Human Subjects Research at Long Island University
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Long Island University operates under a Federalwide Assurance (FWA), #FWA00002562, approved by the Office of Human Research Protections.
|What is Human Subjects
Human Subjects Research is a systematic investigation designed to develop or contribute to generalizable knowledge, which involves the collection of data from or about living human beings. In addition, all student research involving subjects outside the classroom would be considered in this category.
Why Must it be Reviewed?
It is University policy to reasonably ensure that the rights and welfare of human subjects are adequately protected in research conducted under its auspices. In addition, both federal and state laws require this protection. In order for the University to fulfill its responsibility, all human subjects research conducted under University auspices must receive appropriate review and approval.
Who Reviews it?
The University has authorized an Institutional Review Board (IRB) on each residential campus to review and approve human subjects research. The IRB is charged with the responsibility of protecting the rights and welfare of human subjects involved in research, as mandated by the federal Office of Human Research Protection, (Department of Health and Human Services), the Food and Drug Administration, and the State of New York. The IRB membership and the number of members on the committee is in accordance with the Federal Policy. Certain categories of research may be eligible for less intensive review procedures than review by the entire IRB.
Who Must Submit?
Human subjects research must be reviewed if it is conducted by any faculty, staff, student, or any person under the auspices of the University. It applies to all University faculty, staff and students using University facilities, the facilities of another institution, or any other off-campus site. The research of visitors and users of University facilities must also be reviewed by the appropriate IRB. For more information, please see Guidelines for Investigators.
How is it Submitted?
Copies of the application forms and instructions can be obtained from the chair of the IRB or from the University Office of Sponsored Research (516-299-2712). All application questions should be answered as completely as possible and copies of informed consent forms, scripts, recruitment flyers, etc. should be appended. The completed materials are to be returned to the University Office of Sponsored Research, Room 207 at the University Center, Attention: Compliance Review. Human Subjects Application
When does it Have to be Submitted?
Each campus IRB meets on a regular basis and dates are available from the campus IRB chair or from the University Office of Sponsored Research. Applications should be submitted at least two weeks before the scheduled meeting date. This will allow time for administrative review (to assure all information and forms have been submitted), for photocopying, and distribution to committee members. Projects are required to be reviewed on an annual basis; reminders and all necessary forms will be sent to the primary investigator approximately 3 months before the expiration of the current approval period.
How will it be Reviewed?
The review of human subjects research is confined solely to procedures affecting the rights and welfare of human subjects. No evaluation is made of the content or scientific merit of the project, unless subjects are found to be "at risk", at which time the risk/benefit ratio of the project will be evaluated. The review focuses on such issues as risk to subjects, voluntary participation, informed consent, and confidentiality.
NOTE: Approval of a project by the IRB only signifies that the procedures adequately protect the rights and welfare of the subjects and should not be taken to indicate University approval to conduct the research.
Where can I get Assistance?
The University Assistant Vice President for Sponsored Research at the University Center in Brookville, serves as the liaison between the campus communities and the IRB's (as the Executive Secretary of each IRB). This individual is available in the University office of Sponsored Research (516- 299-2523) or at firstname.lastname@example.org and can assist faculty, staff, and students in submitting their projects for review. Also in the Office of Sponsored Research you may contact Michele Morales, Secretary with any questions or assistance that may be needed at (516) 299-3591 or at email@example.com. You may also contact the chairman of the appropriate campus IRB.
How Do I Determine Human Subjects Involvement?
The initial determination as to whether a research project should be considered human subjects research should be made by the investigator. He/she should consult the Chair of the IRB or the University Assistant Vice President for Sponsored Research for advice on this question. Final authority for making this determination rests with the IRB or its designee.
In general, research that involves data gathered solely for internal, on-campus use would not need to be reviewed (e.g., course evaluation or institutional research). If, however, the results of this research will be disseminated in any way, then the research must receive prior approval. If no dissemination is planned at the time the data is gathered, but the possibility of future dissemination exists, the project director would be advised to submit the project for approval before initiating the research.
What is the website where I can complete the required online human research subjects training? The title of the required training is Protecting Human Research Participants. http://www.cancer.gov/clinicaltrials/learning/page2