Wickens: Chapter 2 Research Methods, and IRB

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Wickens Chapter 2Research Methods, and IRB

• IE 8541 / HUMF 8001

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Research methods

• Observational studies and/or usability testing
  experiments may be used at many points in design
  of a DSS
• Requirements gathering
• Early prototype testing
• Final evaluation
• The stage of design and nature of the problem
  determine what method you use, and number of
  subjects.
• All may require IRB review.

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Types of Studies

• Highly controlled experiments
• Observations in uncontrolled, natural settings.

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The Design Process for a DSS Human Centered
Design
A typical spiral design process
Prototype Testing
Prototype Construction
Requirements Gathering
Final Performance Evaluation or Comparison
Design Specification
Design Review
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Types of Research

• Basic Fundamental principles
• Applied Specific conditions and situations

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Types of Experimental Designs (for more formal,
controlled studies)

• Two-Group
• Multiple Group
• Factorial Designs
• Between and within subjects

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Institutional Review Board (IRB)

• The IRBs role is to insure that the rights and
  well being of human subjects are protected.
• Experiments, surveys, or observational studies
  using human subjects need to be reviewed and
  approved by the IRB before proceeding with the
  studies.
• Ditto, if data collected previously from human
  subjects is to be used.

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University of Minnesotas IRB

• Minnesotas IRB http//www.research.umn.edu/irb/
• This site contains
• IRB schedules and deadlines
• Guidelines
• Application instructions
• IRB forms
• Examples of consent forms
• And many more resources.

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Application process

• Which set of forms to fill out?
• Exempt
• Expedited
• Full review
• The answer will depend on the particular study,
  is it research or not, and the potential risks.
  

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Federal Definition of Research

• A systematic investigation, including research
  development, testing and evaluation, designed to
  develop or contribute to generalizable knowledge.
  
• Activities which meet this definition constitute
  research for purposes of this policy, whether or
  not they are conducted or supported under a
  program which is considered research for other
  purposes. For example, some demonstration and
  service programs may include research activities.
  - from 45 CFR 46.102

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What Is Subject to Review?

• The scope of the Institutional Review Board's
  (IRB) charge is broad. Generally, any University
  research that uses humans, human tissue, surveys
  of human subjects, or human subjects' records
  requires IRB review, irrespective of its funding
  source. The IRB's charge extends to research in
  the social and behavioral sciences as well as
  research in the health and biological sciences.

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Students should

• understand the elements of informed consent, 
• develop a readable consent form following the
  sample, 
• plan appropriate recruitment strategies for
  identifying subjects, 
• establish and maintain strict guidelines for
  protecting anonymity and confidentiality, and 
• allow sufficient time for IRB review and
  completion of the project.

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Informed Consent

• Since the central requirement for human subjects
  research is that people participate voluntarily,
  the informed consent process is one of the most
  important parts of planning a research proposal.
  The process must assure that the potential
  subject understands the study and its risks and
  benefits and can certify his or her willingness
  to participate. 

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Informed Consent Website

• Website on informed consent http//www.research.u
  mn.edu/irb/consent/
• contains
• Online Tutorial
• Frequently Asked Questions
• 5 Sample consent forms (see Social and Behavioral
  Science studies).

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What do you need to describe on the forms?

• Example Social and Behavioral Sciences
  Application form
• www.research.umn.edu/irb/download/social.cfm
• Investigator information
• Funding?
• Conflict of Interest?
• Summary of Activities
• Research Study Design
• Tasks to be performed
• Time table
• Participant population, etc.

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Recruitment Strategies

• When contacting potential research subjects to
  solicit their participation in a project, one
  must consider the risks and ethical aspects of
  the contact, as well as those of the research for
  which subjects are sought.
• The most common risks of contacting a potential
  subject are related to intrusiveness and
  violations of privacy for example when the
  potential subject reached is a vulnerable
  individual (child, or prisoner).

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Example Recruitment Strategies

• Post a call for subjects on a bulletin board
• Place an advertisement in the paper,
• Send a email request for participation,
• Send a letter,

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Recruitment Strategies

• For more information on recruitment strategies
  see www.research.umn.edu/irb/consent/recruitment/

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• Clifford Nass 4/17 Daniel Drew
• Effects of Clinical Decision Support 3/8 Esha
  Bhargava
• Tufte James Frye
• Mixed-imitative Planning 4/3 Gauti Reynisson

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Cognitive Engineering

• Design or redesign the tools, work process, or
  work environment to improve cognitive task
  effectiveness

Motivation Incentives/rewards
Organizational structure
Work Process
Work environment
Tools (DSSs, software, etc.)
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The Design Process for a DSS Human Centered
Design
A typical spiral design process
Prototype Testing
Prototype Construction
Requirements Gathering
Final Performance Evaluation or Comparison
Design Specification
Design Review
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User and customer centered design

• Edison did not follow a user-centered design
  process in designing and marketing the
  phonograph.
• He assumed customers were like himself cared
  only about the quality of the sound and the
  music.
• Did not know true customer wants and needs.
• Business failed!!