MyChart is an easy, confidential way for patients to access their care team and medical information online.
CTSI’s Consultation Service, Participant Recruit Program (PRP), implement cohort identification and direct mail campaigns for patient recruitment. Provide the IRB with the following information if you are using this service. Study team must contact PRP before using this service. Failure to do so may result in stipulations and a delay in approval.
1. IRB Application, "Recruitment" section:
Use the following template language to indicate that you will be using the CTSI Consultation Services:
We are collaborating with the CTSI Consultation Service to provide cohort identification and direct mail for recruitment. The Dear Patient letter (attached) will be sent to individuals identified from the APeX record systems via a data extraction by Academic Research Systems (ARS) of patients with a diagnosis of [XXX]. These patients [are/are not] known to or under the care of the researchers.
Also, the IRB’s usual policy is that patients identified through chart review should be approached by someone already involved in their care (see above). Explain why the study cannot be done unless the researchers approach subjects directly. See the CTSI Consultation Services website for more information.
2. IRB Application, "Waiver of Consent/Authorization for Recruitment Purposes" section:
Answer all questions and explain what info will be collected prior to obtaining informed consent.
3. Attach the recruitment letter:
This letter must be printed on the PI's departmental letterhead and approved by the IRB.
The CTSI Consultation Service will print, prepare and mail the letter on departmental letterhead on behalf of the study staff. Interested subjects will be able to contact the study staff as described in the letter. The data extract will be delivered to the CTSI Consultation Service’s MyResearch account in order to facilitate the direct mail activities while ensuring privacy and confidentiality of the patients identified.
Communications in Research
MyChart can also be used to communicate with Research Participants after they have consented to be in the study.
Communications intended for research should be clearly distinguishable from communications intended for clinical care. If you propose to use MyChart to communicate with research participants, the following is required:
- The consent form should indicate that study communication may take place via MyChart.
- The participant should be presented with the opportunity to “opt-out” of receiving communication via MyChart.
- The study team should propose alternate communication methods if participants elect to “opt-out.”
- Template messages should be IRB-approved prior to sending to participants.
- Screenshots or Template language should be included for IRB review and approval