Human subjects protections and the IRb Julie Wilkens, irb compliance

Overview What is the IRB? What kind of research needs IRB oversight? A brief history of human subjects protections What if I want to submit a proposal? Who can help me with my proposal?

What is the irb?

Who we are IRB stands for Institutional Review Board for Human Subject Research The IRB is composed of faculty, staff and community members

What we do The IRB has the authority to review, approve, disapprove or require changes in research or related activities involving human participants.

Goals of The Brockport irb Primary goal: To ensure the protection of human participants as subjects of research at The College at Brockport. Secondary goals: Provide educational resources, training and guidance to faculty, staff and students. Most important goal: Encourage students, staff and faculty to do research (safely)!

What kind of research needs irb oversight?

Human subjects research (under the federal definition) Human subject means a living individual about whom an investigator conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

Human subjects research (under the federal definition) Research means a systematic investigation designed to develop or contribute to generalizable knowledge.

Does it qualify as human subjects research? Testing with 200 kids to determine whether they prefer to eat one marshmallow now or two marshmallows in 10 minutes. A survey given by Old Navy to determine how your experience was during your last shopping trip. Interviews conducted with Brockport professors about the history of adaptive physical education at Brockport. A survey given to suspected shoplifters at a police station to assess their motives for shoplifting. A study done with one seventh-grade student to see whether he does better on paper-and-pencil tests or computer-based tests. An online test given by researchers at Harvard to sort you into the right house at Hogwarts based on your psychological profile. An online test given by Pottermore (the official Harry Potter website) to do the same thing.

A brief history of human subjects protections

The Belmont report (1978) The Belmont Report identified three core principles: Respect for persons: Allowing individuals to enter into research voluntarily and with adequate information (“informed consent”) Beneficence: Maximizing benefits and minimizing risk/harm to individuals Justice: Consider who should receive the benefits of research and who will bear its burdens

What happened before federal oversight? Tuskegee Study (1932-1972) Military chemical experiments (World War II) Milgram experiment on obedience to authority (1961) 2-minute video of original experiment available on YouTube (Search for: Milgram experiment – Jeroen Busscher) Even now, there are gray areas regarding research: Facebook mood manipulation study (2012) U Penn fatigue study for first-year medical residents (2015) Which Belmont principles did these studies violate?

What if i want to submit a proposal?

Basic preparation to be a “PI” Complete CITI certification Contact the IRB office to discuss whether your project needs IRB oversight Determine a timeline that includes IRB review Review the IRB website Make an appointment with the IRB office (if necessary) Do not start any active recruitment or data gathering until you have IRB approval!

Who can help me with my proposal? Thesis/project advisor IRB office (Allen 611) Check IRB website for office hours. When not on campus, available via phone (by appointment) or e-mail.