Institutional Review Board

All Offices & Services

Definitions

Vulnerable Populations - sick persons, pregnant women, fetuses, prisoners, children, elderly persons, mentally disabled persons, and persons who are educationally or economically disadvantaged.

Research Practicum - is a course of study that involves the supervised practical application of previously studied theories of research method. A number of departments offer courses that require students to interview or observe other people. The purpose of these courses is to train students and give them an opportunity to practice various research methods. Such projects do not require review by the Board.

Research Project - is any student-initiated and/or student-conducted research that does not fall under the definition of a research practicum, which uses human subjects, and intends to contribute to generalizable knowledge. Thus, it requires review and approval by the Institutional Review Board. Honors projects that involve the use of human subjects fall within this category.

Research- a systematic investigation designed to develop or contribute to generalizable knowledge.

Generalizable Knowledge - intent it to share with scientific community, information is intended to be used outside the institution.

Human Subject - a living individual about whom an investigator conducting research: (1) obtains identifiable information through intervention or interaction with the individual intervention, and uses, studies, or analyzes the information, or (2) obtains, uses, studies, analyzes, or generates identifiable information.

Identifiable Private Information -  private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. Possible information could include: name, social security number, medical record number, specimen number, etc.

Respect for Persons - recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy or particular vulnerabilities, including prisoners, children, those who are mentally or cognitively disabled, pregnant women, or economically or educationally disadvantaged persons. Human subjects should enter into research voluntarily and with adequate information.

Beneficence - the obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks. Possible risks to human subjects should be weighed against possible benefits to the subjects, as well as against the possible improvement of knowledge.

Justice - fairness in the distribution of research benefits and burdens. In selecting human subjects for research, investigators should ensure that no group of participants is either consistently selected to participate in research, or consistently deprived of the opportunity to do so.

Minor Change - changes that have no impact on risk level, selection of subjects, informed consent, data monitoring, privacy and confidentiality. Examples include: new student investigators, deleting questions from surveys, procedures that pose minimal risks of harm.

Quorum- the minimum number of members required to make the vote official.