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Prison research project is throttled by red tape
19 February 2009
Mental-health services study abandoned after a 14-month bureaucratic nightmare. John Gill reports
A doctoral student has detailed how she was forced to abandon her studies after getting stuck in a "quagmire" of red tape, warning that over-regulation is crippling health research.
Dina Gojkovic, a PhD student at the University of Lincoln, described her efforts over 14 months to navigate "burdensome and obstructive" National Health Service governance and ethics procedures.
This labyrinthine system, she said, was hitting universities in the pocket and ultimately leading to valuable research being abandoned.
Ms Gojkovic, whose aim was to assess mental-health services at six UK prisons, detailed a litany of setbacks and administrative cock-ups that beset her.
The ill-fated project got off to a bad start, she said, when first the system for securing approval was changed and then an ethics council ruled that all prisoners she interviewed would have to be assessed using a "four-point test" to ensure that they were capable of giving consent.
Although a mental-health lawyer told Ms Gojkovic that the ruling was "wrong in law", the extra burden forced her to cut the number of prisons involved and led her to apply to Lincoln for an extension to complete her project.
Her next hurdle was dealing with the National Offender Management Service (NOMS) and NHS research and development offices, neither of which could tell her whether she needed an honorary contract with the NHS or a "research passport" to conduct the research.
Eventually she was told that either designation would do, provided that she had undergone Criminal Records Bureau and occupational-health checks.
Two months later, however, this advice was retracted by an NHS trust that said she would need a research passport, but that it could not issue her with one as it had no links with Lincoln.
The delays continued when staff at the NOMS lost her papers on three occasions before finally telling her that she did not need their permission after all.
Ms Gojkovic then applied directly to HM Prison Service for approval. Her case was passed from its health to its policy department to the National Research Committee.
At this stage she was told to wait three months. When she tried to speed the process up, she was informed that the area psychologist, whose approval was also required, was about to take a long period of leave, threatening further delays.
The project deadline was extended yet again, and a further scholarship was awarded by the university to cover Ms Gojkovic's costs.
By now the application for ethical and governance procedures had taken 14 months, and when one of the mental-health trusts involved withdrew its prison from the study, the project was abandoned.
Ms Gojkovic said that the future of research in prisons, which had been a mainstay of mental-health research over the past 50 years, was being put at risk by an overly complex system.
"The Government is perfectly right in trying to set up strict procedures for evaluating research. Strict, however, should not be confused with disjointed and chaotic."
The Department of Health guidance, she said, states that "the NHS is expected to manage risk, minimise bureaucracy and facilitate research".
"It has spectacularly failed to achieve the last two of these three aims," Ms Gojkovic said.
john.gill@tsleducation.com.
Readers' comments
I am not really surprised that this unpleasant experience occurred.I undertook a research project ion 2004 for a Masters and encountered similar problems and this was not within a prison environment. I think that like a number of initiatives designed to help safeguard individuals fail when implemented because they are done so in a piecemeal way. I wonder how much research has actually been tied into the clinical Governance arrangements between PCTs and prisons and how many actually know how it all works. Lets be frank research governance is a growth industry and much has changed in the past year or so to complicate matters outside never mind within prisons. Lets also be frank that research governance is a mystery to those outside of research governance! Its unsurprising with so much going on and how litte this is generally understood that those trying to actually do research feel so frustrated.I empathise and suggest guidance is provided to SHAs/CSIP/PPBs to take this important matter forward in a practical way
The process of securing research ethics and governance permissions for prison-based health care research can be an involved process predominantly because it involves gaining authorisation from more than one organisation which need to consider different aspects of the impact of conducting the work.
The national Offender Health Research Network (OHRN) has, over recent years, conducted work around streamlining the processes involved. This has been done in partnership with senior professionals from all concerned bodies, for example the NHS National Ethics Research Service, NHS research governance representatives from Primary Care and Community Health Trusts, HM Prison Service and the Ministry of Justice.
Comprehensive advice for researchers and those administering the permissions system is available on our website (www.ohrn.nhs.uk) and we have hosted a number of free regional workshops to further disseminate information and provide a forum for researchers to meet face to face with policy and decision makers to discuss general or individual issues.
We would advise researchers to seek advice from ourselves at the very start of the process to ensure that they are clear about which permissions they require; that applications to different bodies are made in parallel rather than sequentially to reduce potential delays; and that academic supervisors of research are involved proactively in the process to broker contact with regulatory bodies on behalf of more junior staff when problems become apparent."
The Integrated Research Application System (IRAS) has been developed to help researchers prepare their applications to the various regulatory and review bodies that relate to health research of different kinds.
Planning and conducting health research in prisons is particularly complex because of the range of bodies that may need to be involved. IRAS already provides an integrated system to apply to several review bodies including the Ministry of Justice. The IRAS Project Team is now working with the National Offender Management Service to include applications for their review within IRAS. IRAS will help to signpost researchers to the appropriate review required for their project.
A UK-wide Regulatory and Governance Advice Service has been established to support local advice providers in handling complex research situations. Those involved in the Offender Health Research Network, IRAS and the various review bodies are all working together to identify and remove unnecessary barriers to conducting high quality health research in the criminal justice system. These developments will address many of the concerns raised by researchers. We welcome constructive feedback and involvement from researchers to help us make further progress in this area.
Thank you Jane and Jane for clarifying the situation. It sounds very complicated. Regional workshops, fora, constructive feedback, further progress... it makes me wonder why anyone would bother when there are far easier research topics, of far lower importance, for which one can obtain research funding and for which field access is a lot more straightforward. It seems that the more urgently needed and potentially vavluable the research, the more bureaucratic obstacles there are to overcome to actually get it done.
As Dina Gojkovic's academic supervisors we note with great interest the comments posted by Jane Senior and Janet Messer in response to Dina’s article. We would reply as follows:
We did indeed contact the OHRN but the advice obtained was inconclusive due to the system changes that were taking place. The OHRN member of staff tried hard for 2 months to get some useful information for us but there was little that could be done as IRAS was not properly integrated into the existing system.
Dina Gojkovic attended both the OHRN workshop and NRES researcher training days, both of which gave very useful guidelines, but an important point to make is that researchers need help once they are IN the system as well. Neither training day dwelt on the issue of assessing capacity to consent.
In terms of speeding up the process by sending out the application forms to several bodies in parallel, the documents for governance approval were sent out only 1 month after having sent the documents for MREC approval. However this does not alter the fact that DG had to wait for almost 5 months until the research passport was set up.
3 months after the application was sent to HMPS DG received an email from them stating that they had not received copies of the MREC approval despite the fact this had been sent with a large bundle of other papers. We would agree with Senior that when organisations deny receipt of documents this can, indeed, makes the process ‘involved’.
Senior seems to imply that the organisational failings which are self-evident are somehow the product of ‘hands-off’ academic supervision. Those with a responsibility for the ethics/governance system blame individuals whilst individuals blame the system and those administering it. All we would ask that the experiences of users are listened to rather than denied.
Just wanted to say that I have been working on a short contract evaluating services for treatment of alcohol related violence and I have found the same nightmare experience and red tape
I have written to Dina Gojkovic previously to convey my genuine regret for the problems that she encountered with respect to the burdensome governance and ethics procedures that appear to have derailed her project.
I do, however, take issue with the implication by Gill in his article that the ethics review process contributed to the litany of setbacks and administrative cock-ups that he described.
The REC (C for Committee, not Council) office received Ms Gojkovic's application on 13th March 2008 and she attended the next meeting on 11th April. A provisional opinion was given on 21st April and following a response from the researcher, a favourable opinion was given on 8th May. Hardly burdensome.
Further, an amendment to the original protocol was received for review on 19th September and an amendment review subcommittee was convened specifically to expedite the process and a favourable opinion was given on 7th October. Hardly obstructive.
I should also convey that members of the Northern and Yorkshire Research Ethics Committee were extremely impressed with the research proposal and with Ms Gojkovic's enthusiasm, knowledge and motivation for undertaking her project.
A crucial issue, however, appears to be our ruling that the capacity of prisoners had to be assessed to ensure that they were capable of giving consent. The implication by Gill that, because a mental health lawyer deemed this to be 'wrong in law', then this was unnecessary and added yet more burden to her project.
The exact nature of the project remained curiously silent in Gill's article: an evaluation of mental health service provision in UK prisons which would have involved interviews with mentally ill offenders. I concede that the assessment of capacity would inevitably have added time to the project but, irrespective of what any lawyer or 'the law' says, an Ethics Committee is obliged to ensure that the safety and dignity of research particpants are respected at all times. The Committee's view remains that when there are doubts about a research participant's capacity then this should be assessed formally. In practice an informal assessment of capacity is part of good clinical practice whenever consent is sought. People with mental illness are a particularly vulnerable group where I think we were right to be concerned about capacity and to expect this to be assessed.
This is of particular importance for research where there may be a 'no best interest' argument.
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