A clear understanding of how to conduct ethical clinical trials is required for anyone involved in the process. Improper experimentation methods can have devastating and long-lasting negative effects. Just consider the controversy created by Andrew Wakefield when he published a paper in 1998 claiming colitis and autism spectrum disorders were linked to the Measles, Mumps, and Rubella (MMR) vaccine. Journalists revealed that the author of the original research paper had multiple conflicts of interest and manipulated evidence. The General Medical Council found him guilty of professional medical misconduct and he was taken off the register, preventing him from ever practicing medicine again. Yet this claim is still debated and remains a parental concern despite multiple research trials proving there is no link between vaccines and autism. In fact, there are at least 5 preventable diseases, including measles and pertussis, which have made a comeback in part because parents did not adequately vaccinate their children.
While the Wakefield controversy is an extreme example of misconduct, ethical issues evolve with medical advances and need to be revisited frequently to make sure clinical trials serve the best interests of the public. Complying with ethical codes such as the U.S. Common Rule and Council for International Organizations of Medical Sciences (CIOMS) are crucial, but researchers should periodically review their protocols and make sure they address concerns such as privacy issues and the ongoing communication and education of subjects after experimentation is completed.
Scientific research requires protocols that take into account:
- The value of the study and whether the benefits outweigh the risks
- Whether or not the study is scientifically valid
- How subjects are chosen
- Adequate disclosure and informed consent
- A genuine respect and concern for the welfare of subjects, both during and after the trial
Clinical trials should also include an independent review to verify that all the applicable codes of ethics have been followed. In addition, researchers need to take into account potential social issues, such as whether the costs and benefits of a study are equally balanced among populations. Historically, vulnerable populations have taken on more of the risks and negative costs of research and have not benefited from the results. Equally important is making sure all groups, including minorities, women, and children, are adequately represented so the effects of new drugs or treatments are documented across all potential populations.
For a more in-depth look at ethical clinical trials, including strategies on how to avoid bias, download the white paper, Emerging Issues in Clinical Research.
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