PMean: Draft policy on statistical support for research

I am drafting up a policy on statistical support for research at my part-time job at UMKC. It is loosely based on standards at the University of California, Davis and Kansas University Medical Center. An early draft appears below. I’ve gotten some suggestions that setting a minimum percentage effort is a bad idea. What do you think?

Statistical support for your research grant

If you are considering including the support of a statistician from the Department of Biomedical and Health Informatics on your research grant, you’re making a smart move. It not self-serving for us to point this out; it is a conclusion that many researchers have already made on their own.

The money you spend on statistical support will provide you with a far greater return through improved research efficiency. Statisticians have the tools to insure that your sample size is large enough to provide the precision that you need, but not so large as to be wasteful. We are aware of many alternative research designs that can, at times, provide efficiencies large enough to allow you to reduce your sampling needs.

The money you spend on statistical support will also greatly improve your prospects of getting funded. Reviewers expect to see a strong research team and this includes a statistician with graduate level training and substantial data analysis experience. You may be more than capable of conducting your own data analysis, but without the credentials that we already have, you will have a hard time convincing a reviewer of your skills.

The contributions that we offer extend well beyond a sample size justification and a data analysis plan. We have many years of experience in providing consultation across a very broad range of science and medicine. We know about research innovations in other fields that may be less well known in your discipline. We have many contacts in the research community and can help add find expertise for your research team in areas beyond Statistics.

If you want to work with us, we need to set up some ground rules in advance to avoid any misunderstandings.

Planning time frame

You cannot use our name in your grant without having us participate fully in the development of your grant. If we haven’t been active participants in the planning, we have no way to vouch for the integrity of the study design and data analysis plan. Generally, you need to include us early in the development of the research grant, typically two months or more prior to the submission date. Under no circumstances will we consider working on a research grant if we just learn about it less than one month from the submission date.

Data management budget

We will not work on any grant that does not have funding in the budget for a data manager. A data manager is critical to guarantee data integrity and research efficiency. We cannot do our jobs well without this guarantee. If you do not have data management support in house, we can provide assistance through the Center for Health Insights.

Appropriate FTE support levels

The normal FTE effort on a research grant is 20%, and this level needs to be maintained throughout the duration of the research grant. You cannot collect the data on your own and then dump it in our lap during the last year of the grant. We must be active participants during the data collection phase in order to do our job well.

Some grants will require more than 20% effort. These include research studies with

  • a large number of outcome variables,
  • a longitudinal design,
  • multilevel sampling,
  • interim analyses,
  • an adaptive design,
  • an expectation of high dropout rates/many missing values.

Some studies may require less than 20% effort. Generally, these would be studies where you conduct your own data analyses, but we provide oversight and review. The minimum, even in these cases, is 10% effort. The only exception to this rule is a research grant that does not ask for any salary support for anyone on the research team.

Once we agree on a level of support appropriate for your grant, you cannot change that level of support, even if the research methods change markedly, without discussing this with us first.

These are not optional recommendations

The recommendations in this document are mandated for all research. If you do not wish to abide by these recommendations on review times and funding levels, please find your statistical support elsewhere. There may be rare exceptions to these requirements, but these need to be cleared first by the department chair.

Acknowledgements

This document was developed using guidelines at the University of California, Davis1 and Kansas University Medical Center2. We encourage you to review these resources to better understand the justification for our requirements.

1 http://ucdmc.ucdavis.edu/ctsc/area/biostatistics/financialConsiderations.html

2 http://www.kumc.edu/school-of-medicine/department-of-biostatistics/grant-preparation.html