Are you new to human subject research at the University, or could use a refresher on the process? The guidance on this page can be a great resource as you\u2019re getting started.<\/p>\n
Review a step-by-step process for starting human subject research<\/a><\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" Are you new to human subject research at the University, or could use a refresher on the process? The guidance on this page can be a great resource as you\u2019re…<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-906","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"Getting Started with Human Subject Research","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":"","title":"Human Research Protection Program (UR-HRPP)<\/h2>","description":"The University of Rochester\u2019s Human Research Protection Program<\/a> (UR-HRPP) ensures that individuals involved with human research understand and apply their obligations to protect the rights, dignity, welfare, and privacy of research subjects. The UR-HRPP is a coordinated effort among several University departments and committees. Based on the nature of a research proposal, multiple UR-HRPP review processes may be required in order to initiate a study.","background_color":"#f4f4f4","width":"width-medium","columns":"2","cards":[{"card_title":"
UR-HRPP overview<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Human Research Protection Program","url":"https:\/\/www.rochester.edu\/ohsp\/hrpp\/","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":"
HRPP training requirements<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"HRPP Training Requirements","url":"https:\/\/www.rochester.edu\/ohsp\/training\/hrpp-training\/","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":"interstitial","anchor_id":"","classes":"","layout":"layout_inline","lead-in":"Downloadable guide","title":"Acronyms and abbreviations","content":"UR-HRPP? IRB? RSRB? HSP? There are many acronyms and abbreviations used in research. Our Abbreviations page covers a lot of them, and there\u2019s also a downloadable version for you to print and keep on hand.","call_to_action":{"title":"Review commonly-used acronyms","url":"https:\/\/www.rochester.edu\/ohsp\/resources\/acronyms\/","target":""},"bg_color":"#00205b"},{"acf_fc_layout":"text","anchor":"flowchart","css_class":"","title":"
Steps for getting started<\/h2>","content":"Below, you'll find key steps for initiating most<\/em> types of human subject research at the University of Rochester. You can also view a schematic version of this flowchart<\/a>.\r\n\r\nDownload the flowchart<\/a>","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"feasibility","classes":"","title":"
Step one: Validate study feasibility<\/h3>","description":"After you\u2019ve generated an idea, it\u2019s critical to think through whether the research is feasible to conduct. If it is not feasible to meet study objectives, the research should not be conducted.","background":"decorative","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Verify if the study should be done","icon":"","row_content":"
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Step two: Verify the proposal involves 'human subject research'<\/h3>","content":"To be considered \u2018human subject research\u2019, the proposal must meet the definition of \u2018research\u2019 and \u2018human subject\u2019. All proposals involving <\/span><\/span><\/span>\u2018research\u2019 and \u2018human subjects\u2019 (per federal definition), require Institutional Review Board Approval (IRB).<\/span><\/span><\/span>\r\n\r\nProposals that do not meet the definition of \u2018human subject research\u2019 do not require review by an IRB. However, when unsure, when documentation is required for the funding agency or publisher, or the Investigator just would like documentation, proposals may still be submitted through Click IRB for formal review and determination of not human subject research.\r\n\r\nReview when you need IRB approval<\/a>\r\n\r\nNote:<\/strong> If the research involves funding and\/or requires contract\/agreement review, reference our additional guidance below.<\/a>","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"","classes":"","title":"
Step three: PI eligibility, training, and conflicts of interest<\/h3>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Verify Principal Investigator (PI) eligibility","icon":"","row_content":"Per University policy<\/a>, PIs must hold full-time faculty positions or full-time positions enjoying similar rights and privileges. Part-time clinical faculty in the School of Medicine & Dentistry and the School of Nursing having the rank of Assistant Professor or above may also be PI. Exceptions are made for students (including undergraduate, graduate, and medical students, as well as residents and fellows) conducting not human subject research or research deemed exempt.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Complete Human Subject Protection (HSP) training","icon":"","row_content":"Per OHSP Policy<\/a>, all individuals engaged in the conduct of human subject research<\/a> must complete basic human subject protection training<\/a> through the Collaborative Institutional Training Initiate (CITI).\r\n\r\nOne to two days following course completion, internal (University of Rochester) faculty, staff and students will be provided access to the Click IRB module<\/a> in the IORA system.\r\n\r\nLearn more about HSP training requirements<\/a>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Disclose conflicts of interest (if applicable)","icon":"","row_content":"Any new or revised financial interests related to the submission must be reported<\/a> (applicable to all study team members). The resulting Conflict of Interest (COI) Management Plan or Transparency Checklist must be included in the IRB submission.","accordion_anchor":""}]},{"acf_fc_layout":"card_grid","anchor":"","css_class":"","title":"
Step four: Prepare and submit your IRB application<\/h3>","description":"All human subject research must be submitted to the University of Rochester\u2019s Institutional Review Board (IRB), via the Click IRB<\/a> review module in the Integrated Online Research Administration (IORA) system.\r\n\r\nThis includes studies where the URochester IRB will act as the Reviewing IRB (i.e., the IRB designated to review and approve the research), as well as studies that will be reviewed by an External IRB (administrative institutional review is required prior<\/strong> to submission to the External IRB).\r\n\r\nNote: The costs associated with IRB review must be factored into study budgets during the budget development process. For additional information, see the IRB Fee Structure<\/a>.","background_color":"#f4f4f4","width":"width-medium","columns":"2","cards":[{"card_title":"
Learn more about preparing your submission<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Preparing your IRB Submission","url":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/submission-preparation\/","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":"
Have questions? Contact us!<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Who\u2019s My IRB Coordinator?","url":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/coordinator\/","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":"accordion_new","anchor_id":"","classes":"","title":"
Step five: Department, ancillary, and IRB reviews are conducted<\/h3>","description":"There are several different reviews that will be conducted as part of the process.","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Departmental scientific and resource review","icon":"","row_content":"Upon submission, per OHSP Policy<\/a>, the IRB will direct all submissions to the PI\u2019s department (primary appointment) for scientific and resource review and approval. Note:\r\n
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Research involving grants, agreements, and contracts<\/h3>","description":"All grant submissions, agreements (including but not limited to non-disclosure agreements, clinical trial agreements, sponsored research agreements, data use agreements, data transfer agreements and material transfer agreements) and contracts must be reviewed by the Office of Research and Project Administration (ORPA).","background":"decorative","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Initiating proposals and agreement\/contract reviews","icon":"","row_content":"After you've validated study feasibility<\/a>, initiate funding proposals and\/or contract\/agreement reviews via submission in the IORA system<\/a>.\r\n\r\nNote:\r\n
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Step six: Initiate study conduct<\/h3>","content":"Studies cannot be initiated until all of the applicable activities identified above have been completed\/approved.<\/em><\/strong>\r\n\r\nImportant points to keep in mind once research studies begin:\r\n
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Related resources<\/h2>","description":"","background_color":"#FFFFFF","width":"width-large","columns":"2","cards":[{"card_title":"
A\u2013Z resources<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"Resources","url":"https:\/\/www.rochester.edu\/ohsp\/resources\/","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":"
IRB overview<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"RSRB (IRB)","url":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/","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":"
Download protocol and consent templates<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"Templates","url":"https:\/\/www.rochester.edu\/ohsp\/templates\/","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":"
Training opportunities and resources<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"Training","url":"https:\/\/www.rochester.edu\/ohsp\/training\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]}]},"yoast_head":"\n