Biomedical research ethics updating international guidelines jdate speed dating florida
In November 2009, representatives from the Department of Health and Human Services (HHS) and other departments convened to reform the Common Rule with the dual aims of enhancing research participant protections and increasing the efficiency of the research oversight process.The NPRM was initially open for public comment through December 7, 2015; however, the comment period was subsequently extended until January 6, 2016, after widespread demands for additional time to consider and comment on the complex proposals.That consent would generally be obtained by means of ‘broad'consent, a template for which would be provided by the regulators if the rule is finalized.Broad consent has been defined as ‘consent for an unspecified range of future research subject to a few content and/or process restrictions.Informed-consent documents grow ever longer and consistently exceed the eighth-grade reading level, with wide variation in participants’ comprehension.
At present, the Common Rule applies to the secondary research use of biospecimens (meaning use of specimens originally collected for another purpose, either clinical care or other research) only if the biospecimens are identifiable.
The preamble to the NPRM explains that with already existing tools and technologies, ‘biospecimens can be used to generate information unique to individuals and therefore cannot be truly deidentified’.
It is widely accepted that requiring consent for the use of biospecimens in secondary research will create challenges for the research community.
There has been a flood of commentary from researchers, individuals involved in research oversight, and research ethicists.
Here, I will focus on three prominent changes: consent for research use of biospecimens; review of cooperative research by a single IRB; and informed consent documents.