Consent to Contact 

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. These individuals agreed to allow investigators contact them for recruitment purposes.  

The first step is to follow the process outlined by the CTSI, the organization facilitating the “Consent to Contact” program.  

 Click on this link to the CTSI webpage  to obtain information on the actions you need to take to obtain a list of potential subjects. 

After you start the procedures above, you will also need to obtain IRB approval of the process.

Below is a summary of the steps you should take to obtain IRB approval: 

1.    Include a description of your plan to use “Consent to Contact” in your local protocol. 

2.    Provide information needed to obtain a waiver of authorization from the IRB. You will need this waiver to receive the list of potential subjects. To approve the waiver, the IRB must have “written confirmation” from the recipient of the waiver indicating (1) the recipient will destroy the identifiable information at the earliest opportunity, and (2) the recipient will not re-use or re-disclose the information received for any purpose except purposes allowed by the HIPAA Privacy Rule.

To meet this requirement, you need to include in your protocol the following language with both of the checkboxes checked.  

  •  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.      You also need to include in your IRB submission the approved Consent to Contact Script template with the questions you will ask potential subjects included.  You should include questions on the basic eligibility criteria found in your protocol. You may also include language in the script 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. 

4.    Additional requirements must be met if your research involves sensitive matters or if you will ask potential subjects for sensitive information such as:

  • HIV status
  • Sexually transmitted diseases (STD's)
  • Hepatitis infections
  • A mental health diagnosis
  • Substance abuse 
  • Sexual assault

If your research involves this sensitive information, you will need to ensure the person you speak with on the phone is the patient who agreed to be contacted. 

For these types of studies, you must include the following language in the script:

Before I tell you about the study, I need to confirm that you are (subject’s name).  Please provide your birthdate and zip code.  (When the potential subject provides the information, check the record to see if the information provided is accurate.)