Research complaints handling procedure

This procedure is to be read in conjunction with the National Health and Medical Research Council (NHMRC) Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research (the Guide). and the Metro North Hospital and Health Service (MNHHS) Procedure Research: Complaints and Breaches of the Code.

1.    Personnel involved in complaints handling and resolution

1. Responsible Executive Officer (REO)- The Executive Director, RBWH
2. Designated Officer (DO)- the Executive Director Research, RBWH

• Assessment Officer (AO)- the person delegated to make a preliminary assessment of a whether a prima facie case of research misconduct exists

1. Research Integrity Advisors (RIAs)- individuals with experience in research and research practices who can provide advice to researchers on research integrity matters

2.    Receiving Complaints

Complaints or allegations of a breach of the Code may arise from a variety of sources, including research participants, researchers, RBWH staff members, or other external or third parties. In order to promote a consistent approach to the handling of complaints or to provide advice to those who wish to seek guidance on how to approach any complaint, there are two preferred approaches:

1. Approaching a Research Integrity Advisor (RIA)
2. Making a formal allegation or complaint via the Research Services Inbox

2.1  Approaching a Research Integrity Advisor (RIA)

RIAs are people with research experience and familiarity with the accepted practices in research. A network of RIA’s has been nominated across RBWH and are listed in Appendix 1 and on the RIA page

When an RIA is approached, they will inform the complainant about relevant institutional processes and available options, including how to make a complaint. These are:

1. Not proceeding with, or withdrawal of, the complaint if discussion resolves the concerns or the complaint is deemed to be clearly not related to a breach of the Code;
2. Referral of the matter directly to the person against whom the allegation is being made;
3. Referring the allegation to a line manager for resolution by the local Department Head;[1] and
4. Making a written allegation of a breach of the Code in writing to the Designated Officer (DO).

All allegations are treated confidentially. RIAs will not advise on matters where they have a potential, perceived or actual conflict of interest. In addition, their role is not to investigate the complaint, but instead to provide advice to the complainant.

In all circumstances, the decision and reasoning for those decisions must be documented by the RIA, in line with the available options above.

2.2 Making a formal allegation or complaint via the Research Services Inbox

Complaints can be made by contacting the Research Services Complaints Handling service:

• By calling 3646 0245
• By email to RBWH_Research_ESO@health.qld.gov.au
• By completing and submitting the Research Integrity Complaints Form

3.    Complaints Handling

The way in which the complaint is handled will depend upon the nature of the complaint. For example, complaints that relate to the conduct or management of a research project may in the first instance be directed to the RBWH Human Research Ethics Committee (HREC) Chair or Administrator. However, it will also follow the complaints handling procedure outlined below.

3.1       Receipt by the RBWH Designated Officer (DO)

The RBWH DO will be responsible for the receipt, management and investigation of complaints. The DO’s role is to provide advice as to whether allegations appear to be justified and whether a prima facie case exists. The DO has the responsibility to maintain full records of all matters related to any allegations of a breach of the Code.

In RBWH, the DO will be the Executive Director, Research Services.

3.2       Preliminary Assessment

If the DO determines the complaint represents a potential breach of the Code, the matter will proceed to a preliminary assessment. The DO may do this supported by an Assessment Officer (AO) who can support conduct of the preliminary assessment of a complaint. The DO may, as they deem appropriate:

• Confer with or put written questions to the RBWH Researcher involved, the person that has raised the complaint, and/or the Department Head;
• Confer with the HREC Chair;
• Request and receive advice from an RIA; RBWH Human Resources or Legal Services where appropriate.

3.3 Consideration by the Responsible Executive Officer

Once the preliminary assessment has been undertaken, the DO will provide a report with a recommendation for the Responsible Executive Officer (REO) for further action. The possible recommendations of the report are:

• Dismissal of the complaint and/or allegations;
• Referral to the Department Head with instructions for course of action; or
• Handling in accordance with provisions in the Code related to corrective actions and complaint resolution;
• Where there is evidence of a potential breach of the Code with serious consequences, and which meet the criteria for research misconduct, establish an internal or external investigation.

Upon receiving the formal report from the DO, the REO will make a decision as to whether to accept the recommendation of the DO. The REO shall notify all parties, including the DO of their initial decision. All inquiries established on the initial decision of the REO, including an internal or external investigation, shall be constituted and operate in accordance with the Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research, Section 7. Investigation stage.

Upon finalisation of all steps arising from the preliminary assessment and investigation where appropriate, the REO shall make a final decision to resolve the matter. The final decision must include the final findings of the process in their decision. The REO may also include:

• Directions to correct the public record;
• Recommending or taking such disciplinary actions against a RBWH employee who is the subject of the complaint, in accordance with the HR policies of MNHHS, which are appropriate in the circumstances;
• Recommending or taking such disciplinary actions against an employee that has made a mischievous complaint, in accordance with the HR policies of MNHHS, which are appropriate in the circumstances;
• Making recommendations or instituting policies and procedures to resolve or rectify research processes at the MNHHS;
• For any unauthorised disclosure of patient data, referral of the matter to the Integrity Unit of MNHHS, the Department of Health or such other authority responsible for enforcing section 142 of the Hospital and Health Boards Act 2011 (Qld);

The REO shall furnish their final decision to all relevant parties, including the Researcher, the person raising the allegation and the DO.

4.    Collaborative Research

Where a dispute, disagreement or complaint arises regarding collaborative research, and a positive finding of research misconduct is made, each collaborating institution will also be informed of the outcome.

5.    Corrupt and/or criminal misconduct

While a breach of the Code may not necessarily involve matters that are criminal in nature, all employees of RBWH have an obligation to report any suspicion or allegations of corrupt conduct on the part of any RBWH employee.

The Code of Conduct for the Queensland Public Service 2011 (Code of Conduct) and the Public Service Act 2008 (Qld) outline the obligation of all employees to report suspected wrongdoing, which includes corrupt conduct. The MNHHS Procedure Public Interest Disclosure (PROC035) outlines the legislative provisions and procedures in place under the Public Interest Disclosure Act 2010 (Qld), to assist RBWH employees and the public in understanding their obligations in reporting wrongdoing that concerns RBWH employees.

6.    Clinical incident and patient safety reporting

If at any time it becomes apparent that the complaint relates to an activity that is a patient safety risk or has the potential to harm patients or RBWH staff, immediate action must be taken to minimise this harm. This action is outside the scope of this procedure, and RBWH employees are referred to the Procedure Patient safety alerts, notifications/advisories and communiques, Management of (PROC123). Minimum standard processes for identifying and managing patient safety issues/risks are included in the MNHHS Policy Clinical Governance (POL033) and Risk Management (POL002090).

7.    Concerns raised by members of the public

Members of the public are encouraged to raise their concerns directly with the RBWH via the contact details provided. RBWH’s preference is for complainants to identify themselves, but anonymous complaints will be accepted, or complaints de-identified before referral.

RBWH will not provide further information to the complainant about any matters raised. This applies to both identified and anonymous complainants.

[1] This option is dependent on the alleged seriousness of the breach.