Full Disclosure of the ‘Raw Data’ of Research on Humans: Citizens’ Rights, Product Manufacturers’ Obligations and the Quality of the Scientific Database

Authors


Abstract

As advances in medicine continue to develop, questions of how medical research impacts human rights continue to be raised. Research on medical products depends on study participants’ who are willing to donate their time, effort, and willingly take on the inherent risk of trial research. Testing of new products (prescription medicine and medical devices) is always unpredictable. Even higher degrees of unpredictability are always associated with those products having new mechanisms of action. ‘Unpredictability’ refers to:

  • • The inability to estimate four aspects of risk related to a newly designed product with a new mechanism of action:
    • ○ The chance (probability) that an adverse outcome will materialize in a study participant upon whom a new drug with a new mechanism of action is being tested
    • ○ The range of adverse outcomes that can occur to a participant
    • ○ The levels of severity of those adverse outcomes as they occur to a participant
    • ○ The degree of uncertainty in making estimates of chance (probability), range of adverse outcomes, and level of adverse outcome severity.

More work needs to be done across academic boundaries concerning citizens’ rights to receive full information about new medical products. The important tasks of clarifying and communicating the levels of unpredictability of a medical product lie in three areas: (i) consent and informed consent in patient care; (ii) consent and informed consent in research on humans; and (iii) information provided to consumers, physicians, and researchers by product manufacturers. The right to full and open disclosure of risk information regarding medical products affects citizens in three different positions: (i) as study participants bearing the risks of new medical products; (ii) as patients who are asked to consider these products as treatment in their medical care; and (iii) as consumers who may receive less than full disclosures about medical products from product manufacturers. To achieve this goal of full and open disclosure of product risks, society must focus on the obligations of product manufacturers to provide this type of disclosure about their medical products. I will argue that citizens are owed these rights because citizens are the study participants who bear the risks related to medical product testing.

Ancillary