Abstract 3468: High rates of informed consent for biospecimen sharing among hispanic women in a safety-net clinic
Authors: Nodora Jesse , Martinez Maria E. , Schwab Richard , Wells Kristen , Kim Hyeon-eui , Farcas Claudiu , Bouton Marcia , Komenaka Ian 
Published: July 2016

Introduction: Biospecimen sharing among low-income and undeserved individuals has been reported to low. Few data exist on participation in biospecimen sharing for research purposes and reasons for declining participation by individuals from underserved populations. To address this gap, we conducted a randomized study to compare the rate of informed consent for biospecimen collection and data sharing for research when participants were consented by their physician versus a research assistant.

Methods: Eligible participants included Hispanic English or Spanish-speaking patients 18 years of age or older who underwent breast biopsy at the Breast Center in Maricopa Integrated Health Services (MIHS), a safety-net facility in Phoenix, Arizona. Consecutive patients receiving care at the center were asked to participate in the study and individually randomized to be consented by their physician or a research assistant not working in the Breast Center. Informed consent was delivered vi an electronic tablet. Biospecimen sharing for research included a saliva sample for DNA extraction and formalin fixed paraffin embedded tissue. Data collection included sociodemographic variables, health literacy using Newest Vital Sign (NVS) instrument, and a trust questionnaire based on the Biobanking Attitudes and Knowledge Survey (BANKS-SP-Trust). Rate of participation was compared between the two randomization arms and reasons for participation were assessed.

Results: The study enrolled 140 women (70 to each randomization arm). Study participants had a mean + sd age of 46.7 +11.6 years and most (95%) were of Mexican descent and Spanish-speakers (85%). Mean (sd) education level was low (8.7 + 4.1) years. Eighty-five percent of the participants were found to have limited health literacy. Using a 1 to 10 Likert scale, the mean + sd range of responses to the BANKS-SP-Trust in relation to 10 different attributes was from 7.7 + 2.5 for “health insurance companies” to 9.2 + 1.5 for “doctors who do research.” Results showed very high rates of consent with no significant difference between the two randomization arms: 97.1% for the physician and 92.9% for the research assistant. Participants who were current smokers were ∼60% less likely to consent (p = 0.045) and those who were unmarried were ∼90% less likely to consents (p = 0.043). All women who refused consent had limited health literacy whereas 86% of those who consented had this limitation but this was not statistically significant (p = 0.346). No association between consent and trust was observed.

Conclusions: Consent for biospecimen and data sharing among low-income Hispanic women is very high, with only current smokers and unmarried females being significantly less likely to provide consent. More efforts should be made to reach out to patients in safety-net facilities for biospecimen sharing to overcome the scarcity of representation of underserved individuals in biospecimen repositories.

Citation Format: Jesse Nodora, Maria E. Martinez, Richard Schwab, Kristen Wells, Hyeon-eui Kim, Claudiu Farcas, Marcia Bouton, Ian Komenaka. High rates of informed consent for biospecimen sharing among hispanic women in a safety-net clinic. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr 3468.