Improving Informed Consent with Minority Participants: Results from Researcher and Community Surveys

Abstract

Strengthening the informed consent process is one avenue for improving recruitment of minorities into research. This study examines that process from two different perspectives, that of researchers and that of African American and Latino community members. Through the use of two separate surveys, we compared strategies used by researchers with the preferences and attitudes of community members during the informed consent process. Our data suggest that researchers can improve the informed consent process by incorporating methods preferred by the community members along with methods shown in the literature for increasing comprehension. With this approach, the informed consent process may increase both participants’ comprehension of the material and overall satisfaction, fostering greater trust in research and openness to future research opportunities.

Recruiting for Epigenetic Research: Facilitating the Informed Consent Process

“…While limited, there is evidence to suggest that additional information provided to potential participants outside the formal consent document may increase their knowledge and have a positive effect on participant recruitments for several types of studies, including clinical trials involving patients with advanced cancer [36]: African American outpatients [37], pregnant women [38], and women being screened or treated for breast cancer [39]. These results provide support for the premise that strengthening the informed consent process, through an increased understanding of information, may be a potential avenue for improving unbiased recruitment [27]. …”

“…This could be accomplished by considering the cultural and contextual issues that surround the potential participant's reactions to informed consent, the comprehension of information delivered during the process, and the ability of researchers to address these issues [27]. There is evidence to suggest that such a strategy is potentially effective when recruiting for research studies in general [28], yet there is a paucity of published literature that focused on such a recruitment strategy for epigenetic studies.…”

“…There is evidence to suggest that such a strategy is potentially effective when recruiting for research studies in general [28], yet there is a paucity of published literature that focused on such a recruitment strategy for epigenetic studies. Obtaining informed consent is an essential process by which potential study participants are presented with the opportunity to make informed decisions about their participation in research [27]. An informed consent document should always include an explanation of the study, a description of risks, benefits, and confidentiality, methods to contact the investigators in the event of adverse events or questions, a statement that participation in the study is voluntary, and procedures for withdrawing from the study [29, 30].…”

“…Often the focus of informed consent may be on the actual signing of the consent document rather than on the interaction between the researcher and participant to ensure that communication and understanding have been achieved [27]. This focus seems ill-advised, as standard consent forms with their technical language, multiple sections, and length can impede a participant's understanding [33, 34] which, in turn, may undermine the recruitment and retention of participants [35].…”

Ethical considerations for involving Latina adolescents in mental health research

“…Researchers should appreciate that the decision to participate in a research study is not just an individual decision but a family decision as well (Lakes et al, 2012). To show respect for the Latino/a culture, researchers should involve parents in the decision-making process and allow enough time for the family to talk about the adolescents’ participation in the study (Fisher et al, 2002; Quinn et al, 2012). By taking these steps, the researcher will also be demonstrating respeto (respect), another important Latino/a cultural value, to both the family and adolescent (Villarruel et al, 2006).…”