Innovations that lead to the discovery and development of treatments for unmet clinical needs cannot proceed without three kinds of contributions, each involving its own kind of risk and uncertainty.Another 371 biotech medicines in late stage development are targeting more than 250 diseases. Today, there are 168 biotech products and they have helped a quarter billion people worldwide. BIO companies' research leads to cures and treatments for disease.Human Subject Research Is Grounded In Trust And Respect.BIO hopes that this will facilitate more open communication between researchers and participants that will protect research by justifying participants' trust and confidence in the shared effort to deal with the uncertainties and risk that are a necessary part of activities on the frontiers of science The current system of ethical review that scripts communications with human subjects is, for better or worse, grounded in provider institutions' obligations as recipients of federal grants - the biotechnology sponsor's commitments are evident only in its behind-the-scenes activities in relating to the provider institution and in its submissions to the Food and Drug Administration.īy reaffirming these principles, BIO offers sponsoring companies an opportunity to communicate directly with research participants regarding: (1) the researchers' appreciation of participants' contribution to science (2) the arrangements that researchers make to protect participants' rights and well-being and (3) the ways that researchers protect the value of participants' contributions by safeguarding the quality and integrity of research results. Although most of these principles reflect the established practices of responsible researchers, the current system does not readily provide a basis for sponsoring companies to affirm them. However, BIO companies are taking the initiative in finding ways to reassure the public that federal law establishes strong and uniform protection for research and research participants.īIO now reconfirms its commitment to these principles and restates them in a form that researchers and research companies can look to in their conversations with research participants. Data privacy regulations have been promulgated, and BIO has provided comments and obtained important revisions based on these Principles. Since then, legislators have debated the relevant issues, and BIO has provided Congressional testimony based on these Principles. In addition, two years ago, BIO adopted "Principles for Federal Law To Protect Research and Research Participants." BIO stated that its interest in adopting the principles was "to protect the strong public interest in the results of research and public confidence in the research process." These Principles have provided BIO with a basis for participating in what it hoped would be an active legislative and regulatory agenda strengthening and standardizing the federal laws protecting human subjects so that they apply to all research no matter what funding source. Its Statement of Ethical Principles, drafted by its Bioethics Committee and adopted in 1997, pledges adherence to strict informed consent procedures to ensure that research participants are fully aware of the potential risks and benefits of that research. Patients deserve respect and admiration, and protection from inappropriate risks that they may be in no position to evaluate.īIO has long advocated protection for research participants. In addition to facing their disease, in many situations, a primary motivation is to help find cures for the next generation of people with their disease. Some may be just curious and interested in helping, while others may be vulnerable or scared, in turning to the unknown for help for their disease. Research depends on participants' good will. This research cannot go forward without the human subjects who volunteer to participate. Today, there are 168 biotech products on the market and they have helped a quarter billion people worldwide. Federal policy must find the right balance in protecting participants while allowing critical research to continue.īIO companies' research leads to cures and treatments for disease. The public has a strong interest in protecting research and research participants.
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