Determination Process Made Easier
Written by Jackie Gardner, ORP

The applicability of federal regulations requiring Institutional Review Board (IRB) review and approval of proposed projects is not always clear to researchers, administrators and others involved in the research enterprise. Penn State recently developed a determination form and checklist (see "Non-Human/Non-Research Determination Form" at: http://www.research.psu.edu/orp/areas/humans/applications/index.asp) to help investigators decide if their research meets criteria authorizing IRB oversight. The form also provides documentation to both the researcher and the Office for Research Protections, who supports the efforts of the IRB, of the nonresearch/nonhuman determination.

The three simple steps summarize the information that will follow:

Federal regulations and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) define research as "a systematic investigation, including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge." It is helpful to think of this definition in two parts: (1) the project involves the use of a 'systematic' investigation and (2) the goal, purpose or intent of the investigation is to develop or contribute to generalizable knowledge. Still confused? I thought so.

The use of a 'systematic' investigation may apply to both research and nonresearch projects. Quality assessment (QA) and quality improvement (QI) programs, medical research, and outcome analyses are a few examples of projects employing a systematic approach to data collection and analysis. The use of a systematic investigation, however, does not immediately identify the activity as 'research.'

The second element of 'research' declares the primary reason for conducting the activity is to develop or contribute to generalizable knowledge. Not surprisingly, this second criteria can also be found in research and nonresearch activities. Information, generated as a result of the proposed project, that is new, improved and/or in addition to the currently existing knowledge helps to define generalizable knowledge. Asking if publication or presentation is an intended outcome of the proposed project may be useful in determining if the protocol is research, but if the intention is not publication, research cannot be automatically ruled out.

Amdur, Speers and Bankert (in Institutional Review Board: Management and Function, Bankert and Amdur, eds.) have suggested a helpful tip in the evaluative process of 'developing or contributing to generalizable knowledge.' The defining characteristic of research: a major goal of the activity is to learn something for the purpose of benefiting people beyond those who are current participants in the project. Participants can benefit directly from the research but this benefit is never the only, and rarely the primary, goal of the research. The regulations, however, require an be classified as 'research.' Having only one indicates the activity is not research and does not require IRB review and oversight.

Once the project has been declared "research" using the guidelines above, the next step is to determine if the project involves the use of 'human subjects.' Human Subject is defined as a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual OR (2) identifiable private information. Deceased subjects are not included in this definition, except under HIPAA regulations. Since the definition of a human participant is a "living" individual, research involving autopsy materials or cadavers is not considered human participants research and is not regulated by the IRB. However, if protected health information is involved, such research must comply with privacy regulations and be reviewed by the institution's Privacy Board, which is the IRB at Penn State.

However, any time the researcher does something with or to someone and collects data about that individual, or a response is obtained and the reaction is documented or recorded, an interaction with a human subject has occurred. Examples of 'interaction' include both physical procedures where data are gathered (i.e. blood sample) and manipulation of the participant and/or his/her environment for research purposes. Communication or interpersonal contact between the research participant and researcher can be viewed as an interaction.

"Identifiable," for this article, can occur when: (1) the identity of the individual is or may be readily ascertained OR (2) the identity of the individual is or may be readily associated with the information being collected. Private information includes information about behavior that occurs in a setting where one can reasonably expect that no observation or recording is taking place, and the information is not intended to be made public. Private information also includes information which has been provided for a specific purpose by an individual by which the person can reasonably expect will not be made public (i.e., medical record).

If the project is covered under "Food and Drug Administration" regulations, keep in mind the definition of a "human participant" is different. For additional information, please see the following link: http://www.research.psu.edu/orp/education/modules/irb/definitions.asp#fda or contact the Office for Research Protections.

To decide whether a project should be categorized as "research," it is helpful to understand that activities that are not research can incorporate scientific methodology and generate results/data ripe for publication and/or presentation. The distinctive difference, however, stems from the fundamental goal of the activity: to learn something that will provide a contribution to benefit human beings in the near and perhaps, not-so-near future. Additionally, for the project to fall under IRB purview, it must be BOTH research and involve human participants. The new determination form will guide you through a number of questions and inquiries to help you decide if both of these qualifiers are met before your project can be designated as human participant research and undergo subsequent IRB review and oversight.

For more information, please see the following references and resources:

Amdur RJ, Speers M, Bankert EA. Identifying intent: Is this project research? In: Bankert EA, Amdur, RJ (eds.). Institutional Review Board: Management and Function, 2nd ed. Sudbury, MA: Jones and Barlett Publishers; 2006: 101-105.

Office for Human Research Protections (OHRP) guidance http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm#c1

Office for Research Protections (ORP) http://www.research.psu.edu/orp/areas/humans/index.asp

Penn State University Policy RA14 - The Use of Human Subjects in Research http://guru.psu.edu/policies/RA14.html

Pritchard, IA. Searching for "Research Involving Human Subjects" IRB: Ethics and Human Research 23(3):5-12, 2001.