Research Requiring Review
All research conducted by Iona's faculty, students, or staff involving human subjects or human biological material is subject to review by the IRB (or its designee; see next section for details). Projects reviewed by the IRB are organized into three categories, as outlined below. The IRB reserves the authority to determine the category for any project.
Projects that are not designed to develop or contribute to generalizable knowledge may be exempt from IRB review and oversight. Examples of these kinds of activities include normal educational practices and strategies (such as innovative instructional techniques, alterations in curricula, and assessment of same), data collected to support the mission of the college (such as outcomes assessment), oral histories (see section titled Oral History), and the use of archival or publicly available data.
Research involving queries and analyses of the following databases do not require an application: Center for Research in Security Prices databases (and all other publicly available, aggregate financial databases), Uniform Crime Reporting databases, United States Census databases, United States General Social Survey, World Value Survey and the National Study of the Changing Workforce.
Faculty, students, and staff should contact the Chair of the IRB for determination of exempt status for any project that does not fall clearly within these examples.
The bulk of projects reviewed by the IRB fall within this category and have the following characteristics:
- direct or on-line contact with the participant
- designed to develop or contribute to generalizable knowledge
- intended for public dissemination of methods and results
- involves minimal risk to the participant
- does not include special populations (e.g., minors or prisoners)
Projects similar to those above, but involving more than minimal risk to the participant or including special populations are subject to review by the entire IRB membership.
Projects involving human tissue, blood, fluid, cells, or DNA must be reviewed for compliance with applicable regulations. Faculty, students, or staff who wish to use such material must submit the Supplement for Biological Specimens.
The US Office for Human Research Protection, part of the Department of Health and Human Services (HHS), working in conjunction with the American Historical Association and the Oral History Association, has determined that oral history interviewing projects in general do not involve the type of research defined by HHS regulations and are therefore excluded from Institutional Review Board oversight. This determination was based primarily on the grounds that oral history interviews are usually not designed to contribute to "generalizable knowledge."
If a researcher with an oral history project is unsure whether his/her research meets the criteria for exclusion or, alternatively, should be reviewed by the IRB, he/she should contact the Chair of the IRB for clarification.
Accreditation-related studies do not require IRB approval. They are considered program evaluation, not research.
Case studies (single subject design) only need approval if the researcher intends to present at a conference or publish findings.