Washington Update: New Title IX Guidance; Associations Send NIH Letter on Clinical Trial Case Studies; IRS Restores Data Retrieval Tool

OCR Issues Interim Guidance on Title IX
On September 22, the U.S. Department of Education’s Office for Civil Rights (OCR) withdrew the previous administration’s 2011 Dear Colleague Letter on sexual violence and 2014 Questions and Answers on Title IX, saying the “withdrawn documents ignored notice and comment requirements, created a system that lacked basic elements of due process, and failed to ensure fundamental fairness.” As a replacement, OCR issued a new interim Q&A guidance document “to provide information about how OCR will assess a school’s compliance with Title IX” as the Department initiates rulemaking. According to the Department, “the rescission letter and Q&A do not add requirements to applicable law.”

Read APLU President Peter McPherson’s statement on the interim guidance.

Associations Send Letter to NIH on Clinical Trial Case Studies
APLU, along with the Association of American Medical Colleges (AAMC), Association of American Universities (AAU), and Council on Governmental Relations (COGR) sent a letter to the National Institutes of Health (NIH) in response to the agency’s revised definition of a clinical trial. The NIH guidance (in the form of case studies) on what now would fall into the category of ‘clinical trial’ is concerning because it appears to include fundamental and basic health-related research. This would trigger all the application, training, registration, and reporting requirements for clinical trials for these studies.

The letter expresses concern with how the case studies modify the definition of clinical trial to include some basic research and that the case studies lack significant clarity, potentially leading to inconsistent classification of research activities. The letter also highlights the significant consequences of having research be declared a clinical trial.

Community Letter on Department of Education Regulations
The higher education community, including APLU, submitted a letter to the U.S. Department of Education (ED) in response to its request for feedback in accordance with Executive Order 13777, “Enforcing the Regulatory Reform Agenda.” The letter strongly urges ED to consider a number of issues, including the return of Title IV funds when a student withdraws, state authorization, and financial responsibility standards, identified in the report “Recalibrating Regulation of Colleges and Universities: Report of the Task Force on Federal Regulation of Higher Education.” The report was issued by a taskforce (comprised of 16 college and university presidents) that U.S. Senators Lamar Alexander (R-TN), Barbara Mikulski (D-MD), Michael Bennet (D-CO) and Richard Burr (R-NC) convened in 2013 to identify specific federal regulations and reporting requirements that place undue burden on students, families and institutions of higher education.

Higher Education Associations Respond to Overtime Rule RFI
In response to the U.S. Department of Labor’s request for information (RFI) on the Fair Labor Standards Act overtime rule, a number of higher education associations, including APLU, submitted comments answering specific questions posed by the Department. The comments reinforce the higher education community’s support for increasing the overtime threshold while also raising concerns about the level of an increase, statutory authorization for automatic adjustments, and timing of adjustments among other issues. The letter also urges the Department not to make changes to the duties test and to release guidance on the application of the teaching exemption to agricultural extension agents.

IRS Restores Data Retrieval Tool for FAFSA
The Internal Revenue Service (IRS) and Department of Education have restored the Data Retrieval Tool (DRT), which helps automatically populate elements of the Free Application for Federal Student Aid (FAFSA) as well as applications for income-based repayment plans, in time for the new financial aid application cycle. The DRT was disabled in March due to data security concerns.