Use of Humans as Research Subjects
Hofstra University's official policy governing the use of humans as research subjects is published as Faculty Policy Series # 36. In addition, FPS # 36 Implementation Procedures have been developed to provide additional guidance to researchers seeking approval of study protocols which involve humans as subjects.
All research involving humans as subjects conducted under the aegis of Hofstra University (including research conducted by faculty, students and others) will be guided by the principles of the Belmont Report. Additionally, 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 July 14, 2009), a document often referred to as the "Common Rule."
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.
For guidance in determining whether your project is exempt from IRB review, click here.
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.
For guidance in identifying whether your project qualifies for expedited review, click here.
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. For guidance in preparing an "Informed Consent Form," click here.
Special Note to Student Researchers: Students who wish to conduct research involving humans must submit their proposal to the IRB through a faculty advisor.
All persons conducting human subjects research funded in whole or in part by a grant (contract or subcontract) must participate in a formal education/training program before project approval may be granted. In addition, persons conducting research without grant (contract or subcontract) support shall also participate in a training program unless their research has been ruled exempt. A variety of training options are available to researchers. For information regarding the various options, see paragraph III of the FPS # 36 Implementation Procedures.
The National Institutes of Health (NIH) has prepared a tutorial for researchers conducting studies involving humans as subjects. To access the NIH "Human Participant Protections" Tutorial, click here.
For information regarding availability of a human subjects training video prepared by the U.S. Office for Human Research Protection, please contact the Office for Research and Sponsored Programs, at ext. 3-6810 or via email.