CPHS Reporting Responsibilities
POLICY
It is the policy of UTHealth to ensure prompt reporting of reportable incidents that come to the attention of CPHS.
Key Terms
Unanticipated problem involving risk to participants or others is a problem that is unanticipated or unexpected, related to the research and places subjects or others at a greater risk of harm than was previously known or recognized.
PROCEDURE
Reportable Incidents: IRB staff will report the following incidents:
- Any unanticipated problems involving risks to subjects or others;
- Any serious or continuing noncompliance with this policy or the requirements or determinations of CPHS; and
- Any suspension or termination of CPHS approval.
Report Recipients: IRB staff will report incidents to the following entities as applicable:
- Institutional Officials (IO):
- IO for UTHealth for all research under CPHS jurisdiction.
- IO for Memorial Herman Hospital System for all research being conducted by Memorial Herman staff or in Memorial Herman facilities.
- IO for Harris County Hospital District for all research being conducted by Harris Health staff or in Harris Health facilities.
- OHRP for all nonexempt human subjects research that is:
- conducted or supported by HHS;
- conducted or supported by any non-HHS federal department or agency that has adopted the Common Rule and is covered by a Federalwide Assurance (FWA) determined to be appropriate for such research; or
- covered by an FWA, regardless of funding source.
- Sponsor, if applicable including federal agencies like Department of Defense, Department of Education etc.
- FDA for applicable clinical investigations.
Information Included in Unanticipated Problems Report:
- Name of the institution conducting the research;
- Title of the research project and/or grant proposal in which the problem occurred;
- Name of the Principal Investigator on the protocol;
- Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
- A detailed description of the problem; and
- Actions the institution is taking or plans to take to address the problem.
Information Included in Serious or Continuing Noncompliance Report:
- Name of the institution conducting the research;
- Title of the research project and/or grant proposal in which the noncompliance occurred;
- Name of the Principal Investigator on the protocol;
- Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
- A detailed description of the noncompliance; and
- Actions the institution is taking or plans to take to address the noncompliance.
Suspension or termination:
- Name of the institution conducting the research;
- Title of the research project and/or grant proposal that was suspended or terminated;
- Name of the Principal Investigator on the protocol;
- Number of the research project assigned by the IRB that was suspended or terminated and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
- A detailed description of the reason for the suspension or termination; and
- The actions the institution is taking or plans to take to address the suspension or termination.
Reporting Procedure
The IRB Director or designee will prepare the incident report. The IRB Director or designee may solicit guidance from the Executive Chairperson or Chairperson of the IRB that reviewed the protocol to prepare this report.
The IRB Director will submit the report to the IO and / or OHRP as applicable. The UTHealth IO may forward a copy of the letter to:
- Office of Legal Affairs and Institutional Compliance;
- Chair of the Principal Investigator’s department;
- Dean of the school of the Principal Investigator, staff or student;
- Office of Sponsored Projects Administration for research that receives funding by grant or contract;
- Any other authority as deemed appropriate.
Time frame for reporting incidents – The IRB Director or designee shall report all incidents within 30 days of the IRB decision. The ORSC Director or designee may send an initial report, and indicate that a follow-up or final report will be submitted by a specific date, when an investigation has been completed or a corrective action plan has been implemented.
Exception - When continuing review of a research protocol does not occur prior to the end of the approval period specified by CPHS, CPHS approval expires automatically. Such expiration of CPHS approval will not be reported to OHRP and IO as a suspension of IRB approval.
1. 45 CFR 46.103(b)(5)
2. 21 CFR 56.108(b)
3. OHRP Guidance on Reporting Incidents to OHRP
REFERENCE TO OTHER POLICIES
1. Unanticipated Problems Involving Risks to Subjects or Others.
2. Non compliance
3. Suspensions and Terminations
ATTACHMENTS
1. Flow chart – What incidents should be reported to OHRP?
If you find errors in this document, contact clinicaltrials@uth.tmc.edu
Document Number: |
101-E01 |
Document Name: |
Reporting |
Approved by: |
Executive Director, Research Compliance |
Effective: |
1 Jan 2009 |
Revision History: |
1 Aug 2011, 1 Jun 2016 |
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
Committee for the Protection of Human Subjects IRIS Support 713-500-7960 |
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CLINICAL TRIALS RESOURCE CENTER OFFICE OF RESEARCH ENVIRONMENTAL HEALTH & SAFETY |