SOCRA 2024 Annual Conference Program Book - Flipbook - Page 68
DCO Activity – Complaints
•
•
DCO Activity – Complaints
FY
Complaints Website Updates
To better serve the public, the OHRP
website was updated to reflect:
Alleged Complaint Categories ‐ FY 2024*
Complaints
Received
2023
504
2024*
576
Types of complaints OHRP accepts
Steps to take before submitting a complaint
Key information to include
What happens after submitting a complaint
Healthcare complaints
Other federal offices that may be able to help
Not research with humans
Issues related to
research team
100
80
Other
Risks to subjects
60
40
Most complaints received do not fall within
OHRP’s jurisdiction:
20
Issues with a
research study
Industry funded, or not funded or
conducted by HHS
Failure to report an
issue
0
Issues related to
the Institution
Issues with
informed consent
Issues related to
the IRB
37
38
DCO Activity – Complaints
DCO Activity – 2024 Compliance Assessments
• Assessments are generally two types:
• Coming Soon! Research
Complaints Submission
Video
Evaluations (not-for-cause)
Conducted in the absence of
substantive allegations or indications of
noncompliance with the HHS
regulations.
Investigations (for-cause)
This video will provide the public,
who are largely unfamiliar with the
human subjects protections
industry, an explanation of
Conducted when OHRP determines that
what is being alleged constitutes a
substantiated written allegation(s) or
indication(s) of noncompliance with the HHS
regulations.
who OHRP is,
its scope of authority and
to offer approaches a complainant
can take to resolve their concerns
FY 2024
Ongoing modernization and
streamlining of compliance procedures
Active Compliance Assessments
12
10
10
9
9
9
8
6
4
3
2
2
1
1
0
Q1 FY 2024
Q2 FY 2024
For Cause
Q3 FY 2024
Q4 FY 2024
Not For Cause
39
40
OHRP Vision
To advance a
trustworthy, transparent,
and robust system of
human subjects
protections that
leverages federal and
nonfederal partnerships,
and is responsive to the
evolving research
landscape.
Thank You!
Have questions? Email us at OHRP@hhs.gov
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