# version e1.0 Administration Handling Participant (Donor) Complaints
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1 CTRNet Standard Operating Procedure SOP Number: Version e1.0 Supersedes: Effective Date 09 Jan 08 Subject: Handling Participant (Donor) Complaints Category Prepared By: Approved By: Approved By: Jean de Sousa-Hitzler Signature Name Title ddmmmyy Peter Geary CEO 09 Jan 08 Signature Name Title ddmmmyy Signature Name Title ddmmmyy REVISION HISTORY SOP Number Date Issued Author (Initials) e Jan 08 JdSH Initial version Summary of Revisions 1.0 PURPOSE 2.0 SCOPE Voluntary participation of patients will influence the success of the banking program. Participants must be assured that their interests and privacy is of primary importance to the management and employees of the bank. If participants have any reason to believe that their rights or interests have been violated a procedure must be in place to deal with their complaints. The SOP covers handling of participant complaints. This SOP covers steps that should be followed when complaints are received formally or informally from participants in the tumour bank program. These steps may be adopted as is, or modified by specific CTRNet member repositories to allow for differences in local and provincial laws and regulations protecting patient rights and privacy of information. Copyright 2008 Canadian Tumour Repository Network (CTRNet). Page 1 of 7
2 3.0 REFERENCE TO OTHER CTRNET SOPS OR POLICIES 1. CTRNet Policy: POL Informed Consent. 2. CTRNet Policy: POL Ethics 3. CTRNet Policy: POL Privacy and Security 4.0 ROLES AND RESPONSIBILITY The SOP applies to all qualified tumor bank personnel and clinical staff at the collection centres that are involved in handling participant complaints. This may include the following personnel: Tumour Bank Personnel Responsibility/Role Site Specific Personnel and Contact Information Clinical Research Coordinator (CRC)/Repository Nurse/ Tumour Bank Manager Oncology Physicians (Surgeons/Oncologists) at the Cancer Centre/Hospital or their designates, Principle Investigators, Tumor Bank Director REB Members 5.0 MATERIAL, EQUIPMENT AND FORMS Has knowledge of relevant CTRNet policies, accepts and handles complaints Has knowledge of relevant CTRNet policies, accepts and handles complaints. Initiates investigation of Complaint Reviews complaint and investigation of complaint. Recommends or ensures that ethical resolution is achieved. The materials, equipment and forms listed in the following list are recommendations only and may be substituted by alternative/equivalent products more suitable for the sitespecific task or procedure. Materials and Equipment Materials and Equipment (Site Specific) CTRNet Complaint Form 6.0 DEFINITIONS Confidentiality: Prevention of disclosure, to other than authorized individuals, of a subject's identity. Copyright 2008 Canadian Tumour Repository Network (CTRNet). Page 2 of 7
3 Informed and Voluntary Consent: A process by which a subject voluntarily confirms his or her willingness to participate in the tumour repository program, after having been informed of all aspects of the research that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form. Participant: An individual (patient or healthy volunteer, if applicable) who participates in the Tumour Repository Program. The terms patient, participant, subject and potential donor may be used interchangeably. Complaint: A grievance expressed formally or informally if the participant feels that the tumour bank has inappropriately collected, used or disclosed personal or medical information or in any way violated the terms of the Informed Consent Form. Research Ethics Board (REB): An independent body (a review board or a committee, institutional, regional, national or supranational) constituted of medical and scientific professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in research and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favourable opinion on, the research project, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the research program participants. Tumor Bank or Repository: Regional, provincial or local repositories that coordinates the collection, processing, storage and distribution of tumour tissue and associated annotated data; normally derived from consented participants for the purpose of medical research. The term bank and repository is used interchangeably. 7.0 PROCEDURES Procedures are intended to formalize a process for effective and timely resolution of concerns or complaints directed at the Tumour Bank. They are also designed to ensure that the bank complies with CTRNet s ethical and privacy policies. 7.1 GENERAL CONSIDERATIONS 1. Optimally complaints should be handled: In a timely manner, In a manner responsive to participant concerns, With quality and thoroughness, Copyright 2008 Canadian Tumour Repository Network (CTRNet). Page 3 of 7
4 By a neutral individual trained to handle and investigate complaints, With fairness; and With flexibility. 7.2 HANDLING OF COMPLAINTS 1. Assure the participant that the tumour bank is serious about handling all complaints and that there is a procedure in place to deal with it. 2. The tumour bank staff should try to resolve the complaint at the time it is received. 3. If complaints/concerns are not easily resolved by staff, or if the staff feels uncomfortable addressing the complaint refer the complaint to the Director of the tumour bank. 4. Only if the individual lodging the complaint requests a formal independent review, refer the complaint to the REB. 5. For complaints that escalate beyond point-of service, it may be required that any or all of the following steps be completed: Encourage the participant to submit the complaint in writing (using a form such as the one included in Appendix 1), Speak to the person or representative lodging the complaint to confirm the basis of the complaint, Collect additional information, Write a letter to the participant acknowledging the receipt of the complaint. This acknowledgement should include an explanation of the procedure for reviewing complaints, Conduct an investigation if warranted, Produce a report outlining the findings of the investigation and the recommendations, Write a letter to the individual summarizing the resolution and/or summary of the complaint review. Inform relevant authorities if there has been a breach of privacy. 7.3 DOCUMENTATION OF THE COMPLAINT HANDLING PROCESS 1. Document the complaint. 2. Document the results of the complaint investigation/review. Copyright 2008 Canadian Tumour Repository Network (CTRNet). Page 4 of 7
5 3. Document any communications with the participant. 4. Document the resolution and recommendations. 5. Document any changes to inventory after the resolution of the complaint 7.4 COMPLAINT REVIEW 1. Periodically (such as annually) review complaints that have been received. 2. Make necessary modifications to procedures to ensure that the incident precipitating the complaint does not recur in the future. 8.0 APPLICABLE REFERENCES, REGULATONS AND GUIDELINES 1. Declaration of Helsinki International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines, section Tri-Council Policy Statement; Ethical Conduct for Research Involving Humans; Medical Research Council of Canada; Natural Sciences and Engineering Council of Canada; Social Sciences and Humanities Research Council of Canada, August Office for Protection from Research Risks, US Department of Health and Human Services, Tips on Informed Consent Meslin, E. and Quaid, K. Ethical issues in the collection, storage, and research use of human biological materials. J Lab Clin Med. 2004;144: Complaints, SOP #: TTR-12, B.C. Cancer Agency, Draft version 4, Oct. 30, 2003 Copyright 2008 Canadian Tumour Repository Network (CTRNet). Page 5 of 7
6 APPENDIX 1 CTRNET Complaint Form Your Information: Mr. Mrs. Ms. Miss Given Name: Surname: Address: TEL: *: * I consent to being contacted at this address or through that of my representative on my behalf. I acknowledge that sending over the internet is not secure, in that it can be intercepted and/or manipulated and retransmitted. Representative Information: (COMPLETE ONLY IF YOU WILL BE REPRESENTED) I authorize the following person to act on my behalf and to receive any personal information pertaining to me, as necessary to investigate this complaint Mr. Mrs. Ms. Miss Given Name: Surname: Address: TEL: *: Complaint: Name of Repository or collection site that this complaint relates to: Details of Complaint: I have reason to believe that one or more of the following has occurred: The repository has inappropriately collected my personal /clinical information The repository has inappropriately disclosed my personal /clinical information The repository has inappropriately used my personal /clinical information The repository has inappropriately disposed of my personal /clinical information Other - Please Specify. Copyright 2008 Canadian Tumour Repository Network (CTRNet). Page 6 of 7
7 Resolution of Complaint Please describe how the complaint could be resolved: Where to send this form: Please mail this completed form to: (Add name and contact information of responsible individual at collection site or repository) Signature: Date: POST REVIEW (to be completed by Tumour Bank) Immediate actions taken: Tumour Bank Director s findings and comments: Copyright 2008 Canadian Tumour Repository Network (CTRNet). Page 7 of 7
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