POLICY
IRB considers input from research participants to be a valuable source of information for not only enhancing the protection of participants in research but also for helping to continually improve the quality of research.
PROCEDURE
Receiving Calls: Research participants are provided with contact information for addressing concerns regarding their rights as a research participants in the consent document. This information directs the participant to call the IRB office. The IRB website also has contact information including for the IRB office including a phone number and email address.
When the IRB office receives phone calls from participants, the IRB staff answering the call collects basic information such as name, contact information, protocol title of the research study if any, and the reason for the call. If the caller is not willing to provide personal information, the staff attending the call does not insist for these details.
Questions on Participation in Research: If the caller requests more information or answers to questions such as the rights of the research participant or other information regarding participation in a research study in general, the staff attending the call answer the participants questions to the best of their ability .
Complaints or Concerns on Specific Research: If the caller has a complaint or has concerns about a specific research project the IRB staff attending the call gathers as much information as required on the complaint/concern. The IRB staff attending the call asks the caller if they are agreeable to disclosure of their name to the Principal Investigator.
Review: If the complaint/concerns of the participant are not serious or urgent, the 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 Institutional Official. The IRB 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 participant to obtain further details
- Contact Principal Investigator for explanation/further details
- Refer for discussion at the next Full Board Meeting
- Require Principal Investigator to implement corrective actions
- Refer for discussion at the next Executive Committee meeting
If the complaint involves possible noncompliance, it will be handled in accordance with the policy and procedure on noncompliance.
The confidentiality of the participant will be maintained. Participant 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.
REFERENCES
- 45 CFR 46 Protection of Human Subjects
- 21 CFR 56 Institutional Review Board
- 21 CFR 50 Protection of Human Subjects
If you find errors in this document, contact [email protected]
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Document Number: |
101-E06 |
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Document Name: |
Handling Research Participant Communications |
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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
