Biological Material Storage Consent Form Future Use

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Multi-State
Control #:
US-70265NMS
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Word; 
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FAQ

In the revised Common Rule, "broad consent" is an alternative consent process only for the storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for future, yet-to-be-specified research.

As we have argued, broad consent in biobank research is not merely a pragmatic solution but a morally valid, legitimately informed model when used as part of a framework of research governance. This also implies that 'more information' in itself does not necessarily make a consent more informed.

Secondary means the re-use of identifiable information and identifiable biospecimens that are collected from some other ?primary? or ?initial? activity. In other words, data that were not collected for the purpose of the specific proposed study.

In the revised Common Rule, "broad consent" is an alternative consent process only for the storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for future, yet-to-be-specified research.

A document with important information about a medical procedure or treatment, a clinical trial, or genetic testing. It also includes information on possible risks and benefits. If a person chooses to take part in the treatment, procedure, trial, or testing, he or she signs the form to give official consent.

The Final Rule allows broad consent for either a specific type of specified future research (for example, prostate cancer research) or a broader scope of research (for example, any biomedical research). The Final Rule did not contain any templates for broad consent forms.

Consent for future use of data and tissue in research Extended consent involves participants providing consent for the future use of their data/ samples and includes participants providing consent to being contacted again in the future.

Ultra-low temperature (ULT) freezers provide the necessary conditions for storing biological specimens. Storage at -80 °C preserves biological specimens by slowing or stopping natural functions.

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Biological Material Storage Consent Form Future Use