Institutional Review Board Instructions
PROCEDURES FOR SUBMITTING A RESEARCH PROPOSAL FOR IRB REVIEW
HUMAN RESEARCH PARTICPIANTS TRAINING
All researchers must complete one of the following Human Research Participants Training programs. Certificates of completion for each researcher must be submitted with the IRB protocol.
Form 1 and Form 2 are required for all protocols unless the research has already been approved by another IRB and the researcher wishes to submit those forms, with approval letter, to the Farmingdale IRB.
Form 2 should describe the research completely including:
- A brief background of the research topic / summary of why the research is being conducted
- The researcher’s hypotheses / research questions
- Some description of the costs/benefits of the study, specifically the costs to human participants (even if those costs are just their time) and the benefits the research may produce
- Sampling plan including a description of participants and recruitment methods
- If participants are selected from one or more of the vulnerable populations listed in Form 1, Form 8 must be completed
- Description of the research design / method (i.e., survey research, experimental research)
- Variables under investigation (i.e., independent and dependent variables)
- Procedure including a start to finish description of what human participants will experience (stimuli, tasks, measures) as research participants in the study
- Description of data collection procedures including whether the data will be collected anonymously or in an identifiable manner
- Proposed data analysis
- Plans for the completed research (i.e., publication or presentation)
Form 3 must be submitted for proposals that meet the criteria for Exempt Review and Form 4 for proposals that meet the criteria for Expedited Review.
Special Note About Vulnerable Populations FORM 1 and FORM 8
IRB Vulnerable Populations :
Students Only check box if the researcher’s students are included in the study or students are the focus of the study or the study poses greater than minimal risk to this population.
Employees Only check box if subjects work for the researcher or Farmingdale State College or the institution where the researcher works.
Minors Box always needs to be checked if minors are included in the study.
Pregnant Woman/Fetuses Only check box if the focus of the study is on pregnant woman/fetuses or if the study poses greater than minimal risk to pregnant woman/fetuses.
Woman of Childbearing Potential Only check box if the focus of the study is on woman of childbearing potential or if the study poses greater than minimal risk to this population.
Educationally/economically Challenged Only check box if the focus of the study is on Educationally/economically Challenged subjects or if the study poses greater than minimal risk to this population.
Prisoners Only check box if the focus of the study is on Prisoners or if the study poses greater than minimal risk to this population.
Each protocol should include all necessary attachments such as the actual (or detailed descriptions / samples) of the tasks, stimuli, and all measures used in the research.
Each protocol must include the proposed informed consent form. The form must include all elements of informed consent (see: http://www.hhs.gov/ohrp/policy/consentckls.html)
If a waiver of documentation of informed consent or a waiver of informed consent is requested, Form 5 must be completed and all elements necessitating the waiver (see Form 5) must be addressed in Form 2.
If a waiver of documentation of informed consent is requested, researchers must also submit the information that will be provided to participants regarding the elements of informed consent and describe the method for distribution of this information.
IRB proposals should be submitted at least one month prior to the researcher’s planned data collection for Exempt and Expedited Proposals and three months prior for proposals that do not meet the requirements for Exempt (see Form 3) or Expedited (see Form 4) review. Proposals that do not meet these requirements are reviewed by the full board.
Submitting a request to the IRB should include the forms applicable to your research from the list below:
- IRB Form 1 – IRB Application
- IRB Form 2 – Protocol Summary
- IRB Form 3 – Request for Exempt
- IRB Form 4 – Expedited Request
- IRB Form 5 – Consent Waiver
- IRB Form 6 – Conflict of Interest Questionnaire
IRB Form 6a – Investigator Disclosure Form
- IRB Form 7 – HIPAA
- IRB Form 8 – Vulnerable Populations
- IRB Form 9 – Drug Devices Radiation
- IRB Form 10 – Serious Adverse Events
- IRB Form 11 – Modified Request
- IRB Form 12 – Continued Approval
In addition to the pertinent forms you must complete one of the IRB training programs at:
Please submit your application and forms in both electronic and hard copy UNSTAPLED format to
IRB Administrator – Dawn Grzan
Farmingdale State College
2350 Broadhollow Rd
Thompson Hall, Rm 116
Farmingdale, NY 11735