The Common Rule Proposed Changes - An Attempt to Simplify "Common"

Click to access the HHS.gov website with details about the proposed changes.

Click to access the HHS.gov website with details about the proposed changes.

Let's see how simple we can make this...beware, I may go too far.  If you really want to know about this topic, click the "Human Subjects Protections Update" button to the right, and you will have plenty to read.

What is it?

Ethical (and now also U.S. federal policy) guidelines on how to handle human subjects research.  It includes topics such as consent, Institutional Review Boards (IRBs), and special protections for research subjects who are at risk.  If you are involved in human subjects research, you are likely touched by it in some way.

Why care?

The government started a process in 2011 which continues today to make some changes to the guidelines.  Many researchers think the changes are worth a lot of discussion - numerous reports and opinions have been published, and some are hundreds of pages long.  A lot of smart people seem to care about this.

What is being proposed?

Hang on... I'm going to boil pages of information down to a quick list...this is where you may injure yourself if you take what I write here too literally.  Consider this the equivalent of sticking your big toe into the hot tub to test the water.

The Changes:

  1. A more transparent and simplified informed consent process.
  2. Broad consent will be required for use of surplus biospecimens, even if non-identifiable.
  3. With privacy protections in place, low-risk interventions with adults, educational tests, surveys, observations, and secondary analysis will be considered exempt from IRB.
  4. The government will make available a web-based exemption decision tool.
  5. Consolidate multi-site studies to one single IRB.
  6. Continuing review approvals for complete interventions and data collections go away.

TIMELINE:

Public comment is requested before December 7, 2015 on the specific changes that are proposed here.  After that, anything can happen.

Simplified enough for you?  If you care about these topics, I urge you to read more, and submit responses if you feel it is necessary.