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Facilitating Enrollment in a Cancer Registry through Modified Consent Procedures: A Pilot Study

Susan Mazanec, Barbara Daly, Neal J. Meropol and Mary Step
Journal of Empirical Research on Human Research Ethics: An International Journal
Vol. 7, No. 5 (Dec. 1, 2012), pp. 71-75
Published by: Sage Publications, Inc.
DOI: 10.1525/jer.2012.7.5.71
Stable URL: http://www.jstor.org/stable/10.1525/jer.2012.7.5.71
Page Count: 5
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Facilitating Enrollment in a Cancer Registry through Modified Consent Procedures: A Pilot Study
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Abstract

Research registries are increasingly important in medical research and are essential to the mission of cancer centers. However, designing enrollment and data collection procedures that are consistent with ethical norms and regulatory requirements yet are efficient and cost effective is a major challenge. Current standard consent forms can be a barrier to enrollment because of their length, multiple components, and technical language. We pilot tested an IRB-approved registry booklet and simplified one-page, tiered consent form, allowing for choice of extent of participation. The booklet was mailed to patients with breast cancer as part of their routine information packet prior to the first clinic appointment. A research nurse met with 27 patients at initial treatment to review the booklet, answer questions, obtain informed consent, and collect quality of life data. The consent rate was 78% with 21 patients enrolling in the study. Twelve of the 21 patients (57%) did not read the booklet prior to the visit. The 9 patients (43%) who had read the booklet prior to arrival found it easy to understand. The multi-stage, simplified consent process and data collection were acceptable to these patients and readily integrated into clinical operations. An easy-to-read registry booklet may be an effective guide for discussion, but in-person consent procedures and further testing of the approach are required.

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