Culture Clubs: Independent Ethics Committees - Pharmaceutical Executive

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Culture Clubs: Independent Ethics Committees
Independent ethics committees sign off on patient-recruiting strategies around the world. Think laws and regulations shape their decisions? Think again. A new study shows that ethics committees are


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Culture vs. law: respondents who relied on culture (beliefs, convention, and precedent) to determine viability of tactics vs. those who believed a specific law prohibits particular tactics
The ongoing survey, initiated in 2005, has already uncovered some interesting data about the basis for approving or prohibiting certain communications tactics (e.g., television and print advertising, posters, publicity, brochures, referring physician outreach, etc.) within a country. While regulatory guidelines play a role in this process, cultural preferences and even the individual choices of ethics committee members, are seen to play a larger one. In some cases, a committee member's belief that an outreach strategy like Web advertising is not allowed—or at least not appropriate—rests only on the fact that no one has done it before. Having a rough guide to the views of ethics committees around the world can help shape conversations with country study managers, who, like ethics committee members, sometimes reject vehicles for patient recruitment outright, even though they rarely can point to a law or regulation as justification.

Surprising Findings

The most startling finding to date from BBK's survey is that ethics committees appear to have almost capricious systems—rather than clearly established guidelines—for reviewing materials. Even within the same country, committees have been inconsistent about what tactics are allowed or disallowed. The justifications committee members give to support their decisions are varied, inconsistent, and contradictory. Consider the following examples.

Advertising


Ethics committee members around the world approve various patient-outreach tactics, but many are unclear about why they do so. As was the case for advertising media, such standard materials as site tools, press kits, and retention materials fall into a gray area, where culture trumps law.
The survey asked respondents to indicate to what extent advertising was permitted as part of a patient-recruitment campaign. Of respondents from the United Kingdom, 94 percent checked "some forms of advertising are permitted," while six percent marked "convention disallows advertising." Of those six percent, all acknowledged that although they believe advertising is not allowed, they could cite no law that prohibits advertising for patient recruitment. But even though most UK respondents clearly believe that advertising is permissible, the picture gets murky when respondents are asked what specific ad vehicles are allowed. While most believe print is acceptable, television, radio, Web, and direct mail advertising all received mixed responses. Based on survey comments, it seems clear that respondents are reacting to each medium based on what media they've actually seen used before, and perhaps on their own personal ideas and preferences.

Respondents in other countries sent mixed messages as well. In Belgium, 43 percent of ethics committee members responded that the full range of ad vehicles is permitted. Of the 57 percent of members who said advertising is "not permitted," half cited "no law" prohibiting advertising, while the other half indicated they believe there is a law that prohibits use of ads. Respondents in Spain split evenly on the question of whether advertising is allowed, indicating either that the full range of advertising tactics is allowed, or that none is.

In a sampling of respondents from a range of countries, it becomes clear that advertising for patient-recruitment purposes and the forms it takes is inconsistent. The common denominator seems to be that ethics committee members more often use convention and precedent in their judgment of allowable tactics, rather than knowledge of concrete regulations.


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