Access to Federally Funded Research
MLA supports public access to information generated through federal funding, including the development of the NIH Public Access Policy. Recently, Congress and the Office of Science and Technology Policy (OSTP) have introduced legislation and initiatives that call for the development of public access policies across federal agencies. MLA supports these initiatives and believes that this information should and must be equally accessible to all Americans.
Fair Access to Science and Technology Research Act of 2015 (FASTR)
MLA supports FASTR (H.R. 1477 and S. 779) because it will support better patient care, biomedical research and innovation, education, and health information technology through public access to high-quality health information in the United States. FASTR requires each federal agency with extramural research expenditures of over $100 million to develop a federal research public access policy that is consistent with, and that advances, the purposes of the agency, and that follows common procedures for the collection and depositing of research papers. It makes each federal research public access policy applicable to: (1) researchers employed by the federal agency whose works remain in the public domain, and (2) researchers funded by the agency.
Office of Science and Technology Policy Initiative re: Expanding Public Access to the Results of Federally Funded Research
MLA supports the Office of Science and Technology Policy’s (OSTP’s) directive calling upon federal agencies with $100 million in the annual conduct of research and development expenditures to develop a plan to support increased public access to the results of research funded by the federal government. This initiative mirrors the goals of the Fair Access to Science and Technology Research Act (FASTR) to facilitate scientific collaboration and provide researchers with easier access to the results of federally funded scientific research and data. As of July 2015, the National Aeronautics and Space Administration (NASA), the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Agency for Healthcare Research and Quality (AHRQ) have released public access implementation plans. These plans include making publications and digital data resulting from federally funded research freely available to the public in compliance with the OSTP directive.
ClinicalTrials.gov is a publicly accessible database of clinical trials run by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). It is the largest clinical trials database, currently holding registrations from over 130,000 trials from more than 170 countries in the world.
MLA supports efforts that
- promote transparency for the reporting of all NIH clinical trials results information, including adverse events;
- clarify requirements to clinical researchers for registering clinical trials and submitting summary trial results information to ClinicalTrials.gov.; and
- expand the scope of clinical trials required to submit summary results to include trials of unapproved, unlicensed, and uncleared products.
- MLA, Cancer Libraries Section of MLA, and AAHSL comments in support of the NIH Proposed Rulemaking for Clinical Trials Registration and Results Submission under the Food and Drug Administration Amendments Act (February 2015)
- MLA, Cancer Libraries Section of MLA, and AAHSL comments in support of the draft NIH Policy on Dissemination of NIH-funded Clinical Trials Information (February 2015)