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 obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Identifiable Private Information - a link to the subject which could include: name, social security number, medical record number, specimen number, etc.

Systematic Investigation - hypothesis driven, you have a question you want to answer for reasons other than clinical care or routine evaluation, includes research development, testing and evaluation (pilot studies, feasibility studies), begin with specific intent, usually more than one sample/subject.

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.

Informed Consent - an educational process that takes place between the investigator and the prospective subject. The basic elements of the consent process include: full disclosure of the nature of the research and the subject’s participation adequate comprehension on the part of the potential subject the subject’s voluntary choice to participate.