REPORTING

 

 

POLICY

 

It is the policy of UTHSC-H 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: ORSC staff will report the following incidents:

a.       Any unanticipated problems involving risks to subjects or others;

b.      Any serious or continuing noncompliance with this policy or the requirements or determinations of CPHS; and

c.       Any suspension or termination of CPHS approval.

 

Report Recipients: ORSC staff will report incidents to the following entities as applicable:

a.       Institutional Officials (IO):

i.         IO for UTHSC-H for all research under CPHS jurisdiction.

ii.       IO for Memorial Herman Hospital System for all research being conducted by Memorial Herman staff or in Memorial Herman facilities.

iii.      IO for Harris County Hospital District for all research being conducted by HCHD staff or in HCHD facilities.

 

b.      OHRP for all nonexempt human subjects research that is:

i.         conducted or supported by HHS;

ii.       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

iii.      covered by an FWA, regardless of funding source.

 

c.       Sponsor, if applicable including federal agencies like Department of Defense, Department of Education etc.

 

Information Included in Unanticipated Problems Report:

a.       Name of the institution conducting the research;

b.      Title of the research project and/or grant proposal in which the problem occurred;

c.       Name of the Principal Investigator on the protocol;

d.      Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);

e.      A detailed description of the problem; and

f.        Actions the institution is taking or plans to take to address the problem.

 

Information Included in Serious or Continuing Noncompliance Report:

a.       Name of the institution conducting the research;

b.      Title of the research project and/or grant proposal in which the noncompliance occurred;

c.       Name of the Principal Investigator on the protocol;

d.      Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);

e.      A detailed description of the non compliance; and

f.        Actions the institution is taking or plans to take to address the non compliance.

 

Suspension or termination:

a.       Name of the institution conducting the research;

b.      Title of the research project and/or grant proposal that was suspended or terminated;

c.       Name of the Principal Investigator on the protocol;

d.      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);

e.      A detailed description of the reason for the suspension or termination; and

f.        The actions the institution is taking or plans to take to address the suspension or termination.

 

Reporting Procedure

 

The ORSC Director or designee will prepare the incident report. The ORSC Director or designee may solicit guidance from the Executive Chairperson or Chairperson of the IRB that reviewed the protocol to prepare this report.

 

The ORSC Director will submit the report to the IO and / or OHRP as applicable. The UTHSC-H IO may forward a copy of the letter to:

a.       Office of Legal Affairs and Institutional Compliance;

b.      Chair of the Principal Investigator’s department;

c.       Dean of the school of the Principal Investigator, staff or student;

d.      Office of Sponsored Projects for research that receives funding by grant or contract;

e.      Any other authority as deemed appropriate.

 

Time frame for reporting incidents – The ORSC 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.

 

APPLICABLE REGULATIONS

 

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:

ORSC Director

Effective:

1 Jan 2009

Revision History:

1 Aug 2011