IRB Guidelines, Policies, and Regulations
Please find below the Guidelines, Policies, and Regulations that Brandeis University uses in the review and protection of human participants in research. Federal RegulationsBrandeis University Policies
Other Guidelines
Federal Regulations Code of Federal Regulations on the Protection of Human Subjects:
http://hhs.gov/ohrp/humansubjects/guidance/45cfr46.html The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules:
http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/adminsimpregtext.pdf Back to top
Brandeis University Policies Student Training Policy
All students and trainees (undergraduates, graduates, and postdoctoral fellows) who submit a new IRB application or engage in human subjects research through a Principle Investigator's IRB application must complete the online Human Subjects in Research training offered through the CITI Program before such applications will be sent for review to the IRB. This training will cover a period of three years from date of completion, after which time, those students and postdocs still engaged in human subjects research must complete the "Refresher" Training course, also offered through the CITI Program. Directions for completing the training are available on the IRB website: http://www.brandeis.edu/osp/irbtrainingonline1.html. PI Policy
Only faculty and staff members may serve as Principal Investigators on IRB Applications. All students and trainees (undergraduates, graduates, and postdoctoral fellows) will serve as the "Student Researcher". Student-initiated research projects require a member of the faculty or staff to serve as Principal Investigator. Staff members who are conducting human subject research in fulfillment of a degree program must also have a faculty sponsor serve as Principal Investigator. Back to top
Other Guidelines The Belmont Report - Ethical Principles and Guidelines for the protection of human subjects of research:
http://history.nih.gov/research/downloads/belmont.pdf The Nuremburg Code - Directive for Human Experimentation:
http://history.nih.gov/research/downloads/nuremberg.pdf World Medical Association Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects:
http://history.nih.gov/research/downloads/helsinki.pdf Back to top