Compliance with January 2018 Changes to the Common Rule

Memo from the IRB Chair, Dr. Helen Turner

January 16th 2018

Re: Responses to the new NIH Common Rule, effective January 19th 2018

Revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the “Common Rule”) were issued by the Department of Health and Human Services (HHS) on January 18, 2017.  The majority of changes will go into effect on January 19, 2018.

How does this affect Chaminade Humans Subjects research?

1. Who is affected?

These changes only affect studies submitted to the IRB AFTER JANUARY 19 2018. If you have an already approved or an already submitted proposal it will be reviewed under the prior guidelines and no action is required from you.

2. Exemptions from Full Review, clarifications of exemptions.

There are changes to the categories of exemption that are now reflected in the CUH IRB Form II (Applications for Studies Eligible for Exemption from Full Review) and in the FAQ and Guidance documents available on the portal.

3. Changes to Informed Consent.

A new “Key Elements” section and a rearrangement of content is designed to facilitate a potential subject’s decision to participate or not in a study. Your informed consent documents will need to be modified to be compliant with the new guidelines and the CUH IRB Samples of Informed Consent documents available on the Portal now reflect this new guidance.

4. Continuing Review.

Some minimal risk studies may be exempt from continuing review (i.e. annual renewal) and will now be approved for three year periods. However, annual reporting to document Adverse Events and to inform the IRB whether the study is ongoing will still be required by the CUH IRB.