Human Research Protection Program

The purpose of this SOP is to set forth the procedures to be followed in the continuing review of Institutional Review Board-approved human subjects research conducted under the auspices of Brandeis University.

This SOP applies to human subjects research projects conducted under the auspices of Brandeis University.

It is the standard operating procedure of Brandeis University that all human subjects research conducted under its auspices and receiving full board review must be reviewed by the Institutional Review Board at an interval determined by the IRB at the time of its initial review or last requested modification, and based upon the nature of the study, the level of risk to subjects and the vulnerability of the subject population, but no less than annually.

The continuing review timetable is indicated on the research protocol approval letter by the end date of the Institutional Review Board's initial approval of the research. If the research will continue beyond this end date, the principal investigator must submit a continuing review request at least 30 days prior to this end date. The research is considered continuing if the investigators are continuing to recruit human subjects and/or are planning to continue interventions and/or data collection.

Continuing review approvals must include determinations by the IRB regarding risks, potential benefits, informed consent and safeguards for human subjects. In conducting continuing review, the IRB will review, at a minimum, the protocol and any amendments as well as a status report on the progress of the research, including:

The number of subjects originally approved to be enrolled in the research.

• The number of subjects currently approved to be enrolled in the research.

• The number of subjects currently enrolled in the research.

• The total number of subjects currently planned to be enrolled in the research.

• The number of subjects who refused to participate at the time of screening/informed consent.

• The number of subjects who withdrew their participation after informed consent was given.

• A description of any complications, adverse events or unanticipated problems involving risks to subjects or others; withdrawal of subjects from the research; or complaints about the research.

• An explanation of any unapproved modifications made to the research since last review.

• A summary of changes in the literature that would affect the research.