Human Subjects Research

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Human Subjects Research

• Nellie Quezada-Aragon, Director
• Office of Compliance
• Dr. Luis A. Vazquez, Chair
• NMSU Institutional Review Board
• ovpr_at_nmsu.edu

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What is the IRB?

• Institutional Review Board (IRB)
• Committee responsible for approving, monitoring,
  and advising university researchers (students
  included) on the conduct of research that
  involves human subjects.
• Mandated by Federal Regulation that spells out
  the committee composition and powers.
• If the IRB disapproves a project no one can
  overrule that decision.

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Why Have an IRB?

• They are numerous examples in medical and
  behavioral science of research that harmed
  subjects Tuskegee syphilis study (1934),
  Milgram and electric shock, Gelsinger, death at
  Johns Hopkins (2001), Zimbardo prisoner studies.
• The IRB provides independent review that can
  assist you while insuring adequate safeguards.

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Guiding Principles

• Respect for Persons autonomy and protection of
  those with reduced autonomy. Must have informed
  consent
• Beneficence Maximize benefits, minimize harm.
  If there is risk and no benefit then it is not
  valid.
• Justice Costs and benefits of research should
  be equitably distributed.

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What Needs to be Reviewed

• All research with Human Subjects.
• While some research might be exempt or may not
  require a consent form, it is the IRB that makes
  those decisions.
• A human subject is a living individual that the
  researcher interacts with to collect data or
  private and identifiable information.

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What is Research?

• A systematic investigation, including research
  development, testing and evaluation, designed to
  develop or contribute to generalizable knowledge.
• This can include surveys, interviews,
  interactions, observations of public behavior, or
  experimental studies.

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What is not Research

• Class projects designed to assist students in
  learning about the research that will not
  contribute to generalizable knowledge.
• Program review and evaluation, quality assurance
  activities.
• Research involving only the use of published or
  publicly available information.

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Im doing human subject research, now what?

• All forms, regulations, and examples are
  available on the NMSU website under Research
  Office of Compliance http//research.nmsu.edu/comp
  liance.html
• Complete required on-line training.
• Complete the application and consent form (see
  instructions examples for consent forms on
  website).
• Get appropriate approvals from advisor and
  department.

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• Submit application forms, training certificate,
  consent forms, appropriate permissions, copies of
  surveys, etc to the Office of Compliance. (DO NOT
  SEND IT TO THE IRB CHAIR!!!)
• Reviews are conducted weekly by the compliance
  director and the IRB Chair.
• If it can be expedited (minimal risk), the IRB
  Chair will approve sign it.

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• Follow the examples provided. If in doubt, call
  or email the Office of Compliance.

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• DO NOT START ANY DATA COLLECTION UNTIL YOU HAVE
  IRB APPROVAL.
• Failure to have approval may result in unusable
  data non-approved data is not valid and usable.
• Take responsibility to insure you have approval
  if not, you will suffer not your advisor.

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How long does approval take?

• Plan on several weeks or longer. It may take 2
  weeks until it is reviewed, if it needs revisions
  (not infrequent) it gets back in the queue.
• Make sure it doesnt get lost along the way.
  Applications have been know to get hung up on
  messy desks, in folders, etc.

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Why are applications not approved?

• The research process is not clear.
• The consent form is not at an appropriate reading
  level.
• Complete contact information not provided.
• Host site approval not documented.
• Survey materials not included.
• The forms include many misspellings (Use a spell
  checker).

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What happens if application is not approved?

• You will be informed by email as to the
  shortcomings and what we need in order to
  approve. Many are minor, some have greater
  problems.
• Resubmit for a second review. If there are
  questions please call Gloria or Nellie at the
  Office of Compliance, 646-7177.

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Read

• Prior to Submitting an IRB Application, read
• Human Subjects Principles and Procedures
• Expedited Review Procedures
• Exemption Categories Procedures
• Instructions Examples for Consent Forms
• These can be found at
• http//research.nmsu.edu/compliance.html

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Complete

• The appropriate application form
• Application to Use Human Subjects in Research
• or the
• Exempt Application Form
• These application forms can be found at
• http//research.nmsu.edu/compliance.html

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Obtain

• Approvals from the advisor and department.
• Approvals from any agency or facilities you are
  using.
• Approvals to use copy written materials.
• Consent forms in multiple languages, if needed.
• Copies of any proposed surveys, questionnaires,
  interview questions, etc.

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Provide

• Required training certificate for all researchers
  and advisors.
• The examples located under Instructions
  Examples for Consent Forms.

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Remember

• The informed consent document is written to
  simply and concisely explain to the subjects, in
  their level of understanding and language, what
  they are being asked to do. It is not to be
  written in the language of the discipline or to
  impress the faculty.

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CONTACTS

• The Office of Compliance
• Nellie Quezada-Aragon, Director 646-7177
• Gloria Acosta, Administrative Assistant 646-7177
• The IRB Chair
• Dr. Luis A. Vazquez 646-7252