Sec. 38.4055.  APPLICATION FOR ACCESS TO CERTAIN DATA OR INFORMATION IN DATABASE.  (a)  An entity seeking to access data or information that is contained in the database but not accessible through the portal described by Section 38.405 must submit an application to the center for access to that data or information.  The application must include:
(1)  the sources and identity of all funding and funders of the research the entity will perform;
(2)  the names of all individuals who may have access to the data or information that is contained in the database but not accessible through the portal described by Section 38.405, and any affiliations those individuals have with entities other than the entity submitting the application;
(3)  the proposed study, research, or project that the entity plans to undertake and the purpose of the study, research, or project, including any anticipated final product from the study, research, or project;
(4)  how the proposed research will further the purposes of this subchapter, improve the quality of care, or reduce the cost of care;
(5)  a description of the proposed methodology;
(6)  a description of the publication method of the manuscripts, reports, or other forms of output from the research; and
(7)  for access to data that would require such an approval, an institutional review board determination letter that is an approval or an approval with modifications.
(b)  The center shall review and make a determination on all applications in a timely manner.
(c)  If the center denies an application, the center must identify with particularity the deficiencies in the application.
Added by Acts 2023, 88th Leg., R.S., Ch. 603 (H.B. 3414), Sec. 5, eff. June 11, 2023.