Pacific Northwest University of Health Sciences
Institutional Review Board (IRB)
Statement of Investigator Assurances
PLEASE COMPLETE EACH SPACE IN THIS COLUMN
Name of Study:
Principal Investigator (Type or Print):
By signing and submitting this form, the Principal Investigator, on behalf of him/herself and
his/her fellow investigators, as well as on behalf of all project personnel involved in conducting
the study, if any, represents to and assures the IRB that he/she shall:
1. Promptly report to the IRB any changes in approved research, and not initiate any
such changes without prior review and written approval (except where necessary to eliminate
apparent immediate hazards to the human subjects involved in the research, about which the IRB
shall be promptly notified).
2. Promptly report in writing to the IRB and the Chief Executive Officer/President,
and, as applicable, to the Office for Human Research Protections (“OHRP”) and/or the Food and
Drug Administration (“FDA”), as the agency or agencies having regulatory jurisdiction over the
research, any unanticipated problems, including but not necessarily limited to unexpected
adverse events, involving risks to subjects or others.
“Unanticipated problem involving risks to subjects or others” means: Any incident, experience,
or outcome that meets all of the following criteria:
i. Unexpected (in terms of nature, severity or frequency) given (a) the research
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the
characteristics of the subject population being studied;
ii. Related or possibly related to a subject’s participation in the research; and
iii. Suggests that the research places subjects or others at a greater risk of harm
(including physical, psychological, economic or social harm) related to the
research than was previously known or recognized.
“Unexpected adverse event” means: Any adverse event occurring in one or more subjects in a
research protocol, the nature, severity, or frequency of which is not consistent with either:
i. The known or foreseeable risk of adverse events associated with the procedures
involved in the research that are described in (a) the protocol-related documents,
such as the IRB-approved research protocol, any applicable investigator brochure,
and the current IRB-approved informed consent document, and (b) other relevant
sources of information, such as product labeling and package inserts; or
ii. The expected natural progression of any underlying disease, disorder, or condition
of the subject(s) experiencing the adverse event and the subject’s predisposing
risk factor profile for the adverse event.
7d645598-a80c-4056-a2a1-323db5cb1ad1.doc Page 1 of 2
(Additional guidance on these issues may be found on the OHRP website, at
www.hhs.gov/ohrp/policy/AdvEvntGuid.htm, effective January 15, 2007)
3. Keep records sufficient to describe clearly the conduct and results of the study.
4. Inform others assisting in the study, including sub-investigators and co-
investigators, if any, of their respective obligations in connection with the research, and assume
responsibility for their compliance with the terms of the IRB’s approval.
5. Promptly report to the IRB any violations of OHRP or FDA regulations or IRB
The materials submitted with this Statement contain all the information, including a
written informed consent form (if applicable) that complies with the rules of the IRB, required to
be submitted in order for the study named above to be reviewed by the IRB.
7d645598-a80c-4056-a2a1-323db5cb1ad1.doc Page 2 of 2