HRPO Frequently Asked Questions

• What are the unique human subjects protection requirements for research funded through the Department of Defense?
• Explain exempt status for research involving human subjects or anatomical substances?
• If I am claiming exempt status for research involving human subjects or anatomical substances, what forms should I submit?
• How do I download MS Word and MS Excel forms?
• Do I have to fill out any Animal Use forms if no animals will be used in my research?

A: If your research will involve the participation of human subjects or use of human anatomical substances, human data or human cadavers, it will require review and acceptance/approval by our office before your research may be initiated. View a description of the DOD and Army-unique issues and requirements (PDF 55 KB) that should be considered during preparation of your research protocol and informed consent document.

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Q: Explain exempt status for research involving human subjects or anatomical substances.

A: The following list taken from 32 CFR 219.101 (190 KB) details the exemption categories.

1. Research conducted in established or commonly accepted educational settings involving normal educational practices, such as:
   1. research on regular and special education instructional strategies, or
   2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:
   1. information obtained is recorded in such a manner that human subjects can be identified directly or through identifiers linked to the subjects; and
   2. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph 2 of this section, if:
   1. the human subjects are elected or appointed public officials or candidates for public office, or
   2. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available of if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.
5. Research and demonstration projects that are conducted by or subject to the approval of Department or Agency heads, and that are designed to study, evaluate, or otherwise examine:
   1. public benefit or service programs,
   2. procedures for obtaining benefits or services under those programs,
   3. possible changes in or alternatives to those programs or procedures, or
   4. possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies,
   1. if wholesome foods without additives are consumed, or
   2. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the Environmental Protection Agency or the Food Safety and Inspection Service ofthe U.S. Department of Agriculture.

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Q: If I am claiming exempt status for research involving human subjects or anatomical substances, what forms should I submit?

A: Investigators who believe that their protocol is exempt from review should submit

1. a completed Claim of Exemption Form and
2. documentation from the local IRB stating that the protocol has been determined to be exempt.

If human anatomical substances are being used, a copy of the consent form that was used with subjects when the anatomical substances were initially obtained for use in research should be provided. This consent form should demonstrate that subjects consented to the use of their donated samples in the type of research being conducted. Additional information may be requested (e.g. survey tools, etc.) depending upon the category of exemption requested.

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Q: How do I download MS Word and MS Excel forms?

A: You may simply click on the MS Word or MS Excel file links to view them in your browser. Alternatively, you may download the files to your computer by clicking the right mouse button on the file links. You will see a pop-up menu. If you are using Netscape Navigator, select "Save Link As," or if you are using Internet Explorer, select "Save Target As." A dialog box will appear enabling you to save the files on your computer. Please note that in order to use the MS Word/MS Excel applications, you will need a PC running Word, and/or Excel (both for Windows 95 version 7.0 or higher).

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Q: Do I have to fill out any Animal Use forms if no animals will be used in my research?

A: No

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