An Inside Look at Privacy Laws

by Melynda Geurts

We talk a lot about privacy and how we can and cannot reach the public about clinical trials. What is privacy? By definition, privacy is “the quality or state of being apart from company or observation; seclusion or freedom from unauthorized intrusion.” So what does this mean to us in the clinical research industry?  It’s like playing a game of chess. Strategic positioning can occur if the proper guidelines (or rules) are followed.

Interpretation of privacy tends to be varied, vague and gray. Each country /state has its own privacy laws. Some laws are explicit in how they are to be followed and others are not. In the countries where it’s not so explicit, you’ll find that using external recruitment efforts are allowed from a regulatory perspective but culturally you will run into challenges.

Recruitment and retention specialists should be viewed as educators. We find that ongoing education among research staff is just as important, if not more important, in hurdling the privacy challenges.  This is most important in ROW countries where physicians continue to have a strong influence over their patients’ treatment options. You still see this influence in the United States, but on a more limited basis.

When developing an international recruitment and/or retention program, use your historical metrics from previous studies and programs, feedback from research staff and regulatory links (shown below) for guidance as to what strategies can and cannot be used. The cultural acceptability will have to come from your past experiences or that of your recruitment vendor.

Imperial has managed more than 250 projects and more than 75 percent were international in scope. We have yet to have a service rejected due to regulations. It’s just taken time to educate and cultivate relationships with the sites. Misconceptions about recruitment and retention continue. But once sites have a full understanding of the service, they buy in.

Just remember that the majority of all privacy laws represent intellectual property and not that of an individual.

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