{"id":416,"date":"2023-12-22T12:53:08","date_gmt":"2023-12-22T17:53:08","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=416"},"modified":"2026-09-09T17:50:03","modified_gmt":"2026-09-09T21:50:03","slug":"team-members","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/team-members\/","title":{"rendered":"Identifying Study Team Members"},"content":{"rendered":"<p>Determining who needs to be listed as a &#8216;study team member&#8217; on an Institutional Review Board (IRB) submission depends on the Reviewing IRB&#8217;s policies\/requirements.<\/p>\n<p>Of note, funding agencies may have differing definitions of who is considered &#8216;key personnel&#8217;.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Determining who needs to be listed as a &#8216;study team member&#8217; on an Institutional Review Board (IRB) submission depends on the Reviewing IRB&#8217;s policies\/requirements. Of note, funding agencies may have&hellip;<\/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-416","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"Identifying Study Team Members in RSRB (IRB) Submissions","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":"text","anchor":"","css_class":"","title":"<h2>Definition of 'study team member'<\/h2>","content":"At the University of Rochester, individuals are considered study team members when they:\r\n<ul>\r\n \t<li>Act as a Principal Investigator, Co-Investigator, Sub-Investigator, or Study Coordinator;<\/li>\r\n \t<li>Interact with human subjects (e.g., facilitating the informed consent process, manipulating subject\u2019s environment for research purposes, conducting research procedures);<\/li>\r\n \t<li>Are involved in collecting, reporting, or analyzing <em>identifiable<\/em> subject data;<\/li>\r\n \t<li>Function outside of regular work practice (e.g., student administering research testing); and\/or<\/li>\r\n \t<li>Are faculty advisors\/mentors providing direct oversight of student research.<\/li>\r\n<\/ul>\r\nIf an individual is functioning within their regular work responsibilities <strong>and<\/strong> their involvement in the research is limited to those work responsibilities only, <strong>without further contribution to the research<\/strong>, then they are generally<strong> not<\/strong> considered study team members.\r\n\r\nFor example, a phlebotomist working at a central laboratory who performs a blood draw on a subject via a clinical lab requisition would not be considered a study team member.","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"text","anchor":"rsrb","css_class":"pb-0","title":"<h2>When the URochester IRB is the Reviewing IRB<\/h2>","content":"The Institutional Review Board (IRB) requires all study team members, as defined above, to be identified in the Click IRB submission.\r\n<ul>\r\n \t<li>Only study team members with <strong>current<\/strong> <a href=\"https:\/\/www.rochester.edu\/ohsp\/training\/required-human-subject-protection-training\/\">Human Subject Protection (HSP) training<\/a> should be added to IRB submissions. HSP training can be verified in Click IRB on the submission workspace\u2019s Training Details tab (it appears as \u2018Human Research\u2019, under the \u2018Curriculum\u2019 heading).<\/li>\r\n \t<li><strong>Do not include:<\/strong>\r\n<ul>\r\n \t<li>Team members from external sites who will receive IRB approval from their own IRB.<\/li>\r\n \t<li>External collaborators who are not <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/301a_GDL_for_Determining_Engagement_in_Research.pdf\">engaged in research conduct<\/a> (e.g., handing out recruitment information at an external site or providing prospective subjects with information about contacting the study team).<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>If additional individuals join the study team following initial IRB approval, they must be added to the IRB submission via modification and the modification must be approved before the additional team member(s) can engage in the research.<\/li>\r\n \t<li>Existing study team members with a lapse in HSP training must cease involvement in human subject research activities until refresher training is completed. The RSRB may not approve:<\/li>\r\n<\/ul>\r\n<ul>\r\n \t<li style=\"list-style-type: none;\">\r\n<ul>\r\n \t<li>New studies when study team members have lapsed HSP training;<\/li>\r\n \t<li>Existing studies at the time of continuing review when training for key personnel has lapsed<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"","classes":"pt-0","title":"","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"title","sub_heading":"Adding external team members\/collaborators"},{"acf_fc_layout":"accordion","accordion_title":"Single-site research","icon":"","row_content":"When an individual external to the University is collaborating with University of Rochester (URochester) faculty (as part of the URochester site) <strong>and<\/strong> meets the definition of study team member, as defined above (e.g., members of the community and\/or individuals affiliated with community-based organizations\/agencies), they should be identified as 'External Team Members' in the Click IRB submission (reference the <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/ClickIRB_StudyStaffManual.pdf\">Click IRB Study Staff Guide<\/a> for instructions).\r\n\r\nNote:\r\n<ul>\r\n \t<li>As with internal team members, only external study team members with current Human Subject Protection (HSP) training should be added to IRB submissions (reference our <a href=\"https:\/\/www.rochester.edu\/ohsp\/training\/required-human-subject-protection-training\/external\/\">HSP Training for External Personnel page<\/a>).<\/li>\r\n \t<li>The protocol should clarify what roles\/tasks the non-URochester site\/staff will be engaged in and include information regarding how the Principal Investigator will oversee research conduct at the non-URochester site.<\/li>\r\n \t<li>If the external individual is engaged in the research on behalf of their role\/position at a non-URochester research location or facility <strong>and <\/strong>the research is federally funded, the non-URochester facility is considered a separate research site, requiring a Federalwide Assurance and IRB site approval (reference <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_504_RSRB_Reliance_Review.pdf\">OHSP Policy 504: IRB Reliance and Collaborative Research<\/a>). External research personnel would then be managed as described in the drop-down below (multi-site research).<\/li>\r\n<\/ul>","accordion_anchor":"single"},{"acf_fc_layout":"accordion","accordion_title":"Multi-site research","icon":"","row_content":"In accordance with <a class=\"u-link-external\" href=\"https:\/\/smartirb.org\/wp-content\/uploads\/Review_of_Study_Personnel.pdf\">SMART IRB recommendations<\/a>, the Relying IRB (i.e., the IRB that delegates the responsibility of IRB review and approval to the URochester IRB) is responsible for ensuring their local site research staff have \u2018adequate education, training, and qualifications to perform the research\u2019. Other than the site-Principal Investigator, study team members engaged in the research at other participating sites should <strong>not<\/strong> be identified as study team members in the Click IRB submission.","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"external","css_class":"","title":"<h2>When an External IRB is the Reviewing IRB<\/h2>","content":"In accordance with <a class=\"u-link-external\" href=\"https:\/\/smartirb.org\/wp-content\/uploads\/Review_of_Study_Personnel.pdf\">SMART IRB recommendations<\/a>, the Research Subjects Review Board (RSRB) requires all study team members, as defined above, to be identified in the Click IRB submission.\r\n<ul>\r\n \t<li>Only study team members with current <a href=\"https:\/\/www.rochester.edu\/ohsp\/training\/required-human-subject-protection-training\/\">Human Subject Protection (HSP) training<\/a> should be added to IRB submissions. HSP training can be verified in Click IRB on the submission workspace\u2019s training details tab (the appear appears as \u2018Human Research\u2019, under the \u2018Curriculum\u2019 heading).<\/li>\r\n \t<li>External research personnel should <strong>only<\/strong> be identified in the Click IRB submission as a \u2018Local Study Team Member\u2019 when they are engaged in the research <strong>as part of the local University of Rochester site<\/strong>. Reference the information above under <a href=\"#single\">'When the RSRB is the Reviewing IRB \u2013 Single-Site Research\u2019<\/a>.<\/li>\r\n \t<li>If additional individuals join the study team following initial IRB approval, they must be added to the IRB submission via modification and the modification must be approved before the additional team member(s) can engage in the research.<\/li>\r\n<\/ul>","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"","classes":"","title":"<h2>Frequently asked questions (FAQs)<\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"I need to add a study team member to a submission but cannot find them in Click IRB. What should I do? ","icon":"","row_content":"Reference our <a href=\"https:\/\/www.rochester.edu\/ohsp\/click-irb\/#faq\">Click IRB FAQs<\/a> for more information.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"A team member completed HSP training through CITI at a previous institution. What do they need to do to meet the University's training requirements?","icon":"","row_content":"Reference our <a href=\"https:\/\/www.rochester.edu\/ohsp\/training\/required-human-subject-protection-training\/#faq\">HSP Required Training FAQs<\/a> for more information.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Are statisticians considered study team members and therefore need to be included as a study team member in Click IRB submissions?","icon":"","row_content":"Statisticians only need to be identified as a study team member on an IRB submission when\/if they have access to <strong>identifiable<\/strong> subject data. Bear in mind, this determination may be dependent on the level of access the statistician has to the data. Study data may be coded for the statistician to perform analysis. \u2018Coded\u2019 means that the data is still identifiable to the study team because they hold the key linking the identifiable information to the coded information, but if the statistician does <strong>not<\/strong> have access to the key, they would not be able to identify the data and therefore would not need to be identified as a study team member.\r\n\r\nFor additional information on what \u2018coded\u2019 means versus de-identification, reference <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/OHSPExplains_CodedDeidentified.pdf\">OHSP Explains: Coded vs. De-Identified; Anonymized vs. Anonymous<\/a>.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"My funding agency requires documentation from the IRB confirming a proposal is <i>not<\/i> human subject research. Do all team members engaged in the proposed project need to be listed on the submission? ","icon":"","row_content":"No, only the Principal Investigator needs to be listed on the submission. However, if the RSRB determines the proposal <strong>is<\/strong> human subject research, the Principal Investigator is responsible for adding all study team members, as described above, to the submission.","accordion_anchor":""}]},{"acf_fc_layout":"card_grid","anchor":"","css_class":"max-text-center","title":"<h2 style=\"text-align: center;\">Additional resources and support<\/h2>","description":"","background_color":"#f4f4f4","width":"width-large","columns":"2","cards":[{"card_title":"<h5>HSP training for internal personnel<\/h5>","card_text":"","card_background_color":"#FFFFFF","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":"<h5>HSP training for external personnel<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Human Subject Protection Training for External Research Personnel","url":"https:\/\/www.rochester.edu\/ohsp\/training\/required-human-subject-protection-training\/external\/","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":"<h5>Contact your IRB Coordinator<\/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":""},{"card_title":"<h5>Click IRB resources<\/h5>","card_text":"","card_background_color":"#FFFFFF","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":"card_grid","anchor":"","css_class":"pt-0 max-text-center","title":"","description":"<h4 style=\"text-align: center;\">Policies and guidelines<\/h4>","background_color":"#f4f4f4","width":"width-large","columns":"2","cards":[{"card_title":"<h5>OHSP Policy 201: Education Program<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_201_Education_Program.pdf","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":"<h5>OHSP Policy 504: IRB Reliance and Collaborative Research<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_504_RSRB_Reliance_Review.pdf","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":"<h5>OHSP Policy 301: RSRB Scope and Authority<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_301_RSRB_Scope_and_Authority.pdf","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":"<h5>OHSP Guideline for Determining Engagement in Research<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/301a_GDL_for_Determining_Engagement_in_Research.pdf","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":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - 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