Responsibilities

Education 

In addition to clinical experience and medical training, education and training in the ethical conduct of human research is essential to protect the rights and welfare of human subjects participating in clinical trials. Schulman's  Research Site Submission Form requires a detailed description of the education and training that study personnel (principal investigator/qualified investigator, sub-investigators and study coordinators) have received in Good Clinical Practice and Human Subject Protection. At a minimum, all US investigators and staff should review the Belmont Report, ICH Good Clinical Practice Guidelines and FDA Information Sheets before beginning the study. Canadian investigators and staff should be familiar with ICH Good Clinical Practice Guidelines, Division 5 of the Canadian Food and Drug Act, and the Tri-Council Policy Statement.

Education and training in Human Subject Protection is available in many formats, including a variety of in-service and web-based activities, such as the Collaborative IRB Training Initiative Program (CITI). For Canadian studies, the Interagency Advisory Panel on Research Ethics (PRE) provides an online Tutorial for the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). Study personnel conducting clinical research funded by federal grants are required to show a certificate of completion of a module on Human Subject Protection before the Board will grant final approval of the site to conduct the study.