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Department of Health and Human Services (HHS)Office for Human Research Protections (OHRP)Effects of Hurricanes Katrina and Rita on IRB Operations OHRP understands that the effects of Hurricanes Katrina and Rita have been devastating to areas in Louisiana, Texas, Alabama and Mississippi, and as a result, some human subject protection programs at institutions in the affected areas are unable to function, and may be unable to for some time. Oversight of Research OHRP has been asked how such institutions should handle IRB oversight of research. One option is to defer research review to another IRB designated under the institution�s assurance that is not affected by this disaster. However, given the breadth of the disaster, and the likelihood that IRB records may not be available to send to another IRB for review, OHRP understands that it may not be possible or practical to prevent expiration of IRB approval, and may not be possible or feasible to notify investigators that research that has expired must be suspended. Of course, any research that is determined to be in the best interest of the subjects may continue after expiration of IRB approval. OHRP encourages reasonable attempts to defer to another IRB or suspend research. However, if these extraordinary circumstances prohibit such attempts or make them untenable, OHRP will take into account the situation at institutions that are affected by Hurricanes Katrina and Rita, and will use available flexibility in its decision making if an institution failed to conduct continuing review at least annually and failed to suspend expired research. This flexibility will continue during the time the hurricane's devastation prevents the IRB from either conducting continuing review or temporarily relying on another IRB to conduct continuing review. Research Subject Interventions OHRP has also been asked about subjects receiving research interventions at other facilities during this time. If it is in the best interests of subjects to continue to receive investigational treatments at other facilities, then that should occur as appropriate. Institutions dispensing such interventions should have their IRBs review the protocol as soon as possible, or defer to an IRB under their assurance that has reviewed the protocol, or designate an IRB under their assurance that has reviewed the protocol (see http://www.dhhs.gov/ohrp/humansubjects/assurance/renwfwa.htm about updating an assurance). If the institution dispensing such interventions does not have an OHRP-approved assurance, an institution holding an OHRP-approved assurance may extend their assurance to cover two types of collaborating individual investigators: collaborating independent investigators and collaborating institutional investigators (see http://www.dhhs.gov/ohrp/humansubjects/assurance/guidanceonalternativetofwa.htm) Contact Information OHRP wishes the best to those in the affected areas, and we are available to offer advice and guidance. If you need further assistance, please contact OHRP at 1-866-447-4777 or ohrp@osophs.dhhs.gov and reference Hurricane Katrina or Rita in the message or subject line. |
Last revised: October 20, 2005
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