OHRP Closes 2019 Vanderbilt Review, Finds Continuing Noncompliance at Stockton University
Following a year in which it issued only two determination letters, in the month of January, the HHS Office for Human Research Protections (OHRP) posted two such letters—one of which closes a not-for-cause evaluation of Vanderbilt University Medical Center (VUMC) begun nearly five years ago. Both letters are dated Jan. 11. Acknowledging that agency officials “regret the amount of time it has taken us to complete this assessment,” OHRP said it conducted a two-day, onsite, not-for-cause evaluation of Vanderbilt in June 2019. “On January 28, 2022, OHRP requested current copies of the VUMC HRPP’s [human research protections program] organizational chart along with their written procedures, templates, and tools. On February 8, 2022, VUMC sent OHRP the requested information. OHRP requested additional documents and scheduled a meeting with VUMC to clarify certain points. During the March 6, 2023 meeting, VUMC satisfactorily addressed the concerns raised by OHRP,” according to the letter—which makes no mention of these “concerns.” Vanderbilt “agreed to make certain changes,” OHRP said, such as revising definitions. “Based on information obtained during the 2019 site visit, and review of additional documents, OHRP found no evidence of systemic noncompliance with HHS regulations. When changes referenced in your March 28, 2023 letter are finalized, please send us a copy of those revised written procedures,” OHRP wrote.
According to the letter to Stockton University, based in Galloway, N.J., OHRP received a complaint that the university had not updated its policies and procedures to comply with requirements related to institutional review board (IRB) actions, including how meetings are recorded; that consent forms were inadequate; and that it was not using appropriate procedures for expedited research, in violation of the 2018 revised Common Rule, which went into effect in January 2019. OHRP confirmed that all the allegations had merit. The agency wrote to Stockton about five specific allegations on Oct. 18, 2022, and received replies on Dec. 13, 2022, and April 27, 2023. Consent forms OHRP received, for example, violated the regulations because, in at least one study to “learn about health, nutrition, and physical activities in individuals with intellectual and developmental disabilities through interviews,” the documents did not address how identifiable or private information would be safeguarded. Despite all of the issues, it does not appear that OHRP took any actions to halt research at Stockton. According to the new letter, Stockton is still out of compliance with the various requirements; the agency gave the university a deadline of March 7 to submit new policies and procedures that address the deficiencies. “OHRP acknowledges that Stockton University is working diligently to support and stabilize its [HRPP] and IRB,” the agency’s letter said. It listed eight changes Stockton had made, including new staff hires and the use of a consulting firm to help structure its HRPP and develop required policies.