What Does ‘Good’ Science Look Like?
What Does Finished Product Science NOT Look Like?
Genuine Scientific Research
IRB Approval: Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. At VNI we go through the process of IRB approval for our research. Here is what is required:
• Write up research intention, proposal and protocol.
• Submit to accredited Institutional Review Board (IRB) for Approval.
• Research premise must be scientifically valid and acceptable.
• Approved Informed Consent forms to be signed by subjects in study and kept on record by the research institution.
• Safety must be validated and assured to the satisfaction of the IRB scientific reviewers.
• Protection of Confidentiality (HIPAA Requirements).
• When approved, IRB number is assigned and published in study.
• Active & Placebo product are sent to researchers (double-blind placebo controlled).
• Subjects are recruited, accepted (or rejected) and enter the study protocol.
• Data criteria, Statistical parameters and endpoints are established and analyzed at study completion (or rating scale for case studies).
• Manuscript is written, confirmed by co-authors, and submitted to scientific journal.
• The contributory role of each study author is submitted to journal review board.
• Manuscript is reviewed by numerous reviewers on an editorial review board. (This can involve numerous interactions with questions requiring answers from researchers and may take many months to years to finalize.)
• If (and when) accepted for publication, research is published in Peer-reviewed cited journals.
• Complete a copyright document and assign to journal publisher.
• VNI has 40 published peer-reviewed clinical (human) studies on just 3 finished products…so far.
What Genuine Scientific Research Does NOT Look Like?
• Research ([published or not] by a 3rd party [commercial Co. or academic institution]) on an ingredient…but not the exact same ingredient used in the commercial product (i.e. green tea extract, mushroom extracts, phospholipids, chromium nicotinate, grape seed extract, ginkgo biloba, and a thousand other botanicals).
• Single ingredient research, even IF it is the same ingredient as used in the original research (BUT, the VAST majority are NOT ), is not sufficient to validate the multi-ingredient formula in which it is used.
• In-House survey questionnaire compiled to create ‘research’ conclusion.
• White Paper of ‘In-House’ research showing effectiveness – No peer-reviewed and cited scientific Journal publication information on research document. (Research paper is only available from company website).
• List of impressive ‘experts’ on a company scientific advisory board (endorsing product).
• A section of a website that uses scientific language to appear to be scientific.
• The use of testimonials (which are mostly influenced by financial bias) as a substitute for scientific validation.