Unanticipated/Adverse Events
Any
adverse/unanticipated events or deviations from approved
protocols must be reported to the IRB no later than 7 days
after the research team has been made aware of the event in
question.
If you are research staff and need to report an
unanticipated/adverse event/protocol deviation, please
submit an Unanticipated/adverse event form in
IRBManager. Refer to Section 12 of the IRBManager user guide for
assistance with completing this form:
IRBManager User Guide
Research Participants: If you are a
research participant and would like to contact the IRB
regarding your rights as a participant, or to report an
unanticipated/adverse event related to participation in a
research project, please contact the IRB via
email at
IRB@ph.lacounty.gov or by phone at 213-288-7680.
DPH IRB Committee
Click on the link below to view a
roster of the DPH IRB committee members.
IRB
committee roster
Department of Public Health (DPH)
policies
Please refer to the following DPH policy regarding
research and related activities involving human subjects:
Los
Angeles County Department of Public Health Institutional
Review Board (IRB) Policy Regarding IRB Review of
Research and Related Activities Involving Human Subjects
Please refer to the following DPH policy
regarding health equity, diversity and
inclusion in research and related
activities reviewed by the DPH IRB:
Los Angeles County Department of Public Health
Institutional Review Board (IRB) Policy Regarding
Health Equity, Diversity and Inclusion in Research or Related Activities Reviewed by
the IRB
The Health Equity policy above was informed by
a health equity
survey and key informant interviews
which were carried out as
part of the IRB's Health Equity
Initiative (HEI). Please refer to our
Health Equity Initiative page for
more information about the HEI and the
efforts to develop this policy.
Federal Regulations for the
Protection of Human Subjects in Research
The Dept. of Health and Human Services
regulations for the protection of human
subjects in research (45 CFR 46) include
five subparts. Subpart A, commonly
referred to as "the Common Rule",
provides a robust set of protections for
research subjects; subparts B, C, and D
provide additional protections for
certain populations in research; and
subpart E provides requirements for IRB
registration.
Please click the following link
HHS.gov to view the federal
regulations for the protection of human
subjects in research.
The Common Rule, subpart A, was revised
in 2018. In general, research initiated
before January 21, 2019, continues to
comply with the pre-2018 Common Rule
unless the institution chose to
transition it to the revised Common
Rule.
The Belmont Report
![belmont report](images/belmontreport_small.jpg)
The Belmont Report identifies the basic
ethical principles that should underlie
the conduct of biomedical and behavioral
research involving human subjects, and
it forms the foundation for the federal
human subjects regulations known as the
"Common Rule" (45 CFR 46). The Belmont
Report was written by the National
Commission for the Protection of Human
Subjects of Biomedical and Behavioral
Research, and is a direct result of the
National Research Act of 1974.
Click
on the photo above to view a copy of the Belmont Report.