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Setting Up a Participant Recruitment Database

CREd Library and Floris Singletary

DOI: 10.1044/cred-sprs-tth-004

While developing a recruitment database requires an initial investment of time and resources, it can save time in the long term by providing a more efficient system for identifying leads, managing follow up communications, and generating reports for analyzing recruitment trends and issues. When setting up recruitment software, researchers should consider the data and processes involved in screening for multiple studies, procedures for refreshing contact data, and ensuring privacy is protected.

Video: Setting Up a Participant Recruitment Database

Floris Singletary, Brooks Rehabilitation Clinical Research Center

How are you going to archive your data? How are you going to keep it HIPAA-compliant? How are you going to take, maybe, the same stroke patient and recruit them for multiple trials? You have to have a good software program to build your databases.

I started with Access, just and Access database. Which actually wasn’t bad, but today you need something better than just an Excel or Access spreadsheet.

You have to have a system that allows for follow up, and a database that allows for refreshing. So you can build a database for recruitment, or registry, you might say, but if you don’t refresh it once a year, maybe send out cards on a birthdate, whatever, then it will become old and stale. That’s another — you have to have a strategy.

You have to have some funds, initially. I figured it was about $20,000 a year. Most trials will pay us a recruitment fee. It can range anywhere from $5,000 to $15,000 just for one trial. So if you run three or four trials you’ve paid for what it costs to build the registry and help recruit for the clinical trials.

How did you use your registry software to streamline recruitment?

It allowed us a very dynamic process by which we could customize very short questionnaires, and store that information, go back to that information, and do queries. If somebody went onto our website, and they clicked a button that says, “I want to learn more about participating in a research trial.” it would pull up all of our trials and we could ask maybe four make-or-break questions. Is this your first — I’ll use stroke — Is this your first stroke? Are you between the ages of 18 and 80? Maybe four or five of the make or break questions. If they answered yes then they passed that first-pass screening, and it automatically comes to us. We get the email. It moved us into a more dynamic system that allowed us to archive information. The biggest thing was having the registry. It’s minimal risk for the individual, but you have them there for multiple trials. That person who participates in an aphasia trial might also be eligible for lower extremity walking post-stroke trial.

That is what I would want to share with researchers, is that you work with your institution, get a HIPAA-compliant mechanism to contact for research purposes. Then you get some software, a web-based program that will help to drive it. And you have multiple means of recruitment. We have a self-addressed postcard, we have different mechanisms that we use to help build that portal.

How did you build privacy protections into your recruitment process?

We all have to be very careful about the storage of protected health information. One of the biggest hurdles, which applies to all research, across the disciplines, is you have to be sure that you have your human subject protection element built in.

Most of that is with privacy, because, for recruiting you’re going to be screening and collecting health information. We had to use the Western IRB, but we were able to get them to approve Waiver of Documentation of Informed Consent.1

The person is given a registry information sheet that contains all the elements of informed consent, such as what are you going to collect, how are you going to store it, how are you going to protect it, do you have the right to withdraw — all of those things that are in virtually every informed consent that researchers use — that’s in the registry information sheet.

Getting waiver of documentation of informed consent allowed us to get verbal consent, on the phone, and it allowed us get online consent. So folks can be screened with this online mechanism.

That’s the one thing we learned a lot about. How to get waiver of documentation of informed consent. That was critical to our success.

The poster presentation with samples and further details is available under the “Supplemental” tab on this page.

  • Singletary, F. F. & Smith, M. P. (2014, November). Using a Research Registry to Recruit for Clinical Trials. Poster presented at the American Speech-Language-Hearing Association Convention in Orlando, FL.

Further Reading: Recruitment Database Case Studies and Considerations

Dowling, N. M., Olson, N., Mish, T., Kaprakattu, P. & Gleason, C. (2012). A model for the design and implementation of a participant recruitment registry for clinical studies of older adults. Clinical Trials, 9(2), 204–214
Carefully designed research registries can play a valuable role in successful planning and management of recruitment and retention of study participants. Registries can increase participation in and completion of clinical trials by providing an efficient mechanism to identify candidates and meet recruitment targets within specific time frames. Adding a contact management element to the registry design significantly improved the efficiency of communication between clinical study coordinators and potential research participants, as well as the communication among coordinators.

[Article] [PubMed]

Harris, P. A., Lane, L. & Biaggioni, I. (2005). Clinical research subject recruitment: The volunteer for Vanderbilt research program Journal of the American Medical Informatics Association, 12(6), 608–613
The researchers propose the following recommendations to others considering developing a recruitment database: (1) Think about the information flow first, before looking for commercial software or developing a custom solution. (2) Identify and use institutional resources to defray hardware and software costs. Partner with a general clinical research center if available. (3) Consult IRB and HIPAA experts early in the project development stage. (4) Ensure authentication and data security procedures are in place at all stages of project development. (5) Develop clear policies for registry use by investigators. (6) Balance the need to keep public registrant data entry as simple as possible with the goal of collecting sufficient information to allow researchers to prescreen subjects most likely to qualify for participation. (7) Make the system as autonomous and self-sustaining as possible. (8) Instruct university clinical personnel and operators to encourage potential volunteers who inquire about research studies to use the registry.

[Article] [PubMed]

Wipke-Tevis, D. D. & Pickett, M. A. (2008). Impact of HIPAA on subject recruitment and retention. Western Journal of Nursing Research, 30(1), 39–53
If the researcher plans ahead, there are HIPAA compliant strategies to assist with recruitment for future studies while minimizing administrative burden. The creation of a recruitment database is a useful strategy for researchers who do not have a clinical practice and do not have an existing treatment relationship with their population of interest. The researchers describe a simple small-scale IRB-approved recruitment database set up as two separate password protected electronic database files.

Note on Waiver of Documentation of Informed Consent

45 CFR §46.117(c) Documentation of informed consent. An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research. For more information, see: HHS Office of Human Research Protections FAQ: When may the requirement for documentation of informed consent or parental permission be waived or altered?

The content of this page is based on selected clips from a video interview conducted at the ASHA Convention.

Additional digested resources and references for further reading were selected and implemented by CREd Library staff.

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