When obtaining  consent is not required, researchers (and the IRB) may still decide to notify the patients included in research through various mechanisms, which can vary from a poster that provides a general or group notification (e.g., “We do research here”) to individual notification about a specific study. With any form of notification, there may also be an option to opt out.

Individual Notification

Even when a waiver of consent is granted, some investigators provide individual notification to those included in the research and may offer an opportunity to opt out as a mechanism to preserve autonomy. Individual notification can occur through various methods, including a letter sent by mail, an email through a patient portal, individually provided flyers, or a discussion with a physician.

Example from a NIH Collaboratory Trial:

TiME trial information sheet

Group Notification

Group notification can include flyers and posters in clinics. The information can be specific to the study or a general statement that research is being conducted in that setting. For example, the Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate MRSA (REDUCE MRSA) trial (Septimus et al. 2014) compared 3 commonly used strategies for preventing methicillin-resistant Staphylococcus aureus (MRSA) infections in adult intensive care units of a single health system. Although a waiver of consent was granted, the IRB required that patients be informed of the study through notices posted in each ICU room.

Example from a NIH Collaboratory Trial:

PRIM-ER Flyer

Opt Out

With opt out, subjects  are enrolled in the research unless they decline to participate. Opt out can be used along with either individual or group notification. Note that if opt out is an option, there must be a mechanism for tracking those who opt out such that their data are not collected.

Case Example: STOP CRC and Opt Out

The Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC) trial was designed to improve rates of colorectal cancer screening among the predominantly minority and low-income patients who receive healthcare services through Federally Qualified Health Centers (FQHCs; Coronado et al 2014). Prospective participants were identified in the EHR as being aged 50 to 74 years old and not up-to-date with colorectal cancer screening guidelines. Investigators sent these individuals an Introduction Letter explaining the program and provided an option to opt out of the mailed program by contacting the FQHC (Coronado et al 2014). The letter said: “If you have had a colonoscopy in the past 9 years or prefer that we not mail you a test, please contact us at xxx-xxx-xxxx.” Patients who did not opt out subsequently received a fecal immunochemical test (FIT) kit in the mail with a letter and a set of wordless instructions with pictograms of each step. Participants who did not opt out were also reminded by post card or phone to complete their tests.