Institutional Review Board

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.

What constitutes "research" or a "research" project? The US Office for Human Research Protections (OHRP) defines “research” as any “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” 

What is a "human subject"?  It seems obvious but there is a OHRP definition for this as well. A human subject is a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) Identifiable private information.

Role of the Siena College IRB

The Siena College IRB provides oversight of OHRP guidelines. These guidelines help to assure that the wellbeing and dignity of individuals involved in research conducted at Siena College or by Siena College constituents are protected. 

The IRB evaluates (1) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (2) appropriate guidelines for the selection of human subjects for participation in such research, and (3) nature and definition of informed consent in various research settings.

Related Reports:

• Belmont Report (summary)
• Nuremberg Code
• WMA Declaration of Helsinki
• Human Experimentation:  The Good, Bad & the Ugly (SciShow YouTube Video on historical perspective of above reports)

Review Types

Currently, the IRB employs three (3) primary types of review depending on the degree of risk to human subject(s):

• Exemption Review: Feedback sent 1-2 weeks after IRB application is submitted.
• Expedited Review: Feedback sent 2-3 weeks after IRB application is submitted.
• Full Review: Full committee review conducted 1-3 months after IRB application is submitted.

The IRB will consider proposals under an 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, Resources & Templates 

Regulations

• Protection of Human Subjects, 45 CFR 46
• Family Educational Rights and Privacy Act (FERPA)
• Siena College Research Misconduct Policy

Resources​

• CUR Focus - Top 10 Ways to Persuade an IRB to Reject your Research Proposal
• IRB Application (Updated: September 2017)
• Human Subject Certification FAQs (Updated: February 2017)

Templates

• Informed Consent Form Template (Updated:  February 2017)
• Online Informed Consent Form Template (Updated:  February 2017)