Scope:

  • IRB waiving or altering informed consent requirements for certain minimal risk
    clinical investigations
  • no objection to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters informed consent requirements
  • in accordance with 21st Century Cures Act

Waiver: Current Rule

  • life-threatening situations
  • emergency research
  • ‘where it is not feasible or it is contrary to the best interest of such human
    beings’

Waiver Revisions: Based on 21st Century Cures Act

  • clinical investigation involves minimal risk (21 CFR 50.3(k), or 56.102(i))
  • will not adversely affect the rights and welfare of the subjects
  • clinical investigation could not practicably be carried out without the waiver
  • subjects will be provided with additional pertinent information after participation

GUIDANCE


Image credit: FDA

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s