Experimental Design & Ethics

Purpose

The purpose of this discussion is to give you a basic understanding of how to design a question so it can be investigated using fMRI techniques.

Objectives

  • Be able to explain the basic principles of research design.
  • Be able to review any given study and critique the experimental design.
  • Know the difference between box-related and event-related designs and which you would like to use to investigate your hypothesis.
  • Understand basic ethical concerns as they apply to neuroimaging studies.

Basic Principles of Experimental Design

Elements of an Experiment

Idea

Theory

Operationalization

Variables

Protocol

Ideas

  • Observations
  • Case studies
  • Curiosity
  • Other studies
    • Issues
    • Translation
    • Replication
    • Extension
  • Method development
  • Moderators
  • Mediators
  • Testing Theory

Operationalization

Rendering the original abstract idea into something testable.

  • Make the idea measurable.
  • Points to variables of interest.
  • Leads to a testable hypothesis.

In fMRI this is done by specifying conditions or tasks that should uncover patterns of neural activity.

Variables

  • Independent (manipulated)
  • Dependent (measured)

Protocol

  • Select the methods that best fit the operational definition and variables.
  • Guide this selection with a theory.

Designing Your HRF

The HRF

  • HRF - hemodynamic response function
  • Model representing a theoretical fluctuation in hemodynamic activity.
  • Activity in the CNS is statistically compared to the HRF to determine if and how well it matches. This is how we "light-up" the brain.

Basic types of HRF Designs

Blocked Design

  • ​Hemodynamic activity is given a binary model.
    • i.e. activity is either on or off.
  • Good for:
    • Task related investigation
    • Isolating very significant associations

Event Related

  • HRF is modeled on events with a random occurrence and intensity.
  • Good for:
    • Multimodal studies.
    • Estimating the exact shape and timing of the true hemodynamic response

Ethics in fMRI

Why Ethics?

Tuskegee Syphilis Experiment

1932-1972

Declaration of Helsinki

1964

Ethics in Research

  • Respect for persons
    • Individuals have a right to choose to participate or withdraw.
    • Individuals have a right to information.
  • Beneficence
    • Risks should be minimized.
    • Benefits > Risks
  • Justice
    • Risks are equally distributed throughout society.

Ethics in Research

  • IRB
    • Oversees research approval process.
    • Research protocol
    • Consent form
  • Confidentiality of data
    • All participant data is considered health data and protected by law (HIPAA).
    • Must be de-identified before made public.

Ethics in Research

  • Incidental findings
    • Sometimes we happen upon a medically actionable situation.
    • Duty to inform and warn but CANNOT diagnose.
  • Pregnancy
    • While there are no known risks, we cannot say there is no risk.
    • Local IRB gives guidelines on how to screen for pregnancy.

Next time...

  • Complete your hypothesis and literature review.
  • Complete MRI 1 and IRB certification.

fMRI 2 – Experimental Design & Ethics

By Ben Carter

fMRI 2 – Experimental Design & Ethics

Experimental Design & Ethics – this corresponds to chapters 9 and 14 of Huettel et al., 2014 and Kazdin, chapter 5.

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