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Privacy, Information Collection and Human Research Tool

The Privacy, Information Collection and Human Research (PICHR) tool below provides guidance on requirements related to collecting, using, and releasing information on individuals for research and related purposes. The following decision tree may help you determine if your activity is research involving human subjects and will provide you with a broad overview of the compliance requirements. Review the questions in each area below to determine the requirements that may apply to your activity.

Note: While using the PICHR Tool you may be asked about HIPAA and Members of the Public. Examples of these are provided below:

 

  • Human Subjects Research Overview
  • Privacy Overview
  • Information Management Control Overview
  • Results

Human Subjects Research Overview

The Office of the Under Secretary of Defense for Personnel and Readiness Human Research Protection Program supports and encourages research involving human subjects. All research protocols that include human subjects must be compliant with Federal laws, Federal Regulations, and DoD policies intended to protect the subjects of the studies.

1.

Is your activity ResearchA systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge [32 CFR 219.102(d)].

A systematic investigation includes a hypothesis or clearly stated research question, utilizes research methodology, and has a plan for data analysis.

Generalizable knowledge means new information that has relevance beyond the population or program from which the information was collected, or information that is added to the scientific literature.

research?
2.

Does your activity involve Human Subject A living individual about whom an investigator (whether professional or student) conducting research obtains

(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.

Intervention - includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject’s environment that are performed for research purposes [32 CFR 219.102(f)].

Interaction - includes communication or interpersonal contact between investigator and subject [32 CFR 219.102(f)]. This can include surveys, questionnaires, interviews, and focus groups, and can be physical or non-physical, such as a web-based survey.human subjects (living individuals)?
a.

Does your research involve physical intervention?
b.

Will you collect InformationAny communication or representation of knowledge such as facts, data, or opinions in any medium or form, including textual, numeric, graphic, cartographic, narrative, or audiovisual forms [DoDI 8910.01].information using any of the following methods: Survey/Questionnaire, Interview, Focus Group, Automated Survey Tools, Web Based Applications or Any Other Method, Including FormsDoDI 8910.01 defines surveys of persons as systematic data collections, using personal or telephonic interviews, or self-administered questionnaires, paper or web-based, from a sample of 10 or more persons as individuals or representatives of agencies that elicit attitudes, opinions, behavior, and related demographic, social, and economic data to identical questions that are to be used for statistical compilations for research and/or policy assessment purposes.

Focus groups are a tool for collecting qualitative data from group discussions.survey/questionnaire, interview, focus group, automated survey tools, web based applications or any other method, including forms?
c.

Will you obtain Private InformationPrivate information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. [32 CFR 219.102(f)].private information?
3.

Are you a Department of Defense (DoD) employee?
All questions require responses so that accurate results may be provided.

DHA Address: 7700 Arlington Boulevard | Suite 5101 | Falls Church, VA | 22042-5101

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