Consent to Contact is a process that helps investigators meet recruitment goals. Investigators who complete the requirements can obtain a list of names and contact information of individuals who may meet eligibility requirements for their study. During one of their visits to the University of Miami, these patients agreed to allow investigators to contact them for research recruitment purposes.
Consent to Contact may or may not be an appropriate recruitment method for populations involving sensitive diagnoses, such as HIV, diagnosis of and treatment for substance abuse, and some mental health diagnoses. If the IRB approves Consent to Contact as a recruitment method, you are encouraged to work with the CTSI to develop a study-specific Consent to Contact Telephone Script that meets the requirements for studies involving patients with sensitive diagnoses. The Consent to Contact Operational Committee reviews these requests on a case-by-case basis.
The Consent to Contact process allows investigators to access patients’ private information.
It involves a three-step process:
1. Complete the Consent to Contact Script(non-sensitive) OR Consent to Contact Script (sensitive) and Brief Study Description(sensitive). Complete by adding the questions you will be asking the potential subject and the language you will use to schedule an appointment for an in-person visit to confirm eligibility and to obtain the subject’s consent and authorization (if required).
Please note: When you use the Consent to Contact process, you can ask for only the minimum information necessary to conduct a basic screening for your study.
2. Submit the following to the IRB for review:
- Completed Consent to Contact Script
- Updated local protocol that incorporates a description of the Consent to Contact recruitment process
- Provide information needed to obtain a waiver of authorization from the IRB. To approve the waiver, the IRB must have the following “written confirmation” included in your protocol:
- I confirm that you will destroy or de-identify the information you collect at the earliest opportunity.
- I confirm that the information you collect will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study or for other research for which the use or disclosure of PHI is permissible.
3. When you have received IRB approval, submit the request to the Consent to Contact Committee to obtain the patient information. Information about this process is found on this link to the CTSI webpage.
