The death of a research subject

In 2001, a clinical trial participant at Johns Hopkins (JH) died as a result of inadequately researched safety information. Ellen Roche was a 24 year old lab assistant at the JH Asthma and Allergy Center and thought to enrol in the study in altruistic intent (as most clinical trial participants do). Immediately following Roche’s death, research funding was suspended and JH was left scrambling to address the controversy. Medical librarians in the US went into overdrive over the incident. It appeared that the lead researcher did a rudimentary search of the literature. He searched PubMed (Medline records from 1966 onwards were available in 2001 and in order to discover older records (hexamenthonium was used extensively in the 1950s) you would have to have searched print indexes), Google, Yahoo!, LookSmart and GoTo.com. Librarians and researchers said that the literature search was lazy and foolhardy. Not only were the researchers at fault, but the JH Institutional Review Board (IRB) was at fault also for not providing proper oversight. Librarians talked about literature search standards and what should constitute a reasonable search. JH have now included literature search standards in the IRB application form and many other IRBs across the US have too.

JH has well resourced libraries – why didn’t the researcher contact them to ask for assistance? Was this a failing of the library as well? The Welch Medical Library began liaison services in 2000 for a few departments (Asthma and Allergy and the IRB were not included). What does this mean for medical librarians now? Perhaps librarians could try and work closer with their research offices in providing some sort of literature search service – approving search strategies and advising researchers where they can be improved. It could be spun as part of the quality control process of clinical trial management. There also needs to be better reporting of adverse effects.  Apparently in a hexamenthonium trial in the ’70s, adverse effects were not included. Adverse effects reporting is still a problem today and also a problem for librarians in searching for adverse effects literature due to inadequate indexing amongst others.

When I first read reports about the death of Ellen Roche and the swirl of commentary about it in the library e-list, it touched me, as it did others. As health professionals, we have a duty to get involved in research activities in order to prevent another incident like this happening again.

Further reading:

The hexamethonium asthma study and the death of a normal volunteer in research

Johns Hopkins’ Tragedy: Could Librarians Have Prevented a Death?

 

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