Prepare your IRB now for disease outbreaks
Prepare your IRB now for disease outbreaks
Regional agreement, pre-approved protocols
Taking steps now to streamline approval processes for fast-moving diseases will better prepare IRBs to handle not just the current H1N1 virus, but future viruses as well, says Raphael Saginur, MD, FRCPC, chief of the infectious disease division and chairman of the research ethics board (REB) at Ottawa Hospital in Ontario.
"I think there's an important message for the IRB community to think about it now, and not to put their heads in the sand," Saginur says. "So that if things turn nasty in the fall, or another fall with a future influenza outbreak, that people will have thought about the issues and be prepared for them."
How do IRBs become more nimble? Saginur and others suggest some mechanisms by which IRBs can prepare now for infectious disease outbreaks:
-Networking with neighbors – Saginur says IRBs should start speaking to neighboring institutions and frequent collaborators about how they might handle multisite research into a localized outbreak.
"The more you can arrange beforehand, when things are not crazy, the better," he says. "If we can work out among institutions some prior agreements through whatever mechanism, memoranda of understanding, or whatever, we think we can be ahead of the curve."
Saginur currently is working with other REBs (the Canadian equivalent of IRBs) and the Public Health Agency of Canada to figure out a streamlined approval process for pandemic research. He says they hope to have some model in place by the start of the fall flu season, when experts fear this strain of H1N1 could become more virulent.
He says that while there are several possible models for such coordination, including a central REB devoted to influenza, a more likely short-term response could be a simple agreement among institutions to accept each other's reviews.
Straw protocols
Frederick G. Hayden, MD, FACP, influenza research coordinator for the Wellcome Trust in London, says IRBs can give preapproval to protocols that have been worked up in advance of a disease outbreak, based on the likeliest research methods to be used.
"We know what kinds of clinical data and samples need to be collected — they would basically need to be the same if it were H5 (avian influenza), or a novel H1 or a SARS-like agent," Hayden says. "You could have a straw protocol and an associated consent form reviewed and approved in advance. They would be on the shelf ready to go with minor modifications depending on the specific circumstance, so they could be rolled out not in a period of months, but in a period of days."
The CDC already has such preapproved protocols in place, says Chad M. Heilig, PhD, who manages the CDC's Human Research Protection Office in Atlanta.
He says that the relevant researcher or division prepares a protocol on an investigation into a specific illness. The CDC's IRB reviews it and continues to review it annually in anticipation of a time when it might be needed.
"They are used sometimes never, sometimes once or twice a year," he says. "This allows us to have an already IRB-approved protocol ready for deployment in circumstances where there's no other mechanism that would speed up the ability to respond."
Saginur says IRBs should check with researchers at their institutions to see if any might be likely to be involved in infectious disease research.
Gigi Kwik Gronvall, PhD, a senior associate at the Center for Biosecurity at the University of Pittsburgh Medical Center says such arrangements could help with social science research into pandemics as well.
"Researchers outline the types of research, the kinds of people you're likely to interview, the types of activities you're likely to perform and the agreement of steps you will take when the situation is clarified," she says. "You get a kind of blanket approval for these types of activities and also obligations to fulfill once the situation becomes clear."
Regulatory tools
Heilig says the Food and Drug Administration has developed emergency use authorizations (EUAs) that allow the use of unapproved articles without IRB approval in the event of certain emergency infection situations.
The CDC's Web site lists five such EUAs for the H1N1 virus — two for medications, two for test kits and one for a respirator.
"For example, for oseltamivir (a medication), according to the emergency use authorization for the recent H1N1 outbreak, it is allowed to be used in some cases that are not currently labeled, such as for persons under one year of age or people who present with symptoms of severe illness," Heilig says.
He says a 2006 amendment to the federal regulations (21 CFR 50.23e) allows for the use of unapproved investigational devices to identify and facilitate treatment for life-threatening illnesses and to report those illnesses to public health authorities without requiring informed consent in advance.
However, if identifiable private information derived from the use of these devices was used for other purposes, such as to evaluate the devices' safety and effectiveness, that would constitute human subjects research and would require review by an IRB, which would determine whether informed consent could be waived, according to an OHRP guidance on the regulation.
In-house contingency planning
A serious disease outbreak is likely to strain the ability of the IRB to get its work done. Saginur notes that members might be more frequently ill and absent, or hampered by their other clinical or administrative responsibilities, just when researchers need them to move quickly.
"I think there has to be preparedness in the same way that institutions have business continuity planning for outbreaks or other mass emergencies," he says.
Taking steps now to streamline approval processes for fast-moving diseases will better prepare IRBs to handle not just the current H1N1 virus, but future viruses as well, says Raphael Saginur, MD, FRCPC, chief of the infectious disease division and chairman of the research ethics board (REB) at Ottawa Hospital in Ontario.Subscribe Now for Access
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