John Cabot University: the Academic Experience

Institutional Review Board at John Cabot University

Overview

John Cabot University is committed to respecting the rights of the human subjects of scientific research. The JCU Institutional Review Board (IRB) evaluates and monitors the ethics of research projects involving human subjects. The IRB also carries out expedited reviews of projects that would otherwise be exempt from the duty of ethical review.

The IRB has the authority to approve or reject proposals for individual research projects and to suggest modifications to them so that they would meet the ethical standards for research on human subjects. IRB review is limited to the ethical quality of the research on human subjects and does not enter into the substantive merits, scientific or otherwise, of the research itself.

IRB Committee

The JCU IRB is made up of five members with sufficiently diverse backgrounds, and including at least one member whose primary expertise is nonscientific, such as an attorney, ethicist or member of the clergy, and one external member. Members are nominated by the Dean and must be confirmed by the Academic Council and the President. Faculty members are encouraged to make recommendations to the Dean. Length of service is set at 2 years. Members may be reappointed.

Procedures

The IRB gives initial approval to a study for one year. After that, a researcher needs to either close to protocol or renew it for another year. Each renewal request comes with a summary of what has been done in the previous year. Any deviation from the approved protocol is supposed to be immediately communicated to the IRB, otherwise, the IRB may suspend the study and withdraw approval. The IRB may conduct random auditing of research projects, to check that all the forms are in order.

Researchers seeking IRB review of a project should submit the following: a detailed Description of the Research, and Consent Forms and Letters of Information for minor participants, if applicable. Researchers seeking renewal of IRB approval should submit a Summary of research performed over the last year and a description of research still to be performed. IRB approval must be also be obtained whenever there is a modification to the Study or the Consent forms in the course of the project.

Resources

United States Department of Health and Human Services Office for Human Research Protection (OHRP) 

Code of Federal Regulations: Basic HHS Policy for Protection of Human Research Subjects

National Institutes of Health: Institutional Review Boards and the HIPAA Privacy Rule

NIH Office of Extramural Research, Protecting Human Subject Research Participants

The Belmont Report

Contact  

For additional information contact:
Paola Castelli, Chair
Institutional Review Board
[email protected]