Institutional Review Board

Student Handbook on Human Subject Research

August 2006

Glossary of Important Terms

Adverse Research Event

Adverse research events include a wide spectrum of events. Adverse events include, but are not limited to, physical or psychological harm or injuries, threats to privacy or safety, and unusual attrition of human subjects. They also include breaches of confidentiality or emotional harms such as the emotional distress that could be triggered by questions about traumatic life events or a subject's complaints about the experimental procedures or the conduct of the investigators.

Biosafety

The safety procedures associated with the research and/or production of biological products such as radioactive materials.

Case Study

An exploration of a “bounded system” or contemporary phenomenon within its real life context, especially when the boundaries between phenomenon and context are not clearly evident.

Co-author

Any individual, who with the agreement of the author may add his or her name on that individual’s publication or presentation as a collaborator. Designation as a co-author usually indicates sustained involvement with the project.

Ethnography(or ethnographic study)

An approach to inquiry in which the researcher studies human behavior in a natural setting rather than in a laboratory, for purposes of understanding the culture of that particular population. Research may involve observations and/or interviews with people in that setting. Since human participants are involved, the research must be prospectively reviewed and approved by the USM IRB before the research project begins.

Exempt Review

An IRB reviewable research study, typically handled at the administrative level by the Human Protections Administrator (HPA). Exempt research does not require continuing yearly review, however, any revisions to the project still must be submitted for review to the IRB. A protocol qualifies for an exempt review when the following criteria are met:

• Involves minimal risk to human subjects;
• Falls into one of the designated exemption categories set forth in: The Common Rule, 45 C.F.R. § 46.101 (2005).
• Does not involve identifiable or sensitive information; and
• Generally does not involve special subject populations (such as children, prisoners, mentally challenged, etc.)

Expedited Review

An IRB reviewable research study that is typically reviewed by one IRB member and the Human Protections Administrator (HPA). A protocol qualifies for an expedited review when the following criteria are met:

• Involves minimal risk to human subjects;
• Does not involve the identification of human subjects or their responses in a way that would place them at risk of criminal or civil liability or a diminished quality of life.
• Falls into one of the designated expedited review categories set forth in: 63 Fed Reg. 60364-60367 (1998);
• May involve identifiable or sensitive information;
• May involve special subject populations;
• Research overlapping with other regulations (for example HIPAA, FERPA) will typically be reviewed at the Expedited level.

Full Board Review

An IRB research study that is initially reviewed by the Human Protections Administrator (HPA) and then reviewed by the fully convened IRB when:

• Involves greater than minimal risk to human subjects;
• Involve identifiable and/or sensitive information; and
• Involve special subject populations.
• Research overlapping with other regulations (for example HIPAA, FERPA) and that involves identifiable/sensitive information will typically also require Full Board review.

Generalizable Knowledge

Knowledge produced by a project or study which is intentionally shared with others, be it at a poster presentation, at a conference, or in a publication. For example, a “Thinking Matters” presentation would be considered “generalizable knowledge”.

Student classroom projects which are not intended to be shared outside the classroom are usually not considered “generalizable knowledge”. However, when a third party not affiliated with a course attends a classroom presentation, or, receives information from the project, the researcher has contributed to or developed “generalizable knowledge”.

Human Subject

A living individual about whom an investigator (whether professional or student) conducting research obtains

• Data through intervention* or interaction** with the individual, or
• Identifiable private information***.

*Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

**Interaction includes communication or interpersonal contact between investigator and subject.

***Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Note: For research involving health or medical information (and/or the electronic transmission of this type of information) the definition of “private information” is not the same as the definition of “protected health information” (PHI) as defined under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Independent study

In-depth individual projects under the guidance of a faculty member. A course of study that is not part of regular department offerings.

Mentor

An individual (e.g., faculty member, advisor) who provides guidance and recommendations to a more junior person for courses of action and behavior.

Minimal Risk

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.

Oral History

A technique in which the researcher conducts a series of interviews with participants, which may be recorded, or observes a particular historical event or period. Often, the intention is that the archived data becomes available to the public at a specified future time in order to convey historical insight.

If the archived data will be made publicly available then the research must be prospectively reviewed and approved by the USM IRB before the research project begins. The IRB requires that the researcher make provisions for obtaining informed consent from all participants and document the process. Participants in oral history projects should be allowed to review the material prior to public archive and decide if they do not wish any or all of the oral history archived.

Principal investigator

The lead investigator with primary responsibility for the project. The Principal Investigator (PI) is the individual responsible and accountable for designing, conducting, and monitoring a protocol. The PI must be a suitably qualified member of the senior, junior, or research staff. The PI assumes full responsibility for the treatment and evaluation of human subjects and the integrity of the research data.

Qualitative Research

The investigation of phenomena in a non-quantitative, in-depth, and holistic fashion, through the collection of rich narrative materials. Examples of data collection include observation, interviews, and document analysis.

Quantitative Research

The investigation of phenomena that lend themselves to test well-specified hypotheses through precise measurement and quantification of predetermined variables that yield numbers suitable for statistical analysis.

Risk

Measure of the association between exposure and outcome (including incidence, side effects, toxicity).

Service Learning

An educational method by which participants learn and develop through active participation in service that is conducted in and meets the needs of a community. Service learning is coordinated with a school or community service program and with the community. It is integrated into and influences the lifelong learning of a participant and includes structured time for the participants to reflect on the service experience.