Human Subjects Research

Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research [email protected]

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.

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 being that the researcher interacts with to collect data that is private and identifiable.

What is Research?

 A systematic investigation designed to develop or contribute to generalizable knowledge.

 This can include surveys, interviews, interactions 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, 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.

 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.



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.

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. Application have been know to get hung up on messy desks, in folders, etc.

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.

   

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.

Read



II. GENERAL PROCEDURES FOR SUBMITTING AN IRB APPLICATION

 http://www.nmsu.edu/Research/docs/hum an/hs.htm#3

Complete

 The application, appendix D located at: http://www.nmsu.edu/Research/docs/human/hs.htm

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.

Provide

 Copies of any proposed surveys.

 Required training certificate for all researchers.

Follow

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

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.