Should infectious disease research be fast-tracked?
National IRB could expedite approvals
Current federal research regulations in the United States limit efforts to study emerging infectious diseases, and an alternative model is needed to allow a rapid response to immediate threats to public safety, a top U.S. researcher claims.
The recent experience of Canada, Hong Kong, and China during the severe acute respiratory syndrome (SARS) epidemic provides a perfect example of how a completely new disease can rapidly and mysteriously decimate large populations, says Richard Whitley, MD, professor of pediatrics, medicine, and neurosurgery at the University of Alabama-Birmingham. He also is the project director for the Collaborative Antiviral Study Group, a multi-institutional collaborative network funded by grant from the National Institute of Allergy and Infectious Diseases (NIAID).
Although the SARS outbreak appears to be under control, there is every indication the illness will re-emerge in the future. And researchers still do not fully understand where the virus came from and why it is so deadly, Whitley wrote in an editorial in the June 19 edition of The Wall Street Journal.1
"We still don’t understand, for instance, whether there are any genetic variations in the virus that might account for differences in mortality or whether genetic differences in people play a role in who gets sick and who dies," he stated. "Moreover, we don’t know where the virus came from — birds or pigs or some other animal — and how it got into humans."
SARS is just the latest in a new outcrop of emerging infectious diseases that threaten large numbers of people here and around the globe. And as human populations continue to grow, have more contact with one another, and encroach on previously untouched habitats, more diseases will emerge, Whitley tells IRB Advisor.
"What our problem as a research community is, we can neither predict where an emerging infection is going to appear nor when it is going to appear," he states. "Because of that, we cannot put in place a clinical trial network the same way you would for cancer or the way you would to study herpes simplex encephalitis, for example."
This lack of predictability for emerging infectious disease threats, coupled with the need to test new therapies in an ethical, acceptable way, means that new information, therapies or vaccines are going to be slow to emerge, he says.
The local institutional review board at each site enrolling participants in a study must carefully vet research protocols involving human subjects. If a new disease outbreak occurs in a region without a study already in place, the long, cumbersome process must be initiated in the midst of a public health crisis.
"If West Nile breaks out in Des Moines and I don’t have a clinical trial site there, yet all of a sudden there are 10 cases, we end up denying the opportunity of those 10 patients to receive a potential therapeutic drug this summer," Whitley explains. "The local IRB might say, we will grant you one compassionate plea patient, but it would not be good practice for the chair of the IRB to say, I’m going to let you study 10 patients on a compassionate plea protocol.’ It is just bad form. It violates public trust in the institutional review board process because it appears as though someone is coming around to the backdoor to get approval in an easy fashion."
The solution, Whitley argues, is to have a single national IRB devoted to reviewing and approved research protocols that study new and emerging infectious diseases. "What I’ve proposed is to have some sort of omnipresent, universal institutional review board that would be just for emerging infections — not to circumvent all of the cancer protocols that need to go through or the cardiology protocols — but to provide rapid, public health response for the U.S. people," he explains.
The national IRB would approve one protocol that would be followed at each site nationwide studying a particular new disease, vaccine, medication or other treatment. It would eliminate the need for local IRB approval at each participating site.
"In that way, we can guarantee that: 1) an IRB has looked at the protocol and does think that it should be performed; and 2) that the protocol gets the buy-in of the U.S. Food and Drug Administration and the Office of Human Research Protection [OHRP]," Whitley continues. "So, then, we would not be putting ourselves in the position of having an investigator fighting at each institution to get approval in the next 24 hours, so the protocol can be done."
Establishing such a national body, of course, will require new legislation. So, Whitley is now making the rounds, explaining his proposal to representatives with the Infectious Diseases Society of America (IDSA) and the American Association of Medical Colleges (AAMC), as well as select lawmakers.
Once he has input and buy-in from the professional organizations and policy community, he hopes get sponsorship from both the NIAID and IDSA to hold a national meeting in Washington, convening medical, legal, and policy experts to draft a proposal.
Whitley acknowledges his plan might be a tough pill for local IRBs to swallow. "This represents a serious paradigm shift for people who like power — and those are the local institutional review boards. I think we will see challenges possibly from OHRP and from the local institutions," he notes. "Particularly, the legal representatives who serve on local IRBs may not be very receptive. They may not necessarily care as much about what his happening overall with the emerging infection, but about the potential liability of the individual institution for any adverse events."
To those who might think his approach is overkill, he points out that other countries, such as the United Kingdom, are considering similar plans, and that new, infectious diseases are an increasing threat. Each missed opportunity to study a case might be an opportunity for a cure lost forever, he adds.
"Delay in review of research in the face of emergencies may mean missing the emergency and forsaking research opportunities necessary to make advances that may not recur," Whitley states. "The Great Influenza Pandemic of 1918-19 came and went in less than 12 months. To this day, we don’t know what caused it and how to prevent it. Who knows when the next pandemic, terrorist incident, or natural disaster will occur?"
Reference
1. Whitley R. We need to "fast-track" research. The Wall Street Journal. June 19, 2003.
Current federal research regulations in the United States limit efforts to study emerging infectious diseases, and an alternative model is needed to allow a rapid response to immediate threats to public safety, a top U.S. researcher claims.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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