Frequently Asked Questions (FAQs)
1. Is there a charge for review of research?
2. How do I write a research protocol?
3. Do I have to follow GCP?
4. What are the differences between identifiable, re-identifiable and non-identifiable data?
5. Where can I find out more about training?
6. Can I submit my grant application as a protocol?
7. How do I apply for a modification or renewal for a Negligible Risk Project?
8. How do I get approval for a minor modification to my protocol of information statement?
9. What is the difference between a Database and a Databank?
10. Do I need to submit copies of researchers CVs?
11. Can I submit a project if I do not have all the signatures?
12. Do I need to submit signatures from all researchers in a multicentre project?
13. Do I have to use the RCH Information Statement & Consent Form?
14. Who can sign as a witness on the consent page?
15. Is a witness signature always required on the consent page?
16. Is a researcher signature required on the consent page?
17. What additional ethical approval is required for recruiting via schools?
18. Do case reports require HREC approval?
19. Do I have to offer an Information Statement & Consent Form to participants less than 18 years of age?
20 Do participants, who were younger than 18 years when the research began, have to be re-consented when they reach 18 years of age if the study is still ongoing?
21. Do I need to record participation in research in the patient’s medical record?
22. How do I decide if a member of the research team is an Investigator or a Research Assistant?
23. Do I need to notify the Ethics Office if a new Investigator or Research Assistant (RA) starts or leaves the study?
24. Do I need to submit a CTN Form?
25. How do I know if a device is a therapeutic device?
26. Does RCH HREC approval provide Indemnity and Insurance for the Protocol or for the Investigators?
27. If I collaborate on a study that does not have RCH HREC approval, who indemnifies me?
1. Is there a charge for review of research?
The RCH HREC charges for the review of commercially sponsored studies only (please contact Ethics & Research if you are unsure whether your study is commercially sponsored). Please see the Submission Fees here.
2. How do I write a research protocol?
Please consult Guidance and Templates for writing a protocol
3. Do I have to follow Good Clinical Practice (GCP)?
If you are conducting a clinical trial then GCP must be followed as per 4.5.1 of the Investigators Responsibilities in Research Procedure.
A clinical trial is defined as a form of human research designed to find out the effects of an intervention(s), involving allocation of participants to treatments. A clinical trial can involve testing a drug, a surgical procedure, other therapeutic procedures and devices, a preventive procedure, or a diagnostic device or procedure.
For GCP please consult Good Clinical Practice (GCP) (with TGA annotations)
4. What are the differences between identifiable, re-identifiable and de-identified data?
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Identifiable: the identity of a specific individual can be determined.
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Re-identifiable: data from which identifiers have been removed and replaced by a code; however it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets.
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Non-identifiable: data that have never been labelled with individual identifiers or from which the identifier has been permanently removed and therefore no specific individual can be identified.
Please refer Chapter 3.2 of the National Statement located at NHMRC National Statement for Ethical Conduct in Human Research
5. Where can I find out more about training?
The Clinical Research Development Office (CRDO) works closely with
6. Can I submit my grant application as a protocol?
No. Abridged protocols included in a grant application (such as NHMRC project grants) do not usually contain the degree of detail that is required in a full research protocol - refer to the Ethics & Research website - Writing a research protocol
7. How do I apply for a modification or renewal for a Negligible Risk Project?
The modification & renewal process for Negligible Risk research is the same as that for all research. Refer to the Ethics & Research website: Modifications & Renewals
8. How do I get approval for a minor modification to my protocol or information statement?
Minor modifications are reviewed within the Ethics & Research Office and take only days to review and approve. Researchers are required to submit a modification application along with all amended or additional documents. Refer to the Ethics & Research website: Modifications. If your modification is to fix typographical or grammatical errors only then it may not require a modification, if this is the case please email the updated document to rch.ethics@rch.org.au for approval.
9. What is the difference between a Database and a Databank?
A database is a repository of data for a specific use e.g. a list of participants in a research study. A databank is a repository of data for current and future use e.g. participant data to be accessed by researchers in the future.
10. Do I need to submit copies of researchers CVs?
Researcher CVs are not required for an initial submission. In a small number of cases the HREC (or their subcommittee) may require further information on an investigator’s level of expertise; in this case a CV may be requested.
11. Can I submit a project if I do not have all the signatures?
There are some signatures that are required for submission, they are:
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Principal Investigator
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Line Manager
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Head of Supporting Departments, i.e. Pharmacy, Radiology etc
A cover letter advising of any outstanding Associate Investigator signatures must be included with the submission.
12. Do I need to submit signatures from all researchers in a multicentre project?
Only signatures from the local Principal Investigator and all local researchers (that is only the researchers that the RCH HREC is responsible for) are required unless otherwise requested.
13. Do I have to use the RCH Information Statement & Consent Form?
Researchers are required to use the RCH template unless there is a valid case for exception e.g. a multicentre project or a nationwide registry where a consistent form is in the participants’ best interest.
14. Who can sign as a witness on the consent page?
The role of the witness is to witness the signature, i.e. to be present when the consent form is signed. NOT to state that the participant (or parent/guardian) understood what was being explained to them or even to confirm the identity of the person signing. As such the witness may be the researcher, a member of the research team, or any person over 18 years of age who was present when the participant signed the consent form.
15. Is a witness signature always required on the consent page?
A witness signature is not required but is recommended by the RCH HREC. A witness signature reiterates to participants that they are signing a legal document and the decision should be carefully considered. However in some projects, for example low risk, the researchers may make a case for removing the witness signature. This should be outlined in the initial application.
16. Is a researcher signature required on the consent page?
A researcher signature is advisable as it provides a written record that the researcher has explained or provided the information to the participant. For Information Statements which are posted to the participant and the consent is returned by post, the researcher declaration on the consent page should be amended accordingly.
17. What additional ethical approval is required for recruiting via schools?
Rsearch in state schools requires prior approval from the Department of Education and Early Childhood Development. Research in Catholic schools requires prior approval from the Catholic Education Office. To conduct research in private schools, researchers must contact the Principal of the school(s) for their school specific requirements.
18. Do case reports require HREC approval?
The RCH HREC’s policy is that case reports are exempt from HREC review but all measures must be taken by the researchers to gain participant (or parent) consent.
19. Do I have to offer an Information Statement & Consent Form to participants less than 18 years of age?
In accordance with the National Statement (2007) the RCH Human Research Ethics Committee (HREC) considers it inappropriate to state a definite age at which the participant will be offered the opportunity to consent themselves; rather the individual’s “level of maturity and corresponding capacity to be involved in the decision” should be the deciding factors.
As such it is the RCH HREC policy that participants who are evaluated by the investigator as having the maturity and understanding sufficient enough to grasp the nature and consequences of the project should be provided with a Participant Information Statement and Consent Form to allow them to give their consent in addition to parental consent. As a general rule, participants over 12 years old should be offered the opportunity to consent, however this age will vary based on the nature and complexity of the trial.
20. Do participants, who were younger than 18 years when the research began, have to be re-consented when they reach 18 years of age if the study is still ongoing?
If the participant, following the investigator/clinician evaluating that they (the child) had the maturity and understanding sufficient to grasp the nature and consequences of the project, consented themselves in addition to their parent/guardian consent; then this consent is valid from the time of consent, and does not need to be retaken when they reach 18 years of age.
If a child has not consented previously (i.e. only parent/guardian consent was taken at time of enrollment due to the child not having capacity for consent), then the child must consent when they reach 18 years of age (as long as they are competent, i.e. not suffering from any condition which makes them incompetent) if they are still a part of the study.
21. Do I need to record participation in research in the patient’s medical record?
If the research impacts the patient’s clinical care (i.e. the patients treating team should be aware of the project) then researcher may either make a progress note regarding the patient’s participation or they may place a copy of the information statement and consent form in the medical record. In general, if the participant is an RCH patient and assessments completed for the research have relevance to the child’s care then these assessments should also be added to the record.
22. How do I decide if a member of the research team is an Investigator or a Research Assistant?
It is ultimately the Principal Investigator’s decision as to who is an Investigator and who is a Research Assistant (or equivalent). Characteristics helpful in determining who has the role of Investigator are as follows:
- Actively recruiting participants and obtaining informed consent
- Training and supervising research staff
- Providing intellectual input to the research
- Contributing to intellectual property in designing research
- Quoted as authors in articles reporting research
23. Do I need to notify the Ethics Office if a new Investigator or Research Assistant (RA) starts or an Investigator leaves the study?
Any change to the approved list of study Investigators requires a Change of Investigator Form (also available on our website under ‘Forms‘).
If other members of the study team are added or removed (i.e. research assistants, study coordinators etc) the Ethics Office must be notified via email of the change. Please include role and contact details for new members. However if the addition or removal of research staff necessitates a change to the Information Statement then a Change of Investigator Form must be submitted as above. It is advisable that where possible Information Statements list roles (i.e. Research Nurse or Study Coordinator) rather than individual names to avoid multiple amendments.
24. Do I need to submit a CTN Form?
If your project includes one of the following then a Clinical Trial Notification (CTN) form must be completed and submitted to Ethics & Research with your submission:
- Any product (therapeutic drug or device) not approved by the Therapeutic Goods Administration (TGA)
- Use of an approved product in a clinical trial beyond the conditions of its approval (i.e. in an unapproved indication, age group, dosage)
25. How do I know if a device is a therapeutic device?
Refer to the Therapeutic Goods Administration (TGA) website for full details However in short, for a device to be a therapeutic device it needs to be used in or connected with:
a) Preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or
b) Influencing, inhibiting or modifying a physiological process in persons or animals; or
c) Testing the susceptibility of persons or animals to a disease or ailment; or
d) Influencing, controlling or preventing conception in persons; or
e) Testing for pregnancy in persons; or
f) The replacement or modification of parts of the anatomy in persons or animals.
If your device falls into one of these categories then a CTN is required for your trial and the trial must be submitted to the Drug Trials Subcommittee (see the Ethics & Research website for more information).
26. Does RCH HREC approval provide Indemnity and Insurance for the Protocol or for the Investigators?
HREC approval grants indemnity and insurance for the study protocol (from the RCH insurers VMIA). However it does not provide insurance and indemnity to individuals. Individual insurance and indemnity is provided through employment (including honorary positions) at RCH/MCRI/UoM. As such if an external researcher is part of a project on campus then they must be working for (or affiliated with) an institution which provides them indemnity and insurance. Some external parties, such as GPs, may be required to notify their insurers to add the research to their private insurance.
27. If I collaborate on a study that does not have RCH HREC approval, who am I indemnified by?
If your involvement in the study is through your employment (including honorary positions) at RCH, MCRI or UoM you are indemnified by VMIA through your employment. If your involvement in the research is distinct from your employment you may need to seek private insurance.