Data for: Healthy Volunteers’ Perceptions of Risk in U.S. Phase I Clinical Trials: A Mixed-methods Study (doi:10.5064/F6LXO8PS)

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Data for: Healthy Volunteers’ Perceptions of Risk in U.S. Phase I Clinical Trials: A Mixed-methods Study

doi:10.5064/F6LXO8PS

Qualitative Data Repository

2018-10-26

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HealthyVOICES Project 0000-0002-9487-1493. 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

Data for: Healthy Volunteers’ Perceptions of Risk in U.S. Phase I Clinical Trials: A Mixed-methods Study

doi:10.5064/F6LXO8PS

HealthyVOICES Project 0000-0002-9487-1493 (https://ror.org/0130frc33)

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.

Kalbaugh, Julianne M., M.Div.

McManus, Lisa, M.S.

Wood, Megan, M.A.

Edelblute, Heather

R01GM099952

Qualitative Data Repository

Qualitative Data Repository

Fisher, Jill

Fisher, Jill

2018-10-12

https://doi.org/10.5064/F6LXO8PS

Social Sciences, risk perceptions, healthy volunteer, phase I clinical trial, pharmaceutical, health behavior, medication, medical ethics

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.

2013-05-01-2013-12-20

coded qualitative data

<a href="https://qdr.syr.edu/policies/qdr-standard-access-conditions">Standard Access</a>

Fisher, J. A., McManus, L., Cottingham, M. D., Kalbaugh, J. M., Wood, M. M., Monahan, T., & Walker, R. L. (2018). Healthy volunteers’ perceptions of risk in phase I clinical trials: A mixed-methods study. <i>PLOS Medicine</i>.

10.1371/journal.pmed.1002698

Fisher, J. A., McManus, L., Cottingham, M. D., Kalbaugh, J. M., Wood, M. M., Monahan, T., & Walker, R. L. (2018). Healthy volunteers’ perceptions of risk in phase I clinical trials: A mixed-methods study. <i>PLOS Medicine</i>.

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0_Fisher_HealthyVOICES_BaselineInterviewGuide.pdf

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Interview Guide

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0_Fisher_HealthyVOICES_Consent Form_082013.pdf

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Consent Form

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README_Fisher.txt

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README

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Fisher_HealthyVOICES Baseline Risk - Redacted.pdf

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