Privacy and confidentiality in pragmatic clinical trials.
Clin Trials
; 12(5): 520-9, 2015 Oct.
Article
in En
| MEDLINE
| ID: mdl-26374682
ABSTRACT
With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for personswhich encompasses their interests in health information privacycan be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Clinical Trials as Topic
/
Confidentiality
/
Privacy
/
Informed Consent
Type of study:
Prognostic_studies
Limits:
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
Clin Trials
Journal subject:
MEDICINA
/
TERAPEUTICA
Year:
2015
Type:
Article
Affiliation country:
United States