Clinical Trials Resource Center

Safety Reporting

UTHealth policy* requires researchers to report any unanticipated problems involving risks to subjects or others in a timely manner. 


Unanticipated problems are problems that (1) are not expected given the nature of the research procedures and the subject population being studied; and (2) suggest that the research places subjects or others at a greater risk of harm or discomfort related to the research than was previously known or recognized.

Some examples of reportable events include:

1) Adverse Events - Adverse events are events that are undesirable and unintended, although not necessarily unexpected, effect of the research occurring in human subjects as a result of (a) the interventions and interactions used in the research; or (b) the collection of identifiable private information under the research. (definition from the OHRP link in your email). Only adverse events that have been determined by the researchers to be unexpected, related and placing the subjects at risk of harm should be reported. IND Safety reports generally do not meet this criteria unless accompanied by a summary and analysis supporting the determination that the report places the subjects or others at risk of harm. 

2) Information that indicates a change to the risks or potential benefits of the research. For example: an interim analysis or safety monitoring report indicates that frequency or magnitude of harms or benefits may be different than initially presented to the IRB or a paper is published from another study that shows that the risks or potential benefits of the research may be different than initially presented to the IRB.

3) A breach of confidentiality such as theft of a lap top or thumb drive that contains identifiable research data.

4) A change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol.

5) Any change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a research participant.

6) Incarceration of a participant in a protocol not approved to enroll prisoners.

7) Any event that requires prompt reporting to the sponsor or sponsor imposed suspension for risk.

8) Any complaint of a participant when the complaint indicates unexpected risks or cannot be resolved by the research team.

9) Any protocol deviation that harmed participants or others or that indicates participants or others may be at increased risk of harm.

10) Unanticipated adverse device effect i.e. any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

Determining which adverse events or problems need to be reported can sometimes be tricky, here is a downloadable flowchart to help you decide:

~Algorithm for Determining Whether an Adverse Event Should be Reported to the IRB~

We encourage you to learn more about safety reporting to the IRB- here are helpful links for more information:

*CPHS Policy
OHRP Unanticipated Problem Guidance
FDA AE Reporting to IRBs Guidance
FDA Safety Reporting Guidance for INDs
FDA Mandatory Reporting- Form 3500A
FDA IND Regulations
FDA IDE Regulations