Human Subjects Research Grants--Just a Matter of Timing


In an effort to reduce the workload and regulatory burdens on grant applicants and human subject reviewers, NIH released their Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications earlier this month. Although this revised policy changes the timing of NIH's grants procedures, a move that is helpful to all involved with human subjects investigations, NIH's governing policy on human research remains unchanged.

Scientists wanting to test new drugs on members of the public or analyze DNA samples from families, for example, need to obtain institutional review board (IRB) approval before they can receive federal grants--no awards will be made without that approval.

How Does the Revised Policy Affect Applicants?

Under the new guidelines, applicants can now wait until they receive their NIH study section scores before seeking IRB assessments of their research. IRB reviews are performed by local panels comprised of university faculty, experts, and laypersons, who ensure grant applications and research protocols meet ethical guidelines. The process can take up to a couple of months to finalize, and prior to the revised policy, IRB approval had to be submitted to the NIH with the investigator's final application (or before the study sections met), a requirement that sometimes clashed with NIH's grants schedule. But now, by separating grant application requirements from IRB requirements, applicants have some extra breathing space, allowing them to better prepare their research applications and satisfy IRB criteria.

"It's a big change, and it's a good change," judges Ruth Fischbach, NIH's senior advisor for biomedical ethics. She points out, however, that NIH's revision makes no demands upon universities, who may still insist that their faculty and investigators fulfill IRB requirements before sending their grant applications off to NIH. "The expectation, however, is that many institutions will welcome the change," predicts Fischbach, who urges applicants to "check with their institution to ensure they are following the institutional requirements--not only NIH's policies."

With the new guidelines, if an application's priority score falls within a "fundable range," then applicants should plow ahead, get approval from their local IRB panel and submit the review to NIH. A fundable score however, does not guarantee that an award is imminent.

What Does the Revised Policy Mean for IRBs?

"We spend 75% to 85% of our time reviewing protocols which won't be funded--it's an enormous amount of work," says Lowell Maughan, chief of Johns Hopkins Bayview Medical Center's cardiology division, who is also an IRB panelist there. Only a quarter to a third of submissions actually get funded by NIH, which means both applicants and IRBs expend a lot of effort getting applications approved, even though the chances of winning funds are slim. But now, the revised policy should let IRB panelists focus on reviewing only those applications that stand a good chance of being funded.

How Does NIH Benefit?

The revised policy will also help out officials at NIH's Center for Scientific Review (CSR) who receive, track, and handle the 40,000 or so grant applications that flood their offices throughout the year. NIH's scientific review administrators "can spend a lot of time tracking people down" to ensure the relevant IRB documentation accompanies applications, explains Suzanne Fisher, director of CSR's division of receipt and referral. If administrators cannot locate investigators--something that appears to happen with every round of reviews--then "a small number of grants have to be deferred," reveals Fisher, which can leave some applicants "pretty unhappy." The revised policy will hopefully abolish such incidents.

Although many believe the move "makes a great deal of sense," scientists need to keep their desire for funding in check: The take-home message, Fischbach says, is that the protection of research participants is paramount, requires serious consideration, and is the investigator's responsibility: Human subject research should always go well beyond the paperwork.

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