SHARE: Simplifying Human Subject Data Sharing for Alcohol Researchers

Abstract The National Institute of Mental HealthNIMHData ArchiveNDAcollects and shares de identified human subjects data from hundreds of NIH funded research projects across many mental health related scientific domains with qualified researchersA new NDA repository is created for the National Institute on Alcohol Abuse and Alcoholism Data ArchiveNIAAADAand will serve as the portal for NIAAA related data submissions and accessThe NIAAA data sharing policyNOT AAreleased in June ofrequires thatbeginning inall NIAAA grant applications involving human subjects must include plans for the submission of study data to NIAAADAThe first wave of data submission to NIAAADA is expected inMany obstacles exist for alcohol researchers to comply with this policyespecially for those with limited budget and information technology and data management supportTo submit the study dataresearchers have to map their data to the right fields in the right format in a given data templatewhich often requires researchers to manipulate their data by hand or with complicated scriptsor request a new data structure from NDAwhich compromises the goal of data sharingThese data submission processes are error pronetime consumingand require certain technical skillsOur ultimate goal is to provide a nearly automated process for the submission of alcohol research data into the NIAAADA so that the data submission can be performed accurately and efficiently by alcohol researchers with minimum IT knowledge and resourcesWe propose to develop and validate the Share HumAn REsearchSHAREplatform to address the unmet need for assisting alcohol researchers with the submission of study data to NIAAADASHARE does so by offering the SHARE Measure Library of pre defined measures that are already mapped to NDA data dictionariesAlcohol researchers need to only select the measures that they want to use for their studies and let SHARE do the rest for data submission to NIAAADAPhase I aims includeCollect stakeholder feedback from ten alcohol researchers via focus groups and interviews to understand how they currently collect and manage their human subject questionnaire data and explore how they would submit the data to the NIAAADA with anidealtoolDevelop the prototype using a user centric design process and the latest e technologiesAlso code ten common alcohol measures in the SHARE measure library using the NDA data dictionary standards and integrate the SHARE assessment engine with REDCapa popular data collection programEvaluate the prototype by conducting two rounds of usability tests with twenty alcohol researchers to evaluate system usability and perceived usefulness of the SHARE solutionAlso use the NDA Validator to validate data exported from SHARE Project Narrative The NIAAA data sharing policyNOT AAreleased in June ofrequires that beginning inall NIAAA grant applications involving human subjects must include plans for the submission of study data to NIAAADAa central data archive to store and share de identified human subject data from NIAAA funded research studiesThe first wave of data submission to NIAAADA is expected inMany obstacles exist for alcohol researchers to comply with this policyespecially for those with limited budget and information technology and data management supportTo submit the study dataresearchers have to map their data to the right fields in the right format in a given data templatewhich often requires researchers to manipulate their data by hand or with complicated scriptsor request a new data structure from NDAwhich compromises the goal of data sharingThese data submission processes are error pronetime consumingand require certain technical skillsOur ultimate goal is to provide a nearly automated process for the submission of alcohol research data into the NIAAADA so that the data submission can be performed accurately and efficiently by alcohol researchers with minimum IT knowledge and resources