IRBMED Guidance for Blinded Studies
What is a blinded study?
Single Blind Studies: A research study done in such a way that the subjects do not know (are blinded to) what treatment they are receiving to ensure the study results are not biased (the power of suggestion).
Double Blind Studies: A research study in which both the subjects participating and the researchers/investigators conducting are unaware of what treatment the subjects are receiving.
Does it matter if subjects participating on a blinded (either single or double blind) study see their research test results in MyUofMhealth.org? Consider your answer to this question critically and carefully.
If it is not problematic for subjects to see their test results, no further action is needed regarding the subject’s view of MyUofMHealth.org.
If it would be problematic for a subject to view their test results, the subject needs to have a “limited” access placed upon their view of MyUofMHealth.org. See information below for specific actions that need to be taken.
What happens when a subject’s view of MyUofMHealth.org is limited?
By limiting the subject’s view of the patient portal in MyUofMHealth.org, subjects will not be able to see any test results whether they were conducted for clinical or research purposes. Subjects will still be able to utilize all other functionality of the patient portal such as refilling prescriptions, paying bills, setting up appointments, etc.
Lab test results and radiology test results can be shielded from the subject’s view, but please note that it’s not possible to shield outpatient medication lists from the subject’s view at this time. If viewing their outpatient medication list would unblind the subject, they should be instructed to avoid viewing the medication list for the necessary time period.
What actions should be taken to prevent subjects from seeing their test results?
The following action items apply if you have an existing study that requires limiting access to lab tests and radiology tests in MyUofMHealth.org - OR - if you plan to conduct a blinded study in the future where the integrity of the study would be compromised if the subject viewed their test results in MyUofMHealth.org:
Modifying the Subject’s View into MyUofMHealth.org
- Contact the MCIT Service Desk at 734-936-8000, Option 1 MiChart, with the subject’s medical record number (MRN) and the subject’s name.
- Explain that the subject’s view of the patient portal in MyUofMHealth.org needs to be “limited” because s/he is participating in a blinded research study.
- Provide MCIT with the date the subject is expected to end their participation on the study, if known.
- If the end date for subject participation is not known, follow-up with MCIT once the subject is off study in order to restore the subject’s full access to the patient portal in MyUofMHealth.org.
If you have any questions regarding this issue, please contact IRBMED at email@example.com or at 734-763-4768.
What IRBMED procedures do I need to follow if subjects need to have a limited access to their MyUofMHealth.org?
Additional submissions to IRBMED are necessary and the informed consent documentation will need to be updated as follows:
Informed Consent Procedures
Previously Approved Studies
- For subjects already enrolled, contact the IRB to obtain a template letter to send to subjects to inform them of the temporary change in their access to test results via MyUofMHealth.org. An ORIO submission to eResearch will need to accompany the use of this letter.
- For subjects not yet enrolled, modify (via amendment in eResearch) the existing informed consent document to include new language (found in the Informed Consent Instructions template) explaining to the subject the temporary limitation of viewing their test results via MyUofMHealth.org.
- For qualifying blinded studies, utilize the new language available in the Informed Consent Instructions template, alerting subjects to this temporary limitation of viewing their results in MyUofMHealth.org.
- A new question is being added to the eResearch application to identify these studies in advance.
If you have any questions regarding any of the items above, please contact IRBMED at firstname.lastname@example.org or at 734-763-4768.
Page created 11/21/2012