Research Governance for Medical Student Electives

Research Governance for Medical Student Electives

As the area of research governance has become increasingly complex I would like to draw to your attention the University of Aberdeen new research governance handbook which puts some more clarity around what ethics approval is required for the varied types of research undertaken as part of an elective project. This applies to about 1 in 4 students who have a project that constitutes research rather than audit, service evaluation, surveillance and usual practice. There are several decision aids including the attached NRES publication and checklist. Pointers include that the project is aimed to generate new knowledge, especially with a view to disseminating that knowledge to a wider audience through publication.

From this handbook and online resources I have summarised below key points for students to consider and to appraise elective advisors on ethical approval and data management.

Ethical Approval

·  The University of Aberdeen requires that approval from a research ethics committee is required for all research involving human participants or biological samples.

·  Some research projects involve work external to the University and/or the UK. Where research involving human participants is being undertaken at another institution or outwith the UK, it should undergo formal ethical approval via the processes in place at the host institution/organisation. Once it has received ethical approval, formal evidence of that approval will normally be accepted as sufficient to meet the University’s own requirements. The University of Aberdeen takes responsibility for ensuring that its students are only taking part in properly approved activity, whether this be under the umbrella of the host institution and host supervisor or specifically approved for the student as the researcher.

·  NHS Ethics - North of Scotland Research Ethics Service (NOSRES) considers all research projects involving NHS patients, staff or premises, including studies falling within these categories done by students. NOSRES is part of the national Central Office of Research Ethics Committees (COREC) which allocates ethical review applications around the country. NOSRES is also willing to consider other projects such as those involving community-based studies, which might not strictly need its approval. Where ethical approval has been given by the NOSRES, further ethical approval consideration of the same project by the University will not normally be required.

·  The College of Life Sciences and Medicine Ethics Review Board has been established to ensure that all research carried out by staff and students in the College is reviewed by an appropriate ethics committee. For projects not covered by the remit of North of Scotland Research Ethics Committee, the Psychology Ethics Committee or an ethics review board in a different country, the Board provides the ethical review.

• Studies in healthy volunteers

• Studies using data or human tissue samples not obtained through NHS which are not completely anonymised

• Studies carried out outside the UK where there are no appropriate local ethical review procedures

• Studies involving biological samples being sent abroad for research purposes

Data Protection

Caldicott principals

1.  Justify the purpose(s) for using patient data

2.  Don't use patient-identifiable information unless it is absolutely necessary

3.  Use the minimum necessary patient-identifiable information

4.  Access to patient-identifiable information should be on a strict need to know basis

5.  Everyone should be aware of their responsibilities to maintain confidentiality

6.  Understand and comply with the law, in particular the Data Protection Act

The Data protection act has eight principles - personal data shall:

1.  Be processed fairly and lawfully (subject to certain schedules)

2.  Be obtained only for specified and lawful purposes, and not further processed in any manner incompatible

3.  Be adequate, relevant and not excessive

4.  Be accurate and where necessary kept up to date

5.  Not be kept for longer than is necessary

6.  Be processed in accordance with the data subject's rights

7.  Appropriate technical and organisational measures shall be taken against unauthorised or unlawful processing, accidental loss, destruction or damage to personal data

8.  Personal data shall not be transferred to a country or territory outside the European Economic Area (EEA) unless there is adequate protection in place

A.D. Ormerod Electives convenor 10th July 2014