Complaints Regarding the Conduct of Research
Any concern or complaint about the conduct of a project, whether from research participants, members of the public, Defence personnel, committee members or other researchers, should be directed to the Director, Defence Health Research (DDHR) detailing the grounds of the complaint.
Complaints will be recorded on the Health Research Complaints Register. The register includes information necessary to appropriately track the progress and response to the complaint. It will include a history of all referrals and action taken, as well as dates of receipt and resolution of the complaint. DDHR will inform the relevant Committee Chair of all complaints received. All complaints will also be reported to the Director General Strategic Health Coordination (DGSHC) and regularly reported to the Commander, Joint Health (CJHLTH).
The Principal Investigator (PI) will be notified of the complaint and the DDHR will investigate. Further information from all relevant persons may be sought during the investigation of the complaint. In some cases, the PI may be required to attend a Committee meeting to explain the situation.
The decision as to whether a complaint is minor or serious will be made by the DDHR in consultation with the relevant Chair. A complaint may raise several issues with different levels of seriousness including:
- Low - Those that may be resolved easily via telephone or written correspondence with an explanation. These often include misunderstandings or misconceptions where a detailed investigation is unwarranted.
- Medium - Those involving misunderstandings, access to records, disputes about costs, discourtesy, protocol violations, breaches of privacy without serious consequences, and diagnostic or treatment errors without serious consequences.
- High - Those involving significant quality assurance implications, practices that need changing to avoid recurrence of the event, such as amendments to the study protocol, or development of new policy or procedures. This also includes complaints about protocol violations, breaches of privacy, personal injury, professional misconduct, fraud, unlawful or unethical acts, lack of informed consent and diagnostic or treatment errors with serious adverse outcomes.
Any complaint or allegation of research misconduct will be investigated appropriately with due sensitivity and consideration. Should the complaint or allegation be substantiated by evidence, appropriate disciplinary action will be pursued by JHC and any disciplinary action deemed necessary will be consistent with the nature of the misconduct.
The DDHR will, on the advice of the Chair, inform the PI and relevant supervisor in writing, of the result and the actions arising from the investigation. These actions may include:
- a caution;
- increased monitoring;
- the requirement for amendments to the project;
- suspension or termination of approvals.
If the complainant is not satisfied with the outcome of the preliminary investigation, then the complaint may be referred to CJHLTH. DDHR will provide to the CJHLTH all relevant information about the complaint/concern so a determination can be made on any further investigation of the complaint.
If it is decided there is to be a further investigation, then CJHLTH will appoint an investigating officer (IO) to conduct a Quick Assessment (QA), ensuring that both the complainant and the relevant committee are afforded the opportunity to make submissions.
Any enquires regarding the handling of incidents or complaints related to research activities should be directed to:
Director, Defence Health Research
0477 330 020
Complaints regarding the Research Review and Approval Processes
Any concern or complaint about the research and ethical review committee processes within Joint Health Command or the ethical review committee processes by the Australian Defence Human Research Ethics Committee should be directed to the attention of the Director, Defence Health Research (DDHR), detailing in writing the grounds of the concern or complaint.
The DDHR will inform the relevant committee Chair and the Director General, Strategic Health Coordination (DGSHC) as soon as possible of any complaints received. The Director will send a letter of acknowledgement to the complainant, outlining the following mechanism.
Any complaint will be investigated appropriately with due sensitivity and consideration. Should the complaint or allegation be substantiated by evidence, appropriate disciplinary action will be pursued by JHC and any corrective action deemed necessary will be applied. DDHR in conjunction with the Director General Strategic Health Coordination (DGSHC) will investigate the complaint and its validity, and make a recommendation on any corrective action.
If the complainant is not satisfied with the outcome of the investigation, then he/she can refer the complaint to the Commander, Joint Health (CJHLTH), or request DDHR to do so.
The DDHR will provide the CJHLTH with all relevant information about the complaint/concern, including:
- the complaint:
- material reviewed in the investigation;
- the results of the investigation; and
- any other relevant documentation.
CJHLTH will determine whether there is to be a further investigation of the complaint.
Where further investigation is warranted, CJHLTH may access any documents relating to the project, interview other parties, and seek any other internal and/or external expert advice. In conducting this review, CJHLTH will determine if the Committee acted in accordance with the Defence Instructions and national standards, or otherwise acted in a fair and unbiased manner.
Where there is to be no further investigation, the DGSHC will inform the complainant and the Director of this.
CJHLTH will notify the complainant and the Committee of the outcome of the investigation. The outcomes of this process may include:
- The complaint/concern is dismissed;
- The complaint/concern is referred back to the Committee for consideration, bearing in mind the findings of CJHLTH.
CJHLTH may also make recommendations about the operation of the Committee including such actions as:
- Review Terms of Reference and Standard Operating Procedures;
- Review committee membership; or
- Take other such action as appropriate.
In the case of complaints about the ethical review process, ADHREC may be requested to review its decision; the outcome of that review will be final. CJHLTH cannot substitute its decision for the decision of ADHREC.
Any enquires regarding the handling of incidents or complaints related to research review and approval processes should be directed to:
Director, Defence Health Research
0477 330 020