DO NO HARM

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DO NO HARM
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IRRB Presentation
NLU IRRB Home page

• Purposes
• Responsibilities
• Processes

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IRRB Purposes
NLU IRRB Home page

• Assure that research follows ethical principles
  and guidelines.
• Assist the investigator in examining ethical
  implications of their research.

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Nuremberg Code
NLU IRRB Home page

• Voluntary consent of the human subject absolutely
  essential.
• Risk should never exceed benefits.

The Doctors Trial
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Belmont Report
NLU IRRB Home page

• Practice - Interventions that enhance well-being
  of an individual and are likely to be successful.
• Research - Activities designed to contribute to
  generalizable knowledge and/or interpretive
  understanding.

The Belmont Report
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Basic Ethical Principles
NLU IRRB Home page

• Respect for Persons - informed consent
• Beneficence - do no harm
• Justice - fair distribution of burdens benefits

The Tuskegee Syphilis Study
U.S. Dept of Health and Human Services Office for
Human Research Protections
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Federal Definition of Human Research Subject
NLU IRRB Home page

• A living individual about whom an investigator
  (whether professional or student) conducting
  research obtains
• Data through intervention or interaction with
  individual, or
• Identifiable private information.

Title 45, Part 46
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When does research not meet federal definition?
NLU IRRB Home page

• Study of private information about dead people
• Study of public information about living persons
• Observation of public behavior
• Study of publicly available information in which
  persons are not identifiable.

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Federal Requirements
NLU IRRB Home page

• Institutions conducting research will create
• A statement of ethical principles,
• An institutional research review board (IRRB),
• Written procedures for conducting reviews of
  research and reporting actions to investigators.

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IRRB Actions
NLU IRRB Home page

• Review and approve or disapprove all research
  activities.
• Require informed consent and documentation of
  informed consent.
• Notify investigators of its decision in writing.
• Conduct continuing review of research at
  appropriate intervals.

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Elements of Informed Consent(Sample forms
available at NLU)
NLU IRRB Home page

• Purpose of the research
• Participants right to see your study
• Contact for further information
• Advisors/chairs address, telephone, and e-mail
• Affiliation with the university
• Signaturesyou and the participant
• Two copies for you and the participant

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Informed Consent(Do no harm!)
NLU IRRB Home page

• Participant must
• Be informed, and
• Give consent

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Be Informed
NLU IRRB Home page
Answer these questions

• Who do I contact for information?
• What is the purpose of the study?
• How will data be used?
• How long will my participation take?

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Be Informed (cont.)
NLU IRRB Home page
Answer these questions

• How will confidentiality be protected?
• Who will have access to transcripts, field notes?
• What are the risks and benefits?
• How will you report the research findings?

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Give Consent
NLU IRRB Home page
Include the following elements

• Participation is voluntary
• Right to withdraw
• Free of coercion and undue influence
• Consent of parent or guardian when required
• Consent cannot be assumed, but must be explicit
  and written

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Who Applies?
NLU IRRB Home page

• Those engaged in research
• Faculty and staff
• Doctoral Students Dissertation
• Masters Students Thesis
• IDS Students Action Research

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Who Does Not Apply?
NLU IRRB Home page

• Students conducting research as part of a
  class
• Faculty and staff collecting institutional data
  for self study and accreditation

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Designated Category
NLU IRRB Home page

• Exempt
• Expedited
• Full Review

Criteria Standards
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Disposition of Application
NLU IRRB Home page

• Sent to Office of the Provost
• Checked for completeness
• Reviewed
• Database updated
• Proposal filed
• Researcher notified

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THANK YOU!

• For additional information
• Visit
• NLU IRRB Home page
• or contact the
• Office of the Provost
• [phone]