Coordinated IRB Review

TERMS USED IN THIS FORM

Primary Principal Investigator

The overall multi-site Principal Investigator who has the ultimate responsibility for the conduct of research to ensure subject safety and data integrity for research that will be carried out collaboratively among two or more institutions. The Primary Principal Investigator is responsible for assuring proper conduct of the protocol at each site, communication between sites, and assuring that IRB determinations are disseminated to each involved site. The Primary Principal Investigator may or may not be the Lead Investigator at their home institution.

Lead Investigator

The individual at a study site who is responsible for assuring compliance with institutional policies and guidelines, communicating on a regular basis with the Primary Principal Investigator, and assuring adherence to the protocol as approved by the reviewing IRB. When there are multiple investigators at a site, a Lead Investigator must be identified in this Request Form for each institution involved in the research. The Lead Investigator cannot be a student.

Key Personnel

Individuals (including the Lead Investigator) at a study site who contribute substantively to the scientific development or execution of a study.

Coordinating Site

The site that is responsible for coordinating study activities, monitoring data, and assuring communication among all study sites. This site may also be the location of data storage and/or data analysis.

Interacting

Any communication or interpersonal contact between investigator and subject, for example, collecting specimens from individuals, conducting questionnaires or surveys, conducting focus groups, or drug administration.

Record Review

Review of any type of record including confidential records such as medical, educational, or financial, whether paper or electronic.

Recruiting

Providing information about a research study to potential subjects, for example, putting up flyers at a college campus or hospital clinic, putting an ad in a local newspaper or on a website, sending an email to potential subjects, discussing a study with a patient during an office visit

Retrospective

Data or biospecimens to be analyzed for this study already exist at the time of submission to the IRB.

Prospective

Data or biospecimens will be collected as part of this research study.

Risk

The possibility that harm may occur. In research ethics, risk is defined as the magnitude of potential harm or discomfort and the probability of the harm or discomfort occurring.* There are many different types of possible harms, for example psychological distress, embarrassment, physical injury, or legal, social or economic harm. Although a record review may appear to present no risk, there is a risk of loss of confidentiality whenever confidential records are accessed or used.

Minimal Risk

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not in and of themselves greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. **