Clinical Trials
This page provides information that a researcher should be aware of if their application for approval from the Ethics Review Committee (Human Research) constitutes a Clinical Trial.
On this page:
- Definition
- Procedure for review of clinical trial research applications
- Issues relating to methodology
- The status of co-investigators, research assistants and others associated with Macquarie clinical trials
- The indemnity status of Macquarie staff participating in clinical trials conducted by other institutions
- The status of pregnant and breast-feeding women in clinical trials and other research projects
- The indemnity position with respect to “trial failure”
- The status of a university researcher acting as a health care professional with respect to indemnity
- Monitoring of trial safety
Definition:
Any project that prospectively subjects human participants to interventions to study the cause-and effect relationship between a medical intervention - broadly defined - and a health outcome.
Procedure for review of clinical trial research applications:
- The application is reviewed by the Ethics Review Committee (Human Research) via the regular Human ethics application process.
- If determined to be a clinical trial, a condition of approval for the project will be referral to Michael Muhlbauer, the University insurance manager, michael.muhlbauer@ofs.mq.edu.au.
- Final approval of such projects will include the submission to the Ethics Secretariat, ethics.secretariat@vc.mq.edu.au of a determination by Michael Muhlbauer, the University insurance manager, michael.muhlbauer@ofs.mq.edu.au that the project either has been added to the schedule of insured clinical trials, or that the insurer has determined that the project is to be covered under the University's general insurance policy.
- Where methodological or ethical concerns are identified with the application, these must be resolved prior to referral to Michael Muhlbauer, the University insurance manager, michael.muhlbauer@ofs.mq.edu.au.
- Only a staff member (i.e. not a student) can be approved as the chief investigator on an ethics application that is a clinical trial.
Advice from Michael Muhlbauer, the University insurance manager, michael.muhlbauer@ofs.mq.edu.au is that the insurer may need to gain confirmation from the underwriter on specific cases and that this may take up to four weeks to secure.
Issues relating to methodology:
It is common practice for institutions to review the methodology of a clinical trial prior to ethical review. This is usually done by a Scientific Sub-Committee. As Macquarie University currently does not have a Scientific Sub-Committee, the Ethics Review Committee (Human Research) has adopted the following approach in relation to the review of methodology for a clinical trial.
If the application has been reviewed by some other peer review process and considered appropriate (eg. successful grant application) the Committee will not comment on issues of methodology. If no review of methodology has occurred the Committee will determine the level of risk associated with the study. If the level of risk is deemed to be high, the Committee will forward the application external expert review prior to ethical review.
There are three areas of potential concern with methodology which may be appropriately within the ambit of the Ethics Review Committee (Human Research). These are listed below:
- Where the nature of a project may bring the reputation of the University into disrepute eg unscientific or politically insensitive activity
- Where risks are large and/or likely
- Where significance is doubtful eg. very low sample size
The status of co-investigators, research assistants and others associated with Macquarie clinical trials:
The University’s insurer Unimutual has provided the following advice:
The definition of "Protected Person" under the General Clinical Trials protection (pg 44) includes "any sub-contractor, doctor, consultant, physician, hospital or contract research organisation or nurse performing work for the Member or an Affiliate".
Thus, in the case of a Macquarie University trial which is covered under the University’s General Clinical Trials protection, the University's protection with Unimutual would extend to include external individuals and entities participating in the trial, provided that they fell within the definition above.
The indemnity status of Macquarie staff participating in clinical trials conducted by other institutions:
Michael Muhlbauer, the University insurance manager, michael.muhlbauer@ofs.mq.edu.au has clarified that if staff from Macquarie University are involved in trials conducted by another institution, the University should ensure that an indemnity has been granted to its staff, and the position regarding insurance protection should be verified prior to commencement. It cannot be assumed that insurance exists.
The status of pregnant and breast-feeding women in clinical trials and other research projects
The clinical trial indemnity policy stipulates that indemnity does not cover pregnant or breast feeding women in clinical trials. Michael Muhlbauer, the University insurance manager, michael.muhlbauer@ofs.mq.edu.au has confirmed that the indemnity status of pregnant or breast feeding participant women in research projects which are not clinical trials is safeguarded in the University's other liability protections for research projects.
The indemnity position with respect to “trial failure”
Clause 4.5.9 in the Insurance document specifies non-coverage for ‘trial failure’. The wording may appear ambiguous implying that the clinical trial would not be indemnified if the intervention was not found to be efficacious. It has been clarified that this is not the case, but rather that the wording attempts to disavow from indemnity any promise of efficacy, so that participants, for instance, could not seek compensation if their participation did not yield for them personal benefit.
The Ethics Review Committee (Human Research) requires that the Information Statement and Consent Form should not claim that a clinical trial has therapeutic value and this should be explicitly stated in these documents.
The status of a university researcher acting as a health care professional with respect to indemnity
Clause 4.5.5 of the clinical trial insurance policy excludes from cover claims against a University employee where that person is a health care professional acting in the capacity of a health care professional, that is, not acting as a researcher. Michael Muhlbauer, the University insurance manager, michael.muhlbauer@ofs.mq.edu.au has clarified that this is because health care professionals when acting in that capacity are covered by the University's malpractice protection.
Monitoring of trial safety
For approved projects perceived to entail a higher level of risk, a schedule of monitoring of trial progress may be recommended, e.g. quarterly monitoring. The Ethics Review Committee (Human Research) will determine the level and nature of trial monitoring on a case by case basis. The Chief Investigator will also be required to report on any adverse outcomes.