SUBJECT CALLS

POLICY

CPHS considers input from research subjects to be a valuable source of information for not enhancing the protection of subjects participating in research but also for helping to continually improving 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 the CPHS hotline. Subjects may also write to the ORSC email address obtained from the CPHS website.

The person answering the call collects basic information about including name of the caller, contact details, whether caller is a subject or calling on behalf of a subject, the protocol title of the research study if any, and the reason for the call. If the caller is not willing to provide personal details, the staff attending the call should not insist for these details.

Questions on Participation in Research: If the caller requests for 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 and then record the details of the call in the feedback records.

Complaints or Concerns on Specific Research: If the caller has a complaint or has concerns on a specific research project the staff attending the call should gather as much information as required on the complaint / concern. The staff attending the call should ask the caller if they are agreeable to disclosure of their name to the Principal Investigator.

Review: If the complaint / concerns of the subject are not serious, ORSC 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 complaint / concerns which appear to be a major non compliance on the part of the research team, the ORSC Director will consult with the IRB Chair or the Executive Chairperson. The Chairperson and ORSC Director will review the complaint and contact the appropriate institutional individuals and makes 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

§ 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 non compliance, it will be handled in accordance with the policy and procedure on non compliance.

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 ORSC Director will notify the IRB and the Executive Committee at the next scheduled meeting. The ORSC Staff will maintain a log of all subject calls.

APPLICABLE REGULATIONS

1. 45 CFR 46

2. 21 CFR 56

3. 21 CFR 50

REFERENCES TO OTHER POLICIES

1. 101-B04 Conflict of Interest CPHS Members and Consultants.

ATTACHMENTS

1. Agenda template

2. Minutes template

If you find errors in this document, contact clinicaltrials@uth.tmc.edu

Document Number:	101-C06
Document Name:	Subject Calls
Approved by:	ORSC Director
Effective:	1 Aug 2008
Revision History:	1 Aug 2011