P.L. 111–255, Approved October 5, 2010 (124 Stat. 2640)

SEC. 2. [42 U.S.C. 1382a note]  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 treatments and potential cures for these rare diseases and conditions.

SEC. 4.  STUDY AND REPORT.

(a)  Study.—Not later than 36 months after the effective date of this Act, the Comptroller General of the United States shall conduct a study to evaluate the impact of this Act on enrollment of individuals who receive Supplemental Security Income benefits under title XVI of the Social Security Act (referred to in this section as “SSI beneficiaries”) in clinical trials for rare diseases or conditions. Such study shall include an analysis of the following:

(1)  The percentage of enrollees in clinical trials for rare diseases or conditions who were SSI beneficiaries during the 3-year period prior to the effective date of this Act as compared to such percentage during the 3-year period after the effective date of this Act.

(2)  The range and average amount of compensation provided to SSI beneficiaries who participated in clinical trials for rare diseases or conditions.

(3)  The overall ability of SSI beneficiaries to participate in clinical trials.

(4)  Any additional related matters that the Comptroller General determines appropriate.

(b)  Report.—Not later than 12 months after completion of the study conducted under subsection (a), the Comptroller General shall submit to Congress a report containing the results of such study, together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.