Volunteers who participate in medical research and clinical trials are essential to developing the medical advances that help improve both the length and the quality of people’s lives. While many of these research subjects have the benefit of exposure to cutting-edge medicines and procedures, they are also subject to many of the risks that come with medical experimentation. In general, before a researcher can enroll a participant in a medical study, he or she must ensure that the subject provides informed consent. If researchers do not provide participants with all the safeguards of informed consent, they may face significant legal liability .
Elements of Informed Consent
As with informed consent to a medical procedure, three elements must be present in obtaining consent for participation in a medical study: capacity, voluntariness, and disclosure. Capacity refers to an individual’s ability to understand the circumstances and make decisions for him or herself. Voluntariness refers to an individual’s right to make a decision freely without being manipulated or coerced. The third element is often the trickiest: researchers must make a full disclosure of the foreseeable risks and benefits of participating in the study, so that volunteers can make an independent and educated decision about whether to participate. When researchers do not adequately make such disclosures, study subjects are unable to make fully informed decisions about their participation.
Lack of Informed Consent in Studies on Premature Babies
Failing to disclose risks to study participants is particularly troublesome when it comes to children, as they do not even have the capacity to consent. A recent article in the New York Times indicates that the Office for Human Research Protections (OHRP) has found that a study on the effect on oxygen levels for extremely premature babies failed to inform the parents of the serious risks, including blindness and death.
This study, spanning across 23 academic institutions – including the University of Alabama at Birmingham, Stanford, Duke, and Yale – involved approximately 1,300 babies who were born at somewhere between 24 to 27 weeks of gestation. Despite the fact that the researchers had enough prior information to warn parents that differing levels of oxygen might have different impacts on their babies’ chances of developing eye diseases or even of dying, the OHRP found that the consent forms made no mention of such risks. Ultimately, 130 babies in the low oxygen group died, while 91 babies in the high oxygen group developed eye diseases that could lead to blindness.
Since the OHRP’s findings are so new, it will be interesting to see if the parents decide to pursue litigation against the researchers for failing to warn them about the serious risks of eye disease and death that their babies could face in the study. Although the article indicates that the babies’ extremely early births made them more susceptible to blindness and death anyway, that does not change the fact that the parents had the right to be fully informed of the likely risks their babies would face in the oxygen study.
Many of the issues surrounding informed consent in research are very similar to the issues regarding informed consent for medical procedures. If you or someone you know think that you have been subject to any procedure without being fully informed of the risks, consider obtaining guidance from an attorney who deals with these issues.
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