IRB Guidelines - Activities Involving Human Subjects Research

The University of Massachusetts (UMass) Institutional Review Board (IRB) for the Protection of Human Subjects in Research is responsible for protecting the rights and welfare of people who are subjects in UMass research activities.

Several types of activity, both research and non-research, involving human subjects commonly occur at UMass. In order to clarify whether or not an activity is research or if human subjects are involved, UMass employs the federal government's definition of research as:

"A systematic investigation designed to develop or contribute to generalizable knowledge."

Human subjects are defined as:

"Living individual(s) 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."

To apply the definition of research to an activity, one must look at the intent of the investigation, the researcher's relationship with the subjects, and the dispensation of the data.

Activities at UMass involving human subjects commonly fall into the following categories:

Research - the purpose of the activity is to contribute to generalizable knowledge and data gathered may be shared with a research community or the public at large. (Requires IRB approval)

Evaluation/Assessment/Service/Reporting - the purpose of these activities is, upon request, to gather data to measure the current situation in regard to a specific phenomenon or set of factors. Data gathered may be shared only with the sponsor/client/requesting party and where appropriate, the faculty advisor, or used for internal decision making or informational purposes. (Typically does not need IRB approval)

Classroom Assignments/Educational Inquiry/Practice - the purpose of these activities is the education of an individual student through an inquiry or experiential approach to discover known principles or phenomena. Data gathered may be shared only with the course instructor or faculty advisor, or in the case of an internship/practicum, the collaborating party. (Typically does not need IRB approval)

IMPORTANT: Individuals gathering data from human subjects as part of evaluations, assessments, service, reporting, classroom assignments, educational inquiry, or practice abrogate their rights to publish data as research data; if they choose to share observations with others, their actions ought to be governed by the ethical standards of their discipline (e.g. American Psychological Association or American Anthropological Association). Individuals who wish to gather data from human subjects as part of evaluations, assessments, service, reporting, classroom assignments, educational inquiry, or practice AND intend to use the data as research data for the purpose of publishing or sharing with a research community or the public at large, must obtain IRB approval PRIOR to conducting the activity.

The IRB reviews all funded human subject research. Unfunded research is currently reviewed at the departmental level by Local Review Boards (LRB) where a committee exists. Currently LRB exist in Anthropology, Communication, Education, Linguistics, School of Management (SOM), and Sociology (ISSR). Where a LRB does not exist, all human subject research is reviewed by the IRB.

The UMass IRB recognizes that human subjects may be harmed by unethical or careless activities resulting from evaluations, assessments, service, reporting, classroom assignments, educational inquiry, or practice. As a board that values the protection of human subjects and the conduct of ethical behavior, the board strongly disapproves of such unethical behavior. However, the IRB recognizes the limits of its mandate and authority.

For more information on the UMass Institutional Review Board or institutional requirements regarding research involving human subjects, contact:

Human Research Protection Office (HRPO)
108 Research Administration Building
70 Butterfield Terrace
University Of Massachusetts
Amherst, MA 01003-9242

Phone: (413) 545-3428
FAX: (413) 577-1728
Email: humansubjects@ora.umass.edu

Additional materials are available on the Human Research Protection Office website.