Human Subjects |  | Activities Involving Human Subjects & IRB Review |
|  |  | The UNH Institutional Review Board (IRB) for the Protection of Human Subjects in Research is a standing committee responsible for protecting the rights and welfare of people who are the subjects of UNH research activities. UNH's policy regarding the use of human subjects in research is stated in its Multiple Project Assurance of Compliance with DHHS Regulations for the Protection of Human Research Subjects on file with the federal government: All research involving human subjects must be reviewed by the UNH IRB and receive written, unconditional approval BEFORE the project is started. This policy applies to ALL research conducted at UNH or by an agent of UNH, including research in the humanities, and behavioral and social sciences, regardless of whether the research is funded or not. Several types of activity, both research and non-research, involving human subjects commonly occur at UNH. In order to clarify whether or not an activity is research or if human subjects are involved, UNH employs the federal government's definition of human subjects and research. 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." Research is defined as: "A systematic investigation designed to develop or contribute to generalizable knowledge." To apply the definition of research to an activity, one must look at the intent of the investigation, the researchers relationship with the subjects, and the dispensation of the data. Activities at UNH 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. 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. 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. 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. Activities involving human subjects within the context of research methods courses normally require some form of IRB review. Because such courses are designed to lead students to conduct "research," it is plausible to assume that such activities be reviewed as research. Departmental Review Committees (DRC) have been established to facilitate the IRB's responsibility for protecting human subjects by reviewing no more than minimal risk research projects generated within a department. Such authority, when granted, extends only to protocols classified as EXEMPT under federal regulations. Currently, DRCs exist in the anthropology, psychology, social work, and sociology departments. The UNH 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.
Home Quit |  |  |  |  |  |