Finding common ground on Common Rule

Consensus seen in several areas

In the waning days of the comment period for the advance notice of proposed rule-making (ANPRM) for human subjects protection regulation, some of the institutional review board (IRB) community's heavy hitters have weighed in.

In addition to a submission by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), detailed comments also were filed by the Secretary's Advisory Committee on Human Research Protections (SACHRP), the Association of American Medical Colleges (AAMC), and Public Responsibility in Medicine and Research (PRIM&R).

While each organization has its own specific take on the proposed revision of the Common Rule, there were many areas of agreement in their comments:

• Minimal risk definition.

AAHRPP, SACHRP, and the AAMC all propose that the Department of Health and Human Services (HHS) should develop a better definition of "minimal risk" as it applies to research oversight.

SACHRP states that the definition should compare potential harms and discomforts in a study to those that an average person in the general population would ordinarily encounter. As an example, AAMC offers the case of a study of cancer patients. In that case, the risks and discomforts of the study intervention should be compared to those a healthy individual would encounter in a routine medical examination.

• Researcher/sponsor responsibilities.

SACHRP and AAHRPP call for the regulations to more clearly spell out the responsibilities of researchers and sponsors in protecting subjects.

Those responsibilities would include knowing when to seek IRB oversight, disclosing financial interests, employing sound study design that minimizes risks, ensuring there are necessary resources to protect subjects, recruiting subjects in a fair manner, using appropriate informed consent, and ensuring that subjects understand it.

"The Common Rule is written such that it applies to the institutions and the [institutional review boards] IRBs," says Marjorie Speers, AAHRPP's president and chief executive officer. "It is silent on the role of the researcher, who deals with the research subject every single day."

Other than requiring the investigator to obtain consent, the rule "does not spell out the responsibilities," she says. "They're just inferred. All of these regulations should address the roles and responsibilities of the major players."

• Informed consent.

All of the organizations believe that the revisions to the Common Rule focus too much on documentation of informed consent and not enough on the process of obtaining consent.

Ann Bonham, PhD, chief scientific officer for the AAMC, writes in that organization's comments, "This focus may have the effect over time of preventing IRBs from allowing the implementation of novel, effective methods of communicating critical study information to research subjects."

The groups did not support the ANPRM's proposal to set length limits on various parts of consent documents, but they supported the idea of moving some topics to appendices rather than the main document.

Proposed new consent templates could be useful, if they demonstrate to researchers how to craft a shorter document with an addendum that gives more detail, SACHRP proposes.

• Researchers self-exempting.

AAHRPP, SACHRP, and the AAMC raise concerns about the proposal to allow researchers to determine for themselves that their studies qualify for the new "excused" (currently exempt) determination.

Speers writes in AAHRPP's comments, "Anecdotal evidence from some accredited organizations suggests that between one-quarter and one-third of researchers misclassify research as exempt when it is not exempt."

She says that while the process of exempting or excusing research could be much simpler, someone needs to review it, whether it's an IRB member or staffer or even a departmental board.

• Central IRB for multisite research.

While the organizations agree that the regulations should encourage more use of a single IRB for multi-site studies, some balk at making that mandatory.

SACHRP calls such a requirement "premature," recommending instead a more deliberative process of encouraging single-IRB use.

In situations in which one IRB is designated, organizations say that the IRB must be chosen carefully and must have the necessary expertise to handle the study and to communicate and interact with local sites. They note that the costs incurred by IRBs handling different levels of oversight need to be compensated fairly.

• Training requirements.

All of the organizations ask that HHS make education of review boards and researchers a requirement in the regulations.

"This system that we have now, and any system we have in the future, is based on people being knowledgeable and competent to conduct research," Speers says. "And if you don't have any education requirement, if you don't have any way to measure competency, then we're going to continue to have incompetent IRBs and researchers involved."

In all, more than 1,000 comments were filed with HHS during the extended comment period.