Abstract A12: High rates of informed consent for biospecimen and data sharing among low-income Hispanic women: Results of a pilot randomized trial
Authors: Nodora Jesse , Martinez Maria Elena , Schwab Richard , Wells Kristen , Kim Hyeon-eui , Farcas Claudiu , Bouton Marcia , Komenaka Ian 
Published: May 2016

Introduction: Few data exist on the willingness of individuals from underserved populations to provide consent for and participate in biospecimen (e.g., saliva, urine, blood, tissue, DNA, etc.) collection and related data sharing for research and even fewer data are available for Hispanic populations. Lacking in the literature are reports on actual provision of data and biospecimens for research. A pilot study was conducted to compare two methods of informed consent delivery for biospecimen collection and data sharing in a population of women receiving care at a safety net health care facility. The purpose of the randomized study was to compare the rate of informed consent for biospecimen collection and data sharing for research when potential participants were approached by a physician versus a research assistant.

Methods: Eligible participants included women who underwent breast biopsy at the Breast Center in Maricopa Integrated Health Services (MIHS) 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. Hispanic, English or Spanish-speaking women 18 years of age or older undergoing a breast biopsy, regardless of the reason for doing so, were eligible. Exclusion criteria included: women who were not Hispanic or did not speak English or Spanish. Initially, a simple general consent asking patients if they wanted to be included in the study was provided. If women agreed to participate, they were randomized to one of the two arms. Informed consent was collected via an electronic tablet. Consent for donation of a biospecimen for research included collection of formalin fixed paraffin embedded tissue (normal or tumor) and a saliva sample for DNA extraction. Data collection included sociodemographic variables and breast cancer risk factor information. Health literacy was assessed using the Newest Vital Sign (NVS) health literacy assessment instrument. Trust in individuals and organizations associated with biomedical research was assessed using the trust scale of the Biobanking Attitudes and Knowledge Survey (BANKS-SP-Trust).

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 and monthly household income levels were 8.7 (4.1) years and $1,040 ($700.9), respectively. 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. All consenting women (95%) provided a saliva sample and tissue retrieval is ongoing.

Conclusions: Low-income, uninsured and underinsured Hispanic women provide informed consent for biospecimen collection and related data sharing at very high rates. Participants show a high level of trust in individuals and organizations associated with biomedical research.

Citation Format: Jesse Nodora, Maria Elena Martinez, Richard Schwab, Kristen Wells, Hyeon-eui Kim, Claudiu Farcas, Marcia Bouton, Ian Komenaka. High rates of informed consent for biospecimen and data sharing among low-income Hispanic women: Results of a pilot randomized trial. [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr A12.