Adverse Events Update

Adverse events can be tricky to navigate! We have made additions to our Investigator Handbook that give more detail on adverse events to help. Please see the below information on adverse events that is included in the handbook you receive when you create your study in the Axiom Mentor System.

 

An Adverse Events is Any unforeseen occurrence with a research participant, including any abnormal sign, symptom, or raised level of risk, temporally associated with the participants’ involvement in the research, whether or not considered related to participation in the research.

 

A Serious Adverse Event is an adverse event where at least one of the following outcomes is a result of the research activities:

-Death

-Life threatening condition or event

-Inpatient hospitalization

-Persistent or significant disability, incapacity, or disruption of the subject’s ability to conduct normal life activities

-Condition that investigators deem to represent significant risk or hazard to the participant

 

Investigators are required to report any adverse event or serious adverse events that involves human subjects enrolled in the study that are determined to be unexpected and probably, possibly, or definitely related to the test article or research procedures. This should be reported to the IRB promptly, no more than 7 calendar days after the investigators learned of the event. The IRB will then make a determination as to the relation of the adverse event and any impact on human subjects, and if further action is required on the part of the investigator. Investigators are expected to take the findings from adverse events and make appropriate changes to the protocol to ensure safety of participants.

 

All greater than minimal risk studies will be required to maintain an ‘Adverse Event Table’ and submit it at each annual check-in. A table template will be provided at time of initial approval.

What is Human Subjects Research?

National and international ethics codes form a framework for the protection of rights and welfare of human participants in research. These codes have developed over time in response to research misconduct. Examples include horrific experiments conducted on prisoners by Nazi doctors during World War II and the withholding of proven treatment from poor Black men as part of a study of untreated syphilis in Alabama. The Belmont Report, the Nuremberg Code, and the Declaration of Helsinki led to the development of the human subjects in research codes we have today.

Two criteria must be met for a study to be considered human subjects research. First, the study must be considered research according to §46.102: “Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Second, it must involve human subjects. According to §46.102, a human subject is “a living individual about whom an investigator (whether professional or student) conducting research:

  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”

The following questions can help researchers determine whether their study fits the criteria of human subjects research:

 

Is the study considered research according to §46.102? If the answer is ‘No’, the study is not considered human subjects research. If the answer is ‘Yes’, the study is most likely human subjects research.

 

Will the study involve only secondary data or biospecimens collected for purposes other than this study, or belonging to deceased individuals?  If the answer is “yes,” the research may not be considered human subjects research, provided the data/biospecimens come from deceased individuals, the researchers do not have access to participant identifiers, and/or a broad consent or waiver of documentation of consent has been obtained (see §46.116 and §46.117).

 

Author: Mary Lannon, PhD