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

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Page 1: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

Human Subjects Human Subjects ResearchResearch

Dr. John S. IrvineDr. John S. Irvine

Chairperson, NMSU Chairperson, NMSU Institutional Review Board for Institutional Review Board for

Human Subjects ResearchHuman Subjects [email protected]@nmsu.edu

Page 2: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

What is the IRB?What is the IRB?

Institutional Review BoardInstitutional Review Board Committee responsible for approving, Committee responsible for approving,

monitoring, and advising university monitoring, and advising university researchers (students included) on the researchers (students included) on the conduct of research that involves human conduct of research that involves human subjects.subjects.

Mandated by Federal Regulation that Mandated by Federal Regulation that spells out the committee composition and spells out the committee composition and powers.powers.

If the IRB disapproves a project no one can If the IRB disapproves a project no one can overrule that decision. overrule that decision.

Page 3: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

Why Have an IRB?Why Have an IRB?

They are numerous examples in medical They are numerous examples in medical and behavioral science of research that and behavioral science of research that harmed subjects: Tuskegee syphilis study harmed subjects: Tuskegee syphilis study (1934), Milgram and electric shock, (1934), Milgram and electric shock, Gelsinger, death at Johns Hopkins (2001), Gelsinger, death at Johns Hopkins (2001), Zimbardo prisoner studies.Zimbardo prisoner studies.

The IRB provides independent review that The IRB provides independent review that can assist you while insuring adequate can assist you while insuring adequate safeguards.safeguards.

Page 4: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

Guiding PrinciplesGuiding Principles

Respect for Persons – autonomy and Respect for Persons – autonomy and protection of those with reduced protection of those with reduced autonomy. Must have informed autonomy. Must have informed consentconsent

Beneficence – Maximize benefits, Beneficence – Maximize benefits, minimize harm. If there is risk and no minimize harm. If there is risk and no benefit then it is not valid.benefit then it is not valid.

Justice – Costs and benefits of Justice – Costs and benefits of research should be equitably research should be equitably distributed.distributed.

Page 5: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

What Needs to be ReviewedWhat Needs to be Reviewed

All research with Human Subjects.All research with Human Subjects. While some research might be While some research might be

exempt or may not require a consent exempt or may not require a consent form, it is the IRB that makes those form, it is the IRB that makes those decisions.decisions.

A human subject is a living being that A human subject is a living being that the researcher interacts with to the researcher interacts with to collect data that is private and collect data that is private and identifiable.identifiable.

Page 6: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

What is Research?What is Research?

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

This can include surveys, interviews, This can include surveys, interviews, interactions or experimental studies. interactions or experimental studies.

Page 7: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

What is not ResearchWhat is not Research

Class projects designed to assist Class projects designed to assist students in learning about the students in learning about the research that will not contribute to research that will not contribute to generalizable knowledge.generalizable knowledge.

Program review and evaluation, Program review and evaluation, quality assurance activities.quality assurance activities.

Research involving only the use of Research involving only the use of published or publicly available published or publicly available information.information.

Page 8: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

I’m doing human subject I’m doing human subject research, now what?research, now what?

All forms, regulations, and examples are All forms, regulations, and examples are available on the NMSU website under available on the NMSU website under Research Office of Compliance, Policy and Research Office of Compliance, Policy and Procedures, Appendix D is the application.Procedures, Appendix D is the application.

Complete required on-line training.Complete required on-line training. Complete the application and consent Complete the application and consent

form (use examples – appendix A).form (use examples – appendix A). Get appropriate approvals, advisor, Get appropriate approvals, advisor,

department.department.

Page 9: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

Submit forms, training certificate, Submit forms, training certificate, consent forms, permissions, copies consent forms, permissions, copies of surveys, etc to VP Research. (do of surveys, etc to VP Research. (do not send it to me!!!)not send it to me!!!)

It will be reviewed by the It will be reviewed by the compliance officer.compliance officer.

1X per week I will review them, if it 1X per week I will review them, if it can be expedited (minimal risk) can be expedited (minimal risk) then all it needs is my signature.then all it needs is my signature.

Follow the examples provided, call Follow the examples provided, call or email if in doubt.or email if in doubt.

Page 10: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

DO NOT START ANY DATA DO NOT START ANY DATA COLLECTION UNTIL YOU HAVE COLLECTION UNTIL YOU HAVE APPROVAL.APPROVAL.

Failure to have approval may Failure to have approval may result in unusable data, non result in unusable data, non approved data is not valid and approved data is not valid and usable.usable.

Take responsibility to insure you Take responsibility to insure you have approval, you will suffer not have approval, you will suffer not your advisor.your advisor.

Page 11: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

How long does approval How long does approval take?take?

Plan on several weeks or longer. It Plan on several weeks or longer. It may take 2 weeks until it is reviewed, may take 2 weeks until it is reviewed, if it needs revisions (not infrequent) it if it needs revisions (not infrequent) it gets back in the queue. gets back in the queue.

Make sure it doesn’t get “lost” along Make sure it doesn’t get “lost” along the way. Application have been know the way. Application have been know to get hung up on messy desks, in to get hung up on messy desks, in folders, etc. folders, etc.

Page 12: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

Why are they not approved?Why are they not approved?

The research process is not clear.The research process is not clear. The consent form is not at an The consent form is not at an

appropriate reading level.appropriate reading level. Complete contact information not Complete contact information not

provided.provided. Host site approval not documented.Host site approval not documented. Survey materials not included.Survey materials not included.

Page 13: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

What happens if it is not What happens if it is not approved?approved?

You will be informed by email (NMSU You will be informed by email (NMSU address) as to the shortcomings and address) as to the shortcomings and what we need in order to approve.what we need in order to approve.

Many are minor, some have greater Many are minor, some have greater problems. problems.

Use a spell checker.Use a spell checker. Resubmit for a second review. If Resubmit for a second review. If

there are questions please call Gloria there are questions please call Gloria or Nellie at VPR, 6-2481.or Nellie at VPR, 6-2481.

Page 14: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

ReadRead

II. GENERAL PROCEDURES FOR II. GENERAL PROCEDURES FOR SUBMITTING AN IRB SUBMITTING AN IRB APPLICATIONAPPLICATION

http://www.nmsu.edu/Research/http://www.nmsu.edu/Research/docs/human/hs.htm#3docs/human/hs.htm#3

Page 15: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

CompleteComplete

The application, appendix D located The application, appendix D located at:at:

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

Page 16: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

ObtainObtain

Approvals from the advisor and Approvals from the advisor and department.department.

Approvals from any agency you are Approvals from any agency you are using.using.

Approvals to use copy written Approvals to use copy written materials.materials.

Consent forms in multiple languages Consent forms in multiple languages if needed.if needed.

Page 17: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

ProvideProvide

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

researchers.researchers.

Page 18: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

FollowFollow

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

Page 19: Human Subjects Research Dr. John S. Irvine Chairperson, NMSU Institutional Review Board for Human Subjects Research jirvine@nmsu.edu

RememberRemember

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