Many States are now Requiring Cannabis Consumer Surveys without First Getting the Required IRB Approval

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As more and more states pass legal marijuana legislation, some states require their cannabis consumers and patients to complete user surveys that are not IRB approved, in order to purchase legally. “The federal government has a statutory definition of how cannabis (marijuana) users should be surveyed for research purposes,” states the president of Minerva Capitol Solutions, Catherine Jolley, whose firm is now assisting states and private organizations with IRB applications.

“Are you aware that the federal government has a statutory definition of how cannabis users should be surveyed for research purposes?” states the president of Minerva Capitol Solutions, Catherine Jolley, a Nashville based consulting firm representing nationwide clientele. This clientele represents government, academia, corporations, and nonprofits that are desiring publishable research data.

To be clear, this federal requirement and this definition under the IRB section applies to any food and drug survey, not just that pertaining to cannabis (marijuana).

Code of Federal Regulations | HHS.gov    
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102
§46.102 Definitions

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Why is this information critical? Many states, including Oregon and Minnesota, have rules or statutes that require cannabis providers to survey their patients and consumers. As these surveys meet the definition of research above, their execution also falls under federal statutory purview, i.e. they are required to be ethically conducted. Institutional Review Boards (IRB) ensure the ethical basis for human subject research. Minerva Capitol Solutions, Inc. (MCS) has the unique consultation services needed to facilitate IRB certification of cannabis consumer surveys for states, research certificate holders, nonprofits, corporations, academicians, and scientists.

Failure to acquire IRB certification exposes the surveyor to consumer litigation. States requiring survey completion by patients and consumers appears coercive because accessing cannabis by other means is illegal. The grounds for suit not only include privacy concerns of the types of information demanded but also how that is information is acquired, stored, accessed, analyzed, and disseminated.

The purpose of publication is to create a better informed medical and patient population. Information acquired through non-IRB approved surveys cannot be ethically published or disseminated. No peer-reviewed journal will accept any manuscript that contains data from surveys that are not IRB approved.

MCS has the corporate, community, academic, regulatory, and government affairs expertise to address individual state cannabis programming needs. If needed, MCS also has discreet access to IRB review and certification.

IRB approval provides the best standard of practice for cannabis consumer survey protection.

Contact: Catherine Jolley, President    
Ph.: (615) 305-4721    
Email: cjolley(at)minervacapitol(dot)com     
Mitchell H. Parks, MD                                            
Email: mparks(at)minervacapitol(dot)com

Website: http://www.minervacapitol.com Twitter: @minervacapitol
FB: https://www.facebook.com/Minerva-Capitol-Solutions-985316271512597/

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Catherine Jolley

Mitchell H. Parks, MD
@MinervaCapitol
since: 05/2015
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