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Consumer Studies: Pumping the Lifeblood
By: Valerie Hart
Posted: August 5, 2008, from the August 2008 issue of GCI Magazine.
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of Helsinki (Tokyo 2004) states that, “Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject. This is especially important when the human subjects are healthy volunteers.” In Europe, European Directive 76/768/EEC and its amendments on cosmetics as well as European Directive 2001/20/EC on Good Clinical Practice (GCP) in Clinical Trials set the framework for addressing these issues. The Cosmetic Directive 76/768/EC defines a cosmetic product as any substance or preparation intended for placing in contact with the various external parts of the human body or with the teeth and mucous membranes of the oral cavity with the exclusive or principal intention of cleaning them, perfuming or protecting them in order to keep them in good condition, change their appearance or correct body odors. Any “cosmetic” product that seeks to claim to do more than clean, perfume, maintain condition, change appearance or correct body odors might need to be considered as something other than a cosmetic.
In any event, before any product can be used in a consumer preference study, it must satisfy safety criteria. This usually means it must be supported by toxicological data on its ingredients, results of animal testing and any results of prior use on humans.
Selecting consumers to participate in in-home trials is a relatively straightforward matter, and a group of between 150–200 volunteers is generally considered statistically viable. RSSL’s database of volunteers includes approximately 5,000 households, and there are many agencies around the world with equal capacity to call on volunteers of every conceivable gender, age, ethnic, economic, social and religious mix. Some agencies will hold basic data so that it is possible to query a database to narrow down the target range to, for example, women in the 30–45 age group. However, depending on the product to be tested, it will be necessary to carry out a further interrogation of this target group, perhaps to identify those consumers already using similar products habitually or users of specific brands.
It is possible, and sometimes necessary, to be highly prescriptive about the profile of the consumers chosen for the study so that if the target market is highly defined, the consumer group can be equally and appropriately highly defined. One must exercise a little caution in being too defined, of course, since it might be a mistake to define a target market too narrowly. There might be many reasons why an older male will choose to purchase a product that is targeted at a younger, more athletic market. Similarly, a female might purchase a product for other members of her family, which the partner or child might never think to purchase for themselves. On the other hand, it is obvious that recruiting a large sample of bald men would be inappropriate for a consumer study of a shampoo or hair colorant.
In short, the ultimate definition of appropriate criteria for inclusion in an in-home consumer panel will depend on what questions are to be asked and on the profile of the target market.
In addition to the commercial issues that the study is designed to address, there are ethical and, occasionally, medical considerations that might need to be taken into account. The safety of the product itself was dealt with above, but even where no medical implications are involved, each participant needs to give informed consent to take part in the study. To ensure informed consent is given, it is both courteous and good practice to issue each participant a detailed explanation of the study and what will be expected of all parties. The National Research Ethics Service has published a set of guidelines covering the points that need to be addressed in providing information to participants and the completion of consent forms.