Cold Contact Recruitment

Researchers often obtain the names and contact information of possible research participants (say, from medical records) and then send them a “cold contact” letter or email to ask if they are interested in a study. Alternatively, a researcher may use a pre-approved script or ‘talking points’ and contact participants by phone. HSD receives many complaints about these contacts, especially when they contain sensitive information. Additionally, confidentiality breaches involving these methods have increased. Example: A letter addressed to one individual is put into the envelope addressed to another individual and mailed out.

Effective August 5, 2019, studies reviewed by the UW IRB (including non-UW relying sites) may no longer use “cold contact” recruiting methods unless both of the following apply:

1. There is no sensitive or private information about the individual in the communication – for example, a health condition, medical test results, reference to a clinical visit, or academic performance.
   1. This includes information about the study that would imply or indicate something private about the individual (e.g. “We are conducting a study about people with type II diabetes”; “We are conducting a study involving people who have a GPA of 3.0 or higher”; “We are interested in people who were recently seen at the Madison STI clinic”).
   2. For contact by phone, it is acceptable to include specific information about the study AFTER the identity of the targeted individual is verified.
2. The recruitment document contains a statement or explanation about how the individual’s contact information was obtained (e.g. From UW Medicine, by conducting a search of the electronic medical record).

“Cold-contact” recruitment materials reviewed and approved prior to August 5, 2019 are grandfathered in. Revised or new materials submitted after this date will have the above standards applied. We highly recommend modifying all “cold contact” recruitment materials to comply with the new standards. Situations that do not involve a cold contact will continue to be reviewed as usual by the IRB. For example, individuals may receive recruiting letters because they had previously consented to become part of a registry and be contacted about future research. HSD and the UW IRB would not consider those letters to be cold contact letters.