On November 13th, the FDA announced a proposed rule to amend its regulations to allow for waivers
and alterations of consent for certain minimal risk research. Comments on the proposed rule will be
accepted through January 14. 2019 via regulations.gov or in writing via mail/courier/hand-delivery.
Should the proposed rule be finalized as is, FDA will add an additional “Exception from informed consent
requirements for minimal risk clinical investigations” to 21 CFR 50 which would permit IRBs to approve
waivers or alterations of informed consent when the IRB finds and documents that:
• The clinical investigation involves no more that minimal risk to the subjects;
• The waiver of alteration of informed consent will not adversely affect the rights and welfare of
• The clinical investigation could not practicably be carried out without the waiver or alteration
of informed consent; and
• Whenever appropriate, the subjects will be provided with additional pertinent information
The preamble provides some insight into FDA’s interpretation of the application of each of the criteria.
For example, regarding the 3rd criterion, FDA comments:
If scientifically sound research can be practicably carried out using only consenting subjects, FDA
believes it should be carried out without involving nonconsenting subjects. By practicable, FDA
means, for example: (1) that recruitment of consenting subjects does not bias the science and
the science is no less rigorous as a result of restricting it to consenting subjects or (2) that the
research is not unduly delayed by restricting it to consenting subjects. The emphasis is on
situations where it is impracticable to carry out the clinical investigation, as designed, without
the waiver or alteration, rather than on situations where it is not feasible to obtain informed
consent from human subjects.
Importantly, the FDA did not choose to include the fifth criterion present in the revised Common Rule
which only permits waivers or alterations for research involving identifiable private information or
identifiable biospecimens when “the research could not practicably be carried out without using such
information or biospecimens in an identifiable format”. FDA does not comment in the proposed rule on
why it is not proposing to adopt this criterion but does invite comments.
Also of note, the proposed rule does not permit IRBs to omit or alter the consent element at 21 CFR
50.25(c) which requires a specific statement about the inclusion of clinical trial information at
ClinicalTrials.gov. This element of consent must be provided to subjects as is, unless the requirement
for informed consent is waived.
Comments on the proposed rule will be accepted through January 14. 2019 via regulations.gov or in
writing via mail/courier/hand-delivery. The proposed rule provides instructions for each.