FAQ
Frequently asked questions
These are the questions that come up most often in consultations. If yours is not here, please ask.
Is there a charge for the consultation?
No. The initial consultation and the proposed design are free of charge. A contract is required from the point at which the protocol is actually written.
We have no animal or cell data yet. Can we go straight to a human trial?
It depends on whether the safety evidence is sufficient. For a material with a long history of dietary use and existing approvals, a human trial can be considered directly. Otherwise, obtaining safety data first usually saves both time and money.
At the consultation stage we set out which of your data are already adequate and what is missing.
How is the sample size determined?
The primary efficacy endpoint is fixed first, then a power calculation is carried out using the effect size and variance reported in prior studies. Where no prior data exist, we propose an exploratory design to estimate the effect size first.
Where is IRB review obtained?
From the board of the institution hosting the study, or from a public IRB. The institute prepares the full submission package and responds to requests for revision; no recruitment begins before approval.
How long does the whole thing take?
Typically 3–5 weeks to finalise the design, 4–8 weeks for IRB review, 3–12 months for conduct, and 4–8 weeks for analysis and reporting. Recruitment difficulty causes the greatest variation.
Can we commission publication only?
Yes. We can re-analyse data you already hold, prepare the English manuscript and submit it to a journal. Where there is a fundamental flaw in how the data were collected, we will say so at the outset.
How is authorship handled?
It is agreed in advance in the contract. Author order and the corresponding author are set according to contribution, following the ICMJE authorship criteria.
The composition of our material is a trade secret. How is it protected?
Detailed composition is not requested during the initial consultation. Once the discussion becomes concrete, a non-disclosure agreement is signed before any material is exchanged. What may be disclosed on publication is also agreed in the contract.
What if the results are not what we hoped?
They are reported as observed. Where the hypothesis is rejected the finding is described as such; this is stated in the contract.
We do, however, analyse why — insufficient sample size, the wrong endpoint, or a genuine absence of effect — and report that alongside. That information feeds directly into the design of the next study.
Can overseas companies commission work?
Yes. Consultation and documentation are available in English and Japanese, and contracts and reports are produced in the relevant language.
Does the institute provide treatment or medical care?
No. The institute is not a medical institution and does not provide diagnosis, treatment or prescription. Our work is limited to the collection, analysis and reporting of research data under an approved protocol.
Can you help with a grant proposal alone?
Yes. We can review the call, draft the objectives and content, review prior work and prepare the itemised budget.
KGHCRI is not a medical institution and does not provide diagnosis, treatment or prescription. The content of this site is provided for research information purposes and does not claim that any product prevents or treats disease.