Pitt IRB Guidance

Research recruitment involving UPMC patients who have signed the UPMC treatment consent (TPO) and have not declined contact will be coordinated through the “UPMC EHR Research Recruitment Service (Opt-Out).”

Using the “UPMC EHR Research Recruitment Service (Opt-Out)” requires IRB approval. Researchers should follow these steps to initiate the process and submit to the IRB through PittPRO. Contact ehrresearchrecruitment@pitt.edu for questions:

Step-By-Step Instructions

  1. To get started, visit: ehrresearchrecruitment.pitt.edu/get-started and fill out the service request form. The study contact will be responsible for entering the study information. UPMC EHR Research Recruitment Service office will create your account and initiate your study.
  2. Enter the proposed study details into the UPMC EHR Research Recruitment Service (Opt-Out) website and send yourself a test ‘Study Opportunity’ e-mail.
  3. Use the Cohort Discovery Query and Analysis Tool (data.discovery.pitt.edu/webclient/) to identify the appropriate prospects for your study. Use this tool to develop and save a limited data query of study inclusion and exclusion criteria. Note: Inclusion/exclusion criteria must match what is outlined in your PittPRO IRB protocol study design items #5 and #6.
  4. Include the information on the PittPRO Recruitment Methods page (in the initial submission or as a study modification):
    1. In item #2, check the box for “UPMC EHR Research Recruitment Service (Opt-Out)"
    2. In item #3, Use the following template language to indicate that you will be using the UPMC EHR Research Recruitment Service (Opt-Out): This study is working with CTSI to use UPMC EHR Research Recruitment Service (Opt-Out) for recruitment with cohort identification and direct mail/contact for recruitment of patients.
    3. In Item #5, attach: 1) the test ‘Study Opportunity’ e-mail you generated, and 2) the limited data query of study inclusion and exclusion criteria. Study teams must submit this content for IRB approval before recruitment can begin. Any revisions to this form will require IRB approval.

Once the study/modification including the UPMC EHR Research Recruitment Service (Opt-Out) plan is approved by UPMC EHR Research Recruitment Service staff and the IRB. To learn more visit ehrresearchrecruitment.pitt.edu/instructions and locate the ‘Approvals’ section:

  1. Researchers will upload a copy of the IRB approval letter and submit a request to UPMC EHR Research Recruitment Service.
  2. UPMC EHR Research Recruitment Service (Opt-Out) will compare the IRB documents in PittPRO to what was entered on the site, verify it matches what was approved by the IRB, and then activate the study.

Recruitment

Once the study begins recruitment, Researchers will receive contact information on patients who have expressed interest in their study through the Opt Out Study Portal:

  1. UPMC EHR Research Recruitment Service (through HS Data Center) will pull a set of patients (18 years or older), with “opt-out” set to “OK to contact” matching the study criteria.
  2. Eligible patient contact information will be provided to UPMC EHR Research Recruitment Service operations for contact. The patient will receive communication with the study description and the option of clicking a link/button to let UPMC EHR Research Recruitment Service know that they are interested in learning more about the study.

    Only if the patient takes this action will the study team receive information about the patient.

  3. Interested patient contact information will be provided to the researcher to contact for screening and recruitment into the study.
  4. Researchers will contact interested patients within 5 business days of referrals by phone or e-mail.
  5. The messaging in all recruitment communications clearly states that the patient is being contacted about research, not clinical care.

For questions on using the “UPMC EHR Research Recruitment Service (Opt-Out)” please refer to our contact form or e-mail us at ehrresearchrecruitment@pitt.edu.