- 14.1 Introduction
- 14.2 Researcher responsibilities
- 14.3 Annual reporting
- 14.4 Funded research
- 14.5 Clinical research and adverse events
- 14.6 Other adverse events
- 14.7 Complaints and concerns
The National Statement requires that once approved, human research projects must be monitored. Monitoring is intended to ensure that the project is undertaken in the way that was approved, and to ensure that prompt action can be taken in the event of problems arising.
At Deakin, monitoring is undertaken on behalf of the University by the panel that reviewed the project and its secretariat, either by Deakin HREC through the Human Research Ethics Unit, or by one of the Human Ethics Advisory Groups (HEAGs) through their secretariats.
In the event of a serious problem arising, the matter is referred to the Deputy Vice-Chancellor (Research) for resolution.
Approval for a project remains 'current' and subject to monitoring until the end of all processes involving the participants. Usually this will mean the end of data collection, but where further contact with participants may be necessary (eg where transcripts of an interview are to be returned to the participant for checking) researchers should maintain the approval, even if an extension of time is required.
There are a variety of ways in which monitoring may be done (NS 5.5). These can involve:
- Reports from researchers
- Reports from independent agencies (such as a data and safety monitoring board)
- Review of adverse event reports
- Random inspections of research sites, data, or consent documentation and
- Interviews with research participants or other forms of feedback from them.
The standard form of monitoring is for the research team to submit an annual review (DOCX, 49.6 KB) on the progress of the research. However, the frequency and type of monitoring depends on the risks involved in the project, so they may vary from project to project, even if the same researchers are involved.
This may involve more frequent monitoring or additional processes. For example, a project testing a new procedure might be reviewed after a pilot phase, before final approval for the full project.
In addition to planned monitoring, the committee or HEAG or in serious cases the Deputy Vice-Chancellor (Research) may review a project where there is reason to think there is a problem. This may arise out of a serious adverse event (SAE), a complaint regarding the project or a report from the researcher.
Researchers have the most direct responsibility for their own research, including unexpected developments or problems:
Researchers have a significant responsibility in monitoring, as they are in the best position to observe any adverse events or unexpected outcomes. They should report such events or outcomes promptly to the relevant institution/s and ethics review body/ies, and take prompt action to deal with any unexpected
- National Statement 5.5.3
Researchers are required to report immediately any unexpected developments which affect the participants or the ongoing acceptability of the project (eg if a high level of distress is experienced by participants). Contact the Manager, Research Integrity (email@example.com).
Researchers must also comply with the standard monitoring requirements for human research, and with any additional reporting or audit process which the review body or Deakin University requires.
Annual reports are due on the anniversary of approval, or at the end of the calendar year depending on which ethics review body approved the project. A reminder email and report form is sent to the researcher when the report is due, and the form can also be downloaded (DOCX, 49.6 KB) .
The same format is used whether you are submitting a report to Deakin HREC or a HEAG, but the form must be submitted to the secretariat of the review body that approved the research.
The minimum required information (NS 5.5.5) for an annual report is:
- progress to date, or outcome in the case of completed research
- maintenance and security of records
- compliance with the approved proposal, and
- compliance with any conditions of approval.
In cases where the approval has been issued by a partner organisation, researchers are normally required to submit reports to both organisations.
Researchers must ensure that reviews are provided. Failure to meet these requirements will result in suspension of ethics approval and consequently of the project and any funding that has been obtained. In the absence of the principal investigator, another member of the project team will be expected to submit the report. In the event of the project being suspended (eg due to extended leave or illness) it is essential to notify the Human Research Ethics Unit.
Final ethical clearance is a requirement for the release of funds for most forms of research supported by a grant or other funding.
If a funded activity appears to require ethics approval, the ethical clearance status of the activity will be checked. If the approval has not been finalised, the grants monies cannot be released. If an early phase of the project does not require ethical clearance, and grant monies are required (eg to appoint a research assistant or conduct a literature review), the team should liaise with the Grants Office within Research Services, so appropriate arrangements can be made (eg the partial release of the funds).
Similarly, any suspension of ethical clearance for a grant-funded project will be reported to the Grants area of Research Services Division.
While adverse events must be reported for research projects of all kinds, they are most likely to occur in research that is biomedical in nature, particularly clinical research testing a new intervention or therapy.
The National Statement sets our particular requirements for monitoring of 'interventions and therapies including clinical and non-clinical trials and interventions'.
There are two levels of ongoing review that may be required in these circumstances:
- Data and Safety Monitoring Boards must be established in the case of large multi-centre trials; or
- a designated person or committee must be nominated to perform this role for a local trial.
In either case the reviewer/s must have the specialist knowledge to understand the project and interpret any problems that arise.
Serious adverse events include any untoward medical occurrence that:
- results in death
- is life-threatening
- requires inpatient hospitalisation
- results in persistent or significant disability / incapacity
- is a congenital anomaly / birth defect
- is a medically important event or reaction.
These events include (but are not limited to) the results of adverse drug reactions and device events. For Deakin purposes, SAEs include the whole category of serious adverse drug and devise reactions and serious events which may be trial-related.
In accordance with the National Statement (5.5.3), a researcher conducting human research must immediately report any 'adverse events or unexpected outcomes' to the institution and ethical review bodies 'and take prompt steps to deal with any unexpected risks'.
In practice, this means that an event has occurred which was not foreseen and for which there is no plan in place in the protocol, and which has had a harmful effect on a participant(s) or others involved in the project. Alternatively, a risk has arisen which was not planned for and for which measures need to be put in place.
In either case, you must notify the Human Research Ethics Unit and put measures in place to ensure that no further harm of this nature is done. There are a variety of possible paths to take, depending on whether the problem is a single occurrence or a systemic problem, as noted in 14.6 below.
Given the rarity of these events in research reviewed by Deakin HREC, they are dealt with on a case-by-case basis. The best option is to contact the Human Research Ethics Unit to discuss the situation.
It is rare for adverse events to be reported other than in the context of health research, but it is important to be aware of your obligations in this area. An event of this kind might be where information about a person was released and they suffered financial loss or social embarrassment. Alternatively, a person being interviewed about an event in their past might suffer distress beyond what the researchers had thought possible.
In the event of such occurrences, it is important to determine whether this is a 'one off' occurrence, an error, a case of unusual sensitivity, or whether there is a more general problem in the research design.
Depending on the circumstances it may be necessary to withdraw a particular participant from the project, modify the protocol to prevent the harm or risk, suspend the project while the event is considered and measures are put in place, or to cancel the project altogether. The action to be taken will depend on the nature of the problem and whether it is likely to affect other participants.
As required by the National Statement, there are designated contact people for complaints and concerns relating to researchers, research projects, and ethics approval bodies. There are also procedures for complaints, both minor and significant.