Human Subject Review

• Memorandum, Human Subject Review Changes - Effective Spring 2012
• CUR Focus - Top 10 Ways to Persuade an IRB to Reject your Research Proposal
• Human Subject Certification FAQs - November 2012

Overview

Per Federal regulations as prescribed in 45 CFR Part 46, any faculty, student and/or administrator/staff planning to engage in research involving human subjects must receive approval from the Siena College Institutional Review Board (IRB) prior to initiating any research activities, on or off campus. 

Currently, the IRB employs two (2) types of review depending on the degree of risk to subject(s): expedited and full review.

• Expedited Review 
• Full Review  

Beginning on January 17, 2012, the IRB will consider IRB applications under Exemption Review. Below is the link to the Exemption Review policy with definitions of the six (6) Federally defined exemption categories.

• Exemption Review Policy
• Exemption Categories

Regulations, Policies and Codes

Office for Human Research Protections (OHRP)

• Protection of Human Subjects, 45 CFR 46

Food and Drug Administration

• FDA Information and Regulations
• Protection of Human Subjects, 21 CFR 50
• Institutional Review Boards, 21 CFR 56

Ethical Principles and Codes

• Belmont Report
• Nuremberg Code
• WMA Declaration of Helsinki