Bureaucracy is a chronic probem for any research involving the NHS. A national effort is under way to streamline paperwork, but academics are still struggling with the burden. Tony Tysome reports.
For academics submitting proposals for research that involves working with the National Health Service, a jungle of red tape usually awaits. It is a problem that has been recognised at a national level. But the few academics aware of the efforts under way to cut the bureaucratic burden are sceptical that it will bring paperwork down to an acceptable level.
Even organisations at the forefront of attempts to reform the system acknowledge that there is still some way to go before any improvements are implemented and the necessary culture change can take place.
NHS Research and Development Forum has commissioned an evaluation of a pilot "research passports" scheme that aims to streamline the system for seeking research approval from NHS trusts.
Janet Messer, deputy director of the forum, said: "The solutions are still works in progress, so unfortunately most researchers will not have seen any great changes yet. But the systems that are being put in place are designed to target precisely the issues that researchers have been highlighting."
In the meantime, researchers have warned that ideas for potentially ground-breaking studies are being left on the shelf because academics cannot afford to spend the hundreds of hours it can take to wade through all the form-filling and checking required by the NHS, funding bodies and universities.
And it is not only academics working in clinical areas who are affected.
Anyone conducting research that involves working with the NHS - which includes social scientists, sports scientists and forensic experts - is subject to the same regulations.
Edward Winter, professor of physiology and exercise at Sheffield Hallam University and chair of the research ethics committee of SHU's health and wellbeing faculty, said: "I have heard that some researchers are now conducting their research abroad to try to avoid the high levels of bureaucracy. I know some who have asked whether it is all worth it when you have to deal with two thick files' worth of documentation just for a single project proposal. It is an extremely tortuous and bumpy route."
There is almost universal acceptance that some checks and balances on proposals for research and how it is conducted need to be in place to protect NHS patients who may be involved in trials or studies, as well as academics themselves, who could be targets of litigation if things go wrong.
The history of health-related research ethics and governance can be traced back to Hippocrates' medical oath in 500BC. In contrast to that succinct description of medical practitioners' obligations, more recent regulations, many researchers argue, have caused the process of ethical review to take on an unworkable level of complexity.
Some regulations have been the result of public concern over research practice. When it was revealed that between 1988 and 1996 Alder Hey Children's Hospital in Liverpool had removed and kept organs from thousands of dead children without parental consent, scandal ensued.
The 2001 report into the Alder Hey controversy was followed later that year by new governance arrangements for the research ethics committees of hospital trusts. Since then, clinical trials regulations for medicines for human use have been brought in, and a National Research Ethics Service has been launched.
The Department of Health itself has admitted that the new regulatory environment that has emerged in the wake of the Alder Hey inquiry "represents a challenge", particularly for clinical researchers. In its strategy paper Best Research for Best Health , it says: "There are strong indications that it is becoming impossible for clinical researchers to operate effectively without expert support."
Clare Skinner, faculty research manager for medicine and health at Leeds University, said researchers working in non-clinical disciplines could be in an even worse position. Although Leeds has been working closely with local trusts to reduce red tape, she said: "It is not working completely perfectly for everyone."
Ms Skinner added: "If there are other faculties in the university that are involved in research with the NHS, they do not have the direct links and may know less about what is being done to improve the situation. In that case, it can be very difficult."
A spokesman for the UK Clinical Research Collaboration (UKCRC) - the umbrella body that is charged with "re-engineering" the environment in which clinical research is conducted - said the lack of consistency between trusts in the application of regulations was one of the main causes of current problems.
Action being taken includes plans to institute the research passport scheme on a nationwide basis after a successful pilot in Manchester; "imminent" moves to introduce a new national advice service for trusts' research and development offices to standardise regulatory regimes; plans for new clinical research networks to form a central R&D approval system; and the eventual introduction of a non-commercial model research contract for trusts and universities.
The UKCRC admitted that the size of the task it had taken on and the timescale involved was something akin to turning around a tanker. Its spokesman said: "A lot of this is about cultural change within the NHS. We are trying to move it on as quickly as we can, but it is likely to be a gradual process."
'IT IS A COMPLEX AREA, BUT THERE IS NO DOUBT THAT IT INHIBITS WORK
' * Preparing applications for research to be conducted in the National Health Service is a "bureaucratic nightmare" that "inhibits good research", said Eloise Carr , a reader in pain management at Bournemouth University.
"It is an extremely complex arena - there are so many different organisations and agencies involved. There is no doubt that bureaucracy is inhibiting good research. People say it is completely scuppering some projects," she said.
Although she welcomes initiatives that aim to reduce the burden of red tape, such as the research passport scheme, , Dr Carr fears they may have little impact.
* Lawrence Young , head of the division of cancer studies at Birmingham University, has doubts over how much difference current national initiatives will make to the "enormous mountain of regulatory issues" that is clogging up health-related research.
"It is getting better in that they have developed a framework for change. But on the ground I personally have yet to see any benefit.
"The will is there, and they have come up with various proposals," he said.
"There are various policy documents floating around, but what I am concerned about is what difference this will make operationally. It is great to have a national agenda, but what is important is what is happening locally."
* Nibesh Samani , professor of cardiology at Leicester University, acknowledges the need for a system to regulate research activities in the health service.
"But the present system is a heavily bureaucratic process that does not have the turnaround time you want if you are planning a study," he said.
"If you have a bright idea that you want to test out or you want to get medical students involved in research, you are put off from even applying."
Discontent over the problems has risen to a level that the issue is now coming to a head, he added.
* Red tape is not putting academics off submitting applications to conduct studies in the NHS, according to Alistair Burns , professor of psychiatry at Manchester University.
"There are people who will take a negative view, and yes, there are a lot of forms to fill in. But this is just something that has to be done. It is certainly not going to put me off putting in any research proposals," he said.
Professor Burns, deputy dean for clinical affairs at Manchester, thinks the piloting of the research passport scheme by the Greater Manchester Research Alliance has been so successful that it could be a model for the rest of the sector.
* John Saxton barely finds time to carry out research, such is the burden of red tape. The reader in clinical exercise physiology at Sheffield Hallam University has had to ask for administrative support.
"We have so many research project on the go that I sometimes spend the entire week on the paperwork. I accept that checks have to be done. But the system is so cumbersome that sometimes it seems as if the research is only a small part of the whole process."
RESEARCH ETHICS TIMELINE
Hippocrates: An oath outlining physicians' duties is named for and popularly attributed to the Greek 'Father of Medicine'
James Lind: Work detailed in A Treatise of the Scurvy is arguably the first research trial
Sir John Gregory: Scottish physician and philosopher produces the first description of medical ethics in English
Dr Albert Moll: German psychiatrist writes a code of medical ethics
Nuremberg code: Created by presiding judiciary at war-crime trials of accused Nazi physicians
The Helsinki Declaration: A code of practice for physicians involved in medical research
The first Research Ethics Committee in the UK
Central Office for Research Ethics Committees (COREC) established
Alder Hey scandal brings new governance arrangements for research ethics committees
The Medicines for Human Use Regulations
Launch of the National Research Ethics Service.
'THE SUBMISSIONS TOOK 250 HOURS, 56 PEOPLE AND 900 SHEETS OF PAPER'
Beatrice Sofaer-Bennett is a university-based social scientist and reader in health professions.
"As a university-based social scientist, I have studied the effects of illness on sufferers and their families in collaboration with medical and academic colleagues.
"Last year, we designed a study, gained university approval and obtained external peer review. Our application for funding from a charitable trust succeeded.
"The three National Health Service consultants involved will invite patients and families to participate in a voluntary focus group interview, with no medical or psychological intervention.
"Following guidelines from the Central Office for Research Ethics Committees, the application submitted to the local research ethics committee (LREC) ran to 69 pages, with 16 appendices, a variety of explanation sheets and consent forms.
"Before submission to LREC, all the documents were approved by the university's faculty research ethics and governance committee (FREG) to confirm that the university would sponsor the research. The LREC committee had no ethical problems with our proposal and gave approval quickly.
"But research involving NHS service users also requires permission from the governance committees of NHS trusts.
"Two trusts were involved in this project. Trust A required duplicate documentation to that prepared for LREC, plus a copy of the honorary contract already held by me as principal investigator. Trust B is piloting new guidelines, which I understand may become standard across the NHS.
"In addition to duplicates of the papers already sent to LREC for governance committee approval, Trust B required further documentation in order to issue a 'research passport'. This enables the holder to carry out a one-off research project, in theory in any trust in the UK.
"Trust B required a signed three-page declaration that I had not been involved in any fraudulent dealings, and the university to obtain both Criminal Record Bureau and occupational health clearance for me.
"The project was straightforward, but 200-250 hours were spent preparing the submissions, 56 people had been involved and 900 A4 pages of documents generated.
"I am not against checks, but they should be proportionate and reasonable. It will come as no surprise if applications to do medical-social research dry up because gaining approval is an undertaking only for the most resilient."