This guidance represents the Office for Human Research Protections’ (OHRP’s) current thinking on this topic. OHRP guidance should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word "must" in OHRP guidance means that something is required under the Department of Health and Human Services (HHS) regulations at 45 CFR part 46. The use of the word "should" in OHRP guidance means that something is recommended or suggested, but not required. An institution may use an alternative approach if the approach satisfies the requirements of 45 CFR part 46. OHRP is available to discuss alternative approaches by telephone at 240-453-6900 or 866-447-4777, or by email at ohrp@hhs.gov.
Date: May 14, 2018
Scope:
This document provides guidance on the oversight of ongoing human research protections programs in affected areas after disasters. The Office for Human Research Protections (OHRP) understands that the effects of disasters (e.g., hurricanes, tornados, earthquakes) can be devastating to the affected areas. As a result, some human subject protection programs at institutions in the affected areas may be interrupted and unable to function, and may be unable to do so for some time.
Target Audience: Institutions, Institutional Review Boards (IRBs), investigators, and HHS funding agencies
Oversight of Ongoing Research:
OHRP has been asked how such institutions should handle institutional oversight of ongoing, IRB approved research. One option is to rely on another institutional review board (IRB) that is not affected by the disaster. IRB authorization agreements still must be executed. However, depending upon the breadth of a disaster, 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. Investigators should be cognizant of when IRB approval for their research expires. Of course, any research that is determined to be in the best interest of already enrolled subjects may continue after expiration of IRB approval. When investigators determine that it is in the best interest of subjects to continue with the research, they are expected to notify the IRB, when possible.
OHRP encourages reasonable attempts to rely on another IRB. However, if extraordinary circumstances make relying on another IRB untenable, OHRP will take into account the situation at institutions that are affected by such disasters, and will use available flexibility in its decision making if an institution failed to conduct continuing review at least annually. This flexibility will continue during the time that the devastation prevents the IRB from either conducting continuing review or temporarily relying on another IRB to conduct continuing review.
Research Activities:
It is difficult to provide generalized advice on the steps that affected investigators, IRBs, institutions, and sponsors should take. In some instances it may be appropriate to terminate the conduct of a study where doing so would not endanger the subjects. In other instances it may be appropriate to attempt to find a qualified investigator and IRB outside the affected area to take over the conduct and oversight of the study in order to permit the study to continue, particularly where doing so would be in the best interest of subjects (for example, treatment protocols). Unfortunately, in some instances, studies may be disrupted, subjects and study staff so dispersed, and IRB records and research data so compromised that it may take some time to sort through these issues.
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 https://www.hhs.gov/ohrp/regulations-and-policy/guidance/extension-of-institutional-fwa-via-individual-investigator-agreement/index.html). Another option is to make other individuals "agents" under their FWA for the purpose of carrying out some aspect of a research study on behalf of an engaged institution holding an FWA. Agents can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation. The determination of whether an individual or entity is an agent of an FWA-holding institution is generally for the institution and the other individual or entity to determine (see
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/determining-when-institutions-are-engaged-in-research/index.html).
Contact Information:
OHRP wishes the best to those in the affected areas, and we are available to offer advice and guidance. We will approach each situation on a case-by-case basis. If you need further assistance, please contact OHRP at 1-866-447-4777 or OHRP@hhs.gov, and reference "Disaster" in the subject line.
