How do I get NHS ethics approval and Research Governance?

Information on research, statistics and publications - tips including how to recruit participants, gain funding, understand your results and get them published.
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nettyb
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How do I get NHS ethics approval and Research Governance?

Post by nettyb » Fri May 04, 2007 9:02 am

Getting NRES NHS Ethical approval

All research undertaken with NHS patients or staff must have have approval from the nearest NHS ethics committee(s) to the research site before it commences. Failure to do this results in research misconduct.

Ethical approval aims to maintain ethical standards of research practice, protect participants from harm, protect participants’ rights, provide reassurance to the public, and protect researchers from unjustified criticism and harm.

The NRES process has been tightened up in recent years, and many committees will look very carefully at the methodology to see how feasible the study is before giving approval, on the grounds that wasting patients’ or employees’ time is unethical. Think carefully about what you write on your NRES application form. Prepare good consent forms and information sheets, prepare power calculations to justify sample size if required, and think carefully about issues of consent and vulnerability if your sample is to include vulnerable populations such as children with chronic illness.

The NRES website provides information for applicants on the whole application process. What follows here is a summary of the process.

The NHS ethics application form

Application for ethical approval should be made by the chief investigator, using the online NHS ethics form and should be accompanied by supporting documentation. The ethics form comprises three parts:

Part A (p1-25) generic information
Part B (p26-39) specialist information on the study
Site Specific Information (SSI) (p40-50)

Once completed the form is always less than the full 50 pages as irrelevant sections are automatically blanked out. The answers to certain questions automatically complete other parts of the form needing the same information, for this reason parts A and B of the form should be completed before the SSI section. Many questions have an i symbol next to them, which will bring up further guidance specific to the question. It is good practice to use the language of the NRES guidance when completing your form.

Submitting the form:

When you are ready to submit, contact your chosen ethics committee to arrange a meeting. You will be given a reference number to enter on your ethics form. Once you've done this click on 'forms' then 'manage application'. Click 'lock for submission'. Once locked you will be unable to make further changes to the form. The relevant committee will now be able to retrieve it.

Paper copies of all documents, including the form (bearing your signature) should be posted out to your committee. Information about the supporting evidence needed can be found here. The appropriate ethics committee should receive your application within 4 working days of you arranging a meeting.

Do I need Site Specific Assessment (SSA)?

SSA assesses the suitability of each research site and of Principal Investigators at each site.

Is SSA required? In general, all clinical trials of medicinal products, clinical investigations of medical devices, and other clinical trials require SSA. Other types of research are usually SSA-exempt, except where responsibility for informed consent is delegated to local collaborators, or where there is more than minimal risk of harm to participants.

Once research not requiring SSA has gained ethical approval, this approval can be extended to sites elsewhere in the UK without requiring approval from any other ethics committees.

The table below (reproduced from COREC documentation) should help determine whether SSA is required:

SSA-exempt procedures
* Investigations or assessments within the routine professional competence of local collaborators(e.g. blood/urine samples, scans, mental health assessments)
* Routine clinical monitoring
* Questionnaires and surveys
* Qualitative research methods
* Collection of data or human tissue
* Performance evaluation of in vitro diagnostic device (using data/tissue only)
* Laboratory tests and analysis
* Facilitating participant recruitment

Procedures requiring SSA

* Novel clinical interventions(e.g. IMPs, surgery, radiotherapy, mental health interventions)
* Novel clinical assessments (not within routine professional competence of local collaborators)
* Clinical use of non-CE marked medical device, or a CE marked device that has been modified or is to be used outside its intended purpose
* Additional clinical monitoring under study protocol (outside normal clinical responsibilities)
* Taking of informed consent by local collaborators

How to obtain SSA

Application for SSA should be made once confirmation of a valid ethics application has been received from the main ethics committee. The principal investigator should send send the Site Specific Information (SSI) form and their CV to the local ethics committees for each site. Be sure to complete the SSI form only after sections A&B of the ethics form have been completed as some of the answers will be automatically populated from the ethics form. A separate SSI form should be competed for each site requiring SSA.

Which NRES committee do I send my application to?

Ethical approval must be sought from the appropriate NHS Local Research Ethics Committee or NHS Multi-Site Research Ethics Committee. The ethics committees do not have the same geographical boundaries as NHS trusts and this sometimes causes confusion.

Local Research Ethics Committees (LRECs) can generally assess:

* Single site research. Approach the LREC covering the site.
* Research within one Strategic Health Authority Area (even if it involves multiple sites within that area.) Approach either the LREC covering the lead site, or the Central Allocation System - see bottom of page.
* Research involving prisoners in Scotland.

Once ready to submit, contact the relevant LREC directly - see the committee contacts list. If there are no agenda slots left with the LREC you approach, you may go to any other LREC in the Health Authority Area. Often the LREC you approach will advise on which committees are likely to have slots available in the near future.

Multi-site research ethics committee (MREC) assessment is needed for any of the following:

* Research covering sites falling in different Strategic Health Authorities Areas.
* Clinical trials.
* Research involving prisoners in England or Wales.
* Research involving adults with incapacity (unable to consent for themselves) in Scotland (and also in England and Wales after 1 July 2007).

Once you are ready to submit your multi-site application, contact the Central Allocation System to agree a meeting date and committee, by phoning 0845 270 4400 (week days, 9.30am-4pm).

How long does the process take?

Ethics committees must return a decision on approval within 60 days of receiving a valid application. In order to facilitate this turnaround, committees meet monthly. Although attendance is not compulsory, applicants are strongly encouraged to attend.

The committee can seek clarification, in writing, on one occasion. The 60-day clock stops while the committee awaits a response, and restarts when they receive a complete response. If the response is unsatisfactory the committee may reject the application, or if the majority of concerns are resolved, may allow a second attempt at responding to the same questions, with the clock still stopped.

What are my responsibilities after applying?

Changes to protocol:

Significant revisions to the application may not be made between submitting it and receiving a final ethical opinion. If this is necessary you will have to withdraw the application and resubmit. Minor changes may be discussed at the meeting, or if decided upon after the meeting may be included in your response to the ethics committee for further information.

Responsibilities after approval:

Following approval you should inform the main ethics committee of:

* Substantial amendments to research (including additional research sites), using a 'Notice of Substantial Amendments Form' (from the National Research Ethics Service website). A committee will give a decision on any change within 35 days of being notified. If the amendment is rejected you can submit a modified amendment, which will be reviewed within a further 14 days. Administrative changes just need to be acknowledged by your REC administrator.
* Suspected unexpected serious adverse reactions to the treatment or therapy which you are researching using a ‘Serious Adverse Event’ form within 15 days of becoming aware of the event
* Annual progress using an 'Annual Progress Report Form' (submit every 12 months after receiving a favourable opinion on ethics till the end of the study)
* The project finish (this is the final date or event in the protocol rather than the completion of data analysis or publication of results). Use a ‘Declaration of the End of a Study’ form and submit within 90 days if the project finishes as planned, or within 15 days if it terminates early. Also send a summary of the final report on the research, either with the form, or within 12 months the finish of the project.

R&D approval

NHS R&D approval must be given by each NHS trust in which research will take place before research commences. Without this approval the project does not have NHS indemnity cover for negligent harm. The R&D application is used for resource assessment, financial assessment, and the co-ordination of relevant internal authorisations within each trust. NHS R&D approval is sometimes known by other terms, including "trust management approval", and "research governance approval".

Application is made on a Site-Specific Information (SSI) form. This online form is also used to apply for Site-Specific Assessment (SSA) where required. It should be accompanied by supporting documentation. All the documents comprising the application should be emailed or posted to the R&D office of each trust involved. See the instructions for downloading the completed form.

Once a project has R&D approval from any trust, that trust will send project details on to the National Research Register (the Department of Health maintained database of ongoing and recently completed research projects funded by, or of interest to the NHS.)

After applying to R&D

You will be sent a Trust Management Approval letter when R&D approval is granted. The R&D office will not normally need to meet you before granting approval.

After gaining approval the R&D office should be provided with:

* Details of any changes to the project
* An annual update of the study progress
* Notification of project outcome
* Notification of any peer-reviewed papers published as a result of the project.

The exact arrangements for each of these may vary from trust to trust and should be checked with the R&D office.

Glossary

The Chief Investigator (CI) is the investigator with overall responsibility for the research. In a multi-site study, the CI has co-ordinating responsibility for research at all sites. All applications for ethical review should be submitted by the CI.

The Domain is defined as a Strategic Health Authority Area.

End of project The completion of the final date or event in the protocol.

Indemnity cover is provided for students by the University Public Liability policy. Trust R&D approval should confer that you also have cover through the trust. Cover from both the host trust(s) and the University is necessary so that you are covered whichever liability is found to lie with in cases of dispute.

The Local Researcher is the person bearing the day-to-day responsibility for the conduct of research at any given site.

NRES Short for The National Research Ethics Service. NRES provides help, leadership and support to ethics committees. The NRES website provides advice to those applying for NHS ethical approval.

The Principal Investigator (PI) is the investigator responsible for the research site where the study involves specified procedures requiring site-specific assessment. There should be one PI for each research site. In the case of a single-site study, the CI and the PI will normally be the same person.

The Site is usually defined as an NHS trust.

The Sponsor is often not the same as the funder. Whereas a funder provides funding for a study, the sponsor is the organisation that takes overall responsibility for securing the arrangements to initiate, manage and finance a study. Note about sponsors.

Start of project The commencement of any protocol procedures.

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