Posted on February 27, 2017 at 9:10 AM
On January 19, 2017 – one day
before the expiration of President Obama’s second term – the Office of Human
Research Protection (OHRP) in the Department for Health and Human Services issued
a revised regulation dealing with the “Common Rule.” The final regulation is officially
titled “Federal Policy for the Protection of Human Subjects (known as the
new regulation is the product of years of study and deliberation offered as an
update of the Common Rule introduced more than 25 years ago. It’s considered a
“common rule” because it applies to the clear majority of all federal agencies
which fund human subjects research grants and contracts. Of course, the principal
objective of the Common Rule is to have a uniform inter-agency approach to
human subject protections through local institutional review boards (IRBs).
one might expect with many federal regulations, rules quickly become outdated
because they simply cannot keep up with technological advances. With the last
issuance of the Common Rule in 2005, regulators probably gave little thought to
the future problems that might occur with universal computerization of research
data and health records, tissue banking, genomic medicine initiatives,
personalization of therapies, and global privacy concerns.
new Common Rule helps a great deal in that it: (1) clarifies the categorization
of “exempted” or “excluded” research projects using risks to patients as
measures; (2) improves the elements of informed consent required and mandates
posting of the forms online in certain cases; (3) gives researchers broader
authority in using identifiable and future deidentified biologic specimens with
and without specific consent; (4) allows the use of a single IRB to oversee
multi-institutional projects within the United States; and (5) specifically
excludes routine and emergency public health surveillance work from human
OHRP, IRBs, and the Common Rule were solutions offered at a time when abuses in
human subject research were public concerns that required a national response.
The medical research scandals of the 1960s and 1970s are well documented. Modernizing
the Common Rule makes sense. The revisions strike a necessary balance in the
ongoing efforts to protect patient autonomy, assure investigator integrity,
avoid unnecessary or nondisclosed risks to subjects, and provide a national
uniformity and general fairness across the human subject research spectrum.