New GUIDANCE - IRBNet Application.docx - GUIDANCE \u2013 IRBNet Application This Worksheet is designed to support researchers as they plan for and complete

New GUIDANCE - IRBNet Application.docx - GUIDANCE u2013...

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GUIDANCE – IRBNet Application This Worksheet is designed to support researchers as they plan for and complete their IRB application to ensure that the study design, and research protocols adequately address issues related to the protection of human subjects. This Worksheet references several resources (GUIDANCE and FORMS) that are available within the IRBNet Forms and Templates library (from the left menu when you are logged into IRBNet). Best Practices for a Successful IRB Submission Carefully read the READ ME FIRST document BEFORE you begin the IRB application in IRBNet. Across all of your IRB materials, the application form, and your supplemental materials, aim to: o Be Concise. Do NOT copy and paste directly from your research proposals or other documents into your IRB materials. o Be Clear. Avoid jargon and answer each specific question on the application as simply as you can. Grammar and spell check every piece of your IRB application. If the reviewer can’t understand your plans or the materials, you will be asked to revise. o Be Consistent. Double-check that the information you provide in the IRB application and all supplemental documents consistently presents your study plans. Keep in mind that your research plans must reflect an appreciation of the three principles from the Belmont Report, which are: o Respect for Persons, o Beneficence, and o Justice. Use the Office of Human Research Protection “Checklists” to determine what type of IRB review to request. For more see the GUIDANCE - OHRP Decision Tree Checklists (Determining Type of IRB Review). The type of review is determined by the level of risk in your study. For more, see GUIDANCE - Understanding IRB Actions and Decision Letters. Recruitment Throughout your application and supplemental materials, as you consider recruitment-related issues, please reference the following guidance: GUIDANCE – Recruitment
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