Frequently Asked Questions (FAQs)
Electronic Signatures
The
Royal Children’s Hospital Research Ethics & Governance (RCH REG) Office) support
and promote the use of electronic signatures when executing clinical trial
governance-related documents including:
- HREC and Governance Applications
- Clinical trial research agreements
- Clinical trial indemnities
The use
of electronic signatures is legislatively underpinned by the Electronic
Transactions Act (Victoria) 2000 (Vic) and the Electronic Transactions Act
1999 (Cth). When the above documents are signed by two Australian
entities, the RCH REG ask that Sponsors accept electronic signatures on these
documents. This is particularly important during the unprecedented disruptions
that COVID-19 has had on Clinical trial activity and set up.
Electronic
signatures allow RCH REG to accommodate Government-directed requirements and
the Safe
Work principles, by reducing the risks to staff associated with wet-ink
signatures. Electronic signatures also facilitate the expedited processing of
Clinical trial documents, meaning that start-up can occur more quickly.
The use
of electronic signatures is endorsed by the Australian Clinical Trials Project
Reference group, in its document: COVID-19:
Guidance on clinical trials for institutions, HRECs, researchers and sponsors.
This is a joint statement that reflects the shared views of all state and
territory Departments of Health, the Therapeutic Goods Administration (TGA),
National Health and Medical Research Council (NHMRC) and the Clinical Trials
Project Reference Group (CTPRG), of which all of these entities are members.
We
thank our Sponsors for their support and assistance in accepting documents
executed electronically within Australia during this unprecedented time. We
encourage Sponsors to provide us with details of their preferred method of
electronic execution so that we can progress in our commitment to expediting
clinical trial governance. In particular, we ask that Sponsors consider readily available
electronic signature platforms such as Docusign or Adobe which are compliant
with Australian legislative requirements. Whilst these platforms may not be
compliant with CFR Part 11 regulations, it is important to note that this is a
US (FDA) regulation and is not required for documents signed between Australian
entities.
We ask
that you consider the above so that we can together progress in our commitment
to expediting clinical trial governance.
PLEASE NOTE: when obtaining signatures for Commercially sponsored Clinical Trial Agreements - researchers should check with the commercial sponsor which preferred method of document execution should be provided. Signatures should either be collected via wet ink or via electronic not both.
Researcher considerations when using Zoom recordings
- Researchers will need to confirm that the zoom recordings will be
stored on a local drive (not on the iCloud for Mac and iPads)
- Researchers will need to confirm that the recording will be moved
onto a password protected research computer (if it is not already – data can be
stored on MCRIs Owncloud)
- Researchers will need to obtain fully informed consent from
participants for this recording
- Researchers will need to ensure that storage and destruction is as
per the ethics application/consent information states.
Licensing on
questionnaires
Researchers need to be aware that
before you start using a questionnaire or another instrument licensed by a
third-party, you will need to get in touch with the MCRI Legal Office so that can review the
terms and conditions or the licence agreement.
MCRI holds an institutional licence
for some PedsQL questionnaires. Please get in touch with the MCRI Legal Office for more information.
They have also entered into a Master Licence Agreement with Pearson that will
cover any use of their products (eg. SSIS) at MCRI. From now on (and until Sept
2022), if you want to use a Pearson product for a research project, you will
simply need to complete a Statement of Work (SOW) containing the details of the
research project and the product you want to use. The Legal Office will still
need to be involved and sign off on the SOW.
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.
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,
a therapeutic device is one that is used in or connected with:
- Preventing, diagnosing, curing or alleviating a disease,
ailment, defect or injury in persons or animals; or
- Influencing, inhibiting or modifying a physiological
process in persons or animals; or
- Testing the susceptibility of persons or animals to a
disease or ailment; or
- Influencing, controlling or preventing conception in
persons; or
- Testing for pregnancy in persons; or
- The replacement or modification of parts of the anatomy in
persons or animals.
If you are using a therapeutic device outside of its
approved indication, you must submit an eCTN.
What are the differences
between identifiable, re-identifiable and non-identifiable data?
- Identifiable: the identity of a specific individual can be
determined
- 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
- 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
Do case reports require
HREC approval?
In medicine, a case report is a detailed report of
the symptoms, signs, diagnosis, treatment, and follow-up of an individual
patient. Case reports may contain a demographic profile of the patient, but
usually describe an unusual or novel occurrence.
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/guardian) consent, which can be recorded in the
EMR.
A case series tracks subjects with a known
exposure (disease), such as patients who have received a similar treatment, or
examines their medical records for exposure and outcome. A small case series
may not require HREC approval however a larger case series may produce findings
that are generalisable and therefore meet the definition of research. In these
cases the clinician should consider seeking approval via the Negligible
Risk pathway.
Do I need to submit
signatures from all researchers for multi-site projects?
The Coordinating Principal Investigator must sign all of
the documents submitted for ethical approval (HREA, VSM etc). The local
Principal Investigator and Associate Investigators must sign all documents
submitted for governance authorisation (SSA).
Do I need to submit
copies of researchers CVs?
Researcher CVs are not required as part of the initial
submission.
When do I submit tracked copies and how do I submit documents with peer review changes?
The initial submission to the REG Office
needs to have only clean documents (regardless of type of document – protocol,
PICF, poster, etc.). These initial documents need to incorporate the peer
reviewer’s suggestions, where applicable. Do not provide us with a tracked version showing the
changes you made based on their comments. However, you will need to provide us
with a cover letter of your responses to the peer reviewer’s comments so we can
see how their comments have been addressed.
In amendment submissions, you need to provide tracked copies of already approved documents. Please use the 'Review' feature on Word were possible as it clearly shows to us what sections have been removed, amended or added. If there is a brand new document that has not been approved, then obviously a tracked version of this is not required.
What additional ethical approval is required for recruiting
via schools?
- Research in state schools requires prior approval from the Department of Education and Training.
- 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.
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.
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.
My project has participants who
were under 18 years when the research began. Do they have to be re-consented
when they are 18 years old?
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 enrolment 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.
What should I think about when
approaching Aboriginal and Torres Strait Islander people to take part in
research?
Aboriginal or Torres Strait Islander (ATSI) people have cultural
requirements that must be respected.
In order to obtain consent from an ATSI person or their
family to take part in research, researchers should:
- adhere to ATSI Protocols i.e. kinship and relationships
inform who should be asked to give consent e.g. Elders/elder groups. Be
sure to obtain consent from all the relevant people
- involve an Aboriginal liaison worker where possible.
The following guidelines address considerations that arise
when carrying out research that incidentally involves ATSI people:
Clinical Trials involving GMO's
A process for using Genetically Modified Organisms (GMOs) has been developed by the Murdoch Children's Research Institute that must be followed for researchers intending to conduct clinical trials involving GMO at Melbourne Children's Campus. Please refer to the below link on the process:
IBC - Performing Human Clinical Trials involving Genetic Modified Organisms (GMOs) in Melb Children’s Campus – A Process
Good Clinical Practice Training
If you are conducting a clinical trial at the Melbourne Children’s Campus, you must provide evidence that the PI has successfully completed TransCelerate accredited GCP training in order to obtain governance authorisation.
MCRI have a number of GCP workshops scheduled throughout the year. These are free for campus staff & students. PIs, and any other members of the research team, are welcome to enrol in one of these at https://www.mcri.edu.au/research/researcher-training-resources/clinical-research-skills-practice-workshops