Human Subjects Research Nellie Quezada-Aragon, Director Office of Compliance Dr. Luis A. Vazquez, Chair NMSU Institutional Review Board

What is the IRB? Institutional Review Board (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.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.Mandated by Federal Regulation that spells out the committee composition and powers. If the IRB disapproves a project no one can overrule that decision.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.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.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 consentRespect 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.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.Justice – Costs and benefits of research should be equitably distributed.

What Needs to be Reviewed All research with Human Subjects.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.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.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.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.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.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.Program review and evaluation, quality assurance activities. Research involving only the use of published or publicly available information.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 h ttp://research.nmsu.edu/compliance.htmlAll forms, regulations, and examples are available on the NMSU website under Research Office of Compliance h ttp://research.nmsu.edu/compliance.html h ttp://research.nmsu.edu/compliance.html h ttp://research.nmsu.edu/compliance.html Complete required on-line training.Complete required on-line training. Complete the application and consent form (see instructions & examples for consent forms on website).Complete the application and consent form (see instructions & examples for consent forms on website). Get appropriate approvals from advisor and department.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!!!)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.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.If it can be expedited (minimal risk), the IRB Chair will approve & sign it.

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

DO NOT START ANY DATA COLLECTION UNTIL YOU HAVE IRB APPROVAL.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.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.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.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.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 research process is not clear. The consent form is not at an appropriate reading level.The consent form is not at an appropriate reading level. Complete contact information not provided.Complete contact information not provided. Host site approval not documented.Host site approval not documented. Survey materials not included.Survey materials not included. The forms include many misspellings (Use a spell checker).The forms include many misspellings (Use a spell checker).

What happens if application is not approved? You will be informed by as to the shortcomings and what we need in order to approve. Many are minor, some have greater problems.You will be informed by 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, Resubmit for a second review. If there are questions please call Gloria or Nellie at the Office of Compliance,

Read Prior to Submitting an IRB Application, 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:

Complete The appropriate application formThe appropriate application form –Application to Use Human Subjects in Research or the –Exempt Application Form These application forms can be found atThese application forms can be found at

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

Provide Required training certificate for all researchers and advisors.Required training certificate for all researchers and advisors. The examples located under Instructions & Examples for Consent Forms.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.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 The IRB Chair: –Dr. Luis A. Vazquez