Monitoring of research here refers to the process of verifying that the conduct of research conforms to the approved proposal. Responsibility for ensuring that research is reliably monitored lies with the institution under which the research is conducted.
Mechanisms for monitoring can include:
- 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.
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 The frequency and type of monitoring should reflect the degree of risk to research participants.
5.5.3 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 ethical review body/ies, and take prompt steps to deal with any unexpected risks. For monitoring of approved clinical research, see paragraphs 3.3.19 to 3.3.22.
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:
- 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.
Suspension or cessation of research
5.5.6 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.
5.5.7 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.
5.5.8 Where ethical approval for a research project is withdrawn:
- the researcher, the institution/s and, where possible, the participants should be informed of the withdrawal;
- the institution must see that the researcher promptly suspends the research and makes arrangements to meet the needs of participants; and
- the research may not be resumed unless either:
- the researcher subsequently establishes that continuance will not compromise participants’ welfare; or
- the research is modified to provide sufficient protection for participants, the modification is ethically reviewed, and the modified research is approved.
5.5.9 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.
5.5.10 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.