Subject Phone Calls to CPHS
POLICY
IRB considers input from research subjects to be a valuable source of information for not only enhancing the protection of subjects participating in research but also for helping to continually improve the quality of research.
PROCEDURE
Receiving Calls: Research subjects are provided with contact information for addressing concerns regarding their rights as a research subject in the consent document. This information directs subjects to call the IRB office. The IRB website also has the IRB contact information including phone number and email address.
接听电话的人收集基本信息，包括呼叫者的名称，联系方式，呼叫者是主题或代表主题的呼叫，研究的协议标题（如果有）以及呼叫的原因。beplay苹果手机能用吗如果呼叫者不愿意提供个人详细信息，则参加电话的工作人员不应坚持这些详细信息。
参与研究的问题：beplay苹果手机能用吗If the caller requests more information or answers to questions such as the rights of the research subject or other information regarding participation in a research study in general, the staff attending the call should answer the subjects questions to the best of his/her ability.
Complaints or Concerns on Specific Research：如果呼叫者有投诉或对特定研究项目的疑虑，则参加呼叫的工作人员应根据投诉/关注点收集尽可能多的信息。beplay苹果手机能用吗参加电话的工作人员应询问呼叫者是否可以同意向主要调查员披露其姓名。
Review: If the complaint/concerns of the subject are not serious, IRB director will notify the Principal Investigator about the complaint/concern and ask them for an explanation and to outline corrective actions if relevant.
For serious complaints/concerns which appear to be a major noncompliance on the part of the research team, the IRB director will consult with the IRB chair or the executive chairperson. The chair and IRB director will review the complaint and contact the appropriate institutional individuals and make a determination as to the next steps of action. These could include any combination of the following:
- Contact the study subject to obtain further details
- Contact Principal Investigator for explanation/further details
- 在下一次完整董事会会议上参考讨论
- Require Principal Investigator to implement corrective actions
- 在下一个执行委员会会议上参考讨论
If the complaint involves possible noncompliance, it will be handled in accordance with the policy and procedure on noncompliance.
The confidentiality of the subject will be maintained. Subject names will not be disclosed to the individuals involved in the complaint, unless disclosure is required to reconcile the situation (i.e. if individual wants name removed from a database or patient study pool, the disclosure of the name is required).
Upon resolution of the event, the IRB director will notify the IRB and the Executive Committee at the next scheduled meeting.
APPLICABLE REGULATIONS
提及其他政策
- 101-B04利益冲突CPHS成员和顾问。
附件
- 计划模板
- Minutes template
If you find errors in this document, contactcphs@uth.tmc.edu
Document Number: |
101-C06 |
文档名称： |
Subject Calls |
Reviewed by: |
Executive Director, Research Compliance |
Effective: |
1 Aug 2008 |
Revision History: |
2011年8月1日，2016年6月1日，2019年1月21日，2021年6月1日 |
CPHS求助热线713-500-7943
Iris Holpline 713-500-7960
Uthealth的合规性热线（1-888-472-9868）
保护人类受试者委员会 IRIS Support713-500-7960 |
|
|
CLINICAL TRIALS RESOURCE CENTEROFFICE OF RESEARCHENVIRONMENTAL HEALTH & SAFETY |
||
