Finding the Cheese

1
Finding the Cheese

• Navigating the Maze of Federal Regulations on
  Research

Dr. Brian Dille Mesa Community College
2
Why is there a Maze?

• Past abuses, such as the Tuskegee Syphilis Study,
  led to federal regulations and oversight.

3
Constructing the Maze

• Belmont Report of 1979
• Basic Ethical Principles
• Respect for Persons
• Beneficence
• Justice

4
Constructing the Maze

• Belmont Report of 1979
• Basic Ethical Principles
• Respect for Persons
• Beneficence
• Justice
• Application
• Informed Consent
• Assessment of Risks and Benefits
• Fairness in Subject Selection

5
Why Run the Maze?

• To protect human subjects
• Its important to know the rules
• Ethics require an external review
• Need to model discipline standards to students
• Having a process will avoid inadvertent abuses
• Having a process in place allows greater access
  to students and student data, partnerships are
• Having a process keeps you eligible for NSF and
  DOE grants

6
Who Oversees the Maze?

• Federal Level Office of Human Subjects
  Protection (OHRP)

7
Most pedagogical research is exempt, but the
exemption needs to be documented, not assumed.
8
Who Oversees the Maze?

• Federal Level Office of Human Subjects
  Protection (OHRP)
• State Level Case law varies
• AZ Havasupai Tribe 50 Million Lawsuit
• Institutional Level What is the Status of your
  SOP?

9
Lost in the MazeWhat others have been
reprimanded for

• Doing research without an IRB
• IRB meeting without a quorum
• Insufficient Training for IRB and PI
• No SOP guiding the process
• Lack of continuing review
• Problems with Informed Consent
• Poorly maintained records

10
Lost in the MazeTwo Case Studies

• Bluefield State College
• University of Arizona

11
Running the Maze Get Ready

• Determine volume of protocols
• Establish or contract out an IRB
• File a Federal Wide Assurance (FWA)
• Write Standard Operating Procedures
• Train

12
Running the Maze Get Set

• Create A Culture of Compliance
• Is your process Intentional or Ad Hoc?
• Are your faculty and staff trained?
• Do your faculty and staff buy in or seek to
  circumvent?

13
Running the Maze GO!

• Case Studies