The 糖心传媒 conducts Institutional Review Board (IRB) reviews via Click IRB<\/a>. This includes submissions that will be reviewed by an external Reviewing IRB (review OHSP Guidelines for when 糖心传媒 is the Relying IRB<\/a>).<\/p>\n Click IRB is a module within the Integrated Online Research Administration (IORA) system. To access the Click IRB system, you must complete Human Subject Protection (HSP) training<\/a>. All individuals engaged in human subject research must complete this training. Approximately 24\u201348 hours following course completion, all internal faculty, staff and students will receive access to Click IRB.<\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" How to submit to the IRB The 糖心传媒 conducts Institutional Review Board (IRB) reviews via Click IRB. This includes submissions that will be reviewed by an external Reviewing…<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":356,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-396","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"Preparing your RSRB (IRB) Submission","subtitle":"","call_to_action":"","hero_image_placement":"no_image","hero_media":"images","hero_pattern_option":"","hero_video":"","hero_image_landing":"","hero_image_landing_two":"","hero_image_landing_three":"","content_modules":[{"acf_fc_layout":"card_grid","anchor":"","css_class":"pt-0","title":"","description":"","background_color":"#FFFFFF","width":"width-large","columns":"3","cards":[{"card_title":"Log into Click IRB<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/rochesterirb.huronresearchsuite.com","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"
View training requirements to access Click IRB<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"Required Human Subject Protection Training","url":"https:\/\/www.rochester.edu\/ohsp\/training\/required-human-subject-protection-training\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"
Explore Click IRB resources<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"Click IRB Resources","url":"https:\/\/www.rochester.edu\/ohsp\/click-irb\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"
Preparing your IRB submission<\/h2>","content":"
Required Materials<\/h4>\r\nAll IRB submissions must include a study protocol:<\/strong>\r\n
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Keys to facilitating the IRB review process<\/h2>","description":"","background_color":"#FFFFFF","width":"width-medium","columns":"1","cards":[{"card_title":"
Key #1: Study protocol<\/h5>","card_text":"The protocol is the primary mechanism for communicating why and how the research will be conducted.\u00a0Do not leave content open to interpretation; content should be clear and detailed.\u00a0IRBs cannot approve research when it is unclear how:\r\n
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Key #2: Consistency<\/h5>","card_text":"Consistency within a study protocol is critical for providing the IRB (as well as your study staff) a clear picture of how the research will be conducted. It is equally important to ensure consistency among all supporting documents included within the IRB submission. Mismatched content within and among documents does not allow the IRB to validate that the criteria for IRB approval<\/a> will be met.","card_background_color":"#f4f4f4","card_hover_color":"transparent","card_link":"","card_hover_arrow":"","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]},{"acf_fc_layout":"accordion_new","anchor_id":"faq","classes":"","title":"
IRB submission FAQs<\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Can I use my grant submission as my study protocol?","icon":"","row_content":"No. It is a common mistake to assume that the grant and the study protocol are one in the same when they\u2019re not. Grants typically have page limitations and only provide a summary of the intervention\/procedures. Thus, grants are not detailed enough to act as the study protocol.","accordion_anchor":"grant"},{"acf_fc_layout":"accordion","accordion_title":"What is the purpose of a site-specific protocol addendum?","icon":"","row_content":"If you\u2019re acting as an enrolling site on multi-site research, you may be asked to submit a site-specific protocol addendum. The purpose of this addendum is to clarify the University's role in the research and\/or how study procedures will be conducted locally (e.g., local recruitment methods). IRB protocol templates<\/a> can be used as a guide for drafting addendums, as long as sections that do not need clarification are removed. Addendums should only include new or clarifying information. Do not repeat content provided in the primary protocol.","accordion_anchor":"sitespecificprotocoladdendum"},{"acf_fc_layout":"accordion","accordion_title":"What are the RSRB's submission deadlines for convened board review?","icon":"","row_content":"Submissions are scheduled for review on a first come, first serve basis; standard submission deadlines are not set. IRB Coordinators work diligently to schedule review items in a timely manner. However, several extraneous factors may affect the timing of board review (e.g., the quality of the submission, the number of other review items already scheduled for any one meeting, and board member time constraints). If you know in advance you will be submitting a timely review item (e.g., a Just-in-Time application), please notify your IRB Coordinator<\/a> as early in the process as possible.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"I need IRB approval for a Just-in-Time (JIT) proposal in order to obtain funding but the study design and methods have not yet been fully developed? ","icon":"","row_content":"Submit a proposal to the IRB for review as a concept study<\/a>.","accordion_anchor":"jitproposal"},{"acf_fc_layout":"accordion","accordion_title":"How do I know if my grant is Just-in-Time (JIT)?","icon":"","row_content":"\u2018Just-in-Time\u2019 (JIT) refers to a specific award procedure utilized by the National Institutes of Health (NIH), and some foundations. The JIT process allows some elements of a grant submission (e.g. IRB approval) to be submitted later in the application process, thereby allowing the Investigator to initially focus on the science of a specific submission. Once an initial submission has been reviewed by the NIH, those receiving scores in a fundable range will receive notice from NIH requesting the submission of additional materials. At that time, the initial application for approval of the research should be submitted to the reviewing IRB with documentation pertaining to the initiation of the JIT process.\r\n\r\nFor further clarification, the \u2019Just-in-Time\u2019 process applies only<\/strong> to grants that have been:\r\n