The Common Rule Proposed Changes – An Attempt to Simplify

by | Sep 14, 2015 | Human Subjects / IRB


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 to the common rule.

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 the Common Rule?

The Common Rule is a set of 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 common rule guidelines.  Many researchers think changes to the Common Rule 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.

Changes to the Common Rule:

  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 topics like the Common Rule, I urge you to read more, and submit responses if you feel it is necessary.

Currently, the FDA only regulates true direct-to-consumer (DTC) genetic tests, which have no health care provider involved either before or after testing. Consumer-initiated, physician-mediated genetic tests are considered lab developed tests (LDTs), which currently do not require FDA oversight. 

 

Our Study Design

Our study was designed to simulate the experience of an everyday person who is considering doing a health-related genetic test. For this reason, we only reviewed website contents presented to a consumer before ordering a test. By limiting our data collection to pre-test content, instead of digging around or contacting the companies to fill in missing data points, gaps in public-facing information that consumers use to make ‘informed’ decisions were revealed.  

Also, while a genetic counselor supervised the project, a research assistant (RA) conducted most of the website investigations. The RA was familiar enough with genetics and genetic testing to understand and identify the information presented on the websites, but has not had the clinical exposure that might create bias from knowing how specific tests work “behind-the-scenes”. 

 

To Sum Up

We set out to understand the landscape of health-related consumer genomics testing from the public perspective. By limiting our research (by design) to public-facing pre-test website content, we could not complete our data collection as set out in the protocol. However, this uncovered an important observation: consumer genomics websites are highly variable in content, readability and ease of use. 

This begs the question, if we can’t find basic test information on a consumer genomics website, how does a consumer have enough information to make an informed choice about testing? 

Stay tuned for Part 2 in this series, where we will dig into our study findings and reveal our most interesting observations.  

 

 

As experts in FDA user comprehension studies for consumer genomics companies seeking 510(k) clearance, we are interested in how everyday people access and understand health content that is meant for them. If you need help optimizing your consumer-directed health communications, we’ve got the in-house expertise and experience to meet your needs. Let’s chat

About the Author

Scott D. Crawford

Scott D. Crawford is the Founder and Chief Vision Officer at SoundRocket. He is also often found practicing being a husband, father, entrepreneur, forever-learner, survey methodologist, science writer & advocate, and podcast lover. While he doesn’t believe in reincarnation, he’s certain he was a Great Dane (of the canine type) in a previous life.