PURPOSE

Voluntary participation of patients will influence the success of the biobanking program. Participants must be assured that their interests and privacy is of primary importance to the management and employees of the biobank. 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.

SCOPE

This standard operating procedure (SOP) covers steps that should be followed when complaints are received formally or informally from participants in the tumor biobank program. These steps may be adopted as is, or modified by specific TJUH member biobanks to allow for differences in local and provincial laws and regulations protecting patient rights and privacy of information.

REFERENCE TO OTHER TJUHBB SOPS OR POLICIES

TJUHBB Policy: Consent Form
TJUHBB SOP 08.02.004: Records and Disposition

ROLES AND RESPONSIBILITIES

This SOP applies to all qualified tumor biobank personnel and clinical staff at the collection centers that are involved in handling participant complaints. This may include the following personnel:

Tumor Biobank Personnel	Responsibility
Clinical Research Coordinator (CRC)/Nurse/Tumor Biobank Manager	Has knowledge of relevant TJUHBB policies, accepts and handles complaints
Oncology Physicians at the Cancer Center/Hospital or their designates, Principal Investigators, Tumor Biobank Director	Has knowledge of relevant TJUHBB policies, accepts and handles complaints. Initiates investigation of complaint.
Institutional Review Board (IRB) Members	Reviews complaint and investigation of complaint. Recommends or ensures that ethical resolution is achieved.

MATERIALS, EQUIPMENT AND FORMS

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 site-specific task or procedure.

Materials & Equipment	Site Specific Materials
TJUHBB Complaint Form*

DEFINITIONS

See the TJUHBB Glossary.

PROCEDURES

Procedures are intended to formalize a process for effective and timely resolution of concerns or complaints directed at the Tumor Biobank. They are also designed to ensure that the biobank complies with TJUH ethical and privacy policies.

General Considerations

Optimally, complaints should be handled:

In a timely manner,
In a manner responsive to participant concerns,
With quality and thoroughness,
By a neutral individual trained to handle and investigate complaints,
With fairness; and
With flexibility.

Handling Complaints

Assure the participant that the tumor biobank is serious about handling all complaints and that there is a procedure in place to deal with it. The tumor biobank staff should try to resolve the complaint at the time it is received. If staff does not easily resolve complaints/concerns or if the staff feels uncomfortable addressing the complaint refer the complaint to the Director of the Tumor Biobank. Only if the individual lodging the complaint requests a formal independent review, refer the complaint to the appropriate institutional body: this could include a patient ombudsman and/or the IRB. 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 Forms),
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.

Documentation of the Complaint Handling Process

Document the complaint.
Document the results of the complaint investigation/review.
Document any communications with the participant.
Document the resolution and recommendations.
Document any changes to inventory after the resolution of the complaint

Complaint Review

If appropriate, make necessary modifications to procedures and/or policies to ensure that the incident precipitating the complaint does not recur in the future.

APPLICABLE REFERENCES, REGULATIONS AND GUIDELINES

Declaration of Helsinki
http://www.wma.net/en/30publications/10policies/b3/index.html
Tri-Council Policy Statement 2; 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, December 2010.
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/
International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines, section 4.8.
http://www.ich.org/products/guidelines.html
Office for Protection from Research Risks, US Department of Health and Human Services, Tips on Informed Consent.
http://www.hhs.gov/ohrp/policy/ictips.html
Meslin, E. and Quaid, K. Ethical issues in the collection, storage, and research use of human biological materials. J Lab Clin Med. 2004;144:229-34.
Complaints, SOP #: TTR-12, B.C. Cancer Agency, Draft version 4, Oct. 30, 2003

NOTES

Forms – TJUHBB Complaint Form