Types of Applications
Project Application (including Clinical Trials)
If the proposed research could lead to discomfort of participants or involves higher risks, a Standard Project Application must be completed via THEMIS.
Examples of discomfort include:
- minor side-effects of medication
- the discomforts related to measuring blood pressure
- anxiety induced by an interview
High risk research is research which involves, but is not limited to intervention of a physical nature and/or access to sensitive and/or personal details of other human beings. It has the potential to involve:
- physical harms: including injury, illness or pain
- psychological harms; distress, fear related to disclosure of sensitive or embarrassing information or learning about a genetic possibility of developing an untreatable disease
- devaluation of personal worth through humiliation, manipulation or being treated disrespectfully
- social harms: discrimination to access benefits or services, damage to social networks or relationships, or social stigmatization
- economic harms: including imposition of direct or indirect costs on participants
- legal harms: including discovery and prosecution of criminal conduct
Further information can be found in the National Statement on Ethical Conduct in Research Involving Humans.
A clinical trial is a form of human research designed to find out the effects of an intervention. It can involve testing:
- a drug including oral hygiene products with a therapeutic claim
- a surgical procedure (including biopsies)
- other therapeutic procedures and devices, including restorations
- a preventive procedure
- a diagnostic device or procedure (eg sampling and analysing gingival crevicular fluid)
Additional information is required by the HEAG and HESC to enable review of clinical trials. Clinical trials include “Clinical trial involving control comparison group” and/or “drug trial”. THEMIS will guide researchers to complete the Standard Project application and the DHSV Module Two form (Projects Involving Drugs and Therapeutic Devices) for drug trial applications only. Clinical trial applications not of a “drug trial” nature will need to download the DHSV Module Two form from the forms section. Researchers intending to submit an application that involves a clinical trial are advised to contact the HEAG early on in the application process for guidance.
For further information about Clinical Trials, please refer to the National Statement on Ethical Conduct in Human Research, Chapter 3.3.
If your research involves the use of ionising radiation that would NOT normally form part of routine treatment, additional information must be provided to the HEAG. The Use of Ionizing Radiation Form must be attached in Themis. The form contains guidelines for completion. Click here for a list of approved medical physicists (PDF 23kb).