Criticisms of Health Research Regulation in UK

Here are some of the criticisms:

1. Insufficient funding.

2. Confusion about the confidentiality and consent requirements of clinicians working in areas where research is conduted and on whom recruitment processes often rely.

3. Insufficient transparency.

4. It is unethical to request the GP to disclose patient details under the Health and Social Care Act 2012.

5. Data sharing that is legally, ethically and professionally acceptable may nonetheless be considered unacceptable by service users.

6. 'Ownership' of the data, it is intellectual property and therefore intangible property in English Law, can therefore be protected by copyright. It requires further exploration.

7. NHS has a relatively poor record on data protection (privacy protection). There are mainly two aspects of concern for subject privacy: data security (technology) and anonymisation (personal data protection acts).

8 Necessity and proportionality: Human Rights (interference with human rights is only permitted with certain criteria are met), must be held necessary and proportionate. 'Necessary' implied a 'pressing social need'. Exceptions have to be proportionate to the legitimate aim pursued, and the reasons given have to be relevant and sufficient. The public interest in benefitting from audit and research as a justification for interference with the rights to privacy and autonomy. This needs to be assessed on a case-by-case basis, according to principled proportionate governance, the paradigm would be 'consent, anonymise or authorise'.

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