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V.04
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Appeals to CPHS Decision |
PURPOSE
1. The purpose of this policy and procedure is to describe the appeal process initiated by investigators.
SCOPE
2. This policy and procedure is applicable to investigators, CPHS Members and ORSC Staff.
POLICY
3. It is the policy of the UTHealth that research that has been disapproved by CPHS may not be conducted at UTHealth or by UTHealth faculty or staff. However, investigators may appeal decisions made by CPHS that are in contention, including CPHS decisions to disapprove, suspend, terminate, or stipulate modifications to submitted protocols and associated submission materials, including informed consent forms.
PROCEDURE
4. Once CPHS disapproves, suspends, terminates, or stipulate modifications to submitted documentation, ORSC Staff will notify the investigator of the action and rationale of the decision by written correspondence. Within the official notification letter received by the investigator from CPHS, the investigator will be instructed to respond in writing to the decision.
4.1. If clarification of the written notice is needed, the investigator will be instructed to contact the ORSC staff for further clarification and instructions. Investigators who disagree with the decision of CPHS will be informed about the CPHS appeal process and available options for further consideration.
5. Submission of Appeal: Once the investigator has decided to enter into an appeal process, the ORSC staff will instruct the investigator to provide the rationale and supporting information/material that will aid CPHS in the review of the appeal.
5.1. Review Process: The ORSC Staff will forward the response submitted by the investigator to the subcommittee Chairperson. The ORSC Staff will place the appeal for discussion at the upcoming full committee meeting.
5.2. Appeal responses for Expedited and Exempt protocols will be reviewed by the assigned Expedited Chairperson and if resolved will be processed accordingly. If the appeal is not resolved, the ORSC staff will place it for discussion at the upcoming full committee meeting.
5.3. Investigators will be given the option of contacting the IRB Chairperson to discuss their appeal and any additional supporting information prior to submitting their written response to CPHS.
5.4. Investigators will be given the opportunity to attend the next scheduled CPHS meeting to discuss their appeal and answer any questions posed by CPHS regarding the IRB submission and any supporting documentation.
5.5. The ORSC Staff will notify the investigator in writing of CPHS 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 (Executive Vice President for Research). The decision of CPHS to disapprove, suspend, terminate, or modify submitted materials can not be overruled by the Institutional Official.
5.6. There are no limitations placed on the appeal process, allowing investigators to appeal decisions and resubmit information as frequently as warranted.
RESPONSIBILITY
6. The ORSC Staff are responsible for timely processing of appeals.
7. The CPHS Members are responsible for timely review and resolution of appeals.
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Applicable Regulations
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Updated 5/2007, Report
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