Strategies to Increase Recruitment and Retention While Complying with IRB and HIPAA Regulations Lawrence J Appel, MD, MPH Professor of Medicine, Epidemiology and International Health (Human Nutrition) The Johns Hopkins University School of Medicine April 30, 2010
Objectives • Provide learners with insights on how to construct consent forms that enhance the potential for successful recruitment and retention • Provide learners with concrete examples of IRB-approved text that could be included in consent forms
General Approach • To minimize logistic hurdles related to recruitment and retention, imbed flexible language in the consent form
Use the Consent Form to: • Maximize convenience for participants – Flexible contact pattern – Alternative setting for visits
• Enhance rapport with staff – Periodic incentives
• Maintain contact – Secure social security number – Be general about end date – Mention potential contact after end of trial
• Secure consent for future use of specimens and data
Flexible Contact Pattern • Sample text: “Each visit will typically last between 4 and 6 hours, but could last longer or be done on multiple days depending on how long it take you to do the tests, as well as your schedule and preference.”
Alternative setting for visits • Sample text: “While we prefer to collect study information in the clinic, some individuals can no longer attend these visits because they have developed health problems, are very busy, or moved out of the area. If this is the case for you, we will ask you if we can collect this information someplace else, typically your home or workplace.”
Participation by Phone • Sample text: “If you have moved out of the area and cannot come in for visits, we will ask you to provide information just over the phone.”
Unanticipated Contacts • Sample text: “Study personnel may contact you at other times during the year to ask you some additional questions or to join in a new part of this study.”
General Description of End of Study • Sample text: “The study will end close to June 2013 or when funding ends” • Option for recontact: “After June 2013, we may contact you by phone or by mail to update your medical history or inform you of additional research opportunities related to this study or more generally kidney disease.”
Securing Social Security Number • Sample text: “We will ask you to tell us your social security number. By providing this number, we can pay you for the study visits. It also allows us to track your health status and to maintain contact with you.”
Periodic Incentives • Sample text: “Periodically, we provide tokens of appreciation to study participants; the value of each item is no more than $25.”
Secure consent for future use of specimens and data • Sample text: “We would like to store some of the blood and urine collected during the study. Because advances in research are occurring rapidly, we can't be sure what tests we will eventually perform on these stored samples. All tests performed will be related to blood pressure, diabetes, heart disease, or nutrition. We are requesting your permission to use these stored specimens in the future.”
