In addition to research-appropriate experience and qualifications, a working knowledge in the ethical conduct of human research is essential to protect the rights and welfare of human participants. Site submissions to Schulman require documentation of this continuing education.
At a minimum, all U.S. investigators and research staff should review the Belmont Report, ICH GCP Guidelines and FDA Information Sheets.
Schulman offers human subject protection education and GCP training through the online services of Collaborative IRB Training Initiative (CITI). As a value-added service, our clients may register directly with CITI using Schulman’s account by selecting “Register” then searching for “Schulman IRB” in the “Select Your Organization Affiliation” section. Courses in Human Subject Research and GCP are available, and upon successful completion you will receive a certificate of completion from CITI. This training is free to investigators and their staff submitting to Schulman. CME/CEU credit is available through the CITI website. If you need assistance, please email Quality Assurance.
Study personnel conducting clinical research funded by federal grants are required to show a certificate of completion of a human subject protection course before the Board will grant final approval for the site to conduct the study. Schulman recommends free training offered by NIH’s Office of Extramural Research.
Canadian investigators and research staff should be familiar with ICH GCP Guidelines, Division 5 of the Canadian Food and Drug Act, and the Tri-Council Policy Statement. The Interagency Advisory Panel on Research Ethics provides an online training Course on Research Ethics to support research conducted in Canada.