Protecting the Privacy and Health of Human Research Subjects in the Digital Age
Whenever people are used as guinea pigs in academic or clinical research, they are officially called human research subjects. Although research using human subjects has been regulated for years, protections for their health and privacy have greatly improved in the web 2.0 era.
Conducting Research on Humans
Since the dawn of civilization, mankind has realized the value of medicine. Up until the mid-1900s, however, there were few if any requirements that medicinal products be effective. After the thalidomide tragedy of the 1950s, governments began enacting laws to ensure medicines were safe. To achieve this goal, some people had to take the risk of trying potential new drugs in order to demonstrate their efficacy.
This human subject research frequently leads to astounding medical breakthroughs. Consider the recent work on developing a vaccine for AIDS. Were it not for the tens of thousands of human volunteers, this important and necessary medicine would never have been developed.
Nonetheless, this research is not without risk. In recent years, some of the more high-profile research-related injuries include treadmill-induced ankle injuries, hyperstimulation of the ovaries after egg donation, injuries from testing a medicine or device, spinal headaches from lumbar punctures and injuries from investigator error.
Regulating Research on Humans
After the infamous Tuskegee Study, The Belmont Report of 1979 was created to establish guidelines for conducting research on humans. The report was divided into three areas: to distinguish between medical practice and biomedical research, to establish ethical principles, and to identify applications to help achieve the guidelines.
Boundary between Practice and Research
The practice of medicine was said to be those interventions that had a high likelihood of enhancing patient well-being and includes the common practices of diagnosis, preventative treatment and therapy. Research, on the other hand, is intended to test a theory and add to the body of knowledge.
The report directs that human subject research should be guided by the principles of respect for persons, beneficence and justice.
Respect for persons anticipates that people should be treated as capable of making decisions for themselves; but people who cannot should be protected.
Beneficence includes both the Hippocratic oath’s “do no harm,” as well as the goals of maximizing potential benefits and minimizing potential harms.
Justice involves giving each person his fair, although not necessarily equal, share of benefits and burdens.
The report identified informed consent, assessment of risk and benefits and selection of subjects as the best methods for implementing the ethical principles.
Informed consent generally requires that researchers provide sufficient information, in a manner that suits the subject’s intelligence and maturity. The consent should ensure the subject knows the procedure is unnecessary for their health, and that its effects may not be completely known.
Assessment of risks and benefits typically requires a greater benefit to justify the risk.
Applying principles of justice, researchers make potentially beneficial, as well as potentially dangerous, research open to all classes of subjects. That said, justice demands that those who are better situated to bear burdens, such as adults compared to children, should do so.
In 1981, the Department of Health & Human Services (HHS) and the Food and Drug Administration (FDA) built upon the Belmont Report in making the “Common Rule” for protecting all human subjects. More than one dozen agencies have adopted this rule for their research and grants.
Last updated in 1991, the Common Rule shares many of the Belmont Report’s principles and applications, including informed consent. In addition, the rule requires that each institution establish an independent oversight board, known as an Institutional Review Board (IRB), that reviews research proposals to ensure the balance of risks and benefits is appropriate; they are also set to supervise ongoing human subjects research.
Web 2.0 Regulations
In 2011, HHS began enhancing human subjects research regulations to address modern practices. Previously not covered in the Common Rule, uniform privacy standards were established and now apply even to those studies that had been completely exempt from human subjects regulations.
Informed consent regulations were beefed up with requirements for greater specificity in the disclosure of information. Additionally, the old practice of simply removing identifying information from biospecimens to eliminate the need for informed consent has been prohibited. Now, consent must be given for the use of this material, as well.
Greater protections for human health have also been addressed with the creation of a single website where all adverse events are reported. All agencies will have access to this data more easily and more quickly.
Given the grave risk of injury posed by untested products and practices, human subjects research is necessary for the protection of public health. Thankfully, selfless volunteers continue to help researchers conduct this necessary work. Recent changes to the regulations that protect these volunteers will further encourage others to participate, while continuing to safeguard their privacy and health.
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