The effect of privacy legislation on observational research

Gershon, Andrea S.; Tu, Jack V.

doi:10.1503/cmaj.061353

Cited by 20 publications

(20 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

Section: Introductionmentioning

confidence: 99%

“…Since 1995, governments of developed countries have passed legislation which requires consent for the use of health information in order to protect the privacy of identifiable health information 9. Although the privacy laws allow for a waiver of consent, in some special situations, researchers became concerned that conservative interpretations of the legislation by ethical review committees would make mandatory the request for individual consent 9. Ness,10 in a survey carried out 4 years after the implementation of the Health Insurance Portability and Accountability Act Privacy Rule, showed that American epidemiologists perceived that this legislation impacted health research negatively, increasing project costs and time.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Informed consent for record linkage: a systematic review

et al. 2012

View full text Add to dashboard Cite

The results of this review show that, in general, individuals tend to consent to the use of their data for record linkage, with exceptions in specific populations or minorities. The authors believe that this, as well as the cited literature, lends support to policies that, while keeping relevant ethical controls in place, do not require individual informed consent for each and every study that relies on secondary data.

show abstract

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Informed consent for record linkage: a systematic review

et al. 2012

View full text Add to dashboard Cite

show abstract

“…655-56. 41 See also, (The Academy of Medical Sciences 2011; Peto et al 2004;Kielmann et al 2007;Gershon and Tu 2008). 42 When developing his idea of public reason Gaus relies upon an idea of Members of the Public where each "deliberates well and judges only on the relevant and intelligible values, reasons, and concerns of the real agent she represents and always seeks to legislate impartially for all other Members of the Public".…”

Section: Acceptability Of Processing For Health Research Purposes Witmentioning

confidence: 99%

Public Interest, Health Research and Data Protection Law: Establishing a Legitimate Trade-Off between Individual Control and Research Access to Health Data

Taylor

Whitton

2020

Laws

View full text Add to dashboard Cite

The United Kingdom's Data Protection Act 2018 introduces a new public interest test applicable to the research processing of personal health data. The need for interpretation and application of this new safeguard creates a further opportunity to craft a health data governance landscape deserving of public trust and confidence. At the minimum, to constitute a positive contribution, the new test must be capable of distinguishing between instances of health research that are in the public interest, from those that are not, in a meaningful, predictable and reproducible manner. In this article, we derive from the literature on theories of public interest a concept of public interest capable of supporting such a test. Its application can defend the position under data protection law that allows a legal route through to processing personal health data for research purposes that does not require individual consent. However, its adoption would also entail that the public interest test in the 2018 Act could only be met if all practicable steps are taken to maximise preservation of individual control over the use of personal health data for research purposes. This would require that consent is sought where practicable and objection respected in almost all circumstances. Importantly, we suggest that an advantage of relying upon this concept of the public interest, to ground the test introduced by the 2018 Act, is that it may work to promote the social legitimacy of data protection legislation and the research processing that it authorises without individual consent (and occasionally in the face of explicit objection).

show abstract

“…In recent commentaries, new privacy legislation has imposed limitations on observational research, specifically leading to decreased participation and a selection bias in studies. [30][31][32][33][34] Canada's PIPEDA requires study participants to provide informed consent; although institutional review boards can waive this requirement in very select circumstances, this seems to occur only rarely. 32 The RHSCIR was initiated in the same way as a multicenter clinical research study, which meant obtaining an institutional review board/research ethics board (IRB/REB) approval at each site; this allowed the RHSCIR to collect the data at each of the local member sites located across Canada.…”

Section: ■ Functional Aspects Of Rhscirmentioning

confidence: 99%

Population-Based Spinal Cord Injury Registries: Potential Impacts and Challenges

Fehlings¹,

Boakye²,

Ditunno³

et al. 2013

Essentials of Spinal Cord Injury

View full text Add to dashboard Cite

Key Points1. Prospective data registries provide an effective way of tracking outcomes and epidemiology and can be useful in collecting valuable observational data that can inform clinical practice. 2.A registry should be focused on key data elements to be useful. 3.To ensure that the data collected remain focused, specific research questions should be formulated when setting up the registry. 4.Challenges in setting up such registries can include issues of privacy related to collecting data on patients, which is a further incentive to have focused research questions making the value and intended use of the data clear to those concerned.

show abstract

The effect of privacy legislation on observational research

Cited by 20 publications

References 8 publications

Informed consent for record linkage: a systematic review

Informed consent for record linkage: a systematic review

Public Interest, Health Research and Data Protection Law: Establishing a Legitimate Trade-Off between Individual Control and Research Access to Health Data

Population-Based Spinal Cord Injury Registries: Potential Impacts and Challenges

Contact Info

Product

Resources

About