Research Involving Human Subjects
Research Involving Human Subjects
The use of human subjects in research is governed by laws and regulations set forth at the University, State and Federal levels. The faculty, staff and students of the University are mandated to comply with these laws and regulations.
This policy applies to all University faculty, staff and students using University facilities, the facilities of another er institution, or any other off-campus site. The policy also applies to visitors and users of the campus or off- campus University facilities.
Each campus has an established Institutional Review Board (IRB) as required by:
- The Office for Human Research Protection (Department of Health and Human Services)
- The Food and Drug Administration
- The State of New York
The purpose of the IRB is to assure protection of the rights and welfare of human subjects in research. These rights include ensuring that the subject has the opportunity to voluntarily give informed consent to participate in the project. The members of each IRB are appointed by and serve at the pleasure of the Vice President for Academic Affairs. The Assistant Vice President for Sponsored Research serves as the Executive Secretary on each University IRB.
Reports of violations of this policy will be brought before the appropriate campus IRB at a convened meeting. The IRB will make a determination regarding the need for additional information or further investigation. The affected Chair and Dean will be copied on all correspondence between the committee and the involved parties. Upon determination that a violation of this policy has occurred, the IRB may, for example, require that the activity in question be halted until such time that corrective action is taken. If the IRB determines that the violation involves possible scholarly or scientific misconduct, the Vice President for Academic Affairs will be notified, through the Assistant Vice President for Sponsored Research, and appropriate action will be taken in accordance with established University assurances, polices, and procedures.
APPLYING FOR APPROVAL FOR RESEARCH INVOLVING HUMAN SUBJECTS:
All research involving human subjects conducted under the auspices of Long Island University or any campus-related organization must be reviewed and approved by the campus IRB prior to commencement of the research activity. Materials submitted for review should include the current “Application for Review of Research Involving Human Subjects,” a detailed protocol outlining all experimental procedures including anticipated risks and benefits to the subject, consent forms (in accordance with 45 CFR 46 [DHHS] and, when applicable, 21 CFR 50 [FDA]), and samples of test or survey instruments. The application and supporting documents must be endorsed by the department chair or unit head and then submitted to the University Office of Sponsored Research/Compliance. Investigators will be notified in writing of the outcome of the IRB’s review.
Approved research must be reviewed at least once annually. Renewal forms will be sent to the principal investigator approximately 3 months prior to the end of the approved period. Projects are inactivated if response to renewal notification is not received within 30 days after the expiration of the approval period. If the project is to continue after this expiration, a full application must be made to reactivate the project.
Unanticipated problems involving risks to subjects, adverse events or other problems must be reported immediately to the IRB (Chair or Executive Secretary) for evaluation.
Any revisions or amendments to the approved research activity must be submitted to the IRB prior to implementing the new activity in order to determine the need for additional committee review.
Participation by students in any teaching activity which involves risk to the student, or is unusual or not necessary to the course of study or training in which it occurs must be accompanied by the student’s voluntary, informed consent and must be reviewed and approved by the IRB.
There are additional special considerations for:
- special subject populations (e.g., pregnant women, minors [under 18 years of age], subjects with impaired capacity to consent)
- research involving investigational drugs or devices
- emergency use of investigational drugs or devices
- use of biological specimens in research
Chair of the campus IRB
Assistant Vice President for Sponsored Research
University Center / Bush-Brown Hall
Phone: (516) 299-2523 or Fax: (516) 299-3101
DHHS: Code of Federal Regulations, Title 45 Part 46: Protection of Human Subjects
FDA: Code of Federal Regulations, Title 21 Parts 50 (Informed Consent), 56 (IRB’s), 312 (Investigational New Drugs), 812 (Investigational Device Exemptions
The Belmont Report: “Ethical Principles and Guidelines for the Protection of Human Subjects in Research”
Appropriate Articles of the NYS Public Health Law