Failed TB Vaccines Raise Questions and Mistrust

Oxford University researchers have been creating and testing the MVA85A vaccine, meant to serve as a booster to the Tuberculosis (“TB”) vaccine. In the course of the research, it was discovered that the researchers falsely portrayed pre-clinical results of the booster in order to gain funding for clinical trials. The researchers misrepresented information in both applications for funding and in information given to parents whose children would receive the booster. They claimed that the booster was both safe and more effective at protecting against TB than the regular vaccine alone. The researchers also falsely claimed that the booster had been safely tested in multiple animal studies, which had never occurred. In fact, researchers at Stellenbosch University in South Africa later performed an animal study and the results did not support use of the booster as a way of increasing the effectiveness of the TB vaccine.

The misrepresentations made by the Oxford University researchers have raised questions about the safeguards in place for pre-clinical research. Unlike the extensive requirements for clinical trials, pre-clinical trials do not have to be registered with appropriate authorities, which increases the likelihood that errors and omissions go unnoticed.  Many believe that a registry should be established for pre-clinical trials to provide proper oversight and ensure that unsafe drugs do not reach the marketplace.

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Use of Social Media to Recruit Participants in Clinical Trials Raises Ethical Concerns

Difficulties faced by researchers in recruiting participants to clinical trials has resulted in the increased use of social media as a research tool. Although recruitment through social media is akin to traditional methods in many aspects, online recruiting raises several additional ethical and regulatory issues, such as privacy concerns and online security risks. However, little guidance has been provided to investigators and Institutional Review Boards to facilitate the review and use of social media as a recruitment mechanism. In light of the many benefits this form of recruitment has to offer to increasing participation in clinical trials, Harvard scholars published an article in the American Journal of Bioethics, offering practical recommendations to assist investigators and Intuitional Review Boards with the implementation of explicit policies for social media recruitment.

Excerpt from Article:

One issue that is specific to the online platform in regards to transparency is whether investigators are required to let people know that they are collecting data. Depending on the nature of the research study, investigators could reasonably obtain information just by “lurking” on the group page. 

 

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