{"id":4736,"date":"2024-01-08T16:42:26","date_gmt":"2024-01-08T21:42:26","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=4736"},"modified":"2025-02-10T14:01:17","modified_gmt":"2025-02-10T19:01:17","slug":"hrpp-training","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/training\/hrpp-training\/","title":{"rendered":"HRPP Training Requirements"},"content":{"rendered":"

To achieve its aims, components of the University\u2019s Human Research Protection Program (HRPP)<\/a> have set forth training requirements related to the conduct of human subject research. The information below provides a summary of potential<\/strong> institutional training requirements, as they relate to the nature of the research being conducted, the sponsor\/funding agency, and\/or an individual\u2019s role.<\/p>\n

Note:<\/strong> This list is not inclusive of all Sponsor and\/or Department-Specific training requirements.<\/p>\n

\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

To achieve its aims, components of the University\u2019s Human Research Protection Program (HRPP) have set forth training requirements related to the conduct of human subject research. The information below provides…<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":546,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-4736","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"","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":"accordion_new","anchor_id":"","classes":"pb-0 pt-0","title":"

Training requirements based on research nature<\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"If the research involves human subjects...","icon":"","row_content":"All personnel engaged in the research are required to complete and maintain Human Subject Protection (HSP) training<\/a> via the Collaborative Institutional Training Initiative (CITI). Refresher training is required every 3 years.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"If the research involves prospective assignment to one or more health-related biomedical or behavioral intervention...","icon":"","row_content":"Research personnel may<\/strong> be required to complete and maintain Good Clinical Practice (GCP) training<\/a> by the sponsor\/funding agency (e.g., see NIH Policy on GCP Training<\/a>). Refresher training is typically required every 3 years.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"If the research will involve access to or processing of PHI or other identified health information\u2026","icon":"","row_content":"Study staff must complete Health Insurance Portability & Accountability Act (HIPAA)<\/strong> training. HIPAA training is routinely included in the University of Rochester\u2019s Office of Human Resources\u2019 New Employee Orientation for URMC and Affiliates workforce members (via MyPath<\/a>), though it is the responsibility of a trainee\u2019s supervisor to ensure the training is completed (see HIPAA Policy 0P6 Privacy Training for Workforce<\/a>). Training is available for study team members that do not have access to MyPath via the Privacy Office website<\/a>.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"If the research involves a billable clinical service\u2026","icon":"","row_content":"All research personnel responsible for tracking patient visits and reviewing patient charges are required to complete eRecord (Epic) Research Coordinator<\/strong> and OnCore Clinical Trial Management System (CTMS)<\/strong> training.\r\n\r\nFor eRecord (Epic) Research Coordinator course availability, search the class schedule for the course on the eRecord training page<\/a>.\r\n\r\nOnCore CTMS training is role-based. Training requirements are assigned to trainees once the access request form<\/a> has been completed.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"If the research involves exposure to potentially hazardous materials, processes, and\/or experiments (e.g., biological materials, radiation)\u2026","icon":"","row_content":"All research personnel subject to potential safety hazards must complete Environmental Health and Safety\u2019s (EH&S) Hazard Assessment Tool & Training Indicator<\/strong><\/a>. This assessment tool will identify required EH&S training, based on the individual\u2019s responses\/role. The \u2018Hazard Assessment Tool\u2019 is available in MyPath<\/a> for 糖心传媒 faculty\/staff. New staff are encouraged to complete the tool with the assistance of their supervisor, as the supervisor will have a greater understanding of what hazards the trainee may be exposed.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"If the research involves an Investigational New Drug (IND) or Investigational New Device (IDE) submission by a 糖心传媒 Investigator...","icon":"","row_content":"The Principal Investigator (PI) is required to complete IND training<\/a> \/ IDE training<\/a> (as applicable), <\/span><\/span>prior<\/span><\/span> to FDA submission. Training is optional, but strongly recommended, for research personnel who will be involved in FDA-related aspects of the study.<\/span><\/span>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"If the research involves magnetic resonance imaging (MRI) via the Center for Advanced Brain Imaging & Neurophysiology (CABIN)\u2026","icon":"","row_content":"All research personnel involved in image acquisition and subject handling that requires access to the scanner or scanner console are required to complete UR CABIN MRI Safety Training<\/strong><\/a>.<\/strong>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pt-0 pb-0","title":"
","content":"","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"","classes":"pt-30","title":"

Training requirements based on funding<\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"If the research is sponsored...","icon":"","row_content":"The administrator with functional responsibility for the sponsored project is required to complete Continuous Learning for Administrators of Sponsored Programs (CLASP)<\/strong> training. \u2018Functional responsibility\u2019 is characterized as having an ability to originate, authorize, or approve transactions associated with sponsored programs; involvement with proposal preparation; or active review and monitoring of the financial activities of sponsored project accounts. CLASP training<\/a> is facilitated by the Office for Research and Project Administration (ORPA), with both instructor-led and online sessions. Maintenance, via continuing education hours, is required annually.\r\n\r\nIndividuals involved in creating grant proposals in the Integrated Online Research Administration (IORA) system are required to complete IORA Overview<\/strong> training. The \u2018Integrated Online Research Administration Overview\u2019 training course is available in MyPath<\/a>.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"If the research is funded by any federal agency...","icon":"","row_content":"The Principal Investigator, named key persons, and anyone who will be delegated Purchasing Authority for the project is required to complete 2 CFR 200 Procurement Principles<\/strong> training. The course is completed once; maintenance training is not required.\r\n\r\nThe \u20182 CFR 200 Procurement Principles\u2019 course is available in MyPath<\/a> for 糖心传媒 faculty\/staff.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"If an individual receives support from the National Institutes of Health (NIH) via a training grant, career development award, fellowship award, research education grant, or as otherwise stated in relevant funding opportunities\u2026","icon":"","row_content":"The trainee\/fellow\/participant\/scholar is required to complete and maintain Responsible Conduct of Research (RCR)<\/strong> training. Refresher training is required every 4 years. For additional information, see NIH RCR Requirements<\/a>.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"If the research is sponsored by the National Science Foundation (NSF)...","icon":"","row_content":"All individuals participating in the NSF-funded research are required to complete Responsible Conduct of Research (RCR)<\/strong> training. For additional information, see NSF RCR Requirements<\/a>.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"If the research is funded by US Public Health Service (PHS) or components of PHS, including but not limited to the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), and Food & Drug Administration (FDA)...","icon":"","row_content":"All personnel meeting the PHS definition of \u2018investigator\u2019 are required to complete Conflict of Interest<\/strong> training prior to receipt of a PHS award. \u2018Investigator\u2019 refers to any individual who is responsible for the administration, design, conduct, or reporting of sponsored research, internally funded research that involves human subjects, or proposals for such funding. Refresher training is required every 4 years.\r\n\r\nThe \u2018糖心传媒 Conflict of Interest Policy Course\u2019 and \u2018Conflict of Interest Refresher Course\u2019 are available in MyPath<\/a> for 糖心传媒 faculty\/staff. For additional information, see the Faculty Conflict of Commitment and Interest Policy<\/a> and corresponding FAQs<\/a>.","accordion_anchor":""}]},{"acf_fc_layout":"card_grid","anchor":"","css_class":"","title":"

Related resources<\/h2>","description":"","background_color":"#f4f4f4","width":"width-large","columns":"3","cards":[{"card_title":"

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":"
Required human subject protection (HSP) training<\/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":"
Training overview<\/h5>","card_text":"","card_background_color":"#FFFFFF","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":"\nHRPP Training Requirements - Office for Human Subject Protection - 糖心传媒<\/title>\n<meta name=\"description\" content=\"Training requirements related to the conduct of human research at the University of Rochester. 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