From now on, all "unanticipated problems" occurring in participants of clinical trials sponsored or supported by the HHS must be reported.
"An unanticipated incident, experience, or outcome will generally warrant consideration of substantive changes in the research protocol or informed consent process/document or other corrective actions in order to protect the safety, welfare, or rights of subjects," says the new >guidelines, released by the HHS's Office for Human Research Protections (OHRP).
The OHRP stressed, however, that an unanticipated problem should not be confused with an adverse event - the vast majority of adverse events occurring in human subjects are not unanticipated problems.
"Only a small subset of adverse events occurring in human subjects participating in research will meet the three criteria for an unanticipated problem."
According to the guidance, "The OHRP will consider any incident, experience or outcome an unanticipated problem if it is of an unexpected nature, severity or frequency given the research procedures described in the IRB-approved research protocol or informed consent form and taking into account the characteristics of the subject population; if it is or may be related to participation in the clinical trial; and if it may place trial participants or others at greater risk of physical, psychological, economic or social harm than was previously known."
The OHRP did acknowledge the potential difficulties that may be experienced when trying to determine whether a particular incident, experience, or outcome is unexpected and whether it is related or possibly related to participation in the research.
However, it stressed the importance of doing so and advises that once an unanticipated problem is identified, those running the trial should consider taking immediate corrective actions.
These included making changes to the research protocol initiated by the investigator prior to obtaining IRB approval to eliminate apparent immediate hazards to subjects; modification of inclusion or exclusion criteria to mitigate the newly identified risks; implementation of additional procedures for monitoring subjects; suspension of enrollment of new subjects; suspension of research procedures in currently enrolled subjects; modification of informed consent documents to include a description of newly recognized risks; and provision of additional information about newly recognised risks to previously enrolled subjects.