AAHRPP says regulators need more information

Before proceeding with revisions to Common Rule

In assessing the recent revisions to the Common Rule proposed by the Department of Health and Human Services (HHS), the accrediting agency for human subjects protection programs suggests that HHS may lack the necessary information to move forward with a final rule.

While the Association for the Accreditation of Human Research Protection Programs (AAHRPP) supports the need for revising the regulations, its comments express concern over the many questions asked in the document.

Marjorie Speers, PhD, president and chief executive officer of the independent, non-profit accrediting body, says that given the reach of the new recommendations, it's important for HHS to be as informed as possible in order to go forward.

"Based on what they are asking for in this advance notice, it appears to us that they don't have the very basic information that they need in order to proceed with rule-making," Speers says.

"I think that if they get a lot of comments that are similar to AAHRPP's comments or they get comments where there's no clear consensus, then I would look for them to make a decision to start over," she says. "There's nothing that says that this advance notice has to move to a notice of proposed rule-making and then to a final rule. They can stop it and start afresh."

Focus on burden or protection?

AAHRPP's response to the advance notice of proposed rule-making (ANPRM) details its concerns with the revisions — concerns that are echoed in many cases by other organizations (see accompanying story).

One complaint addressed by the ANPRM is that oversight of research often doesn't match actual risk level of studies, resulting in both excessive restrictions on low-risk studies and too little attention to higher-risk studies.

While AAHRPP shares that concern, the organization says there is not enough emphasis in the ANPRM on strengthening human subjects protections.

"The apparent primary purpose of the proposed rule-making seems to be to reduce burden on researchers," Speers writes in AAHRPP's official comments. "We are disappointed that it is not clearly stated in the ANPRM, and not observed in many of the proposed revisions, that reducing the burden on IRBs is an additional intention — not the principal objective."

AAHRPP also opposes the planned expansion of the Common Rule to all research conducted at an institution that receives funding from a Common Rule agency, saying it lessens IRBs' flexibility in handling different types of protocols.

And the organization does not favor the ANPRM's proposal to strengthen data protection standards by applying the HIPAA criteria to all covered research. Speers says that she believes there is strong opposition to this provision, and notes this is a good example of an issue where OHRP needs to gather more information.

"The HIPAA data security requirements are not appropriate, but to go back and say 'What is appropriate, do we need something?'" Speers says. "They can gather some information on that and come out with a better idea."

Suggesting new changes

In addition to critiquing the various provisions of the ANPRM, AAHRPP's response suggests a number of changes that the organization would like to see in a future version of the federal regulations.

For example, Speers says the revisions do not address the growing importance of community-engaged research.

"One of the major funding initiatives, for example at the NIH, are the clinical and translational science projects, where they all have a community engagement component," Speers says. "The Centers for Disease Control and Prevention, just by the nature of their mission in public health, are constantly engaged in community-based research.

There is plenty of community-based participatory research occurring, and our regulations are not sensitive to it."

She says that on this subject, along with others, OHRP could benefit from looking at regulations in other countries.

"In a number of areas, other countries have moved beyond the basic regulations that the U.S. has," Speers says.

"Canada addresses research in communities. The European Union, for Phase 1 clinical trials, has one deadline on review time; for Phase 3 trials they have a different deadline. In Mexico, for example, they have some very good regulations that relate to protecting vulnerable populations.

"There are other countries that have really moved beyond us and it's time for us to learn from them."