Dennis J. Mazur
Oregon Health and Sciences University
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Commentary 1 PDF – Alicia Hall (California State University, Fresno)
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More work needs to be done across academic boundaries in the area of rights of study volunteers, consumers, and patients related to full and open disclosure of risk information related to medical products and the obligations of product manufacturers to provide this information about their medical products.
While emphasizing risk disclosure to patients in the patient-physician relationship through the concepts of consent and informed consent, society protects the product manufacturer in many ways from its obligations of full and open disclosure of risks related to its medical products. Here, for example, product manufacturers may insist that the academic research and medical institutions and their scientific investigators—involved in securing the study volunteers for study and obligated to carefully monitor all study volunteers during study participation—not disclose new risk information to the public about new drugs being tested on human research volunteers without full permission of the product manufacturer. Here, the product manufacturer assumes it has the legal right to restrict investigators’ and medical institutions’ disclosure of the risks—that these parties see occurring in the study participants who are under their care—through non-disclosure contracts.
This paper reviews the origins of study volunteer, consumer, and patient rights related to risk disclosure and the obligations of product manufacturers related to disclosures related to their medical products. Here, the citizen is the subject of a research study who volunteers his or her participation in order to benefit present and future generations in the development of more accurate scientific knowledge. With this voluntary participation, that same study volunteer agrees to bear the risks of death and morbidity from adverse outcomes that befall him or her during the research study and bears the often heavier burden of risks and effects of unknown mechanisms of action from studies of newly developed drugs. The citizen is not only the study volunteer, but also the consumer and patient listening for new medical products that might be helpful to extend life or at least to improve the quality of life.
But what does it mean to say that the research study participant agrees to bear risks for the goal of development of scientific knowledge and what rights guarantee that the study sponsor, the product manufacturer, fulfills the requirements of free and open disclosure which is necessary for any development of scientific knowledge? In particular, what are the rights accorded to research study volunteers, consumers, and patients for free and open disclosure of risks related to newly designed medical products when product manufacturers’ attempts to bypass their obligations of disclosing risk information to the public related to the new products under study in human volunteers as such risks become known during research trials involving humans? In the United States, the Freedom of Information Act may be used to attempt to garner raw data related to scientific studies from federal regulators, but where is the open disclosure of the raw data held by product manufacturers who are the primary repositories of data related to risk information from these research trials?