Study Design 101

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Study Design 101

• Tips To Reduce Regulatory Burden

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Burden By Design

• Not Human Subject Research
• Exempt
• Expedited Waiver or Alteration of Consent or
  Written Consent

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Study Design

• Hypothesis
• Dead or Alive
• De-identified Data
• Survey or Interview Questions
• Methods of Communication
• Third Party Participation
• Maintenance of Identifiers

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Ethical Conduct Not Optional

• Belmont Report
• Beneficence
• Justice
• Respect for Persons

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Not Human Subject Research

• Who/What is the subject of the research?
• Will the proposed activity involve collecting
  identifiable private information from a living
  individual?

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Privacy

• Having control over the extent, timing and
  circumstances of sharing oneself (physically,
  behaviorally, or intellectually) with others

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Identifiable

• Name, social security number, address, e-mail
  address, birth date, graduation year
• Deductive disclosure
• Anonymous

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Exempt

• Research conducted in established or commonly
  accepted educational settings, involving normal
  educational practices, such as (i) research on
  regular and special education instructional
  strategies, or (ii) research on the effectiveness
  of or the comparison among instructional
  techniques, curricula, or classroom management
  methods.

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Exempt

• Research involving the use of educational tests
  (cognitive, diagnostic, aptitude, achievement),
  survey procedures, interview procedures or
  observation of public behavior, unless
• (i) information obtained is recorded in such a
  manner that human subjects can be identified,
  directly or through identifiers linked to the
  subjects and
• (ii) any disclosure of the human subjects'
  responses outside the research could reasonably
  place the subjects at risk of criminal or civil
  liability or be damaging to the subjects'
  financial standing, employability, or reputation.

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Waiver of Signature

• That the only record linking the subject and the
  research would be the consent document and the
  principal risk would be potential harm resulting
  from a breach of confidentiality. Each subject
  will be asked whether the subject wants
  documentation linking the subject with the
  research, and the subject's wishes will govern
  or
• That the research presents no more than minimal
  risk of harm to subjects and involves no
  procedures for which written consent is normally
  required outside of the research context.
• In cases in which the documentation requirement
  is waived, the IRB may require the investigator
  to provide subjects with a written statement
  regarding the research.

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Waiver or Alteration

• An IRB may approve a consent procedure which does
  not include, or which alters, some or all of the
  elements of informed consent set forth in this
  section, or waive the requirements to obtain
  informed consent provided the IRB finds and
  documents that
• The research involves no more than minimal risk
  to the subjects
• The waiver or alteration will not adversely
  affect the rights and welfare of the subjects
• The research could not practicably be carried out
  without the waiver or alteration and
• Whenever appropriate, the subjects will be
  provided with additional pertinent information
  after participation.

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Study Design

• Hypothesis
• Dead or Alive
• De-identified Data
• Survey or Interview Questions
• Methods of Communication
• Third Party Participation
• Maintenance of Identifiers

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Mentoring Student Research

• Sages
• Medical Students
• Undergraduate Class Projects
• Research Exercises

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Consultation

• Christian.LaMantia_at_case.edu
• IRB Members
• Case IRB Office
• Isabel.Sanchez_at_case.edu