Patient Contact Studies

Texas Cancer Registry
Guidelines for Research Involving Patient Contact

August 2022

Purpose

The Texas Cancer Registry (TCR) has policies and procedures for the review, approval, and oversight of proposed research involving patient contact, in addition to those set by the Texas Department of State Health Services (DSHS) Institutional Review Board #1 (IRB) and Research Executive Steering Committee (RESC). The TCR applies the following programmatic criteria and guidelines for evaluating and approving these requests prior to DSHS IRB and RESC submission.

Study and Investigator Requirements

  1. TCR patient data must be an essential component in meeting recruitment goals and study aims.

  2. The principal investigator or a co-principal investigator must have experience conducting patient contact studies.

  3. The principal investigator cannot be a student.

Patient Recruitment and Participation

  1. Upon receipt of patient contact information provided by TCR, researchers can contact the patient directly, as approved by the DSHS IRB and RESC.

    • Initial contact with patients must be by mail. TCR recommends sending a post card to inform the patient about the study prior to the initial recruitment letter. See more information under item 9.

    • For pediatric patients ages 0-17, letters should be addressed “To the parents/guardians of <patient name>”.

  2. Patient recruitment letters must be sent within three months of receiving the patient contact list from the TCR. If patient recruitment letters are not sent within three months, letters cannot be sent until the TCR receives the study recruitment report and updates the dataset by removing any deceased patients and patients that have requested not to be contacted.

  3. The number of recruitment letters and calls to each patient must be specified in the study protocol.

    • The TCR recommends no more than one introductory post card, one recruitment letter and two calls to each patient.

    • If additional recruitment letters or calls are requested, include a detailed justification in Attachment 2: Patient Contact Study.

  4. Copies of all written materials provided to the patient must be approved by the DSHS IRB.

  5. Written patient materials translated into languages other than English must be included in the IRB application. The DSHS IRB requires submission of a Translation Certification Form along with any translated materials.

  6. First contact with patients must be by mail (see Example Patient Contact Letter). Each recruitment letter must include:

    • Statement that the study involves research, an explanation of the purposes of the research, the expected duration of participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

    • Statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the patient is otherwise entitled, and he/she may stop participating at any time without penalty or loss of benefits to which he/she is otherwise entitled.

    • Description of procedures or courses of treatment, if any, that might be advantageous to participants.

    • Description of any reasonably foreseeable risks or discomforts to the participant, as well as a description of any benefits to the participant or to others which may reasonably be expected from the research.  

    • Information on exclusion from future patient contact studies must be written in the letter before any institutional contact information:

      If you don’t want to be contacted for research studies that use information from the cancer registry, contact the Texas Cancer Registry by email, CancerData@dshs.texas.gov, or phone, 1-800-252-8059 (in Texas) or 512-776-3080. If you have questions about your rights as a research participant, contact the Department of State Health Services Institutional Review Board Administrator at InstitutionalReviewBoard@dshs.texas.gov or 512-776-2202. 

    • Contact information for the person(s) who can answer questions about the research and participant rights and who can report a participant’s research-related injury.

    • If the research involves more than minimal risk, information on whether any compensation or medical treatments are available if an injury occurs and what they consist of, or where further information can be obtained.

    • Statement that patient data is not being sold to the researchers (i.e., that DSHS and the TCR are not being paid or otherwise compensated for the data).

    • Copy of the TCR document “How Did You Get My Name?” (available in English and Spanish).

    • Consider that nearly 30% of Texans over age 5 speak Spanish as their primary language. Include the following paragraph in Spanish if study materials will not be provided in both English and Spanish:
        
      Le invitamos a participar en un estudio de investigación sobre el cáncer. Tanto si decide participar como si no, su decisión no afectará de ninguna manera la atención médica que usted recibe. Toda la información que nos proporcione es estrictamente confidencial y está protegida por la ley. El equipo de investigadores obtuvo el nombre de usted a través del Registro del Cáncer en Texas (Texas Cancer Registry), un programa del Departamento de Salud y Servicios Humanos (DSHS) de Texas, después de recibir la aprobación del Consejo de Revisión Institucional (IRB). Para participar en este estudio, es necesario que tenga conocimientos de inglés, ya que los materiales solamente están disponibles en este idioma. Si no desea participar, no es necesario que haga nada más al respecto. Si tiene alguna pregunta relacionada con sus derechos como participante en el estudio, comuníquese con el administrador del Consejo de Revisión Institucional (IRB) del DSHS enviando un correo electrónico a InstitutionalReviewBoard@dshs.texas.gov, o llame al 512-776-2202. Si desea que su nombre sea eliminado de todos los estudios futuros de investigación sobre el cáncer que usen información procedente del registro sobre el cáncer, por favor comuníquese con el Registro del Cáncer en Texas a CancerData@dshs.texas.gov, o llame al 1-800-252-8059 (en Texas) o al 512-776-3080 para avisarnos de su decisión.

  1. Envelopes for mailed patient letters and materials must be discrete and must not indicate that the patient receiving the letter is a cancer survivor. Study names should not be on the envelope.

  2. Researchers must allow three weeks for patient to respond to initial recruitment letter before contacting the patient again.

  3. Patient consent to participate must be obtained.  

  4. For telephone calls and interviews, verbal scripts must be provided and approved as part of the DSHS IRB and RESC proposal. The phone script should include confirmation that the caller is speaking to the correct person and an option to opt-out of the call or study. To avoid disclosure of cancer diagnosis to those other than the intended recipient, voicemail messages should be limited to leaving the caller’s name and telephone number. Research staff should also state that the call is related to research they are conducting (but should not specifically mention cancer).

  5. If a patient contacts the TCR to be removed from current or future patient contact research studies:

    • The patient’s name will be recorded in a “Do Not Contact” list by the Epidemiology Group, and the Quality Assurance Team will flag the patient record.

    • TCR staff will contact the current researcher that the patient has opted out and no additional contact should be made.

  6. Researchers must immediately report any complaints regarding the release of patient information to the TCR at 512-776-3080 or CancerData@dshs.texas.gov.

Communicating Patient Information with TCR

  1. Researchers must never send personally identifiable information via email or email attachment, including encrypted messages.

  2. Inquiries regarding specific patients must either be conducted by telephone or by email utilizing only the TCR patient ID.

Recruitment Report and Study Changes

  1. Researchers must submit the template (shown in TCR Patient Contact Study Guidelines ) every 3 months while actively recruiting to CancerData@dshs.texas.gov. At the same time, also email CancerData@dshs.texas.gov a list of patient IDs (only the IDs, with no personally identifiable information) for patients who have contacted you and asked not to be contacted again.

  2. If changes are made to any recruitment materials or processes after DSHS IRB and RESC approval, an IRB amendment must be submitted and approved before the changed materials may be used.

Restrictions on Patient Data

  1. The IRB application must specify the number of TCR cancer patients you aim to enroll, the expected response rate, and the number of cases you are requesting from the TCR.  The TCR releases data for up to 1,000 patients at a time. Additional datasets of 1,000 or fewer patients can be provided after the TCR reviews the study recruitment report that is required every 3 months.

  2. The TCR will not release contact information for a patient diagnosed within the last eight weeks to ensure that the physician has sufficient time to notify the patient of his/her diagnosis.

  3. The TCR will not release information on deceased patients for studies requesting contact with next of kin. Studies with previous approval by the DSHS IRB and RESC are not affected.

  4. A patient’s contact information will be released to only one study every two years.

Download PDF of TCR Patient Contact Study Guidelines

Resources for Patient Contact Studies

If you have any questions or need additional information regarding patient contact studies with TCR, please call 512-776-3080 or email CancerData@dshs.texas.gov.

Texas Cancer Registry

Texas Cancer Registry

Research Data