Reforming health research regulation: an incomplete solution

2011 ◽  
Vol 20 (10) ◽  
pp. 632-634
Author(s):  
Jean McHale
Keyword(s):  
Health Research ◽  
Research Regulation

scholarly journals Beyond categorisation: refining the relationship between subjects and objects in health research regulation

2021 ◽  
pp. 1-29
Author(s):  
Catriona McMillan ◽  
Edward Dove ◽  
Graeme Laurie ◽  
Emily Postan ◽  
Nayha Sethi ◽  
...  
Keyword(s):  
Health Research ◽  
Research Regulation ◽  
The Relationship

scholarly journals Co-production and Managing Uncertainty in Health Research Regulation: A Delphi Study

2019 ◽  
Vol 28 (2) ◽  
pp. 99-120 ◽  
Author(s):  
Isabel Fletcher ◽  
Stanislav Birko ◽  
Edward S. Dove ◽  
Graeme T. Laurie ◽  
Catriona McMillan ◽  
...  
Keyword(s):  
Health Research ◽  
Delphi Study ◽  
Research Regulation

scholarly journals Epistemic Injustice as a Basis for Failure? Health Research Regulation, Technological Risk and the Foundations of Harm and Its Prevention

2019 ◽  
Vol 10 (4) ◽  
pp. 693-721
Author(s):  
Mark L FLEAR
Keyword(s):  
Clinical Trials ◽  
Knowledge Base ◽  
Medical Devices ◽  
Health Research ◽  
Health Data ◽  
Epistemic Injustice ◽  
Research Regulation ◽  
Technological Risk ◽  
Research Participants

I use the examples of medical devices, clinical trials and health data, to look at the framing of harm through the language of technological risk and failure. Across the examples, there is little or no suggestion of failure by those formally responsible. Failure is seen as arising when harm becomes refracted through calculative techniques and judgments, and reaches a point where the expectations of safety built into technological framings of regulation are thwarted. Technological framings may marginalise the contribution patients, research participants and others can make to regulation, which may in turn underlie harm and lead to the construction of failure. This marginalisation may amount to epistemic injustice. Epistemic injustice and its link to failure, which has normative weight over and above harm, can present a risk to organisational standing and reputation. This risk can be used to improve the knowledge base to include stakeholder knowledges of harm, and to widen responsibilities and accountabilities. This promises to allow regulation to better anticipate and prevent harm and failure, and improve the efficacy and legitimacy of the health research enterprise.

scholarly journals Self-Determination in Health Research: An Alaska Native Example of Tribal Ownership and Research Regulation

2017 ◽  
Vol 14 (11) ◽  
pp. 1324 ◽  
Author(s):  
Vanessa Hiratsuka ◽  
Julie Beans ◽  
Renee Robinson ◽  
Jennifer Shaw ◽  
Ileen Sylvester ◽  
...  
Keyword(s):  
Alaska Native ◽  
Health Research ◽  
Self Determination ◽  
Research Regulation

scholarly journals Harmonising the human biobanking consent process: an Irish experience

2022 ◽  
Vol 4 ◽  
pp. 96
Author(s):  
Lydia O'Sullivan ◽  
Tomás P. Carroll ◽  
Niamh Clarke ◽  
Sarah Cooper ◽  
Ann Cullen ◽  
...  
Keyword(s):  
Informed Consent ◽  
Data Protection ◽  
Health Research ◽  
Relevant Information ◽  
Communication Process ◽  
Research Regulation ◽  
General Data Protection Regulation ◽  
Information Leaflets ◽  
Informed Consent Form ◽  
General Data

Biobanks are repositories of human biological samples and data. They are an important component of clinical research in many disease areas and often represent the first step toward innovative treatments. For biobanks to operate, researchers need human participants to give their samples and associated health data. In Ireland, research participants must provide their freely given informed consent for their samples and data to be taken and used for research purposes. Biobank staff are responsible for communicating the relevant information to participants prior to obtaining their consent, and this communication process is supported by the Participant Information Leaflets and Informed Consent Form (PI/ICFs). PILs/ICFs should be concise, intelligible, and contain relevant information. While not a substitute for layperson and research staff discussions, PILs and ICFs ensure that a layperson has enough information to make an informed choice to participate or not. However, PILs/ICFs are often lengthy, contain technical language and can be complicated and onerous for a layperson to read. The introduction of the General Data Protection Regulation and the related Irish Health Research Regulation presented additional challenges to the Irish biobank community. In May 2019, the National Biobanking Working Group (NBWG) was established in Ireland. It consists of members from diverse research backgrounds located in universities, hospitals and research centres across Ireland and a public/patient partner. The NBWG aimed to develop a suite of resources for health research biobanks via robust and meaningful patient engagement, which are accessible, General Data Protection Regulation/Health Research Regulation-compliant and could be used nationally, including a PIL/ICF template. This open letter describes the process whereby this national biobank PIL/ICF template was produced. The development of this template included review by the Patient Voice in Cancer Research, led by Professor Amanda McCann at University College Dublin and the Health Research Data Protection Network.

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