Chapter 5.6: Handling complaints. National Statement on Ethical Conduct in Human Research (2007) - Updated 2018
Introduction – Chapter 5.6
Institutions may receive complaints about researchers or the conduct of research, or about the conduct of a Human Research Ethics Committee (HREC) or other ethical review body. Complaints may be made by participants, researchers, staff of institutions, or others. All complaints should be handled promptly and sensitively.
The Australian code for the responsible conduct of research describes 'research misconduct ' and specifies institutional processes for dealing with it. Where complaints about researchers or research raise the possibility of misconduct fitting this description, they should be dealt with under those processes. Where complaints about researchers are serious and fall outside that description of research misconduct, they should be handled under institutional processes for dealing with other forms of misconduct, for example harassment or bullying.
There can be justifiable differences of opinion as to whether a research proposal meets the requirements of this National Statement. For this reason, while this chapter provides for complaints about the process of review, it does not provide for appeals by researchers against a final decision to reject a proposal.
Guidelines – Chapter 5.6
5.6.1 To handle complaints about researchers or the conduct of research, institutions should:
- (a) identify a person, accessible to participants, to receive these complaints
- (b) establish procedures for receiving, handling and seeking to resolve such complaints.
5.6.2 Where such complaints raise the possibility of 'research misconduct ' as described in the Australian code for the responsible conduct of research, they should be handled in accordance with the 'research misconduct ' processes specified in that document.
5.6.3 Where complaints about researchers allege serious misconduct that falls outside the range of 'research misconduct ' as described in the Australian code for the responsible conduct of research, they should be dealt with under institutional processes for dealing with other forms of misconduct, for example harassment or bullying.
5.6.4 Institutions should also establish procedures for receiving, handling and seeking to resolve complaints about the conduct of review bodies in reviewing research proposals.
5.6.5 Where these complaints cannot be readily resolved by communication between the complainant and the review body that is the subject of the complaint, complainants should have access to a person external to that review body to handle the complaint.
5.6.6 Institutions should identify a person or agency external to the institution to whom a person can take a complaint that has not been resolved by the processes referred to in paragraphs 5.6.1 to 5.6.5.
5.6.7 Institutions should publicise their complaints-handling procedures.
Authors of this National Statement
This National Statement has been jointly developed by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia (UA). This joint undertaking reflects a widely shared conviction that there is a need for ethical guidelines that are genuinely applicable to all human research and it gives expression to the shared responsibility for ethically good research described above.
Clinical Research News
Upcoming Clinical Research Training and Conferences
-
on demandACROSS Global Training AcademyOnline
-
29 September 2023 – 02 October 2024SCDM (Society of Clinical Data Management)United States
-
17 – 19 April 2024SCDM (Society of Clinical Data Management)Poland
-
21 – 23 May 2024InformaBelgium
-
03 – 04 June 2024The Society for Clinical Research Sites (SCRS)United States
-
16 – 17 July 2024The Society for Clinical Research Sites (SCRS)Australia
-
27 September – 29 October 2024The Society for Clinical Research Sites (SCRS)United States
Nadchodzące badania kliniczne
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Jeszcze nie rekrutacjaRak jelita grubegoStany Zjednoczone
-
Hull University Teaching Hospitals NHS TrustRekrutacyjnyPrzewlekły kaszelZjednoczone Królestwo
-
University of Roma La SapienzaRekrutacyjny
-
The Second Hospital of Nanjing Medical UniversitySIR RUN RUN hospital of Nanjing Medical UniversityJeszcze nie rekrutacjaZespół deficytu uwagi/nadpobudliwości ruchowejChiny
-
Parnassia GroepRekrutacyjnyZaburzenia ze spektrum autyzmuHolandia
-
Dickran Kazandjian, MDRegeneron PharmaceuticalsJeszcze nie rekrutacjaSzpiczak mnogiStany Zjednoczone
-
Ray Therapeutics, Inc.The Vision Research and Assessment Institute (VRAI)RekrutacyjnyBarwnikowe zwyrodnienie siatkówkiStany Zjednoczone
-
Istituto Ortopedico RizzoliJeszcze nie rekrutacja
-
University of Missouri-ColumbiaGilead SciencesRekrutacyjnyZakażenia wirusem HIV | SZTUKA | Niezgodność, pacjentStany Zjednoczone
-
Florida International UniversityAnn & Robert H Lurie Children's Hospital of Chicago; Care Resource Community...Jeszcze nie rekrutacjaPrzestrzeganie ARTStany Zjednoczone
-
Hebei Medical University Fourth HospitalJeszcze nie rekrutacja
-
Peking Union Medical College HospitalJeszcze nie rekrutacja