Page:United States Statutes at Large Volume 124.djvu/2666

124 STAT. 2640 PUBLIC LAW 111–255—OCT. 5, 2010 Public Law 111–255 111th Congress An Act To provide for an exclusion under the Supplemental Security Income program and the Medicaid program for compensation provided to individuals who partici- pate in clinical trials for rare diseases or conditions. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ‘‘Improving Access to Clinical Trials Act of 2009’’. SEC. 2. FINDINGS. Congress finds the following: (1) Advances in medicine depend on clinical trial research conducted at public and private research institutions across the United States. (2) The challenges associated with enrolling participants in clinical research studies are especially difficult for studies that evaluate treatments for rare diseases and conditions (defined by the Orphan Drug Act as a disease or condition affecting fewer than 200,000 Americans), where the available number of willing and able research participants may be very small. (3) In accordance with ethical standards established by the National Institutes of Health, sponsors of clinical research may provide payments to trial participants for out-of-pocket costs associated with trial enrollment and for the time and commitment demanded by those who participate in a study. When offering compensation, clinical trial sponsors are required to provide such payments to all participants. (4) The offer of payment for research participation may pose a barrier to trial enrollment when such payments threaten the eligibility of clinical trial participants for Supplemental Security Income and Medicaid benefits. (5) With a small number of potential trial participants and the possible loss of Supplemental Security Income and Medicaid benefits for many who wish to participate, clinical trial research for rare diseases and conditions becomes exceptionally difficult and may hinder research on new treat- ments and potential cures for these rare diseases and condi- tions. 42 USC 1382a note. 42 USC 1305 note. Improving Access to Clinical Trials Act of 2009. Oct. 5, 2010 [S. 1674]