Chapter 5.5: Monitoring approved research. National Statement on Ethical Conduct in Human Research (2007) - Updated 2018

Monitoring approved research

5.5.1 Each institution has ultimate responsibility for ensuring, via its research governance arrangements, that all its approved research is monitored.

5.5.2 Monitoring arrangements should be commensurate with the risk, size and complexity of the research.

5.5.3 For each clinical trial, institutions and review bodies should ensure that there are appropriate mechanisms for safety monitoring and reporting, including standard safety reporting and the use of a Data and Safety Monitoring Board (DSMB) or (an) identified person/s or committee with suitable expertise to assist and advise the institution and/or review body in carrying out their safety monitoring responsibilities. Researchers should refer to other published NHMRC guidance addressing these matters.

5.5.4 Researchers are responsible for notifying the review body that mechanisms for monitoring are in place, and for satisfying the review body that the mechanisms are appropriate to the research.

5.5.5 At regular periods – reflecting the degree of risk, and at least annually and at the completion of the project – researchers should provide reports to the relevant review body/ies and institution/s, including information on:

1. (a) progress to date, or outcome in the case of completed research
2. (b) maintenance and security of records
3. (c) compliance with the approved proposal; and
4. (d) compliance with any conditions of approval.

5.5.6 The granting and extension of ethical approval for a research project must be on the condition that the researchers:

1. (a) conduct the research in compliance with the approved protocol or project description
2. (b) provide reports of the progress of the trial and any safety reports or monitoring requirements as indicated in NHMRC guidance and in accordance with the manner and form specified by the review body
3. (c) submit for approval any amendments to the project, including but not limited to amendments that:
   1. (i) are proposed or undertaken in order to eliminate immediate risks to participants;
   2. (ii) may increase the risks to participants; or
   3. (iii) significantly affect the conduct of the research
4. (d) inform the review body as soon as possible of any new safety information from other published or unpublished research that may have an impact on the continued ethical acceptability of the research or that may indicate the need for modification of the project;
   1. (i) for clinical trials with implantable medical devices, confirm the existence of, or establish, a system for enabling the tracking of the participant, with consent, for the lifetime of the device.

Discontinuation or suspension of research

5.5.7 Researchers should inform the relevant institution/s, the review body/ies that approved the research and, wherever possible, the research participants, if the research project is to be discontinued before the expected date of completion, and why. For research at more than one site, or research where there has been multiple ethical review, it must be clearly established, before the research begins, how this information will be communicated.

5.5.8 Where a review body finds reason to believe that continuance of a research project will compromise participants' welfare, it should immediately seek to establish whether ethical approval for the project should be withdrawn. This process should ensure that researchers and others involved in the project are treated fairly and with respect.

5.5.9 It may be unethical for a researcher to continue a clinical trial if:

1. (a) there are or have been substantial deviations from the trial protocol
2. (b) adverse-effects of unexpected type, severity, or frequency are encountered, or
3. (c) as the trial progresses, the continuation of the trial would disadvantage some of the participants as determined by the researchers or others monitoring the trial.

5.5.10 Where ethical approval for a research project is withdrawn:

1. (a) the researcher, the institution/s and, where possible, the participants should be informed of the withdrawal
2. (b) the institution must see that the researcher promptly suspends the research and makes arrangements to meet the needs of participants
3. (c) the research may not be resumed unless either
   1. (i) the researcher subsequently establishes that continuance will not compromise participants' welfare, or
   2. (ii) the research is modified to provide sufficient protection for participants, the modification is ethically reviewed, and the modified research is approved.

5.5.11 If an institution or review body considers that urgent suspension of research is necessary before the process described in paragraphs 5.5.7 and 5.5.8 is undertaken, the instruction to stop should come via the management of the institution.

5.5.12 In the light of reports received under paragraph 5.5.3 and paragraph 5.5.5, review bodies may require researchers to amend research procedures to protect participants. If such amendments cannot achieve that end, a review body may rely on the provisions of paragraphs 5.5.6 to 5.5.9.

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.