Learn more about the Recruitment Letter Service:

  1. Process
  2. Feasibility and Planning
  3. IRB Approvals
  4. Privacy of patients

Process

CTSI acts as an honest broker of the EHR data and sends letters to a cohort that meets the study’s inclusion/exclusion criteria.  The letter is sent from “Research Participant Services” on the study’s behalf using a template that was developed in coordination with the Institutional Review Board. Interested patients contact the study team directly to learn more about the study or complete pre-screening activities. 

The timeline from initiating the request to use the service to sending out the recruitment letters is around 2 months and is dependent on IRB approval. Here's how it works:

1. Submit a Recruitment Consultation Request.

2. Work with your consultant to prepare the recruitment letter (template link). CTSI approval is required before IRB submission.

2. Study team requests IRB approval to add the Recruitment Letter Service as a recruitment method, also including the prepared letter.

3. CTSI Data Intelligence Manager will contact you to initiate and complete the data query process. Once the query is complete, the data results will be co-validated by the research team and Data Intelligence Manager, and then delivered directly to the CTSI Honest Broker. 

4. CTSI sends letters to cohort using a schedule determined by the study team.

Depending on how many patients are identified in the search, you may want to narrow the mailing list. CTSI staff can do random sampling of the cohort and can also filter for patients in targeted zip codes.

Feasibility and Planning

Before starting the process to start this service, you can use the UCSF Research Data Browser (RDB) to determine how many patients at UCSF meet your eligibility criteria. The Research Data Browser (RDB) is a point-and-click browsing tool that allows researchers to explore UCSF patient records de-identified from APeX. The RDB does not require IRB approval and is a free, self-service for the UCSF research community.

Registration and account activation is required. Visit the Research Data Browser page for more information.

The rate of return varies for these mailings, but you can expect a 2% enrollment rate, though your results may differ depending on your study. If you do not have comparison studies that have recruited using this method as a benchmark, it is better to be conservative in your estimates.

IRB Approvals

IRB approval is required to use this service. For IRB approval:
  1. In the study site section: ensure that UCSF is a study site (Note: we do not currently offer the Recruitment Letter Service for sites other than UCSF Health).
  2. Request a HIPAA Waiver for Recruitment. This  may appear in different ways, depending on which version of the application form you are using:
  • For applications with a section titled "Waiver of Consent/Authorization for Recruitment Purposes": Answer all questions and explain what info will be collected prior to obtaining informed consent.
  • For all other applications: In the Recruitment Methods section, check the box indicating “medical records review”; answer all questions and explain what info will be collected prior to obtaining informed consent.
  1. In the Recruitment section: Use the following template language:

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 UCSF patients 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 researcher team. The CTSI Consultation Service will coordinate the mailing on behalf of the study. Interested subjects will 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. Protected data elements included in the data pull and delivered to the honest broker may include MRN, name, mailing address, and diagnosis or encounter date. Additional non-PHI data elements may also be collected to facilitate the mailing.

  1. If your application version includes the question “How and by whom will records be assessed and searched,” select the checkbox for “UCSF Academic Research Services” (only applicable if the question exists.)
  2. Under the section “Confidentiality and Privacy” -- Identified data elements (PHI) being requested should be specified (by checkbox or text explanation; use the same data elements referred to in the template text above.)
  3. Submit the letter as a recruitment material. Recruitment letters should be prepared using the direct mail template and submitted to your consultant or [email protected] for initial review and feedback before submitting to the IRB.
Special instructions for studies recruiting minors or cohorts identified via sensitive information:
  • Studies recruiting minors must ensure that the age range is reflected in the IRB application under the section “Sample Size and Eligibility.”
  • Studies identifying cohorts based on sensitive health information such as (1) drug or alcohol abuse, (2) HIV/AIDS testing information, (3) genetic testing information, or (4) mental health diagnosis or treatment must ensure that this is reflected in the IRB application under the section “Privacy and Confidentiality.” 
Note:
  • All studies using the recruitment letter service should complete an intake consultation prior to submitting for IRB approval.
  • IRB application versions may vary in how information is collected; if you have questions about how to implement this guidance in your specific version please contact [email protected].

Privacy of patients

Requests to not be contacted for research

Protecting the privacy of the cohort has been at the forefront of development of this process. The letter template has been developed to appear as general as possible and not include diagnosis information. In the letter template we provide a link to an FAQ site with information about why people were contacted and other information about participating in research at UCSF. If a patient contacts the study with concerns around being contacted to participate in research, it is the study team’s responsibility to provide basic information on the direct mail process and to escalate the inquiry to [email protected].edu if not able to resolve. All email inquiries or action items resulting from a call should be sent via secure email to [email protected].

Patients reported as deceased

If you are contacted by someone who has received the letter on behalf of a deceased person, please apologize and let them know you will work to update the patient record, then take the following steps:

1. Record the date of death with the patient name and send via secure email to [email protected]. CTSI will ask the APeX team to mark the patient deceased and “do not contact for research” 

2. If the date of death is unknown, you can ask the family to contact SheRee Garcia at  415-353-2885 to update the death status. Collect the name of the deceased person and send via secure email to  [email protected] for a partial records update.