Abstract A04: Preferences for models of informed consent for secondary research uses of biospecimens among diverse women
Authors: Brown Katherine , Drake Bettina F. , Gehlert Sarah , Wolf Leslie , DuBois James , Perkins Hannah , Goodman Melody S. , Kaphingst Kimberly 
Published: May 2015

Background: Research with stored biospecimens can provide substantial societal benefits. Yet achieving translational research goals and reducing health disparities require the participation of large numbers of people from diverse populations in biobanks. One key ethical issue with biobanks is informed consent for secondary research use of biospecimens. Various models of consent have been proposed for using biospecimens for studies not planned when samples are collected. These models differ in the level of donor control and the amount of information received. Limited empirical data exist regarding the attitudes of potential biospecimen donors related to different models of consent, particularly from groups underrepresented in research, including individuals from racial and ethnic minority groups.

Methods: We conducted semi-structured individual interviews with 60 women seeking breast health services in the St. Louis region, stratifying recruitment by race (Black/White) and prior biobank participation. The interviews focused on participant preferences for four different models of informed consent for secondary research uses of biospecimens (i.e., study-specific, broad, opt-out, notice models of consent), factors affecting consent model preferences, and perceived benefits and concerns of donating biospecimens for research. Two independent coders are coding each interview transcript; the qualitative thematic analysis is based on consensus codes.

Results: Participants prefer models of informed consent that allow for more control and provide more information, irrespective of race. The least preferred model, notice model, informs participants that their samples may be used in future research. The most preferred model, broad consent, allows for future use of samples in multiple research studies once participants have given their permission. Preliminary analysis has shown that Black and White women had many similar reasons for preferring this model, citing their trust in research and desire to help others. However, while White women mentioned their trust in research and the importance of research as factors affecting their consent model preference, Black women put greater emphasis on the importance of consent and being asked permission. One White participant noted for broad consent, “That's when you feel that you're confident with the individuals that you've donated to will follow a strict protocol and do the best they can for a goal that's written, well documented.” One Black participant noted for broad consent, “I don't need to have any control over the, over it. The only control I needed was to be able to make the decision that said, sure you can use it.”

Conclusion: The most widely used consent model (notice model) is the least preferred among both Black and White women, while consent models providing more control and information ranked higher. These qualitative data will be used to develop educational materials with the purpose of making the informed consent process more accessible for prospective biobank participants. Recently, the US Department of Health and Human Services sought input on their proposal to change regulations governing the type of consent processes that can be used for research use of biospecimens. Findings from this study investigating preferences for consent for biobank participation among a diverse sample can therefore be used to inform future policy.

Citation Format: Katherine Brown, Bettina F. Drake, Sarah Gehlert, Leslie Wolf, James DuBois, Hannah Perkins, Melody S. Goodman, Kimberly Kaphingst. Preferences for models of informed consent for secondary research uses of biospecimens among diverse women. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr A04. doi:10.1158/1538-7755.DISP13-A04