1. Human subjects protections and the IRb

2. 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?

3. What is the irb?

4. Who we are
Institutional Review Board for Human Subject Research
Faculty, staff and community members

5. For research involving human participants:
What we do
For research involving human participants:
Review
Approve
Require changes
Disapprove

6. Goals of The Brockport irb
Primary: Protect human participants as subjects of research at The College at Brockport.
Secondary: Provide resources, training and guidance to faculty, staff and students.
Most important: Encourage students, staff and faculty to do research (safely)!

7. What kind of research needs irb oversight?

8. 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.

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

10. Does it qualify as human subjects research?
Testing 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.
Watching online videos of tennis players and analyzing their grunts when they hit the ball.
Asking tennis players to come in and play tennis so you can observe and record their grunts when they hit the ball.

11. A brief history of human subjects protections

12. Three core principles:
The Belmont report (1978)
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

13. What happened before federal oversight?
Tuskegee Study ( )
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)
Misdiagnosis of skin diseases among people of color (ongoing)
Which Belmont principles did these studies violate?

14. What if i want to submit a proposal?

15. 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!

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