Data Broker Corner: How May Investigators Contact Potential Research Subjects?
In our August 2019 newsletter, we have discussed the process for obtaining lists of patients that may be eligible to participate in research studies. The next step is to start the conversation with those patients. Generally, initial contact with an eligible patient must be made by someone with whom the potential research subject has had prior clinical contact. Therefore, an investigator and his/her staff should work together with medical staff with whom the patient is familiar (e.g. the patient’s treating physician) to make the first contact.
The following scenarios are just a few examples of other HIPAA-compliant methods of contacting potential study participants. A recruitment plan, including the methods of contacting potential subjects, must be included in the study protocol (or addendum) submitted to the IRB for approval.
- Scenario 1: The potential research subject may initiate the contact by responding to an IRB-approved advertisement or recruitment notice.
- Scenario 2: A treating physician who is also an investigator may talk directly to the patient about recruitment into a research trial.
- Scenario 3: If the treating physician is not the investigator, the treating physician may obtain an authorization (UM Research Authorization or JMH Research Authorization) to refer the patient to the investigator. The investigator may then rely on the authorization to contact the individual. The investigator will then obtain a second authorization from the patient to participate in the research.
- Scenario 4: Investigators may submit a request to obtain a list of potential participants through the Consent to Contact Initiative. This initiative allows investigators to receive a list of patients meeting specific inclusion/exclusion criteria that have already agreed to be contacted should they qualify for any research studies at the University of Miami. Information about using Consent to Contact for recruitment must be included in the study protocol. Additionally, the approved Consent to Contact Script along with the screening questions to be asked during the phone calls must be submitted. For more information, please visit CTSI’s Consent to Contact page and the HSRO’s Consent to Contact page.
Also remember that any disclosures made pursuant to an IRB-granted Waiver of HIPAA Authorization requires accounting for disclosure. The HIPAA Accounting for Disclosures form must be prepared and submitted to the Office of Privacy & Data Security to record disclosures for each disclosure of patient information made under a waiver of authorization. For specific instructions on how to account for disclosures, including multiple disclosures for a single study, please contact the Privacy Office.
For further information please contact the Office of Privacy and Data Security at 305-243-5000 or at firstname.lastname@example.org. For questions regarding IRB submissions, contact the Human Subject Research Office at 305-243-3195. For technical assistance with UChart, contact the UHealth Help Desk at 305-243-5999 or email@example.com.