A-Z research advice

 

We provide advice and support in the following areas:

Adverse event reporting

Any project might encounter an adverse event and it is important that these are dealt with appropriately. We have put together some guidance on adverse events to help you.

Archiving

See Data Management

Data Management

Data Management encompasses two, sometimes contradictory, requirements - the management of personal data, and the management of research data. In the design of your research and application for Research Ethics Committee or other approvals - it is important to distinguish between these two types of data and your intentions for them. 

1. Personal Data - Data Protection

Research working with identifiable personal data is subject to Data Protection legislation. The Secretary's office host information relating to Data Protection and Research and details relating to Transparency wording, for Patient Information Sheets and other study documents.

A key principle of Data Protection is that identifiable data should only be held if necessary, and only for as long as necessary. All research working with identifiable personal data will require review by a Research Ethics Committee; your intended use, retention and anonymisation or disposal of identifiable data should be clearly and consistently described in your application and may require revision as part of the REC review. Records must then be managed in accordance with the agreed version of your intentions, throughout the project.

If your study involves transcription of identifiable data please visit the Information security webpages, for information on approved transcription services.

Health and/or Social-Care Research: 

Patient Information Sheets: Any study that requires Health Research Authority approval must include the standard Transparency wording, describing how records will be used and retained, or it will not be approved by the HRA. 

Archiving of Study Records: There are various requirements to retain records of the conduct of a study for specific periods, in order to demonstrate the veracity of findings. However, the specific requirements tend to relate to or be derived from requirements for Clinical Trials of Investigational Medicinal Products (CTIMPs) - so cannot be applied to all studies. The basic principle is that; which records will be retained, how, who by, in what formats and for how long - should be clearly stated in your protocol, IRAS application and Patient Information Sheet (see note above) and approved by your Research Ethics Committee. Five years is typically considered a reasonable period of time (and is the legal requirement for CTIMPs) but may not be appropriate in all cases. Your approved intentions should be communicated to collaborators and must be followed at the conclusion of the study.

Paediatric Research: It is a requirement of the NHS that the healthcare records of anyone aged under 18 must be retained at least until they turn 25. If you are conducting healthcare research involving an intervention (including investigations) and the study records are the primary record of that intervention then you must retain the records of all participants until the youngest participant turns 25.

Retention of Consent Documents:

If any ethical or legal requirement to retain Consent documentation applies to your work (e.g. if you are holding Human Tissue and are required under the Human Tissue Act to retain corresponding - identifiable - consent documents) then such retention is not a contravention of Data Protection legislation, as it is covered by a legal basis.

2. Research Data - Retention and Sharing

Research Data is data which has been generated by a research project and which, to the extent possible, has been fully anonymised. The general principle with research data is that it should be shared where possible; for transparency, reproducibility and making the best use of data.

For more information, visit the Research Data Service webpages.

FAIR Data: UoB aim to meet the requirements of FAIR data principles; data should be Findable, Accessible, Interoperable and Reuseable. More information can be found in this Nature publication (external link).

Research Data Storage Facility (RDSF): Longer-term storage of data is available on the RDSF, managed by the Advanced Computing Research Centre. More information on the RDSF webpages.

data.bris Repository: Research Data can be made available to other researchers or to the public through publication on data.bris. See these webpages for more information about the repository and details of access restrictions.

Consent for Future Use: If you intend to share research data, it is advisable to include a clear statement of you intentions in your consent process - including who you intend to share data with (anyone; Open, researchers; Restricted, specific researchers; Controlled) and in what format.

Disclosure and Barring Service (formerly CRB)

Work involving certain groups of participants, particularly NHS patients, children and vulnerable adults, will generally require you to have a Disclosure and Barring Service (DBS/CRB) check. For more details on this, please visit the Disclosure and Barring Service website and the Human Resources website. You must also contact the organisation giving you access to the research participants to ensure you meet their requirements for these checks. Human Resources will help with staff DBS/CRB applications and the Faculty Office will help with student DBS/CRB applications.

Ethics

Research involving human participants, their tissue and/or data should undergo an ethical review.

Grant support

We are able to help researchers at the time of grant writing if a specific section is required to indicate research governance and ethics review arrangements. This is particularly important if the study has complex governance needs e.g. international collaborations, studies with particular insurance / indemnity requirements or studies involving vulnerable groups. In these cases we can work with you to help you establish the Research Governance-related time and cost implications that should be incorporated into your grant application. Please email research-governance@bristol.ac.uk for further information.

The University's Research Development (Funding) team provides expert advice and assistance on obtaining external funding for your research.

Insurance

Research Governance can advise on matters relating to Research Insurance, particularly for Health or Social-Care Research. You can find more information from our Research Insurance guidance page.

You can find suggested answers for the insurance questions in IRAS forms on our IRAS Insurance Guidance page. NOTE: If you have been informed that your research will be managed as a Clinical Trials of an Investigational Medicianl Product, or as a Clinical Investigation of a Medical Device, please refer instead to the CTIMP / CIMD IRAS Insurance Guidance.

You can find guidance on describing research harm and compensation arrangements in participant information on our PIL Insurance Guidance page.

Intellectual property

If you think your research may have commercial value then please visit the webpage of the University's Commercialisation team.

International collaboration

International research will normally be expected to have received ethics approval from a properly constituted and independent ethics committee in the country/ies concerned. It is the responsibility of the researcher to check the requirements for ethics review in the country/ies concerned or seek advice from its Foreign Office and to make the appropriate applications.

If such review is not available or appropriate then the research, and the reasoning for not obtaining local ethics approval, must be agreed by the University research ethics committee. For some studies it might be necessary to complete a risk assessment; please refer to the risk assessment section below.

For more guidance on making sure you get the right approvals please email research-governance@bristol.ac.uk.

Monitoring

The University currently monitors approximately 10% of active studies via a Service Level Agreement with University Hospitals Bristol NHS Foundation Trust (UH Bristol). It is undertaken in a supportive and constructive way to help ensure the ongoing integrity of a project, including the proper engagement and treatment of research participants. If your study is selected for monitoring you will be notified by the UH Bristol team. Reports are reviewed by the Head of Research Governance who will deal with any issues that might arise. Any recurring issues are incorporated into the University's Research Governance training programme. Please email research-governance@bristol.ac.uk if you have any questions or concerns about monitoring.

Open access publishing

The University supports Open Access Publishing and the principles of Open Research.

Organisational approval

If your research is taking place in a Social Care Organisation, or other non-NHS setting, and/or you are recruiting participants through one of these organisations, you should clarify with that organisation's management what you will need to put in place in order to have access to or contact with the proposed research participants. We require evidence of approval e.g. a letter of access or e-mail from the relevant organisation before the study can commence.

Peer review

For guidance please refer to our Peer Review pages.

Procurement

For Clinical Trials of Investigational Medicinal Products (CTIMPs) any necessary purchasing requirements should have input from the University's Procurement department and the Research Governance Team to ensure any contract/purchase orders fulfil the Medicines for Human Use (Clinical Trials) Regulations 2004 requirements. Further information is available in the University Purchasing Policy.

Research involving animals

For guidance please refer to the Animal Services Unit.

Research Passports

The NHS Research Passport is the mechanism for arranging access in order to undertake research involving the NHS.

Risk assessment

Some studies might require a risk assessment either for the whole study or certain aspects of the study. These include:

  • studies that involve research undertaken in the community;
  • studies that involve drugs and substances that do not fall under the Medicines for Human Use (Clinical Trials) Regulations 2004 (e.g. giving human participants caffeine, vitamin supplements, dietary interventions or studies of licenced drugs if information regarding the safety or efficacy of the drug will not be an ouptut of the study);
  • studies conducted overseas, particularly in high risk countries as indicated by the Foreign Office.

For guidance please see:

Transcription

If your study involves transcription please visit Information Security's Transcription pages, for information on approved transcription services.