The future of informed consent - Federal regulations series part 3 of 5

Part 3 of MESM’s series on proposed federal research regulation amendments and the impacts on commericial sponsors and research organisations.

In this article, we review the proposed changes to informed consent and the potential impacts for life science companies and academic research institutions.

The proposed changes are designed to ensure that prospective trial participants have sufficient information to make a well-informed decision about participating in research, with information presented in an accessible manner and easy to read format to help individuals understand the reasons why they may or may not wish to participate in the trial. The other big change to be aware of is that informed consent will be required for secondary research with a biospecimen, even if the investigator has no information that could enable identification of the original donor.

Read this article to find out more detail about the changes that are being proposed and how it may affect your organisation's research. 

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