Data for: Healthy volunteers’ perceptions of risk in U.S. phase I clinical trials: A mixed-methods study

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HealthyVOICES Project. 2018. "Data for: Healthy volunteers’ perceptions of risk in U.S. phase I clinical trials: A mixed-methods study". Qualitative Data Repository. https://doi.org/10.5064/F6LXO8PS. QDR Main Collection. V2

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Description	These data include excerpts from interviews that were part of an initial "baseline" interview as part of the HealthyVOICES study (http://healthyvoices.web.unc.edu). The study examined the risk perceptions (among other things) of healthy people who enroll for financial compensation in Phase I pharmaceutical drug trials. All the excerpts were coded with the parent code "Risk Perception." These include their initial perceptions of risk, their current general perceptions, and study-specific perceptions. Where information contained in the excerpt might have been identifying to the participant or clinic at which they participated, we redacted potentially compromising words. For our use of these data, we analyzed these risk perceptions in the article which this dataset supplements. Detailed information in our study methods can be found in that article as well as in the following published articles: - Edelblute, H. B., & Fisher, J. A. (2015). Using "Clinical Trial Diaries" to Track Patterns of Participation for Serial Healthy Volunteers in U.S. Phase I Studies. Journal of Empirical Research on Human Research Ethics, 10(1), 65-75. - Cottingham, M. D., & Fisher, J. A. (2016). Risk and Emotion among Healthy Volunteers in Clinical Trials. Social Psychology Quarterly, 79(3), 222–242. The data are organized by participant ID so that all quotes from a single participant are grouped together. However, they might not appear in the order in which they were spoken during the interview. Some excerpts have time stamps that can provide a sense of where they occurred in the interview.
Subject	Social Sciences
Keyword	risk perceptions, healthy volunteer, phase I clinical trial, pharmaceutical, health behavior, medications, medical ethics
Related Publication	Fisher, Jill A., Lisa McManus, Marci D. Cottingham, Julianne M. Kalbaugh, Megan M. Wood, Torin Monahan, & Rebecca L. Walker. “Healthy Volunteers’ Perceptions of Risk in Phase I Clinical Trials: A Mixed-Methods Study.” PLOS Medicine. doi: 10.1371/journal.pmed.1002698
Notes	Update Notes for Version 2.0 Version 2.0 is a QDR-administered technical update. Files have been reprocessed to improve digital accessibility; the content of materials remains unaltered.
License/Data Use Agreement	Standard Access

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	0_Fisher_HealthyVOICES_BaselineInterviewGuide.pdf - 198.7 KB Published Nov 1, 2023 10 Downloads SHA512: 05a94edd6b07c8ee874fdad5cc0d707d6dbdcfede6665f3aea8082ad5ed47fcfc0001bb7bc23fed7b581ff1b0db09473fddc59f4e580475a9508c0338c3d9906 Interview Guide Documentation	Preview "0_Fisher_HealthyVOICES_BaselineInterviewGuide.pdf" Access File File Access Public Download Options Adobe PDF Download Metadata Data File Citation EndNote XML RIS BibTeX
	0_Fisher_HealthyVOICES_Consent Form_082013.pdf - 173.5 KB Published Nov 1, 2023 10 Downloads SHA512: 9735c6f9ed7936f0cc9f72e7b4fa01dfd0d2306f44ab81235327f408103b9168af44a56101607d0f9effdc1c07a08ec9890d97fe144cd61a70077abff07c8354 Consent Form Documentation	Preview "0_Fisher_HealthyVOICES_Consent Form_082013.pdf" Access File File Access Public Download Options Adobe PDF Download Metadata Data File Citation EndNote XML RIS BibTeX
	README_Fisher.txt - 2.8 KB Published Oct 26, 2018 66 Downloads SHA512: eda01f962e6c7769e57b8f15d39747f4997274ad144b82a08990230c6231727e97e5abc0eefdcb2725f38d4949f5cfa74509a8d0085f08c5f7fa56f2c4751815 README Documentation	Preview "README_Fisher.txt" Access File File Access Public Download Options Plain Text Download Metadata Data File Citation EndNote XML RIS BibTeX
	Fisher_HealthyVOICES Baseline Risk - Redacted.pdf - 9.3 MB Published Nov 1, 2023 2 Downloads SHA512: 1fe88dbc39ec1cef71e01c0d96d5c206aeafd5d0ec13d5f5212c5558b09c0b3c0f9262b87d4fabb45a2c990a45e9223d0ec23597241a0668982ba15dffb194eb Data	Access File File Access Restricted Request Access Download Metadata Data File Citation EndNote XML RIS BibTeX

Data Project Persistent Identifier	doi:10.5064/F6LXO8PS
Publication Date	2018-10-26
Title	Data for: Healthy volunteers’ perceptions of risk in U.S. phase I clinical trials: A mixed-methods study
Creator	Department of Social Medicine and Center for Bioethics, University of North Carolina at Chapel Hill0000-0002-9487-1493
Point of Contact	Use the Contact button at the top right to email this Data Project's contact. Fisher, Jill (Department of Social Medicine and Center for Bioethics, University of North Carolina at Chapel Hill)
Description	These data include excerpts from interviews that were part of an initial "baseline" interview as part of the HealthyVOICES study (http://healthyvoices.web.unc.edu). The study examined the risk perceptions (among other things) of healthy people who enroll for financial compensation in Phase I pharmaceutical drug trials. All the excerpts were coded with the parent code "Risk Perception." These include their initial perceptions of risk, their current general perceptions, and study-specific perceptions. Where information contained in the excerpt might have been identifying to the participant or clinic at which they participated, we redacted potentially compromising words. For our use of these data, we analyzed these risk perceptions in the article which this dataset supplements. Detailed information in our study methods can be found in that article as well as in the following published articles: - Edelblute, H. B., & Fisher, J. A. (2015). Using "Clinical Trial Diaries" to Track Patterns of Participation for Serial Healthy Volunteers in U.S. Phase I Studies. Journal of Empirical Research on Human Research Ethics, 10(1), 65-75. - Cottingham, M. D., & Fisher, J. A. (2016). Risk and Emotion among Healthy Volunteers in Clinical Trials. Social Psychology Quarterly, 79(3), 222–242. The data are organized by participant ID so that all quotes from a single participant are grouped together. However, they might not appear in the order in which they were spoken during the interview. Some excerpts have time stamps that can provide a sense of where they occurred in the interview.
Subject	Social Sciences
Keywords	risk perceptions healthy volunteer phase I clinical trial pharmaceutical health behavior (ICPSR Subject Thesaurus) https://www.icpsr.umich.edu/icpsrweb/ICPSR/thesaurus/index medications (ICPSR Subject Thesaurus) https://www.icpsr.umich.edu/icpsrweb/ICPSR/thesaurus/index medical ethics (ICPSR Subject Thesaurus) https://www.icpsr.umich.edu/icpsrweb/ICPSR/thesaurus/index
Time Period	Start Date: 2013-05-01 ; End Date: 2013-12-20
Type of Data Project	coded qualitative data
Related Publication	Fisher, Jill A., Lisa McManus, Marci D. Cottingham, Julianne M. Kalbaugh, Megan M. Wood, Torin Monahan, & Rebecca L. Walker. “Healthy Volunteers’ Perceptions of Risk in Phase I Clinical Trials: A Mixed-Methods Study.” PLOS Medicine. doi: 10.1371/journal.pmed.1002698 https://doi.org/10.1371/journal.pmed.1002698
Notes	Update Notes for Version 2.0 Version 2.0 is a QDR-administered technical update. Files have been reprocessed to improve digital accessibility; the content of materials remains unaltered.
Language	English; Castilian, Spanish
Contributor	Project Leader : Fisher, Jill A. Cottingham, Marci, Ph.D. Davis, Arlene, JD. de Guzman, Rebecca, Ph.D. Monahan, Torin, Ph.D. Roman Isler, Malika, Ph.D. Walker, Rebecca, Ph.D. Project Manager : Kalbaugh, Julianne M., M.Div. McManus, Lisa, M.S. Wood, Megan, M.A. Edelblute, Heather
Funding Information	NIGMSNIGMS: R01GM099952
Distributor	Qualitative Data Repository (Syracuse University) (QDR) https://qdr.syr.edu
Depositor	Fisher, Jill
Deposit Date	2018-10-12

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Data for: Healthy volunteers’ perceptions of risk in U.S. phase I clinical trials: A mixed-methods study

Update Notes for Version 2.0