GSK to grant access to mother and baby home vaccine trial documents

ireland
Gsk To Grant Access To Mother And Baby Home Vaccine Trial Documents Gsk To Grant Access To Mother And Baby Home Vaccine Trial Documents
The trials were raised in the Commission of Investigation into Mother and Baby Homes' report published earlier this year. Photo: PA Archive/PA Images
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Pharmaceutical company GlaxoSmithKline (GSK) is to publish documents relating to trials carried out on former residents of mother and baby homes in Ireland between 1934-1973.

The trials were raised in the final report of the Commission of Investigation into Mother and Baby Homes published in January.

In response, GSK has announced it will establish "an enhanced information service for former residents", confirming the process open to those who wish to access trial summary documents.

The matter relates to nine separate trials, including seven vaccine trials referred to as vaccine trials A to G in the Commission's report, and two infant milk formula trials.

The company said the documentation has been collated from archives and other published sources "to evaluate, as far as possible, the history of the vaccine of milk products after their trials were conducted by researches in mother and baby homes".

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Each summary document will detail what the trial was for, when and where it took place, the number of participants included in the trial, the name of the trial organisers, the vaccine ingredients and dosage, how the vaccine was administered, any side-effects observed in the trial and subsequent trials, the follow-up process following the trial vaccination, and information on the further commercialisation and/or licensing of the product.

"GSK recognises that many survivors are understandably seeking to access their personal information. The company has spent time reflecting on its response to the Commission’s report and has endeavoured to find a meaningful way to assist survivors and their families.

"GSK believes these measures undertaken to simplify the information request service and publish trial summary documents represents the most valuable way to support those seeking further transparency in relation to the trials," a statement published on Wednesday said.

Those who believe they may have been included in one of the trials while resident in a mother and baby home can submit a 'subject access request' to the company.

Ireland
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"GSK wants to ensure that survivors who believe they may have been a participant in a trial are aware they have a statutory right to submit an information request to the company in relation to their personal information.

"It is important to note, however, that the records are not complete for every trial. While some of the individual clinical trial records do contain important identifying information such as names and dates of birth, this information is not available for all trials.

"This means it is not possible to verify the identity of every participant and part of the reason why GSK has also published trial summary documents with information about the development and, where applicable, the licensing history of the trial products," the company added.

For those seeking to access information relating to the trials, additional information can be found on the GSK website.

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