Privacy and confidentiality have always been a concern when the IRB reviews and approves Human Subjects Research, but it has become apparent in recent years that the greater community is becoming more aware of these issues and more involved in protecting their data. Amid ever-growing news stories about data breaches, AI mining information, and the sale of personal information, the public is reaching out to the IRB more and more with concerns about how their data is being used, who is viewing it, and how it is being retained. A particular area of concern is for studies that engage with community partners, non-University of Utah clinics, and other sites or hospitals that are not affiliated with the University of Utah researchers who may be contacting potential participants for recruitment.
To help ease recipient concerns and address the kinds of questions that are regularly asked of the IRB and U of U Privacy Office, consider the following recommendations when crafting recruitment procedures and materials:
“I’ve never been to a University of Utah facility. Who are you and how did you get my data?”
This is usually the first question recipients of recruitment materials have when they reach out with concerns. Potential participants ask this question even when they have been to a U facility but especially when they haven’t. Please consider including information in your recruitment materials about how the process works and how you received their information. When the consent cover letter or other recruitment outreach indicates who is conducting the research, consider explaining the agreement you have with the non-Utah facility, what limited data has been shared, and how it will be used or destroyed if the recipient should decline.
“I never agreed to have my data shared. What gives you the right to view my data and use it in this way?”
Concerns of this nature have grown steadily over the years. For participants seen at University of Utah facilities, it’s a matter of educating recipients on the inclusions in the Notice of Privacy Practices regarding use of data for research. When participants sign this document at a U facility upon treatment, they agree to having their data used in certain ways, including recruitment for research. When individuals are seen at non-Utah facilities, they can become confused and angry that their data was used without their consent. In recruitment materials, it can be helpful to inform potential participants of the Notice of Privacy Practices information for the site/clinic where they were seen, agreements between that site and the University of Utah, and why the investigator was allowed to use that data.
“I never agreed to this and don’t want my data used in this way.”
Some recipients of recruitment materials not only wish to decline participation in the study but to ensure their data is not retained or used in the future. In recruitment materials, it is recommended that you clearly describe how to decline and what will be done with any data received by the investigator prior to contact. Depending on the partner facility, there may also be ways for individuals to not be contacted in the future as well. If this is an option, including such details may be helpful to concerned recipients.
The University of Utah IRB, Research Participant Advocate Office, and Privacy Office have all fielded questions and concerns of this nature and are here to help investigators when crafting appropriate contact procedures and recruitment materials. Please reach out with questions about how best to prevent issues with potential participants and to help maintain a positive relationship with the greater community surrounding research participation.