Managing Approved Applications
Request for Amendment
Requests for Amendment are required where:
- The method in which the project is conducted changes and in turn has a direct impact on participants
- Changes to documentation ie Plain Language Statements, Consent forms or questionnaires etc are changed or amended; or additional documentation is required to complete the application
- Adding or removing researchers
The signature of the responsible researcher (not the entire research group) is needed and the application needs to be submitted online via THEMIS and in hard copy to the HEAG Administrator. Click here for instructions on how to enter and print a Request for Amendment. One (1) signed hard copy is submitted to the HEAG Administrator at:
Melbourne Dental School, HEAG Administrator
4th Floor, 720 Swanston Street
The University of Melbourne VIC 3010
Ph (03) 9341 1509
The HEAG can only approve a Request for Amendment where the original application was approved by the HEAG committee i.e. Minimal Risk or Project-within-Program. If the Chair of the HEAG approves your Request for Amendment, the HEAG Administrator will then forward the Request for Amendment to the HREC for noting.
A formal letter approving the Request for Amendment will be sent to the person named as the Responsible Researcher in THEMIS.
Any Request for Amendment to an application that was originally submitted to the HESC for approval i.e. Project and Program applications, can only be recommended for approval by the Chair of HEAG. The Request for Amendment is then forwarded to the HESC for review and approval.
Once an Amendment has been submitted, the ID number will change to reflect the new version of the application eg. from 0700000.1 to 0700000.2. This can occur as many times as necessary.
The (NHMRC) National Statement on Ethical Conduct in Research Involving Humans requires Human Research Ethics Committees to monitor all research projects which have ethics approval. This is to ensure that work is being undertaken in accordance with the approved protocol and that the rights and interests of those who have consented to take part as participants are protected. As part of the monitoring process University researchers are to provide an annual report on projects for which they have ethics approval.
Approved projects are granted approval until 31 December of the current year. Human ethics annual reports are required for all research projects that are continuing in the current year, as well as those that were completed in the previous year.
Annual reports are to be submitted on-line via THEMIS Research Self Service http://www.themis.unimelb.edu.au during January/February each year. All researchers with continuing projects or completed projects from the previous year will be sent notification via email, through the THEMIS system, that annual reports are to be completed and submitted by a given date. Failure to comply will result in your project’s approval lapsing.
For instructions on how the enter the annual report refer to this Quick Reference Card http://www.THEMIS.unimelb.edu.au/resources/RC_Human_Annual_Report.pdf
All researchers listed on the approved ethics application can access the annual report in THEMIS. Information can be entered and saved Until the report is ready for submission.
If you require access to annual reports submitted in previous years, please contact the Research Administrators at email@example.com.
If there changes have been made to your research, including those in the annual report, this may delay approval of the project for the coming year. It is recommended to enter your annual report first, then submit a Request for Amendment.
The period of retention of data and records is as follows:
- Research data and records should be maintained for as long as they are of continuing value to the researcher and as long as specified by patent law, and other legislative regulatory requirements.
- The minimum retention period for research data and records is five (5) years from the date of the last publication or public release of the work of the research.
- Clinical trials require that records and data be retained for a minimum of fifteen (15) years from the date of termination of the study and preferably for the lifetime of the product.
- The Australian Psychological Society advises members that files/records of adult clients should be maintained for a minimum period of seven (7) years from the last date upon which the client received services. In the case of children the records should be kept for a minimum period of seven (7) years after the child reaches the age of 18.
- Time intervals for the retention of data are generally established by external organisations, such as the NHMRC, and may be amended from time to time.
- Funding bodies may have specific requirements for the retention of research data and records.
- Where there are known disciplinary practices or codes establishing norms for retention of research data and records these should be adopted.
- In many instances, departments and researchers will resolve to retain research data and records for a longer period than the minimum requirement.
For further information go to Policy on the Management of Research Data and Records, and also see the brochure “Management of Research Data and Records”