11.4 Extending skills


T ere are various possible answers, and it is impossible to cover them all. T e key when evaluating students’ answers is that there needs to be a clear case of the benefi ts to an individual or to society of the disclosure, outweighing the public’s and the patient’s interest in keeping the information private.


Suggested answers


1. clinical benefi ts, confl ict of interest, patient safety, legal compliance, confi dentiality issues


2. T ese could include the clinical justifi cation for the trial, the implications of the outcome for the target patient group, the societal benefi ts and the broader economic justifi cation.


3. Data might be released: • with the patient’s consent


• without the patient’s consent when it is in the public interest


• accidentally 4. Data might be accidentally released:


• when transferring data to another department, institution or organization


• when disposing of personal data


• by including too much information when creating statistical data sets


• by data system users accessing data for a use other than intended


• by unauthorized users gaining access to the record system (hacking)


5. An example from the UK is ‘notifi able diseases’. T ese are diseases where information about a patient must be shared with the government for public health reasons, such as to prevent the spread of the disease.


Hadmore Research Ethics Committee Resources and guidance


These pages contain resources to help applicants produce good-quality applications for clinical trials. To ensure a successful application, it is essential that these examples are followed carefully.


Extracts from successful trial applications • Clinical justification • Implications of trial outcome for target patient group • Societal benefits of trial outcome • Economic justification • Statement of conflict of interest


Guidelines on legal compliance • Human Tissue Act (2004)


• The Human Fertilisation and Embryology (Parental Orders) Regulations (2010) • Data Protection Act (2018)


Useful research papers •


Jones AM, Bamford B. The other face of research governance. BMJ. 2004 Jul 29; 329: 280. Available from: https://doi.org/10.1136/ bmj.329.7460.280


• Luyckx VA, Biller-Andorno N, Saxena A, Tran NT. Health policy and systems research: towards a better understanding and review of ethical issues. BMJ Global Health. 2017; 2(2): e000314. Available from: https://dx.doi.org/10.1136/bmjgh-2017-000314


Patient consent and safety sample documents • Patient information sheet • Consent form • Current health status checklist • Checklist for preclinical testing


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