In addition to the general recruitment guidelines, these guidelines apply to research studies that identify potential participants from the electronic health record or will identify and recruit participants in a clinical health care setting (i.e., patients). The guidelines apply regardless of the reviewing IRB. Other healthcare entities outside of UW/UW Health may have additional guidelines or policies that apply.

• Initial contact by letter, phone, email, and MyChart
  • Initial contact by letter or phone should come from someone who, by virtue of their position, patients would reasonably expect has access to their health information. The list below is provided as examples and is not intended to be exhaustive:
    • A member of the potential participants’ clinical team, and those individuals working on behalf of members of the clinical team (e.g., nurses, PAs, pharmacists);
    • An administrator from the clinic, department or center where the potential participant receives care;
    • An individual, such as a study nurse, investigator, or research coordinator, acting as an agent of a clinical researcher involved in the potential participants’ care;
    • An individual, such as a study nurse, investigator, or research coordinator, who works within a clinic, department, or center where a potential participant has or will receive care (e.g., from the Department of Surgery for a patient who has an upcoming surgery scheduled);
    • The administrator of a database housed within a clinic, department, or center where a potential participant has or will receive care (e.g., from a recruitment database or registry within the department or clinic where the patient has been seen for clinical care).
  • “Cold calling” of potential participants by phone is generally not permitted. “Cold calling” is a planned communication with a potential participant by the study team when not known to the potential participant or not expected to have access to their protected health information.
  • The IRB generally requires telephone calls to be preceded by a letter that alerts potential participants that they will be called about the study. The letter should provide contact information for the individual to opt-out if they do not want to receive a phone call or further contact.
  • Phone calls for studies that fall under VA purview must be preceded by a recruitment letter because VA regulations do not permit cold calling, unless there is prior written documentation that the potential participant is willing to be contacted by phone.
  • Use of patient email addresses in HealthLink for research recruitment is not permitted.
  • Use of MyChart for recruitment purposes is permitted if conducted with approval from UW Health and the IRB.
• In Person Contact
  • How and who initiates contact with patients in a clinical setting depends on the circumstance. Any patients in private clinic rooms or hospital rooms should first be approached by someone who is part of their care team or an administrator who is part of the clinic or department in which the study is being conducted.
  • Unless a member of the care team is also a member of the study team, potential patient-subjects should provide oral or written permission to be approached by researchers in this private setting.
    
    • Researchers who are employees of the covered entity or members of its workforce for research purposes (e.g., members of the UW/UW Health Affiliated Covered Entity when accessing PHI from Health Link) may use PHI to recruit participants as a preparatory to research activity.
    • For all other researchers, the IRB may grant an altered authorization to permit an abbreviated written authorization or to permit an oral authorization process (see suggested template language below).
      
      Permission to Contact template language:
      
      The HIPAA Privacy Rule requires this clinic to get your permission to release your name and phone number to Dr. _______ and his/her research team at the University of Wisconsin-Madison so that they can contact you about taking part in this study. Your information will only be used for this purpose and not be shared with anyone other than the UW research team. If you decide to provide your name and contact information, you can still decline to participant in the research study. You do not have to give your name and contact information if you don’t want to. If you don’t want to provide your name and contact information, it will not affect your health care at this clinic.
      
  • Recruitment of potential participants in waiting areas or other similar space requires permission from the institution or clinic to ensure minimal interruption of workflow.