Information Blocking in a Blinded Study

Jun 4, 2021 4:00 pm

Single Blind Studies: 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 (the power of suggestion).  Blinded studies are sometimes called “masked studies.”

Double Blind Studies: 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.

In a few blinded studies, the results of research tests entered into MiChart Electronic Health Record (EHR) could ‘unblind’ a participant by giving clues as to the research intervention arm assigned.

  • Limiting a Research Participant's View of MyUofMHealth (Patient Portal)

    Participants are unable to view radiology or lab test results that have been formally associated to the research study in MiChart.  Results 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.  It is not possible to shield outpatient medication lists from the participant’s view at this time.  If viewing their outpatient medication list would unblind participants, instruct them to avoid viewing the medication list for the necessary time period.

    For all research studies, “Research Visit Notes” entered in MiChart are not visible to patients during the conduct of a study.  HITS  is developing the functionality to release Research Visit Notes and any previously shielded test results when a study is finished.

    Note that if a research note is inadvertently entered as a clinical Progress Note, it will be shared, by default, once signed by the provider.

  • What actions should be taken to prevent participants from seeing their test results?

    Request a Patient Portal restriction only if the results of tests could ‘unblind’ participants as to their research intervention assignment.

    Before the study starts enrolling and entering orders in MiChart:

    1. Submit a Ticket for MiChart Research IT service through the MichMed ServiceNow portal. Include the study’s HUM# in the request.  Explain that the study requires lab test results and/or radiology test results to be restricted from access in the Patient Portal.  An expected End Date for the restrictions will be helpful, but is not required.
    2.  Maintain accurate enrollment records in OnCore, because the interface between OnCore and MiChart allows for associating MiChart entries for a participant with the research study.
    3. When you place an order for a research radiology or lab test, associate the order to the research study. This must be completed before the order is signed.  

    A 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.  If a HUM# has ‘results blocking’ added after participants are enrolled:

    • Orders previously associated to the study will be retroactively blocked.
    • Prior orders not associated to the study cannot be blocked. 
  • What IRBMED procedures do I need to follow when a research study limits access to the Patient Portal?

    • Use the “Required language for blinded studies” paragraphs available in the Standard Informed Consent Template, alerting participants to this temporary limitation on viewing results in the Patient Portal.
    • Identify the study need in eResearch application section 1-2.

Contact us at or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

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Last Updated: June 4, 2021 3:30 PM