Human Subjects Research

1
Human Subjects Research

• Dr. John S. Irvine
• Chairperson, NMSU Institutional Review Board for
  Human Subjects Research
• jirvine_at_nmsu.edu

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What is the IRB?

• Institutional Review Board
• 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 being that the
  researcher interacts with to collect data that is
  private and identifiable.

6
What is Research?

• A systematic investigation designed to develop or
  contribute to generalizable knowledge.
• This can include surveys, interviews,
  interactions 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, Policy and Procedures,
  Appendix D is the application.
• Complete required on-line training.
• Complete the application and consent form (use
  examples appendix A).
• Get appropriate approvals, advisor, department.

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• Submit forms, training certificate, consent
  forms, permissions, copies of surveys, etc to VP
  Research. (do not send it to me!!!)
• It will be reviewed by the compliance officer.
• 1X per week I will review them, if it can be
  expedited (minimal risk) then all it needs is my
  signature.
• Follow the examples provided, call or email if in
  doubt.

10

• DO NOT START ANY DATA COLLECTION UNTIL YOU HAVE
  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,
  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.
  Application have been know to get hung up on
  messy desks, in folders, etc.

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Why are they 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.

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What happens if it is not approved?

• You will be informed by email (NMSU address) as
  to the shortcomings and what we need in order to
  approve.
• Many are minor, some have greater problems.
• Use a spell checker.
• Resubmit for a second review. If there are
  questions please call Gloria or Nellie at VPR,
  6-2481.

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Read

• II. GENERAL PROCEDURES FOR SUBMITTING AN IRB
  APPLICATION
• http//www.nmsu.edu/Research/docs/human/hs.htm3

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Complete

• The application, appendix D located at

http//www.nmsu.edu/Research/docs/human/hs.htm
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Obtain

• Approvals from the advisor and department.
• Approvals from any agency you are using.
• Approvals to use copy written materials.
• Consent forms in multiple languages if needed.

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Provide

• Copies of any proposed surveys.
• Required training certificate for all researchers.

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Follow

• The examples located under Human Subject Policy
  and procedures/Instructions for the Informed
  Consent Document.

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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.