HUMAN SUBJECTS RESEARCH
REVIEWITC – ALPHA 2205
BINGHAMTON, NY 13902-6000
TELEPHONE: (607) 777-3818
FAX : (607) 777-5025
E-MAIL: hsrrc@binghamton.edu
BINGHAMTON, NY 13902-6000
Reportable Events Form
(See page 2 for list of Reportable Events)
1. This subject was enrolled at Binghamton University:
Yes
No
a. If No, where was the human subject recruited from:
2. Date of Event:
3. Study Title:
4. Principal Investigator:
5. Protocol Number:
6. Was the event:
Yes
No
a. Unexpected or unanticipated?
Yes
No
Yes
No
b. Did it involve risk to subjects or others not involved in the
study?
c. Was it more likely than not related to the research? (Do not limit
this to research procedures only)
7. Did the event include/involve:
Yes
No a. Non-compliance
Yes
No
b. Deviation(s) from the protocol
Yes
No
c. Protocol violation
Yes
No
d. A change to the protocol without HSRRC review to eliminate
an apparent immediate hazard to subject(s)
8. Note a description of event:
9. Have there been previous similar events concerning this study?
Yes
No
a. If yes, total for this study?
10. Is this event covered in the currently approved consent form?
11. Individual who is documenting:
Principal Investigator
Human Subjects Office
Other
Yes
No
HUMAN SUBJECTS RESEARCH
REVIEWITC – ALPHA 2205
BINGHAMTON, NY 13902-6000
TELEPHONE: (607) 777-3818
FAX : (607) 777-5025
E-MAIL: hsrrc@binghamton.edu
BINGHAMTON, NY 13902-6000
IRB STAFF
DETERMINATION:
Review by Convened IRB Required
Requires Administrative Action Only
FOR IRB USE ONLY:
Yes
NO
1. The event is an unanticipated problem involving risk to subjects or
others.
Yes
NO
2. The event is non-compliance.
Yes
NO
3. The event requires reporting.
________________________________________________
Signature of Reviewer
________________
Date
I do not have a conflict of interest in this review.
REPORTABLE EVENTS
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Allegations or findings of non-compliance. Non-compliance is defined as: failure to follow
the requirements or determinations of the HSRRC
Any deviations from the approved protocol should be reported in writing. Examples of a
more serious nature include incidents of a person being enrolled in a study before signed
consent has been obtained.
Change to a protocol taken without HSRRC review to eliminate an apparent immediate
hazard to a subject.
Protocol violation (meaning an accidental or unintentional change to the HSRRC
approved protocol) that harmed subjects or others or that indicates subjects or others
might be at increased risk of harm.
Adverse events or any harm experienced by a subject or other individual regardless of
whether the event meets FDA definition of “serious adverse event”, which in the opinion
of the investigator are both unexpected and indicate new or increased risks to subjects
Information that indicates a change to the risks or potential benefits of the research. For
example:
o An interim analysis or safety monitoring report indicates that the frequency or
magnitude of harms or benefits might be different from those initially presented to
the HSRRC
o A paper is published from another study that shows that the risks or potential
benefits of the research might be different from those initially presented to the
HSRRC.
Breach of confidentiality
Incarceration of a subject in a protocol not approved to enroll prisoners.
Any problems involving the conduct of the study or patient participation. For example,
social and behavioral interviews may deal with sensitive issues - occasionally, research
subjects will become upset because of the nature of the questions, these incidences
requires reporting.
Any problems involving the recruitment and/or consent processes require reporting. For
example, if a person who is contacted, either in writing or in person, about participating in
a study becomes upset about the recruitment process, this should be reported.
HUMAN SUBJECTS RESEARCH
REVIEWITC – ALPHA 2205
BINGHAMTON, NY 13902-6000
BINGHAMTON, NY 13902-6000
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TELEPHONE: (607) 777-3818
FAX : (607) 777-5025
E-MAIL: hsrrc@binghamton.edu
Any other problem that the investigator considers to be unanticipated and indicates that
subjects or others are at increased risk of harm.
Complaint of a subject when the complaint indicates unexpected risks or cannot be
resolved by the research team.
Unanticipated adverse device effect (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 supplemental plan or
application), or any other unanticipated serious problem associated with a device that
relates to the rights, safety, or welfare of subjects.
Change in FDA labeling or withdrawal from marketing a drug, device, or biologic used in
a research protocol.
Event that requires reporting to the sponsor.
Sponsor imposed suspension for risk.