POLICY
Human subjects research not approved by the IRB may not be conducted at UTHealth Houston or by UTHealth Houston faculty or staff. However, investigators may appeal decisions made by the IRB that are in contention, including decisions to disapprove, suspend, or terminate, or stipulate modifications to submitted protocols and associated submission materials, including informed consent forms.
PROCEDURE
When the IRB disapproves research or suspends or terminates IRB approval, IRB staff will notify the investigator of the action and rationale of the decision by written correspondence that includes instructions to the investigator for responding to the IRB determination.
If clarification of the written notice is needed, the investigator will be instructed to contact the IRB staff for further clarification and instructions. Investigators who disagree with the IRB decision will be informed about the IRB appeal process and available options for further consideration.
Submission of Appeal: Once the investigator has decided to enter into an appeal process, IRB staff will instruct the investigator to provide the rationale and supporting information/material that will aid the IRB in the review of the appeal.
Review Process: The IRB staff will forward the response submitted by the investigator to the subcommittee chairperson. The IRB staff will place the appeal for discussion at the upcoming full committee meeting. The IRB staff will notify the Institutional Official of the appeal.
IRB staff will assign review of appeal responses for protocols reviewed by expedited review process or requests for exemptions for discussion at a convened meeting.
Investigators will be given the option of contacting the IRB chairperson of the panel that made the decision to discuss their appeal and any submitted additional supporting information.
Investigators will be given the opportunity to attend an IRB meeting to discuss their appeal.
IRB staff will notify the investigator in writing of the IRB final decision regarding the current appeal. In this notification, investigators will be informed that they can direct additional unresolved questions, express concerns, and convey suggestions to the Executive Committee or Institutional Official. The decision of the IRB to disapprove, suspend, or terminate a protocol cannot be overruled by the Institutional Official.
There are no limitations placed on the appeal process, allowing investigators to appeal decisions and resubmit information as frequently as warranted.
REFERENCES
- None
If you find errors in this document, contact [email protected]
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Document Number: |
101-E03 |
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Document Name: |
Appeals to IRB Decision |
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Reviewed by: |
Associate Vice President, Research Compliance |
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Effective: |
1 Aug 2008 |
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Revision History: |
1 Aug 2011, 1 Jun 2016, 21 Jan 2019, 1 Jun 2021, 1 Jun 2026 |
Please contact the IRB office for answers to questions, express concerns, and convey suggestions regarding human subjects protections.
IRB Office House: Thursdays, 1–4pm via Teams Room
Email: [email protected]
IRB Helpline: 713-500-7943 (please leave a message and we will get back to you as soon as possible)
iRIS Helpline: 713-500-7960
IRB Review Feedback: IRB Survey
Houston, Texas 77030
Phone: 713-500-7943
Email: [email protected]
Committee for the Protection of Human Subjects
IRIS Support: 713-500-7960
