Clearance Process for Surveys and Questionnaires

Research

Clearance Process for Surveys and Questionnaires

Clearance Process for Surveys and Questionnaires

Summary:

  • All prospective data collection that includes more than one Department of Defense (DoD) component service or includes civilians is subject to review and potential clearance through issuance of a control number prior to implementation.
  • The process is distinct and separate from human subject protection review and oversight provided by an Institutional Review Board (IRB).
  • Survey review and clearance should occur in parallel with other review processes, including IRB review, for timely initiation of a research program.
  • Began planning for survey and questionnaire clearance early in the research implementation process with an expectation of six months for clearance of a new survey that does not qualify for an exception.
  • The Uniformed Services University of the Health Sciences has a dedicated Information Management Control Officer (IMCO) in the Defense Health Agency (DHA) to assist with the survey clearance process and to provide additional information. All inquiries and submissions should be directed to the DHA IMCO (see below).

Background

The federal government defines data collection as “The obtaining, causing to be obtained, soliciting, or requiring the disclosure to an agency, third parties or the public of information by or for an agency by means of identical questions posed to, or identical reporting, recordkeeping, or disclosure requirements imposed on, ten or more persons, whether such collection of information is mandatory, voluntary, or required to obtain or retain a benefit."

Since 1944 the federal government required clearance prior to information collection on behalf of the government. The most recent update of the federal clearance process for information collection is in the Paperwork Reduction Act of 1995 and Department of Defense Instruction (DoDI)1100.13 (DoD Surveys) of 1996 and revised in 2015 and DoD Instruction 8910.01 (Information Collecting and Reporting)of 2014.

Clearance Process Overview

The survey clearance process has several steps, whether it is performed by the Department of Defense for military surveys or the Officer of Management and Budget (OMB) for civilian surveys.

The first step is a determination whether the data collection requires formal clearance or if the activity qualifies for an exception. Examples of exceptions include but are not limited to:

  1. Information collection with less than 10 respondents in a 12-month period
  2. Open-ended questions
  3. Information collection from a single DoD component (for example, only the U.S. Air Force)
  4. Information from individuals under treatment or clinical examination in connection with research to prevent a clinical disorder (includes active treatment for an ongoing condition or preventive measures to avoid a condition)
  5. Examinations designed to test the aptitude, abilities, or knowledge of the person tested for a collection

For a full list of exceptions, review the references cited above and the links below.

If the activity does not qualify for an exception, then following review by either DoD or OMB, the intended survey is submitted by the survey applicant to the Federal Register for publication of a notification of intent to collect data with a public comment period of 60 days.

At the close of the comment period, substantive comments are addressed by the survey applicant and the revised survey is resubmitted to and published in the Federal Register for a second public comment period of 30 days.

After the completion of the 30 days, the survey can be issued a Report Control Symbol from DoD or a Clearance Number from OMB.

The entire process is typically 180 days or more, so careful planning is required.

For further details on the DoD process see https://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Health-Care-Program-Evaluation/MHS-Patient-Satisfaction-Surveys/Conducting-Health-Care-Surveys-in-the-DoD with additional information at http://www.esd.whs.mil/Directives/collections/overview/

If the data collection is directed exclusively at non-military individuals or groups, application should be made through the Office of Management and Budget, Office of Information and Regulatory Affairs. A guide may be obtained at https://www.opm.gov/about-us/open-government/digital-government-strategy/fitara/paperwork-reduction-act-guide.pdf and detailed instructions are available at https://www.opm.gov/forms/pdfimage/omb83ins.pdf

 

USUHS specific instructions for initiating the clearance process

The determination of whether a proposed data collection qualifies as an exception, and is therefore exempt from compliance with the law and DoD instructions, is made by a designated Information Management Control Officer (IMCO). A determination in writing must be made prior to any data collection. The survey applicant does not have authority to make their own determination.

Obtaining formal clearance and the issuance of a Report Control Symbol is also made through the same DoD IMCO.

Additional Resource for Students with limited time

The DoD provides databases of previously collected survey information that is accessible with permission through the IMCO Office for training and analytic purposes. These databases are particularly recommended for students with limited time to learn analytic techniques and methodologies without a need to conduct an original survey.

USUHS Information Management Control Officer

To request a determination for an exception or to formally initiate the clearance process to obtain a Report Control Symbol or to request access to the DoD datasets for secondary analysis and training or for further information, please contact the USUHS Information Management Control Officer, who is:

Ms. Kim L. Frazier (DHA IMCO) at 703-681-3636 or Kim.L.Frazier.civ@mail.mil or her support assistant Ms. Sandra E. Dennis (Contractor, Altarum Institute), at 703-681-8818 or Sandra.E.Dennis4.ctr@mail.mil.

Additional Resource

The Office of the Undersecretary for Personnel and Readiness, Health Affairs, Research Regulatory Oversight Office has offered to prescreen USUHS submissions to facilitate the determination or the clearance process. To use this service, follow the instructions below.

 

RCS/OMB Pre-Coordination Summary Form

The purpose of the attached form is to request pre-coordination from the Defense Human Resources Activity’s Office of People Analytics (OPA) and the ASD(HA) Information Management Control Officer (IMCO) for information collections that may require a DoD Report Control Symbol (RCS) or OMB licensure (e.g., surveys, focus groups, interviews).  Submission of this form will allow OPA and the IMCO to provide helpful hints and an estimated timeframe for completion of the RCS/OMB review process prior to a formal submission, thereby allowing the investigator to appropriately plan activities that involve a collection of information.  The OPA will highlight any duplication with current collections and identify any issues related to DoD’s Survey Burden Action Plan that might require modifications to the proposed collection.  The IMCO will help you determine if you have an information collection that requires licensure and serve as your Technical Advisor to assist you through the process.

 

In order to facilitate this process and to receive a timely response, the attached form must be filled out completely.  Please submit this form to the Research Regulatory Oversight Office (R2O2) at DHA.R2O2.PR@mail.mil.  You should receive a response within 10 working days.

 

The following conditions describe when this form should and should not be submitted:

 

  1. Use this form to request pre-coordination of an information collection when information is being collected from more than one Component (e.g. Army and Navy).

 

  1. This form should not be used for an information collection from a single Component, even if the Component is other than your own. Collections from a single Component should be coordinated with the responding Component.

 

  1. Do not use this form for information collections from fewer than 10 people, who are members of the public, in a 12 month period.

 

Pre-Coordination Summary Form (click here)