IRB review is required for regulated NON-EXEPT human subjects research.
QUESTION 4 – Is this human subject research EXEMPT
from the IRB review requirement?

The effect of an exemption is to say that, although the activity meets the human subjects research definition, it is not required to undergo IRB review.  Failure to use exemptions or to use them correctly has resulted in mission creep and in asking more of some studies than is actually necessary.

Exemptions were added to the 1981 regulations at the very last moment (just before President Reagan’s inauguration) so that studies, mostly in the social science realm, would not have to meet review criteria that were felt to be inappropriate.  They were added as a compromise in order to have the regulation accepted.  The categories were included in regulation and can’t be easily changed.  

Exemptions are defined primarily by the settings and procedures and make no reference to risk. They were written before the internet or social media when privacy and confidentiality meant something very different.

Review of Exemptions:

No one is allowed to made an exemption decision for themselves; it should be made by someone who is very conversant with human subject protection regulation.  At E&I, staff IRB administrators who hold the CIP certificate review exemptions.

The primary regulatory question is whether all of the procedures fit into one or more of the categories.  Activities that are deemed exempt should conform to ethical practices in the field including appropriate consent. 

The “Project”:

Many studies, particularly evaluations, are written into larger grants for activities that may (if investigational) or may not (a demonstration program) require IRB review.  The regulatory language at 45CFR46.101(b) says,

“Except for exempt research, no human subjects may be involved in any project supported by these awards until the project has been approved by the IRB, and certification submitted by the institution to the department or agency.”  [italics added]

The certificate mentioned is an NIH form submitted with the grant.  It asks if “the project” is exempt or, if not, if it is approved.  Must all grant activities be reviewed as one or can the evaluation be considered separately?  There seem to be differences among institutes.  E&I will follow the lead of the client.  

Limits on Exemptions

Some studies involving children, pregnant women, and prisoners may not be exempt.  If your study is federally funded or your institution requires use of the vulnerable subject subparts, the restriction may apply.

Children:  Exemption 2 cannot be used for most studies involving children IF the regulations about children must be applied.  .

FDA:  FDA does not allow any of the exemptions except for taste tests

To have E&I experts review your request for exemption, complete Form 12 with the requested attachments and send it to [email protected]