Policies and Procedures for Grant Proposals

Biostatisticians in the Department of Biostatistics participate in grant development in various ways including:

  • assisting with the formation and operation of a proposal development team
  • assisting the investigators in refining study questions and measurement methods
  • developing study and experimental designs
  • writing statistical analysis plans
  • computing precision, power, and sample sizes necessary to achieve a given precision of estimation or a given power

When an investigator claims to need only a sample size calculation, we usually find that their fundamental study design requires improvement. Unless we are provided sufficient time to participate in the study design, we do not work on proposals for which the investigator "only needs a sample size calculation."

Investigators Served

We provide grant development assistance for proposals that are:

  • explicitly covered under the auspices of the CTSA or Cancer Center Biostatistics Core Resources
  • multi-department proposals of major importance to the School that are initiated by the School of Medicine (not by a department of the School)
  • developed by a research group that is participating in our collaboration cost-sharing plan
  • developed by other groups who we will charge by the hour (see ServicesOverview)
  • logical extensions (e.g., competing renewal) of a grant that is already funding a biostatistician who will work on the new proposal
  • research areas of special interest for a PhD faculty biostatistician

FOR INVESTIGATORS

Requirement of Advance Notice

Grant proposals require input from a number of experts. Teams assembled at least four months before submission generate the strongest grant proposals. Optimally, team meetings should meet every three weeks to generate at least two major proposal revisions. From the point of view of the biostatisticians, they will then have sufficient time to do their best work and thus, significantly enhance the likelihood of funding.

We usually require two or more months advance notice when asked to provide assistance with proposals. If not, we will provide assistance only if personnel are available and we will charge departments and divisions by the hour for this service. Exceptions will be granted for cases involving resubmissions, renewals, or submissions of proposals that are substantially similar to previous grants in which the biostatisticians have fully participated.

When there is insufficient time for one of our PhD or MS biostatisticians to work with you on a proposal, we will still provide free consultation during our daily Biostatistics Clinics. Although you will not be able to name the consulting statistician as a Key Personnel on the proposal, you will receive valuable advice on how to avoid major design or analysis pitfalls. On rare occasions, when the design is very simple, we can analyze simple pilot datasets or perform sample size calculations.

Use of Biostatisticians' Names on Proposal

We do not allow an investigator to use the name of a PhD or MS biostatistician on a grant or contract proposal unless the biostatistician has fully participated in the development of the proposal from its inception and can vouch for the study design and analysis plan. Donna Bock is grants manager for the Department of Biostatistics; she will work closely with you when preparing your proposal.

Prohibition of unauthorized change of Biostatistician's Names

We do not allow an investigator to change or to remove a biostatistician's name once it is officially listed on a grant proposal unless special permission is obtained from the Chairman of Biostatistics.

Percent Efforts

It is departmental policy that the percent efforts of statisticians on grant proposals reflect their anticipated actual efforts. A faculty member may not be on more than 3 projects with less than 7.5% effort each; the minimum percent effort is generally 5%. Unless the granting agency disallows funding percent efforts, statisticians will not participate on grant applications as internal consultants or be paid a fixed dollar amount or for a fixed number of hours.

We strongly recommend that a grant proposal name both a PhD and an MS biostatistician as members of the research team, with the ratio of MS:PhD percent efforts being about 2.5:1.

Figuring actual percent efforts on grant proposals is more art than science. Generally speaking, without sufficient time invested in the proposal, we cannot make accurate estimates of the future effort required for your project. Factors that necessitate both a PhD and an MS statistician include:

  1. many variables (measurements) per subject or animal
  2. repeated (serial, longitudinal) measurements per animal or subject
  3. a significant number of subjects dropping out before the planned termination of their follow-up
  4. other types of missing data
  5. plans for sequential monitoring of treatment effects or safety with an eye to possible early termination of the study
  6. data and safety monitoring committees
  7. data from other sources where the data must undergo major transformations or cleaning to be analyzable
  8. data from multiple clinical sites
  9. measurements that are only partially observable (e.g., when concentrations may be below the lower limit of detectabilty)

Make sure that in any grant in which you are involved you include the following in the regular budget:
  1. Computer systems analyst support if this support is directly for the aims of the grant, e.g., dealing with large medical databases, web application programming, other data management, programming (especially for simulations). This would be as a % effort to a named IT member.
  2. Travel to professional meetings if (1) you need to go to a medical/basic science meeting that will give you knowledge to collaborate with the investigators or (2) you need to acquire methodologic skills that are directly used in the project for which you need to attend a specific session or short course at a statistical meeting. For (1) funding should be for all costs of the meeting and for (2) funding should be for all or some pro-rated portion of the meeting depending on your % effort on the grant and how directly related the methods are to the grant.
  3. By all means insure that the % effort for the senior + junior biostatistician team are adequate, and the mixture of junior and senior % efforts is appropriate for the expected mixture of Biostat I, II, III, faculty-level tasks involved.

StarBrite

Other Notes

  • Faculty biostatisticians must be designated as Key Personnel
  • Faculty should be designated as a Co-Investigator, when, as a participant in a grant or application he/she contributes substantively to the scientific development or execution of a project or he/she contributes a specified level of time as per NIH guidelines.

Who to contact when considering a new grant proposal

Unless the proposal is a renewal or resubmission (in which case you should contact the biostatisticians currently involved in the project), all requests for assistance on proposals must go to DonnaBock. If you are unsure about whether the proposal development is covered by an existing relationship with our department, contact FrankHarrell.

eRA Commons User Names

Faculty Name eRA Commons
User Name
Ayers, Dan AYERSGD
Byrne, Dan BYRNEDW
Chandrasekhar CHANDRR
Chen, Heidi CHENH5
Chen, Qingxia (Cindy) CHENQ3
Choi, Leena CHOILEENA
Crimin, Kim CRIMINKS
Dupont, William D DUPONTTWD
Federspiel, Charles FEDERSCF
Fonnesbeck, Chris FonnesCJ
Gebretsadik, Tebeb GEBRETT
Greevy, Robert GREEVYRA
Harrell, Frank FHARRELL
Koyama, Tatsuki KOYAMAT
Li, Chun LICHUN3
Li, Ming LIMING2
Saville, Benjamin SAVILLBR
Schildcrout, Jonathan SCHILDJS
Shepherd, Bryan SHEPHEB1
Shintani, Ayumi SHINTAAK
Shyr, Yu SHYRYU
Slaughter, Chris SLAUGHJC
Wang, Lily WANGL8
Wu, Hyiyun (William) WUWILL
Xu, Lei XULEI5
Yu, Chang YUCHANG
Zhou, Chuan ZHOUC2
Zhu, Yuwei ZHUYU1

To Administrators: For instructions to set up an eRA Commons User Name, click here.

Recommended Reading

Topic attachments
I Attachment Action Size Date Who Comment
GrantApplication_Numbers.pdfpdf GrantApplication_Numbers.pdf manage 21.7 K 15 Jul 2009 - 09:49 LindaStewart This helpful tool describes grant ID numbers.
GrantSubmissionTimeline2008.pdfpdf GrantSubmissionTimeline2008.pdf manage 19.8 K 13 Nov 2007 - 11:03 DianeKolb Grant Submission Timeline 2008
coeus_for_approvers_and_PIs.pdfpdf coeus_for_approvers_and_PIs.pdf manage 710.5 K 05 Jun 2008 - 16:15 DonnaBock COEUS Premium for PIs and Approvers
Topic revision: r63 - 15 Aug 2016, MattShotwell
 

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