Related Experiment Video
Updated: Jul 5, 2025
Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management
Published on: November 30, 2022
Stakeholder perspectives on data sharing from pragmatic clinical trials: Unanticipated challenges for meeting
Stephanie R Morain1,2, Juli Bollinger1, Kevin Weinfurt3
1Berman Insitute of Bioethics Johns Hopkins University Baltimore Maryland USA.
Introduction:
Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trial data. However, data sharing in pragmatic clinical trials (PCTs) presents ethical challenges. While prior scholarship has described aspects of PCTs that raise distinct considerations for data sharing, there have been no reports of the experiences of those at the leading edge of data-sharing efforts for PCTs, including how these particular challenges have been navigated. To address this gap, we conducted interviews with key stakeholders, with a focus on the ethical issues presented by sharing data from PCTs.
Methods:
We recruited respondents using purposive sampling to reflect the range of stakeholder groups affected by efforts to expand PCT data sharing. Through semi-structured interviews, we explored respondents' experiences and perceptions about sharing de-identified, individual-level data from PCTs. An integrated approach was used to identify and describe key themes.
Results:
We conducted 40 interviews between April and September 2022. Five overarching themes emerged through analysis: (1) challenges in sharing data collected under a waiver or alteration of consent; (2) conflicting views regarding PCT patient-subject preferences for data sharing; (3) identification of respect-promoting practices beyond consent; (4) concerns about elevated risks or burdens from sharing PCT data; and (5) diverse views about the likely benefits resulting from sharing PCT data.
Conclusion:
Our data indicate unresolved tensions in how to fulfill the expectation to broadly share de-identified, individual-level data from PCTs, and suggest that those promulgating and implementing data-sharing policies must be sensitive to PCT-specific considerations. Future work could inform efforts to tailor data-sharing policy and practice to reflect the challenges presented by PCTs, including sharing experiences from trials that have successfully navigated these tensions.
More Related Videos
07:31Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack
Published on: May 15, 2020
14:43A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
Related Concept Videos
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...
01:23Ethical Standards II
Nurses are entrusted with upholding various ethical principles and standards. Nurses forge solid therapeutic relationships using trust, empathy, autonomy, confidentiality, and professional competence.
Confidentiality is crucial, embodying respect for individual privacy...
01:25Ethical Standards I
The Code of Ethics provisions outline the nurse's duty to the patient, the healthcare team, the profession, and society. The Code's fundamental principles include advocacy,...
01:29Issues And Trends In Healthcare Delivery System
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
01:27Nursing Ethical Principles II
Consider the following scenario, which illustrates how these principles are applied in the care of Mr. John, a fifty-year-old teacher diagnosed with metastatic liver cancer.
Initially, Mr. John's...