Common Rule extension could end 'unchecking'

IRBs say extending regulations to non-federally funded research could add to burden

In the past several years, many IRBs across the country have been seeking to carve out areas of flexibility in the federal regulations by "unchecking the boxes" on their federalwide assurance (FWA).

That action releases them from having to apply every aspect of the regulations to every study at their institutions. IRB officials at these institutions argue that it allows them to find more appropriate ways to review low-risk research that isn't federally funded and that doesn't fit well within the regulatory framework.

Now, with the proposed revision of the Common Rule, that option may no longer be available. The advance notice of proposed rulemaking (ANPRM) released this summer by the U.S. Department of Health and Human Services would, if approved, extend Common Rule protections to all research conducted at an institution that receives any funding from a Common Rule agency.

"It appears that it will take away much of the flexibility that organizations have now," says Marjorie Speers, PhD, president and chief executive officer of the Washington, D.C.-based Association for the Accreditation of Human Research Protection Programs (AAHRPP).

Forty-six percent of AAHRPP-accredited agencies reported in 2010 that they unchecked the boxes applying federal regulations to all research regardless of funding. Another 9 percent checked the box applying only Subpart A to all research.

Speers says there have always been institutions that declined to check the boxes, but that number has grown in recent years. One institution that made the decision to uncheck the boxes is the University of Southern California in Los Angeles, which has formed a Flexibility Coalition to explore ways in which low-risk, non-federally funded studies can be handled more effectively.

At USC, that's meant adding exempt categories not included in the federal regulations, says Susan Rose, PhD, executive director of the Office for the Protection of Research Subjects.

"So a simple student project that uses a game, or tasks, or some other word that is not found in the six exempt categories, could be called exempt, rather than expedited," Rose says.

USC also has extended continuing review periods to two years on these low-risk, non-federally funded studies.

Greater burden

While the ANPRM would make similar changes to low-risk studies — introducing new exempt or "excused" categories, lessening continuing review requirements — Speers says other parts of the revised regulation would create greater regulatory burdens on institutions if the Common Rule is extended to all research.

"The ANPRM describes the major risk with behavioral and social science research as an information risk, and proposed to apply data security rules, which means HIPAA," she says. "That doesn't make sense. Researchers have voiced very strongly over the last eight years the challenges they have in applying the HIPAA regulations to research. To extend it beyond that isn't going to provide any better subject protection and it's going to be tremendously burdensome."

She notes other problems raised by the extension of the Common Rule to non-federally funded research:

• The federal regulations make it difficult to do social and behavioral research with pregnant women because of Subpart B's requirement that research has to either directly benefit the woman or fetus or contribute to the development of "important biomedical knowledge."

"That's going to be difficult for an institution that conducts behavioral or social science research to meet, because the regulations don't allow that to occur, because the regulations say biomedical knowledge," Speers says.

An institution that unchecks the box relating to Subpart B may be able to allow non-federally funded behavioral research with pregnant women, but extending the Common Rule would eliminate that option, she says.

• Speers says unchecking the boxes can allow institutions to write more appropriate consent forms, by eliminating unnecessary language that doesn't apply to non-clinical studies.

"So in behavioral and social science research, where it might not make sense, for example, to talk about loss of benefits because there are no benefits to lose, you wouldn't have to include that statement."

• For surveys of children, the regulations make it difficult to waive parental permission. Speers uses the hypothetical example of a non-federally funded survey of gay teenagers. "Especially if we're talking about 16- and 17-year-olds, it's not necessarily in the children's best interest — and could put them at risk — to get parental permission."

Reporting requirements

Unchecking the boxes also gives institutions more leeway in their reporting requirements to federal agencies, says Moira Keane, MA, CIP, director of the University of Minnesota's Research Subjects Protection Program in Minneapolis. As an example, she points to a student researcher who might have an incident or compliance problem with a study.

"If it were federally funded, we would have a reporting obligation to the federal agency," Keane says. "When we have unchecked our box, we have reporting obligations internally, based on our own policies, but we would not have to report to the federal agency.

"And we see that as a significant advantage on our part, to work collaboratively with our researchers, keep them in compliance, but not jeopardize their future opportunities by creating a spotlight on their minor infractions."

Speers says the flexibility that institutions have been employing doesn't lead to two tiers of protection for subjects in federally funded and non-federally funded studies.

"Unfortunately when we talk about unchecking the boxes, it's described in terms of not having to meet certain reporting requirements and not having to apply the regulations," she says. "But that doesn't mean a lessening or lowering of the protections for human subjects. It can mean just the opposite."

Rose says she would like to see HHS consider some of the innovations created by flexibility initiatives such as USC's incorporated in the final revision.

"A middle ground would be really wonderful to take advantage of the creativity of these various institutions, but to expand what they're capable of doing," she says. "That would be a wonderful contribution, to do it through a regulation."