Developing a Simplified Consent Form for Biobanking

BACKGROUND: Consent forms have lengthened over time and become harder for participants to understand. We sought to demonstrate the feasibility of creating a simplified consent form for biobanking that comprises the minimum information necessary to meet ethical and regulatory requirements. We then gathered preliminary data concerning its content from hypothetical biobank participants. METHODOLOGY/PRINCIPAL FINDINGS: We followed basic principles of plain-language writing and incorporated into a 2-page form (not including the signature page) those elements of information required by federal regulations and recommended by best practice guidelines for biobanking. We then recruited diabetes patients from community-based practices and randomized half (n = 56) to read the 2-page form, first on paper and then a second time on a tablet computer. Participants were encouraged to use "More information" buttons on the electronic version whenever they had questions or desired further information. These buttons led to a series of "Frequently Asked Questions" (FAQs) that contained additional detailed information. Participants were asked to identify specific sentences in the FAQs they thought would be important if they were considering taking part in a biorepository. On average, participants identified 7 FAQ sentences as important (mean 6.6, SD 14.7, range: 0-71). No one sentence was highlighted by a majority of participants; further, 34 (60.7%) participants did not highlight any FAQ sentences. CONCLUSIONS: Our preliminary findings suggest that our 2-page form contains the information that most prospective participants identify as important. Combining simplified forms with supplemental material for those participants who desire more information could help minimize consent form length and complexity, allowing the most substantively material information to be better highlighted and enabling potential participants to read the form and ask questions more effectively

Tissue Specific Profiling of Females of Schistosoma japonicum by Integrated Laser Microdissection Microscopy and Microarray Analysis

Schistosomes are parasitic worms responsible for important human diseases in tropical and developing nations. There is urgent need to develop new drugs and vaccines to augment current treatments for this disease. In recent years, concerted efforts by many laboratories have led to extensive genetic sequencing of the parasites, and the publication of genome sequence for two agents of schistosomiasis appears imminent. This genetic information has revealed many molecules expressed by the schistosome parasites for which no functional information is available. This lack of information extends to ignorance of where in the complex multicellular schistosome parasites the genes are expressed. We integrated two molecular and cellular techniques to address these knowledge gaps. We used laser microdissection microscopy to dissect small but highly important tissues involved in nutrition and reproduction from sections of female Schistosoma japonicum. From these dissected tissues we then used a broad molecular biology method to identify the multiple genes active in these tissues. Our approach has allowed us to formulate the basis of a “gene atlas” for schistosome parasites, defining the expression repertoire of specific tissues. The better understanding of the roles of tissues in parasite biology, especially in development, reproduction and interactions with its human hosts, should promote future investigations into pathogenesis and control of these significant parasites

Lost in Translation: Assessing Effectiveness of Focus Group Questioning Techniques to Develop Improved Translation of Terminology Used in HIV Prevention Clinical Trials

INTRODUCTION: Achieving participant comprehension has proven to be one of the most difficult, practical, and ethical challenges of HIV prevention clinical trials. It becomes even more challenging when local languages do not have equivalent scientific and technical vocabularies, rendering communication of scientific concepts in translated documents extremely difficult. Even when bilingual lexicons are developed, there is no guarantee that participants understand the terminology as translated. METHODS: We conducted twelve focus groups with women of reproductive age in Mwanza, Tanzania to explore the effectiveness of four questioning techniques for: (1) assessing participants' familiarity with existing technical terms and concepts, (2) generating a list of acceptable technical and non-technical terms, (3) testing our definitions of technical terms, and (4) verifying participants' preferences for terms. Focus groups were transcribed, translated, and qualitatively analyzed. RESULTS AND DISCUSSION: A translation process that uses all four questioning techniques in a step-wise approach is an effective way to establish a baseline understanding of participants' familiarity with research terms, to develop and test translatable definitions, and to identify participants' preferred terminology for international HIV clinical research. This may help to ensure that important concepts are not “lost in translation.” The results emphasize the importance of using a variety of techniques depending on the level of participant familiarity with research concepts, the existence of colloquial or technical terms in the target language, and the inherent complexity of the terms