What if my study team is not affiliated with a clinical department or unit but we need to recruit patients for our study?

Frequently Asked Question

Study teams whose members are not part of UW-Madison Health Care Component (HCC) or the Affiliated Covered Entity (ACE) but who need to recruit clinical patients for a study must use a specific HIPAA authorization form to obtain permission to contact these patients when the initial contact with the patients occurs in person.

Institutional policy requires that patients initially informed about a study by someone they would recognize as being involved in their care. In addition, only study team members listed on the IRB application may conduct the recruitment process. When the study team is outside the UW-Madison HCC/ACE, a health care provider from within the HCC/ACE must approach patients initially, usually at a regular clinic visit, to tell them about the study. In order for the study team to be able to contact these patients, the healthcare provider must have the patients complete a permission-to-contact form, which contains the appropriate HIPAA language and asks for the patient's name and contact information. The health care provider then gives the contact information to the study team member(s) responsible for enrolling subjects in the study. The IRB typically considers the individual(s) obtaining the patients' permission-to-contact to be part of the study team.

The permission-to-contact form template is designed for use by UW-Madison researchers recruiting patients within the UW-Madison HCC/ACE. However, this template may be used for research studies recruiting patients from other health care institutions under certain conditions (e.g. approval from the institution's HIPAA Privacy Officer). Please contact the HS IRBs Office for additional questions.

Keywords:FAQ, HCC, ACE, health care component, affiliated covered entity, permission to contact HIPAA recruitment   Doc ID:26807
Owner:Monica E.Group:Health Sciences IRBs
Created:2012-10-12 12:33 CDTUpdated:2015-10-13 15:15 CDT
Sites:Health Sciences IRBs
Feedback:  2   1