Human Research Protections: Time for Regulatory Reform?(Essays‪)‬

Ever greater numbers of us will be asked at some point in our lives to participate in a research study. We might be invited to participate in surveys and focus groups, asked to let researchers conduct studies with our tissue or medical information, or recruited for clinical trials that test whether drugs, medical devices, or biologics--like vaccines and genetic materials--are safe or effective. One company involved in recruiting human subjects estimated that the number of participants needed to fill industry-sponsored trials grew from 2.8 million in 1999 to 19.8 million in 2005. (1) There is also a growing need for children, the elderly, and people with certain diseases to enroll in studies that test interventions targeted to those populations. The very fact that record numbers of people are being recruited for research makes thoughtful attention to how we safeguard human subjects of the utmost importance. On top of that, though, there are problems with the current regulatory system. Some requirements may be overprotective and excessively bureaucratic. And yet there are also gaps that may leave many research participants without adequate protection. Some of the gaps exist because regulations have not kept pace with recent developments, such as stem cell and other biotech research, and the globalization of clinical trials. Increasing numbers of American-based trials are being conducted abroad, and participants in those trials may be less well protected than participants in trials conducted domestically. There are also gaps in the empirical data about the research enterprise, including such basic information as the number of adults and children who enroll in trials.