Interactive Patient-Centered Informed Consent: Developmental Research
Dates: 6/4/2015 - 12/4/2016
Co-Investigators: Alicia Matthews, Emily Anderson
Abstract: Available data suggest that only about half (54%) of all research participants adequately understand the goals of a given research proposal, and fewer understand concepts associated with randomization, risks, voluntary participation, or the ability to withdraw participation (Nishimura et al., 2013). Comprehension levels may be even lower for underrepresented minorities, the elderly, and patients with low literacy (Anderson & Iltis, 2008). Additional research aimed at improving the informed consent process is warranted as we seek to appropriately engage and assist underrepresented populations in the complex decision-making associated with research participation. Improving the informed consent process is not only an ethical imperative; it has the potential to increase recruitment diversity and improve retention, enhance patients’ trust in and experience of research, support decision-making and produce more engaged research participants. In preparation for a Fall 2015 application to the Patient Centered Outcomes Research Institute (PCORI), here we propose to engage key stakeholder groups (patients, clinical researchers and research oversight personnel) to conduct a qualitative study of stakeholder attitudes regarding challenges to and experiences with the informed consent process in research. We will also explore attitudes towards the potential of technology-based tools for improving understanding, informed consent and decision-making among potential research study participants. Our planned PCORI application will then focus on the development and pilot evaluation of a technology-based and interactive method for enhancing comprehension of study objectives, risks and benefits, and rights and responsibilities. Better evidence of the potential for various interactive multimedia strategies to improve understanding is critical to ensuring informed, voluntary consent for research participation. The development of an informed consent tool and decision-support process that can be easily adapted by any research project – and that has been vetted by patient advocates, researchers, and Institutional Review Board (IRB) professionals– will fill a critical gap in our current understanding of best practices for informed consent.