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In total, 99 patients (44% response) agreed to participate in the study and signed the Informed Consent paper including the consent for the case manager to perform the usual neurological evaluation under supervision of the neurologist, to read the medical dossier, and to contact the general practitioner when necessary.
In total, 77 caregivers agreed to participate in the study and signed the Informed Consent paper: Thirty-nine caregivers were included - with the MS-patients they were related to - in the case management group and 38 caregivers were included in the usual care group.
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If the resident is not able to understand the information and/or to sign the informed consent papers a close family member will be invited to participate and provide proxy information on the outcomes.
The "informed consent" papers signed by parents, which were reviewed and approved by institutional review boards at the CDC and Kaiser, said children would receive one of two vaccines and that two different doses of the E-Z vaccine would be studied.
These procedures are made explicit in the informed consent papers and protocols.
The Office of Protection from Research Risks has frequently found that informed-consent papers understate or misstate the risks.
Among the issues the IGZ highlighted was that the informed-consent papers for the study stated there were no known complications to the probiotic formulation used, while the trial's official protocol acknowledged several.
The mail package included a 4-double page questionnaire that consisted of 33 questions together with a cover page and an informed consent form; a paper tape measure; an introduction leaflet and a prepaid return envelope.
In an era when information is shared digitally at the global level, mechanisms of informed consent remain static, paper-based and organised around national boundaries and legal frameworks.
Participation in the study is completely voluntary and the participants receive oral and written information about the study and are giving their informed consent by signing a paper.
For all experiments in this paper, informed consent procedures were approved by the Partners Human Research Committee, protocol 2007P000646/BWH.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com