Tuesday, January 21, 2014

How to increase value and reduce waste 3

Post #3 of my little series on the Lancet papers on how reduce waste in research is a take on how bureaucracy is contributing to the problem. I think the best way to summarize this contribution is to cite an example that was given in it. Imagine a group of researchers aiming to pool data from several cohort studies. In biomedical research you generally need approval to use patient relevant information. Such an approval is usually provided by an ethics committee. Sweden has a central research ethics committee for this.

In 2010, a group of researchers in Sweden wanted to pool data from several cohort studies to identify risk factors for subarachnoid haemorrhage (a form of stroke). They identified about 20 studies, and spent about 300 h contacting all investigators and getting signed data-sharing agreements and data security processes agreed. The team recorded the time taken for each step of the approval process. About 200 h of office time was spent on the ethics approval and resubmission process alone. The research ethics committee wanted to see all information that the participants of all cohorts had been given about the purpose of the study. These documents had to be provided as 18 copies and submitted manually. It took the team 6 months to collect all the information sheets from the 20 different cohorts, several of which began recruitment in the 1960s and for which little knowledge about what information was given by whom to whom in the recruitment phase was poor. The research ethics committee eventually had the team advertise in national newspapers about the pooling project, listing all original cohorts so that all individuals who did not want the team to use their data for this project could withdraw their consent for the study. Not one participant withdrew. It took more than 3 years to reach the stage of pooling data from the cohorts, ready for analysis.

Three years before the team could start researching. Frankly, I would probably have suffered a stroke myself if I had to jump through all those hoops. Luckily, in our field of research bureaucracy is usually not that excessive because most of what we do does not involve experiments or empirical studies on humans. Funnily enough, I had to write a few similar applications for our school program although we are not collecting any information of the children but gather data together with them. However, that took only 1-2 h of my time and not years. Overall, the three major categories in bureaucracy I have to deal with are grant proposals, permits for field work/research or university internal approval of research funding. All have their relevance and are required, and you can find both very stringent, clear-cut or cumbersome, time-consuming procedures for them. The last I am going to do here is to complain about specific ones but I can see that an increasing number of regulations can drive colleagues mad. Let's face it - all of us were trained to do research to the best of our abilities and we were -hopefully- given all the tools to do good science but nobody taught us how to write a grant proposal, how to write interim and final reports, how to apply for research permits, or how to apply to be able to apply for grants. Well, we learn that over the years. We even learn to live with the fact that each funding organisation, authority or university admin uses different formats and puts an incomprehensible emphasis on formatting. The only unfortunate thing is that the main teaching and learning tools are rejection and repeated revision.

All recommendations in the paper are addressing the science regulators and policy makers. Here are some that might be - at least in parts - applicable in other domains of science:

  • People regulating research should use their influence to reduce other causes of waste and inefficiency in research
    • Monitoring—people regulating, governing, and managing research should measure the extent to which the research they approve and manage complies with the other recommendations in this Series
  • Regulators and policy makers should work with researchers, patients, and health professionals to streamline and harmonise the laws, regulations, guidelines, and processes that govern whether and how research can be done, and ensure that they are proportionate to the plausible risks associated with the research
    • Monitoring—regulators, individuals who govern and manage research, and researchers should measure and report delays and inconsistencies that result from failures to streamline and harmonise regulations
  • Researchers and research managers should increase the efficiency of recruitment, retention, data monitoring, and data sharing in research through the use of research designs known to reduce inefficiencies, and do additional research to learn how efficiency can be increased
    • Monitoring—researchers and methodologists should do research to identify ways to improve the efficiency of biomedical research

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