Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing

Abstract

BACKGROUND Sharing of participant-level clinical trial data has potential benefits, but concerns about potential harms to research participants have led some pharmaceutical sponsors and investigators to urge caution. Little is known about clinical trial participants’ perceptions of the risks of data sharing. METHODS We conducted a structured survey of 771 current and recent participants from a diverse sample of clinical trials at three academic medical centers in the United States. Surveys were distributed by mail (350 completed surveys) and in clinic waiting rooms (421 completed surveys) (overall response rate, 79%). RESULTS Less than 8% of respondents felt that the potential negative consequences of data sharing outweighed the benefits. A total of 93% were very or somewhat likely to allow their own data to be shared with university scientists, and 82% were very or somewhat likely to share with scientists in for-profit companies. Willingness to share data did not vary appreciably with the purpose for which the data would be used, with the exception that fewer participants were willing to share their data for use in litigation. The respondents’ greatest concerns were that data sharing might make others less willing to enroll in clinical trials (37% very or somewhat concerned), that data would be used for marketing purposes (34%), or that data could be stolen (30%). Less concern was expressed about discrimination (22%) and exploitation of data for profit (20%). CONCLUSIONS In our study, few clinical trial participants had strong concerns about the risks of data sharing. Provided that adequate security safeguards were in place, most participants were willing to share their data for a wide range of uses. (Funded by the Greenwall Foundation.)

Challenges of independent assessment of potential harms of HPV vaccines

“…US survey data indicate that most people are willing to have their data shared with independent researchers 31. While it is important that participants remain anonymous and efforts to ensure an acceptably low risk of identification should be maintained, liability for re-identification could rest with those who assess the clinical study reports and be punishable by law.…”

Research Participant Views regarding Qualitative Data Sharing

“…Research in the U.S. and other countries regarding views about sharing quantitative data derived from biospecimens or clinical trials reveal that respondents are generally supportive of sharing their deidentified research data to benefit themselves, their immediate community, the public, or science as a whole. Respondents in those studies did express concerns regarding privacy and confidentiality, discrimination, or misuse of data by secondary users, but overall, they were widely supportive of data sharing 25 . Nonetheless, many reported being unaware of quantitative data‐sharing plans, which address how data will be shared and with whom 26…”

“…Respondents in those studies did express concerns regarding privacy and confidentiality, discrimination, or misuse of data by secondary users, but overall, they were widely supportive of data sharing. 25 Nonetheless, many reported being unaware of quantitative datasharing plans, which address how data will be shared and with whom. 26 In this article, we report findings from semistructured, in-depth qualitative interviews with individuals who participated in sensitive qualitative research studies to explore their understanding, experience, and concerns regarding qualitative data sharing.…”

Academic criteria for promotion and tenure in faculties of biomedical sciences: a cross-sectional analysis of 146 universities

“…Similarly, some criteria, such as data sharing, has a high research integrity value; patients support sharing of their data 22 and it facilitates assessments of reproducibility. To facilitate data sharing it is likely that the FAIR (Findability, Accessibility, Interoperability and Reusability) principles will need to be in place.…”