Abstract
PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 79-96 |
| Number of pages | 18 |
| Journal | Accountability in Research |
| Volume | 23 |
| Issue number | 2 |
| DOIs | |
| State | Published - Mar 3 2016 |
Fingerprint
Keywords
- Data management
- Empirical studies of research ethics
- Ethics and public policy
- Human subjects ethics
- Human subjects regulation and oversight
- Informed consent
- Public policy
- Research ethics
- Translational research
ASJC Scopus subject areas
- Education
- Library and Information Sciences
Cite this
Anticipated Ethics and Regulatory Challenges in PCORnet : The National Patient-Centered Clinical Research Network. / Ali, Joseph; Califf, Robert; Sugarman, Jeremy.
In: Accountability in Research, Vol. 23, No. 2, 03.03.2016, p. 79-96.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Anticipated Ethics and Regulatory Challenges in PCORnet
T2 - The National Patient-Centered Clinical Research Network
AU - Ali, Joseph
AU - Califf, Robert
AU - Sugarman, Jeremy
PY - 2016/3/3
Y1 - 2016/3/3
N2 - PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.
AB - PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.
KW - Data management
KW - Empirical studies of research ethics
KW - Ethics and public policy
KW - Human subjects ethics
KW - Human subjects regulation and oversight
KW - Informed consent
KW - Public policy
KW - Research ethics
KW - Translational research
UR - http://www.scopus.com/inward/record.url?scp=84948671470&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84948671470&partnerID=8YFLogxK
U2 - 10.1080/08989621.2015.1023951
DO - 10.1080/08989621.2015.1023951
M3 - Article
VL - 23
SP - 79
EP - 96
JO - Accountability in Research
JF - Accountability in Research
SN - 0898-9621
IS - 2
ER -