Fanfare for the Common
Rule

By

Leonard Zwelling

         There is relief in sight for the clinical investigators of
America struggling with the duel curse of over-regulation and underfunding.
Changes to the Common Rule that governs all clinical investigation have been
proposed and are likely to go into effect next year. Caution and vigilance are
needed—NOW!

http://www.nejm.org/doi/full/10.1056/NEJMp1512205

         In the December 10, 2015 issue of the New England Journal of Medicine, Drs. Kathy L. Hudson and Francis
S. Collins outline changes that have been proposed in the oversight of human
subjects research, The Common Rule. This could mean the first truly meaningful
change in these rules since their advent following the Belmont Report over 30
years ago.

         I urge you to read the article plus the one following it by
Ezekiel J. Emanuel who seems to have had an active hand in getting this ball
rolling four years ago in an Advanced Notice of Proposed Rulemaking that may
soon be coming to fruition.  Here are
some of the benefits, but I add a cautionary tale upfront. The infrastructure
of any institution doing clinical research will have to alter to implement
these changes for the benefit of patients (human subjects, really) and
investigators. That will likely mean changes to the supporting IS structure,
data management and oversight of the clinical research bureaucracy. Here are
some examples:

1. Participants will be able to grant broad consent for
the use of biospecimens.

2. IRB activities will be streamlined by relying less on
single site IRBs and more on centralized ones.

3. Some low-risk activities will be excluded from the
need for IRB approval

4. Deidentified sample research may need consent.

5. There will be a 3-year phase in period for the new
consent rules

6. Consent forms will be simplified

7. Continuing IRB review will not be needed for studies
granted expedited review or when all that remains to be done in a study is data
collection

8. “IRBs WILL NO LONGER BE REQUIRED TO REVIEW GRANT
APPLICATIONS OR CONTRACT PROPOSALS”

9. Research involving standard educational practices,
program evaluations or benign interventions will not need IRB approval.

         I suggest that all of you who still do
clinical research get these two articles, read them carefully, determine how
the new provisions apply to your research and keep aware of the government’s
final ruling when it occurs after the end of the comment period on January 6.
Finally, press the Provost’s Office to assure the faculty that it is ready to
implement the changes once codified in Washington so that the investigators
at Anderson do not give up a competitive edge to researchers at other centers
already gearing up for such change.

         At MD Anderson, I am going to assume
that someone is responsible for the implementation of these changes, the
associated changes to computer systems, the education of the investigators and
the guidance of the support staff as to how decisions will change. This was my
job when HIPAA came in and it was a true pain, but necessary.

         Is someone doing this?

         I know in the days of the Moon Shots,
all the resources are aimed at the lunar target or the launch platforms to get
the rocket to Tranquility Base. I still remember the day when Dr. Mendelsohn
was taking proposals for multi-million dollar research projects and I begged
for one percent for infrastructure and didn’t get it. Please do not make that
mistake here.

         Judicious investment could pay off with
less bureaucracy and quicker transitions from ideas to data, but you have to be
ready on day one to take advantage of the new Common Rule.

         Unfortunately, like common sense, use
of the new Common Rule is likely to be anything but common unless MD Anderson’s
administration is ready.

         Is it?

Leonard Zwelling