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.
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 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.
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.
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.
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.