{"id":1477,"date":"2018-05-30T15:28:21","date_gmt":"2018-05-30T14:28:21","guid":{"rendered":"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/?page_id=1477"},"modified":"2026-03-10T16:47:16","modified_gmt":"2026-03-10T16:47:16","slug":"being-involved-in-the-studies","status":"publish","type":"page","link":"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/for-participants\/being-involved-in-the-studies\/","title":{"rendered":"Being involved in the studies"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; admin_label=&#8221;section&#8221; _builder_version=&#8221;3.0.47&#8243; global_module=&#8221;322&#8243;][et_pb_fullwidth_menu menu_id=&#8221;7&#8243; submenu_direction=&#8221;downwards&#8221; fullwidth_menu=&#8221;off&#8221; active_link_color=&#8221;#ffffff&#8221; mobile_menu_text_color=&#8221;#000000&#8243; module_class=&#8221;main-navigation&#8221; _builder_version=&#8221;3.0.47&#8243; menu_font=&#8221;Open Sans Light||||&#8221; background_color=&#8221;#28a0d8&#8243; background_layout=&#8221;dark&#8221;][\/et_pb_fullwidth_menu][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;3.0.74&#8243; custom_padding=&#8221;||0px|&#8221; transparent_background=&#8221;off&#8221;][et_pb_row custom_padding=&#8221;||0px|&#8221; custom_margin=&#8221;||0px|&#8221; parallax_method_1=&#8221;off&#8221; module_class=&#8221;breadcrumbs-row&#8221; _builder_version=&#8221;3.0.47&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.0.47&#8243; parallax=&#8221;off&#8221; parallax_method=&#8221;off&#8221;][et_pb_text module_class=&#8221;breadcrumbs&#8221; _builder_version=&#8221;3.0.87&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; module_alignment=&#8221;left&#8221; custom_css_main_element=&#8221;border-bottom: 1px solid #ececed;&#8221; use_border_color=&#8221;off&#8221; border_color=&#8221;#ffffff&#8221; border_style=&#8221;solid&#8221;] <span><span><a href=\"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/\">BCRD\/BSPAR<\/a><\/span><\/span> [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;2&#8243; specialty=&#8221;on&#8221; parallax_method_1=&#8221;off&#8221; parallax_method_2=&#8221;off&#8221; _builder_version=&#8221;3.0.74&#8243; transparent_background=&#8221;off&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.0.47&#8243; parallax__hover=&#8221;off&#8221; parallax_method__hover=&#8221;off&#8221; parallax=&#8221;off&#8221; parallax_method=&#8221;off&#8221;][et_pb_sidebar area=&#8221;et_pb_widget_area_1&#8243; show_border=&#8221;off&#8221; module_id=&#8221;left-nav-menu&#8221; _builder_version=&#8221;3.0.74&#8243; remove_border=&#8221;on&#8221;][\/et_pb_sidebar][\/et_pb_column][et_pb_column type=&#8221;2_3&#8243; specialty_columns=&#8221;2&#8243; _builder_version=&#8221;3.0.47&#8243; parallax__hover=&#8221;off&#8221; parallax_method__hover=&#8221;off&#8221; parallax=&#8221;off&#8221; parallax_method=&#8221;off&#8221;][et_pb_row_inner admin_label=&#8221;Row&#8221; _builder_version=&#8221;3.0.47&#8243;][et_pb_column_inner type=&#8221;4_4&#8243; saved_specialty_column_type=&#8221;2_3&#8243; _builder_version=&#8221;3.0.47&#8243; parallax__hover=&#8221;off&#8221; parallax_method__hover=&#8221;on&#8221; parallax=&#8221;off&#8221; parallax_method=&#8221;on&#8221;][et_pb_text admin_label=&#8221;Text: Intro &#8211; being involved&#8221; _builder_version=&#8221;3.3.1&#8243;]<\/p>\n<h1>Being involved in the studies<\/h1>\n<p style=\"font-size: 1.692308em;line-height: 1.5;font-weight: 300;padding: 0 0 30px;color: #14516e\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-1460 alignright\" src=\"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/wp-content\/uploads\/sites\/37\/2018\/05\/KimmeHyrich.jpg\" alt=\"Prof Kimme Hyrich\" width=\"200\" height=\"200\" srcset=\"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/wp-content\/uploads\/sites\/37\/2018\/05\/KimmeHyrich.jpg 200w, https:\/\/sites.manchester.ac.uk\/bcrdbspar\/wp-content\/uploads\/sites\/37\/2018\/05\/KimmeHyrich-150x150.jpg 150w\" sizes=\"(max-width: 200px) 100vw, 200px\" \/>Both the BCRD and BSPAR ETN studies have been reviewed and approved by the Research Ethics Committee, and are overseen by a highly experienced Consultant Rheumatologist who is also a Professor of Epidemiology (the study of disease) at The University of Manchester, Professor Kimme Hyrich.<\/p>\n<p>[\/et_pb_text][et_pb_accordion _builder_version=&#8221;3.17.6&#8243;][et_pb_accordion_item title=&#8221;Registering for the correct study&#8221; open=&#8221;off&#8221; _builder_version=&#8221;3.0.106&#8243; title_text_shadow_horizontal_length=&#8221;0em&#8221; title_text_shadow_vertical_length=&#8221;0em&#8221; title_text_shadow_blur_strength=&#8221;0em&#8221; body_text_shadow_horizontal_length=&#8221;0em&#8221; body_text_shadow_vertical_length=&#8221;0em&#8221; body_text_shadow_blur_strength=&#8221;0em&#8221;]<\/p>\n<ul>\n<li>Participants starting etanercept (Enbrel or any etanercept biosimilar) are registered with BSPAR ETN.<\/li>\n<\/ul>\n<ul>\n<li>Participants starting any other biologic\/biosimilar (ie not Enbrel or an etanercept biosimilar) are registered with BCRD.<\/li>\n<\/ul>\n<p>[\/et_pb_accordion_item][et_pb_accordion_item title=&#8221;When is information is collected during the study?&#8221; open=&#8221;off&#8221; _builder_version=&#8221;3.0.106&#8243; title_text_shadow_horizontal_length=&#8221;0em&#8221; title_text_shadow_vertical_length=&#8221;0em&#8221; title_text_shadow_blur_strength=&#8221;0em&#8221; body_text_shadow_horizontal_length=&#8221;0em&#8221; body_text_shadow_vertical_length=&#8221;0em&#8221; body_text_shadow_blur_strength=&#8221;0em&#8221;]<\/p>\n<ol>\n<li>Information supplied to studies at &#8220;baseline&#8221; (ie the time you start treatment).<\/li>\n<\/ol>\n<ol start=\"2\">\n<li>Additional follow-up information collected six months after you start treatment.<\/li>\n<\/ol>\n<ol start=\"3\">\n<li>Further follow-up information collected at 12 months, then annually for at least five years . This data collection may be continued on an annual basis dependent on additional funding being received to extend the study. Some participants have been involved for over ten years now.<\/li>\n<\/ol>\n<p>[\/et_pb_accordion_item][et_pb_accordion_item title=&#8221;Participants are flagged with NHS England&#8221; open=&#8221;on&#8221; _builder_version=&#8221;3.0.106&#8243; title_text_shadow_horizontal_length=&#8221;0em&#8221; title_text_shadow_vertical_length=&#8221;0em&#8221; title_text_shadow_blur_strength=&#8221;0em&#8221; body_text_shadow_horizontal_length=&#8221;0em&#8221; body_text_shadow_vertical_length=&#8221;0em&#8221; body_text_shadow_blur_strength=&#8221;0em&#8221;]<\/p>\n<p>All participants are &#8220;flagged&#8221; with NHS England, who will then inform us if any of the participants on our studies develop a serious illness such as cancer, or if they pass away.<\/p>\n<h3>What does being \u201cflagged\u201d mean?<\/h3>\n<p>An organisation called NHS England has information about the health of everyone in the country, and they store details about any hospital stays or serious illnesses that people experience. When you consent to be involved in the BCRD or BSPAR ETN study you give consent for your name, date of birth and NHS number (or CHI number if you are in Scotland) to be shared with other national databases (including NHS England). This is for the purpose of matching identifiable information already held by these national databases so that they are able to \u201cflag\u201d you. This flag means that if you experience a really serious illness, such as cancer, then the research studies will be informed of these events directly by the national databases. This is a resource that is really important for research into health and diseases such as JIA, as the information that we get from NHS England and other national databases is added to the information that we collect from your healthcare team. This makes our data more complete, stronger and more reliable.<\/p>\n<p>When you consented with BCRD or BSPAR ETN and joined the study, you may have opted in (or out) of this data linkage on the consent form. This data linkage will continue even after the age of 16 years old. <strong>If you would like to opt out of this data linkage you are free to withdraw consent at any time<\/strong>. Please note that NHS England will apply the national opt-out criteria to the data linkage (if applicable).<\/p>\n<p>Please contact the <a href=\"praksha.jariwala@manchester.ac.uk\">project administrator<\/a> if you would like to withdraw your consent for participation in the studies, or to opt out of the data linkage with NHS England, or you would like more information.<\/p>\n<p>In addition to collecting information from your hospital notes and by linking to NHS England, we also collect a blood or saliva sample for genetic studies.<\/p>\n<p>[\/et_pb_accordion_item][et_pb_accordion_item title=&#8221;At the end of the study&#8221; open=&#8221;off&#8221; _builder_version=&#8221;3.0.106&#8243; title_text_shadow_horizontal_length=&#8221;0em&#8221; title_text_shadow_vertical_length=&#8221;0em&#8221; title_text_shadow_blur_strength=&#8221;0em&#8221; body_text_shadow_horizontal_length=&#8221;0em&#8221; body_text_shadow_vertical_length=&#8221;0em&#8221; body_text_shadow_blur_strength=&#8221;0em&#8221;] All of this information is gathered together and looked at by our team of researchers to see what they can find. [\/et_pb_accordion_item][et_pb_accordion_item title=&#8221;Questions or concerns about the study?&#8221; open=&#8221;off&#8221; _builder_version=&#8221;3.17.6&#8243; title_text_shadow_horizontal_length=&#8221;0em&#8221; title_text_shadow_vertical_length=&#8221;0em&#8221; title_text_shadow_blur_strength=&#8221;0em&#8221; body_text_shadow_horizontal_length=&#8221;0em&#8221; body_text_shadow_vertical_length=&#8221;0em&#8221; body_text_shadow_blur_strength=&#8221;0em&#8221;]<\/p>\n<p>If you have any concerns about any aspect of this study, you should speak to the study coordinators who will do their best to answer your questions.<\/p>\n<p>If they are unable to resolve your concern or you wish to make a complaint regarding the study, please see below.<\/p>\n<h2><strong>Minor complaints<\/strong><\/h2>\n<p>If you have a minor complaint, please get in touch with the Chief Investigator of the studies:<\/p>\n<p><strong>Professor Kimme Hyrich<\/strong><br \/> email:\u00a0<a href=\"mailto:kimme.hyrich@manchester.ac.uk\">kimme.hyrich@manchester.ac.uk<\/a><br \/> tel: +44 (0)161 275 1679<\/p>\n<p>&nbsp;<\/p>\n<h2><strong>Formal complaints<\/strong><\/h2>\n<p>If you wish to make a formal complaint or if you are not satisfied with the response you have gained from the researchers in the first instance, please contact:<\/p>\n<p><strong>The Research Governance and Integrity Manager<\/strong><br \/> Research Office<br \/> Christie Building<br \/> The University of Manchester<br \/> Oxford Road<br \/> M13 9PL<br \/> email:\u00a0<a href=\"mailto:research.complaints@manchester.ac.uk\">research.complaints@manchester.ac.uk<\/a><br \/> tel: +44 (0)161 275 2674 or +44 (0)161 275 2046<\/p>\n<p>[\/et_pb_accordion_item][\/et_pb_accordion][\/et_pb_column_inner][\/et_pb_row_inner][\/et_pb_column][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;Connect Title&#8221; module_class=&#8221;footer-section&#8221; _builder_version=&#8221;3.0.90&#8243; background_color=&#8221;#1d1d1d&#8221; custom_padding=&#8221;0px||0px|&#8221; global_module=&#8221;380&#8243;][et_pb_row parallax_method_1=&#8221;off&#8221; parallax_method_2=&#8221;off&#8221; parallax_method_3=&#8221;off&#8221; admin_label=&#8221;row&#8221; module_id=&#8221;footer-row&#8221; _builder_version=&#8221;3.0.89&#8243; locked=&#8221;off&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.0.47&#8243; parallax=&#8221;off&#8221; parallax_method=&#8221;off&#8221;][et_pb_text admin_label=&#8221;Contact Us Title&#8221; _builder_version=&#8221;3.0.74&#8243; text_text_color=&#8221;#ffffff&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; background_layout=&#8221;dark&#8221;]<\/p>\n<h4>Contact Us<\/h4>\n<p>[\/et_pb_text][et_pb_text admin_label=&#8221;Contact Us&#8221; module_class=&#8221;contact-us&#8221; _builder_version=&#8221;3.17.6&#8243; text_text_color=&#8221;#aaaaaa&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; use_border_color=&#8221;off&#8221;]<\/p>\n<p><a href=\"tel:441612751763\">+44 (0)161 275 1763<\/a><\/p>\n<p>\u00a0<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.0.47&#8243; parallax=&#8221;off&#8221; parallax_method=&#8221;off&#8221;][et_pb_text admin_label=&#8221;Find Us Title&#8221; _builder_version=&#8221;3.0.74&#8243; text_text_color=&#8221;#ffffff&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; background_layout=&#8221;dark&#8221;]<\/p>\n<h4>Find Us<\/h4>\n<p>[\/et_pb_text][et_pb_text admin_label=&#8221;Address&#8221; module_id=&#8221;address&#8221; _builder_version=&#8221;3.17.6&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; background_layout=&#8221;dark&#8221; use_border_color=&#8221;off&#8221;]<\/p>\n<p><strong>Biologic Studies Group<\/strong><br \/>1st Floor Bright Building<br \/>Manchester Science Park<br \/>Pencroft Way<br \/>Manchester<br \/>M15 6GZ<\/p>\n<p>\u00a0<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.0.47&#8243; parallax=&#8221;off&#8221; parallax_method=&#8221;off&#8221;][et_pb_text admin_label=&#8221;Connect Title&#8221; _builder_version=&#8221;3.0.74&#8243; text_text_color=&#8221;#ffffff&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; background_layout=&#8221;dark&#8221;]<\/p>\n<h4>Connect With Us<\/h4>\n<p>[\/et_pb_text][et_pb_code admin_label=&#8221;Social Media&#8221; _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<ul class=\"inlineList footer-socialIcons\"><!-- [et_pb_line_break_holder] --><\/pee><!-- [et_pb_line_break_holder] --><\/p>\n<li><!-- [et_pb_line_break_holder] --> <a href=\"https:\/\/twitter.com\/BCRD_Study\"><!-- [et_pb_line_break_holder] --> <img loading=\"lazy\" decoding=\"async\" class=\"lazy\" src=\"\/\/assets.manchester.ac.uk\/phase1\/templates\/images\/icon-twitter-50.png\" alt=\"Twitter page for The University of Manchester\" width=\"40\" height=\"40\" \/><!-- [et_pb_line_break_holder] --> <\/a><!-- [et_pb_line_break_holder] --><\/li>\n<p><!-- [et_pb_line_break_holder] --><pee><!-- [et_pb_line_break_holder] --><\/ul>\n<p>[\/et_pb_code][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p><span><span><a href=\"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/\">BCRD\/BSPAR<\/a><\/span><\/span> Being involved in the studies Both the BCRD and BSPAR ETN studies have been reviewed and approved by the Research Ethics Committee, and are overseen by a highly experienced Consultant Rheumatologist who is also a Professor of Epidemiology (the study of disease) at The University of Manchester, Professor Kimme Hyrich. Participants starting etanercept (Enbrel [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":0,"parent":1454,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_exactmetrics_skip_tracking":false,"footnotes":""},"class_list":["post-1477","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/wp-json\/wp\/v2\/pages\/1477","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/wp-json\/wp\/v2\/comments?post=1477"}],"version-history":[{"count":10,"href":"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/wp-json\/wp\/v2\/pages\/1477\/revisions"}],"predecessor-version":[{"id":1909,"href":"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/wp-json\/wp\/v2\/pages\/1477\/revisions\/1909"}],"up":[{"embeddable":true,"href":"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/wp-json\/wp\/v2\/pages\/1454"}],"wp:attachment":[{"href":"https:\/\/sites.manchester.ac.uk\/bcrdbspar\/wp-json\/wp\/v2\/media?parent=1477"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}