Research Requiring Review

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.

Course-related research assignments are designed to teach students about class concepts and/or research methods and are implemented to fulfill course requirements. Classroom-based research assignments may involve activities where students interact with and collect data from other individuals within the Iona University community (for some of these projects, data is also collected from participants outside Iona). However, these investigations are conducted for educational purposes, and are not considered research because there are no plans to disseminate the findings. Importantly, all classroom-based research assignments that involve data collection from human participants must be carefully reviewed and supervised by the course instructor to ensure that ethical standards of conduct and fair and humane treatment of subjects are upheld. Classroom-based research assignments do not require IRB approval as long as the following requirements are met:

• The course instructor must complete the required research ethics training and certification through CITI and complete all renewal training to maintain certification;
• The instructor is responsible for reviewing and supervising each classroom-based research assignment;
• The investigation data will not be published or disseminated in a public forum. Iona Scholars Day presentations, undergraduate Honors theses, and master’s theses that are published in the Iona University library must have IRB approval prior to the initiation of data collection if they involve collecting data from human subjects;
• The investigation does not pose more than minimal risk to participants. According to federal regulations, “minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” (See section §46.102 of the Basic HHS Policy for Protection of Human Research Subjects, available at www.HHS.gov.);
• The investigation does not require recording of personal identifying information; and
• The investigation does not involve vulnerable populations (e.g., minors, prisoners, persons of limited capacity, etc.).