Report Says Johns Hopkins Researchers
Must Collaborate with Librarians
Among new safeguards to be put in place at Johns Hopkins University to ensure the safety of medical research study participants is a requirement that researchers collaborate with librarians to strengthen literature searches. The requirement is part of a corrective action plan recommended by an external committee appointed to review research procedures at the university following the recent death of a volunteer in an asthma study.
The committee’s report, released by the university August 29, calls on the institution to tighten research-study oversight and to lead efforts to “collegially develop appropriate standards” for the use of non-approved drugs in human studies.
Librarians and pharmacists will assist investigators in searching databases for potential side effects of substances for which the FDA does not require an investigational new drug application.
Kate Oliver, associate director for communication and liaison services at the university’s Welch Medical Library, told American Libraries that a multidisciplinary ad hoc group will test draft guidelines over the next few months to develop a literature-search standard.
Posted September 10, 2001.
|
