Definition of Research and Human Participants

In determining whether a research proposal falls under the IRBPHP approval process it is important to establish whether the projects constitutes research and, secondly, whether the protocol uses human participants in the manner defined by the Common Rule.

2.1. Research

Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge. Research contributing to general knowledge includes following a deliberate plan to conduct an exploratory study or collect data to test a hypothesis. (34CFR97.102d) http://www.gpo.gov/fdsys/pkg/CFR-2009-title34-vol1/xml/CFR-2009-title34-vol1-sec97-102.xml Most of the research conducted in the social sciences, clinical, and biomedical specialties would fall within the definition of “systematic investigation.”

2.1.1 Student Projects

Student research conducted by both undergraduate and graduate students falls into three basic categories:

2.1.1.1 Research Practica

Research practica are classroom research projects, which provide research training. This would include practical application of studied theories of research methods supervised by the course instructor. Often these practica involve individuals outside of the practica class that are interviewed, observed, or otherwise serve as participants. The object of the practica is to train students in the practice of research methods. Since these activities seldom contribute to generalized knowledge and are not designed to do so, the IRB does not consider Research practica research under the definition of Common Rule. Board review and approval is not required so long as the participants are not identifiable by name or description and do not include vulnerable populations. Projects must not require participants to discuss personal issues or behaviors that might place them at risk by virtue of their participation.

2.1.1.2 Research Projects

Research Projects are either directed or independent activities, which require the student to collect data using a clearly defined and systematic protocol with the intent to disseminate for general knowledge. Any student initiated or conducted research outside of the definition of Research Practica using human participants as participants with the intent to contribute to general knowledge requires review and approval. This includes undergraduate and graduate thesis and dissertation research projects. (Note: theses and dissertations are considered research publications.)

2.1.1.3 Research Involving Sensitive or Vulnerable Populations

These research projects identify the human participant. Identification might be from any of the following:

results of responses to specific questions or specific behaviors
small sample sizes involving questions of age, ethnicity, or sex
selection of participants from vulnerable populations (children, prisoners, homosexuals) for projects concerning behavior or opinion regarding sensitive topics such as: HIV/AIDS, rape or incest, substance abuse/use, mental health, eating disorders, sexual abuse, sexual orientation, contraception and/or abortion issues, religious views. These research projects are subject to IRBPHP expedited or full board review.

2.1.2 Oral History

Scholarly and journalistic activities (e.g., oral history, biography, literary criticism, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected is not considered research per the 2017 Common Rule and is therefore not subject to IRB review.

2.1.3 Other Types of Projects May or May not Require Review

Research involving program evaluations or questionnaires related to quality assurance may or may not fall under the IRB. If the project contributes to the general knowledge it should be submitted for review. If it is for internal use and not for publication or wider distribution it need not be submitted.

Projects that result in accumulation of information from a variety of sources or development of handbooks of information for distribution to particular populations to be used as resource guides do not constitute research and do not have to come before the IRB for review. Example: Development of booklets that address various issues that would help in the self-education process of diabetes patients and distribution of these completed booklets to a community care facility with request for an evaluation by users.

2.2 Human Participant

Human participant is defined as “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.” http://www2.ed.gov/about/offices/list/ocfo/humansub.html Intervention includes both physical procedures by which data are gathered and manipulations of the participant or the participant’s environment performed for research purposes. Interaction includes communication or interpersonal contact between investigator and participant. Private communication 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, e.g. school transcripts.

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