Transcript Human Subjects Research

Human Subjects Research
Nellie Quezada-Aragon, Director
Office of Compliance
Dr. Luis A. Vazquez, Chair
NMSU Institutional Review Board
[email protected]
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.
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.
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.
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.
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.
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.
I’m 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/compliance.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.
• 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.
• Follow the examples provided. If in doubt,
call or email the Office of Compliance.
• 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.
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 doesn’t get “lost” along the way.
Applications have been know to get hung up
on messy desks, in folders, etc.
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).
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.
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
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
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.
Provide
• Required training certificate for all researchers
and advisors.
• The examples located under Instructions &
Examples for Consent Forms.
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.
CONTACTS
• The Office of Compliance:
– Nellie Quezada-Aragon, Director
– Gloria Acosta, Administrative Assistant
646-7177
646-7177
• The IRB Chair:
– Dr. Luis A. Vazquez
646-7252