Office: Thompson Hall, Rm 116
IRB Email: IRB@farmingdale.edu
Procedures for Submitting a Research Protocol for IRB Review
Please note: The Federal Policies mandating the protection of human subjects known as the "Common Rule" have been revised as of January 21, 2019. These changes apply only to new studies approved on or after January 21, 2019. FSC's IRB forms and the information provided on this page have been updated to reflect these revisions. All existing studies approved prior to the implementation date will remain governed by the pre-2018 Common Rule. Amendments to and continuing review of these studies will be reviewed in accordance with the pre-2018 rules.
Human Subjects Research Training
All researchers must complete a Human Research Participants Training program. Certificates of completion must be submitted with the IRB protocol. Please note: The complimentary NIH training course has been discontinued. NIH certificates will be accepted for five years past the date of completion.
https://www.citiprogram.org/ (Please note: RFSUNY is adopting this system-wide.)
IRB protocols should be submitted at least one month prior to the researcher's planned data collection for Exempt and Expedited protocols and three months prior for protocols that do not meet the requirements for Exempt or Expedited review. Protocols that do not meet these requirements are reviewed by the full board.
UPDATE: Exempt categories now encompass various types of research such as studies conducted in educational settings; interactions involving educational tests (cognitive, diagnostic, aptitude, achievement); survey procedures, interview procedures, or observation of public behavior; research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses; secondary research for which consent is not required; taste and food quality evaluation and consumer acceptance studies; and more. Restrictions apply. Please see IRB Form A- Exempt for detailed descriptions of each category.
IRB Forms and Attachments
- Exempt: (1) Form A - Exempt and (2) Proof of IRB Training for the Principal Investigator
[and a faculty advisor for student PIs]. No supplemental materials are required.
- Expedited and Full Board: (1) Form A - Expedited / Full Board, (2) Form B, (3) Form C for all study personnel, (4) Proof of IRB Training for all study personnel, and (5) supplemental materials including Informed Consent documents [see Informed Consent Template], recruitment materials, and/or dependent measures.
Projects that Do Not Meet the Definition of Research
The revised Federal Policy alters the definition of research to exclude several projects previously deemed to be research including some oral histories from which results will not be generalized. If you believe that your project does not meet the definition of research as defined on the IRB main webpage, and thus would not require IRB review, please complete the IRB Research Questionnaire. The IRB will make the final determination as to whether your project meets the definition of research.
FSC Student Researchers
Research protocols with a Principal Investigator (PI) or Co-Principal Investigator (Co-PI) who is a Farmingdale State College (FSC) student are governed by the same Federal policies mandating the protection of human subjects known as the "Common Rule" as other researchers on campus. More information can be found here
Researchers not affiliated with Farmingdale State College (FSC) must obtain approval from the appropriate Department Chairperson and Dean (if applicable) and FSC's Provost/Vice President of Academic Affairs (facilitated by the IRB) prior to conducting research accessing FSC facilities and/or resources; and recruiting Students, Faculty, and/or Staff as research participants. More information can be found here
Annual Continuing Review
Under the previous guidelines, annual continuing review of research is not required for Exempt protocols. As per the revised Federal Policy, annual continuing review will also not be required for Expedited protocols that were approved after 9/1/2018. Thus, researchers with Exempt or Expedited protocols approved after this date will not be required to submit renewal paperwork annually. Additionally, Full Board protocols approved after 9/1/2018 will not require annual review once the research has progressed to the point that it involves only one or both of the following: (1) Data analysis, including analysis of identifiable information or identifiable biospecimens or (2) accessing follow-up clinical data from procedures that subjects would undergo as part of a clinical care. *Please note that the IRB may institute approval expiration dates and/or deem that a protocol requires continuing review dependent on the risk-level of the research.
Modification Requests, Reporting of Adverse Consequences, and Closure Forms
Despite changes to continuing review procedures, please note that researchers must continue to submit modification requests for changes to approved Exempt, Expedited, and Full Board protocols. Researchers must promptly inform the IRB of any changes or adverse consequences of the research. Upon completion of Expedited and Full Board approved protocols, researchers must submit a Project Closure Form (Form J).
Research Conducted at Other Institutions
Researchers who plan to recruit participants and/or conduct study procedures at institutions other than Farmingdale State College (e.g., schools, hospitals, organizations), must obtain and submit written permission from each site to conduct the research in addition to receiving approval through FSC's IRB. Please see the Site Permission Letter template. While researchers do not need to use this template, the permission letter must include all essential elements found in the template.
Collaborative/cooperative research includes projects for which multiple institutions are engaged in human subjects research and/or investigators from multiple institutions are engaged in human subjects research. When possible, collaborative research projects will be reviewed and approved by one IRB (typically the IRB of the Principal Investigator) to avoid dual or multiple reviews. The IRB reviewing the protocol is referred to as the IRB of Record. All institutions will enter into an Institutional Authorization Agreement (IAA) with the IRB of Record relying on their review and approval of the research. If you are planning a collaborative research project, contact the IRB Office to coordinate approval during the initial phase of research protocol planning.
IRB Form A: Exempt Application
IRB Form A: Expedited / Full Board Application
IRB Form B: Protocol Summary
IRB Form C: Researcher Conflict of Interest Questionnaire
IRB Form D: Investigator Disclosure Form
IRB Form E: HIPAA
IRB Form F: Drug Devices Radiation
IRB Form G: Serious Adverse Events
IRB Form H: Modification Request
IRB Form I: Continued Approval Form
IRB Form J: Project Closure Form
IRB Form K: Student Researcher Certifications
IRB Form L: Faculty Researcher Certifications
IRB Form M: External Research Request
IRB Research Questionnaire
Site Permission Letter Template
Informed Consent Template
IRB Member Conflict of Interest Procedures
Please submit your application and forms in either electronic OR hard copy UNSTAPLED
Farmingdale State College
Office of the Institutional Review Board (IRB)
2350 Broadhollow Road
Thompson Hall, Rm 116
Farmingdale, NY 11735