{"id":6899,"date":"2020-09-16T13:46:35","date_gmt":"2020-09-16T17:46:35","guid":{"rendered":"http:\/\/149.4.100.129\/academics\/psychology\/?page_id=6899"},"modified":"2022-10-27T13:46:16","modified_gmt":"2022-10-27T17:46:16","slug":"orcnews","status":"publish","type":"page","link":"https:\/\/www.qc.cuny.edu\/academics\/orc\/orcnews\/","title":{"rendered":"CUNY Implementation of Revised Common Rule"},"content":{"rendered":"

[et_pb_section fb_built=”1″ _builder_version=”4.16″ background_color=”rgba(0,0,0,0)” custom_padding=”16px|||||” global_colors_info=”{}”][et_pb_row _builder_version=”4.18.0″ global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ header_6_font=”Ubuntu|700|||||||” header_6_text_color=”#ffffff” header_6_font_size=”35px” background_color=”#e71939″ custom_margin=”||||false|false” custom_padding=”10px|20px|10px|20px|true|true” border_radii=”off|20px|20px||” global_colors_info=”{}”]<\/p>\n

The Revised Common Rule
& CUNY HRPP\u00a0 Implementation<\/h6>\n

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The purpose of this announcement is to provide you with the Human Research Protection Program (HRPP) plans to implement the revised regulations governing research involving human subjects, the Common Rule<\/em>. We refer to the revised regulations as ‘the revised Common Rule’ throughout this notice.<\/p>\n

Summary<\/strong><\/p>\n

The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies issued final revisions to the Common Rule<\/em>, the Federal Policy for the Protection of Human Subjects, on January 19, 2017. The implementation was delayed twice in the last year. The final implementation and compliance date is\u00a0January 21, 2019<\/u><\/em>. <\/strong><\/p>\n

The revised rule is not applicable to FDA (Food and Drug Administration) and DOJ (Department of Justice) regulated research. However, FDA plans to post a notice of draft revised FDA regulations intended to harmonize with the revised rule requirements. If you are involved in the conduct of FDA-regulated research, you should be aware that these changes may be directly applicable to your research in the future.<\/p>\n

CUNY published revised HRPP policies, procedures and guidelines on the CUNY HRPP Policies & Procedures website<\/a>.<\/p>\n

This communication addresses the following aspects of the revised Common Rule<\/em> that may be important to you:<\/strong><\/p>\n

    \n
  1. Application of the revised Common Rule<\/em> to research approved by the IRB prior to the implementation date<\/li>\n
  2. Minimal risk research<\/li>\n
  3. Exempt research\/modified and new exemption categories<\/li>\n
  4. Informed consent requirements<\/li>\n
  5. Single IRB of Record requirements<\/li>\n<\/ol>\n

    [\/et_pb_text][et_pb_accordion open_toggle_text_color=”#e71939″ open_toggle_background_color=”#ffffff” closed_toggle_background_color=”#ffffff” icon_color=”#e71939″ _builder_version=”4.18.0″ _module_preset=”default” toggle_text_color=”#e71939″ toggle_font=”Open Sans|600|||||||” toggle_line_height=”1.3em” body_font=”Open Sans||||||||” body_font_size=”16px” hover_enabled=”0″ border_color_all=”#000000″ global_colors_info=”{}” sticky_enabled=”0″][et_pb_accordion_item title=”1) Application of the revised Common Rule to research approved prior to the implementation date” open=”on” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

    As of January 21, 2019, ALL<\/u><\/strong> applications (not just initial applications) will be processed in accordance to the Common Rule changes.\u00a0Any applications (i.e., Amendment Requests, Continuing Reviews) submitted for existing IRB-approved projects will be required to update their IRB protocols as per the revised Common Rule<\/em>. Research approved prior to January 21, 2019 will continue to conduct their pre-2018 IRB-approved research procedures until an Amendment Request or Continuing Review is submitted. <\/strong><\/p>\n

    IRB protocols submitting Continuing Reviews for the first time after the implementation of the revised Common Rule<\/em>, will be asked to submit an Amendment Request so the protocol can be updated as per the new federal changes. <\/strong><\/p>\n

    [\/et_pb_accordion_item][et_pb_accordion_item title=”2) Minimal Risk Research” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n

    The revised Common Rule<\/em> allows for most minimal risk research to be conducted without IRB continuing review.<\/p>\n