University of Florida Health Science Center Institutional Review Board (IRB-01)

Identifying & Recruiting Research Subjects

Want to Recruit Subject By: / The Correct Way / What You Need From the IRB / What Not To Do
Asking a colleague to give you names of potential Subjects for your study. / The investigator can inform his\her colleague about the study; that colleague could approach a potential study subject if the colleague has a clinical relationship with the potential subject. If the subject is willing to be contacted, then the colleague can let the investigator know to the potential subject can be contacted.
If you want to review potential subjects records to confirm they meet entrance criteria prior to approaching the subject, the IRB would have to grant a waiver of authorization. / 1.  An approved protocol
2.  A waiver of authorization for the screening of potential subjects / Discuss potential research subjects with a colleague in which PHI is discussed.
Sitting in on a patient care conference (e.g. tumor board, morning rounds, etc.) when you have no patient care reason to be there. / Since you do not have the right to have knowledge regarding these patients, then the only way you can recruit in this manner is if the IRB has approved this recruitment procedure. Otherwise, this may not be done. / 1.  An approved protocol.
2.  A waiver of authorization for the screening of potential subjects / Attend these patient conferences, identify potential study subjects, and contact them for possible enrollment into your research.
Asking Medical Records, Clinical Resource Management, or any other group to give you a list of names of potential subjects based on some entrance criteria (eg, Cystic Fibrosis, Diabetes, High Blood Pressure, etc.) / Ask one of these groups to provide a list of potential study subjects, and contact them for possible enrollment into your research.
Spending time in a waiting room area hoping to run into patients that might be eligible for your study. / Since you do not have the right to have knowledge regarding these patients protected health information, and then the only way you can recruit in this manner is if the IRB has approved this recruitment procedure. The specificity of the clinic (e.g. general peds vs. HIV clinic), the nature of the research, and your clinical role are all factors the IRB will weigh. The director of the specific clinic will also need to be aware and approve. / 1.  An approved protocol.
2.  A waiver of authorization for the screening of potential subjects / Hang around a patient care clinic; discuss your protocol with these patients for possible enrollment into your research.
Looking through your department's clinical database for potential study subjects, then contacting them. / If you want to use your department's clinical database for research, the database must be approved by the IRB. Once approved, then each protocol in which this database will be used for recruitment must be approved by the IRB. / 1.  An approved protocol covering your clinical database to use for research purposes.
2.  An approved protocol for your research.
3.  A waiver of authorization for the screening of potential subjects / Simply look through your department's clinical database, identify potential study subjects, and contact them for possible enrollment into your research.
Looking through an IRB approved research database for potential study subjects, then contacting them. / If you want to use an IRB approved research database to recruit subjects for your study, your study must be approved by the IRB and your Introductory Questionnaire must indicate that you will be using the research database to identify and recruit subjects. / 1.  An IRB approved research database.
2.  An approved protocol for your research, that includes
3.  an Introductory Questionnaire that indicates which IRB approved research databases you will use to identify and recruit subjects. / Access any database to identify potential subjects without obtaining specific IRB approval to do so, identifying potential study subjects, and then contacting them for possible enrollment into your research.

Identify & Recruit Subjects Page 2 of 2

IRB version: 01/11/2007