by letter or email, and should explain the findings of the NIH review of the merits of the complaint, and the actions to be taken, if any. The response should consider the nature and timeliness of the information involved and such factors as the significance of the correction on the use of the information and the magnitude of the correction. The response should also describe how the complainant may request reconsideration. NIH will respond to all requests for corrections within 60 calendar days of receipt. If the request requires more than 60 calendar days to resolve, the responsible official will inform the complainant that more time is required and indicate the reason for the delay and an estimated decision date.

    Whether or not corrective action is warranted, the response to the complainant should describe the preparation, clearance, review, and approval process prior to the information being disseminated, including any specifics about the peer review process to support the rigor and objectivity of the review, e.g., the breadth and depth of experts, community input, and message testing. The response should also reiterate any disclaimers that accompanied the information when it was first released.

    Additional guidance on appropriate responses can be sought from the OSP, or OCPL, OD, NIH, particularly if the complaint involves a policy statement or official position.

  4. Reporting Requirements

    The IC (or OD office) receiving a request for information correction is required to enter the complaint into the NIH tracking database for this purpose. The IC is encouraged to contact OSP, OD, NIH to discuss the nature of the complaint, and to provide a preliminary assessment of whether the complaint is legitimate. Among the criteria to be used:

    • The information is considered official NIH information, i.e., approved through the NIH clearance process and intended to represent the views of NIH.
    • The information is substantive (i.e., reports, studies, summaries) rather than pertaining to basic agency operations.
    • The information was disseminated on or after October 1, 2002
    • The information is not exempt according to Section C (Applicability) of this chapter.
    • The complainant is someone who may benefit or be harmed by the disseminated information. This includes persons who are seeking to address information about themselves as well as persons who use information.

    If the IC determines that corrective action is warranted, the IC shall forward the following information to the OSP and OCPL, OD, NIH without delay:

    • A copy of the complaint.
    • A list of the relevant contacts within the NIH IC or OD office, including the names of those most knowledgeable about the information in question.
    • A draft letter response with any supporting documentation.

    OSP and OCPL responsibilities include:

    • Assisting with the review of the complaint for legitimacy. If the complaint is later determined not to be legitimate, the IC must provide a clear explanation of the rationale for that determination to the complainant.
    • Reviewing the proposed IC response for appropriateness, and assisting in finalizing the response.
    • Maintaining a tracking database of complaints, including information on their disposition and any resolution or corrective action taken.
    • Submitting an annual report on behalf of NIH to the Department of Health and Human Services (HHS) with the number and types of complaints, and the action taken, in time for the HHS to report to OMB by January 1 (beginning in 2004).
    • Posting on the OSP Web site any further clarifications, guidelines, and Frequently Asked Questions (FAQs) about handling NIH information complaints.
    • Making examples of typical complaints and appropriate responses available to ICs.
  5. Appeals

    If NIH denies a request for correction, the complainant 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, "Information Quality Appeal," and send the appeal to the following address:

    Office of the Director
    Office of Science Policy
    National Institutes of Health
    Building 1, Room 218
    9000 Rockville Pike
    Bethesda, MD 20892

Any office that originally disseminated the information and/or responded to the original complaint should not have responsibility for the resolution of the appeal. If the information in dispute was originally disseminated by the NIH, then an appeal should be addressed to the NIH Director at the address listed above, or sent electronically to InfoQuality@od.nih.gov.

NIH will respond to all requests for appeals within 60 calendar days of receipt. If the request requires more than 60 calendar days to resolve, the agency will inform the complainant that more time is required and indicate the reason for the delay and an estimated decision date.