Adverse Event Report

Institutional Review Board

for the Protection of Human Subjects in Research

New Mexico Tech's Institutional Review Board (IRB) is charged with protecting the rights and welfare of human research participants recruited to participate in research activities conducted at New Mexico Tech.

Thank you for bringing this to our attention.

This form should be used to report single adverse events. A separate Incident Report (i.e., reports of problems involving the conduct of the study or human participants, including problems with the recruitment and/or consent processes, and/or any deviations from the approved protocol) in letter format, addressed to the IRB Administrator, should attached to this form.

IMPORTANT: Once the IRB Adverse Event Report Form is complete request a copy be sent to your NMT email for your records. Forward that email to the IRB Admin at irb@nmt.edu

Researcher Name

Department

Primary Phone #

Phone

Primary NMT Email

Title of Project/Research

Original Period of Project / Research

IRB Database Number:

Numbers only

IRB Approval Date:

mm/dd/yyyy

IRB Expiration Date:

mm/dd/yyyy

Adverse Event Details

Please attach your incident report statement to this document as well in the file upload located at the bottom of this form.

Adverse Event (3-4 words)

Date of Event

mm/dd/yyyy

Adverse Event Appears to Be

Directly related to the research

Indirectly related to the research

NOT related to the research

Additional Details or Summary of Adverse Event

A detailed report should also be attached

Questions

Please answer the following questions to the best of your ability

Question 1

Was use of procedure intended to directly benefit the subject?

Yes

Question 2

Has this type of adverse event been reported before?

Yes

Question 3

Is this type of event likely to occur again?

Yes

Question 4

Is the event adequately described in the protocol and consent form?

Yes

Question 5

Have other agencies or sponsors been notified of this adverse event?

Yes

Principal Investigator/Researcher Assurance

As principal investigator/researcher, I hereby assure that the information I have provided on this form is correct and accurate, to the best of my knowledge.

Is a Faculty Advisor Assurance Required?

Yes

File Upload

Please attach a full Incident Report describing the Adverse Event for the IRB to this form. Attach any other necessary documents here as well.

~Thank you

Drop your files here

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