{"id":783,"date":"2018-05-09T10:41:05","date_gmt":"2018-05-09T10:41:05","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/information-blocking-blinded-study\/"},"modified":"2026-03-06T13:47:24","modified_gmt":"2026-03-06T18:47:24","slug":"information-blocking-blinded-study","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/information-blocking-blinded-study\/","title":{"rendered":"Information Blocking in a Blinded Study"},"template":"","categories":[24],"tags":[84,85,80],"content-type":[41],"topic":[42,40,30,26,66,67],"update-type":[97],"class_list":["post-783","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","tag-michart","tag-oncore-support","tag-participant-management","content-type-guidance","topic-application-types","topic-clinical-research","topic-clinical-trial","topic-informed-consent-assent","topic-investigator-study-team-responsibilities","topic-subject-populations","update-type-information-only"],"acf":{"use_legacy_editor":true,"updated_date":"2021-06-04 16:00:00","update_notice":false,"author":"IRBMED","summary":"Single Blind Studies<\/a>: A research study done in such a way that the participants do not know (are blinded to) what treatment they are receiving to ensure the study results are not biased<\/a> (the power of suggestion).\u00a0 Blinded studies are sometimes called \u201cmasked<\/a> studies.\u201d\r\n\r\nDouble Blind Studies<\/a>: A research study in which both the participants participating and the researchers\/investigators conducting the study are unaware of what treatment the participants are receiving.\r\n\r\nIn a few blinded studies, the results of research tests entered into MiChart Electronic Health Record (EHR) could \u2018unblind\u2019 a participant by giving clues as to the research intervention arm assigned.","button_links":null,"related_content":[730],"legacy_path":"information-blocking-blinded-study","legacy_node_id":326,"legacy_related_nids":"259","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Limiting a Research Participant's View of MyUofMHealth (Patient Portal)","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"Participants are unable to view radiology or lab test results that have been formally associated to the research study<\/a> in MiChart (level-2 login required)<\/em>. \u00a0Results with no research study association will be visible to the participant. Participants will still be able to utilize all other functionality of the Patient Portal such as refilling prescriptions, paying bills, setting up appointments, etc. \u00a0It is not possible to shield outpatient medication lists from the participant\u2019s view at this time. \u00a0If viewing their outpatient medication list would unblind participants, instruct them to avoid viewing the medication list for the necessary time period.\r\n\r\nFor all research studies, \u201cResearch Visit Notes\u201d entered in MiChart are not visible to patients during the conduct of a study. \u00a0HITS\u00a0 is developing the functionality to release Research Visit Notes and any previously shielded test results when a study is finished.\r\n\r\nNote that if a research note is inadvertently entered as a clinical Progress Note, it will be shared, by default, once signed by the provider.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"What actions should be taken to prevent participants from seeing their test results?","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"Request a Patient Portal restriction only <\/strong>if the results of tests could <\/strong>\u2018unblind\u2019 participants as to their research intervention assignment.\r\n\r\nBefore the study starts enrolling and entering orders in MiChart:<\/strong>\r\n
    \r\n \t
  1. Submit a Ticket<\/a>\u00a0for MiChart Research IT service through the MichMed ServiceNow<\/a> portal. Include the study\u2019s HUM# in the request. \u00a0Explain that the study requires lab test results and\/or radiology test results to be restricted from access in the Patient Portal. \u00a0An expected End Date for the restrictions will be helpful, but is not required.<\/li>\r\n \t
  2. \u00a0Maintain accurate enrollment records in OnCore<\/a>, because the interface between OnCore and MiChart<\/a> allows for associating MiChart entries for a participant with the research study.<\/li>\r\n \t
  3. When you place an order for a research radiology or lab test, associate the order to the research study<\/a>. This must <\/strong>be completed before the order is signed.<\/li>\r\n<\/ol>\r\nA study can request radiology and\/or lab test order blocking in the portal after enrollment has begun, but every effort should be made to address it prior to participant enrollment. \u00a0If a HUM# has \u2018results blocking\u2019 added after participants are enrolled:\r\n