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Research and Sponsored Programs

Hofstra Institutional Review Board

Use of Humans as Research Subjects

Background

Hofstra University's official policy governing the use of humans as research subjects is published as Faculty Policy Series # 36 and FPS # 36 Implementation Procedures.

All research involving humans as subjects conducted under the aegis of Hofstra University will be guided by the principles of the Belmont Report. All externally sponsored research involving humans as subjects, both Federal and non-Federal, shall be conducted in full compliance with Federal Policy, published as Code of Federal Regulations Title 45, Part 46 (effective November 16, 2015), a document often referred to as the "Common Rule."

In Brief

Activities that involve humans as subjects of study are subject to review and approval by a University committee known as the Institutional Review Board or IRB. In some cases, the proposed research may pose no real risk to individuals and, therefore, may be considered exempt from IRB review.

Get guidance in determining whether your project is exempt from IRB review.

In many other cases, the proposed research may pose minimal risk to subjects and, consequently, may qualify for expedited review. Under an expedited review, research can commence upon receipt of written authorization from the IRB administrator based upon the review of a single IRB representative, i.e., without the review of the full IRB committee.

Get guidance in identifying whether your project qualifies for expedited review.

In many cases, researchers will be required to prepare an Informed Consent form. The Informed Consent form serves to advise prospective subjects and participants about the proposed study and any known benefits or risks associated with participating in the study. Get guidance in preparing an "Informed Consent Form".

Special Note to Student Researchers: Students who wish to conduct research involving humans must submit their proposal to the IRB through a faculty advisor.

Training in Basic Human Participants’ Protection

All persons conducting human subjects research must participate in a formal human participants’ training program before project approval is granted. A variety of training options are available to researchers. For information regarding the various options, see paragraph III of the FPS # 36 Implementation Procedures.

Hofstra's Institutional Review Board recommends the Collaborative Institutional Training Initiative (CITI) Program. Register for the Collaborative Institutional Training Initiative Program. Help for CITI Learner Registration

IRB Proposal Submission Forms

Other Useful Links

Hofstra University IRB Membership
2017-2018

IRB Committee Chairperson
Dr. Alan D. Flurkey
Professor
Department of Specialized Programs in Education

Dr. Sarah A. Novak
Associate Professor
Department of Psychology

Dr. Deborah L. Elkis-Abuhoff
Associate Professor
Department of Counseling and Mental Health Professions

Dr. Holly Seirup
Dean
School of Health Professions & Human Services

Dr. Thomas Kwiatkowski
Assistant Dean for Education/Simulation
Medical Director, Patient Safety Institute; Medical Director, Center for Emergency Medical Services
Professor of Emergency Medicine
Hofstra North Shore-LIJ School of Medicine

Dr. Shane G. Owens
Licensed Clinical Psychologist
Licensed School Psychologist
*Community Member

IRB Administrator
Ms. Sofia Kakoulidis
Associate Provost for Research and Sponsored Programs
Office of the Provost
Telephone: (516) 463-6810
Fax: (516) 463-6505

Help for CITI Learner Registration

From the Hofstra IRB home page, click on “Register for the Collaborative Institutional Training Initiative Program” > Register. 

Step 1: Find the box beneath CITI – Learner Registration > Select Your Organization Affiliation: Enter “Hofstra University”
Note: Do not use “Log In Through My Institution” at the top of the registration page to register.

Steps 2 – 6: Enter personal information to complete your profile.

Step 6: Institutional Email Address (required): Enter your Hofstra email address.

Step 7: Select Curriculum

  • Question 1 – Responsible Conduct of Research
    Select "Not at this time" and continue to Question 2.
  • Question 2 – Would you like to take the Conflicts of Interest course?
    • This course is optional. Select at your discretion.
  • Question 3 – Laboratory and Animal Research
    • Not required of Biomedical or Social & Behavioral Researchers conducting research on human subjects.
  • Question 4 – Human Subjects Research
    • Select either "Biomedical Research Investigators" or "Social & Behavioral Research Investigators" depending on your area of study.
  • Question 5 – Institutional/Signatory Officials & IRB Chair
    • Select only if you are an IRB member.
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