FAQs

AEC members are remunerated for their time and contribution.

CCAP members are remunerated for their time and contribution.

Not necessarily. CCAP membership is built around lived experience, rather than formal qualifications. If you, or someone close to you, has experience as a patient, carer or family member affected by a health issue, that’s the most important thing you bring to the panel.

Bellberry provides an induction program for all new members, along with ongoing mentoring and training, so you’ll never be reviewing a study without support.

You’ll review study protocols and documents from a participant’s point of view, considering whether the research is fair, practical and designed with people like you in mind. You’ll provide feedback before studies go to full ethical review.

Membership is a paid role, and members are remunerated for their time and contribution.

Meetings will be held dependent on the number of applications received – we expect meetings to be held monthly initially.

Bellberry welcomes people from a range of backgrounds, including researchers, clinicians, legal professionals, pastoral or community representatives, and lay members. See the ‘Who can become a member’ section above for the full requirements.

Our HREC Committee meetings are usually held on a Wednesday. A Principal Investigator can expect to receive comments detailing the committee’s deliberations two business days following the HREC meeting. Comments are provided via eProtocol.

Refer to BA G1 Submission requirements and responsibilities.

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Not all projects require HREC review. Studies with more than a low level of risk must be reviewed by an HREC. Some low-risk or quality assurance activities may follow other pathways or be exempt. Refer to the National Statement on Ethical Conduct in Human Research for details, or see our Review Pathways guide.

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Meetings are held weekly, on Wednesday evenings. How often you’re asked to attend depends on your membership category and availability — some scientific members attend 3 to 4 meetings a year, while others attend 12 to 20. Non-scientific members may attend regularly or occasionally, depending on availability.

All HREC meeting are held virtually via Microsoft Teams. HREC members are required to have a computer with a good internet connection.

Proposals and supporting materials are distributed 12 calendar days before each meeting, giving you time to review everything in advance.

Any post-meeting or ongoing items should be actioned within 48 hours. Outcomes and any follow-up are managed through Bellberry’s secure online portal, so everything stays in one place.

Your privacy is taken seriously when you participate in a clinical trial. Researchers must follow strict laws, ethical guidelines, and security procedures to protect your personal information.

Your information is kept confidential
Your personal details, such as your name, address and contact information, are kept confidential. In most studies, you are identified by a participant number or study code rather than your name.

Access is restricted
Only authorised individuals can access your identifiable information, including:

• The study doctor and research team
• Human Research Ethics Committees (HRECs), if required for monitoring
• Regulatory authorities, if required for oversight or auditing

All are required to comply with strict privacy and confidentiality requirements.

Your data is stored securely
Study information is stored in secure systems, such as locked filing cabinets or password-protected databases. These systems are designed to prevent unauthorised access, loss, or misuse of your information.

Study results do not identify you
When study findings are shared or published, your personal information is removed. The results are reported using de-identified, anonymised data, so you cannot be personally identified.

Legal and ethical protections apply
Clinical trials must comply with privacy laws and ethical guidelines. In Australia, this includes the Privacy Act and national health research guidelines. All clinical trials must also be reviewed and approved by a Human Research Ethics Committee (HREC), which helps ensure your rights, safety, and privacy are protected.

You will be informed before you consent
Before joining a study, you will receive a Participant Information and Consent Form (PICF) explaining:

• What information will be collected
• How it will be used and stored
• Who it may be shared with

You are encouraged to ask questions and make sure you understand this information before deciding whether to participate.

You can withdraw from a clinical trial at any time, for any reason, without penalty. Taking part in a clinical trial is entirely voluntary, and you do not have to explain your decision if you choose to leave.

Let your study team know
Tell your study doctor, study coordinator, or research nurse that you wish to withdraw. While they may ask why you are leaving, giving an answer is optional; you are not required to provide a reason.

Your participation will end
You will stop receiving the study treatment and no longer need to attend study visits. In some cases, the study team may ask if you are willing to come in for a final safety assessment.

Your safety remains a priority
Depending on the study and your health situation, the study doctor may recommend follow-up care or monitoring to help ensure a safe transition out of the trial, especially if stopping suddenly could affect your health.

Information already collected may still be used
Data collected before you withdraw will usually remain part of the study and may be used in the final analysis, as outlined in your Participant Information and Consent Form (PICF). Some studies may ask for permission to continue collecting information from your medical records, but you can choose whether or not to allow this.

Your regular healthcare will not be affected
Choosing to withdraw from a study should not affect your access to regular medical care or your relationship with your healthcare providers.

If you experience any problems during your clinical trial, contact your study team. They are there to support you, answer your questions, and help ensure your safety throughout the study.

• Study doctor — Your main medical contact for any health concerns, side effects, or questions about the study treatment.
• Study coordinator or research nurse — Often your first point of contact for practical questions, study-related concerns, or reporting issues.
• 24/7 or after-hours contact number — Most clinical trials provide an emergency contact number on your Participant Information and Consent Form (PICF). Use this if you need assistance outside normal business hours.

In urgent situations: If you have a serious or life-threatening medical issue, call emergency services immediately rather than waiting to contact the study team.

For non-medical concerns: If you have a complaint about the study or concerns about your rights as a participant, contact the Human Research Ethics Committee (HREC) using the details provided on your Participant Information and Consent Form (PICF). For more information, view our Complaints page.

If you experience a reaction to a study drug, contact your clinical trial team (study doctor, study coordinator or research nurse) immediately using the information on your Participant Information and Consent Form (PICF). They can assess your symptoms, provide advice, and ensure you receive appropriate care.

In an emergency
If you experience a serious reaction — such as difficulty breathing, chest pain, severe swelling or rash, or loss of consciousness — call emergency services immediately rather than waiting to contact the study team.

It is important to report any side effects or reactions, even if they seem minor, as this information helps researchers monitor the safety of the study treatment.

Bellberry’s Human Research Ethics Committees provide independent ethical oversight for human research across Australia.

We don’t run studies or recruit participants. Instead, our committees review research proposals and clinical trials to ensure they meet national ethical standards and prioritise participant safety.

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Bellberry’s goal is to provide high-quality and timely review. From the Wednesday submission closing date, applications are usually allocated to an HREC meeting within two weeks. The committee aims to return its decision within approximately 20 working days of submission (excluding any time the application spends back with the investigator for clarifications). This turnaround is recognised as one of the fastest in Australia and supports swift study start-up while maintaining rigorous ethical oversight

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Participant Identification Card Guidance

All Updated Documents: File names for updated documents should include:

• Standard naming conventions with the addition of either ‘Clean’ or ‘Tracked’. Abbreviations are acceptable (e.g., CL, TK/TC).
• Bellberry preferred file name:
  • Multi-Centre: VRP1001 BB Master Main PICF V1.0_30Mar2020_Clean
  • Multi-Centre: VRP1001 BB Master Main PICF V1.0_30Mar2020_Tracked

(I, the undersigned)

Understand that once any of the image(s) referred to above have been published, the researchers have no control over subsequent use and disclosure of the images; the images will be in the public domain, and it will not be possible to revoke consent.

Understand that I can withdraw permission for the further use of my image(s) at any time.

Annual/Progress Reports
A site-specific MAR F4.1.1 Progress Report form must be completed by each site and included in the Milestone Annual/Progress Report submission in REGIS.

Lead Site in REGIS:

• Request each site included in the REGIS application to complete and provide the MAR F4.1.1 Progress Report. If there are any issues, the site/s can email the form to the EPCT team at epct@bellberry.com.au.
• Complete the Annual/Progress Report in REGIS and upload the MAR F4.1.1 Progress Report forms for all sites.

Multi-centre site in REGIS with lead site in REGIS:

• Complete the MAR F4.1.1 Progress Report form for your site and provide it to the site that will be submitting the milestone in REGIS. If there are any issues, the form can be emailed to the EPCT team at epct@bellberry.com.au.

Multi-centre site in REGIS with lead site in eProtocol:

• Where the lead site is in eProtocol rather than REGIS the lead site in eProtocol will only submit their own site-specific Final Report in eProtocol.
• One of the sites in the REGIS application will need to be the submitting site and submit the report on behalf of themselves and any other REGIS sites following the instructions above.

Ethics approval expiry
Ethics approval will expire on the day of the approval end date. The Annual/Progress Report in REGIS should be submitted with the MAR F4.1.1 Progress Report form prior to the ethics approval expiry date to allow time for review and approval.

If there are any issues with submitting the Annual/Progress report in REGIS prior to the ethics expiry date, please contact the EPCT team at EPCT@bellberry.com.au.

If ethics approval expires, researchers must ensure:

• All research activities stop.
• New enrolment of participants does not occur.
• If the site has participant visits scheduled, the HREC will decide if it is in the best interests of individual participants to continue participating due to an over-riding safety concern or ethical issue.
• The site must outline what participant visits and other study-related conduct have occurred in the period between the report being due and the submission of the notification.

Final Milestone Reports
In addition to the REGIS Milestone Final Report submission, a site-specific MAR F4.1.2 Final Report form must be completed by each closing site and included in the submission.

Lead site in REGIS:

• Where all sites in the REGIS application are closing out:
  • All sites will need to complete the MAR F4.1.2 Final Report form and provide to the submitting site, if there are any issues the report can be sent via email to the EPCT team at epct@bellberry.com.au
  • The submitting site will need to submit the Milestone Final Report in REGIS and upload the MAR F4.1.2 Final Report for each site.

• Where some but not all sites in the REGIS application are closing out:
  • The closing site/s will need to complete the MAR F4.1.2 Final Report form and provide to the submitting site, if there are any issues the report can be sent via email to the EPCT team at epct@bellberry.com.au

• • The submitting site will need to submit a General Amendment notifying the HREC of the closing sites and upload the MAR F4.1.2 Final Report forms for each closing site.

Lead site in eProtocol:

• Where the lead site is in eProtocol rather than REGIS the lead site will only submit their own site-specific Final Report in eProtocol.
  • One of the sites in the REGIS application will need to be the submitting site and submit the Milestone Final Report on behalf of all closing REGIS sites following the instructions above.

Guidance
Please see the below link to the Bellberry progress and final report guidance document:
MAR G4 Progress and Final Reports

For information on how to submit a Milestone in REGIS, refer to the below QRG:
Submitting Annual Progress or Final Report (Milestone)

For further REGIS guidance, please refer to the following link to the Quick Reference Guide web page: https://regis.health.nsw.gov.au/how-to/

Bellberry Education Evening’s

Professor Ian Frazer AC, Thurs 9 November 2017, Adelaide

• Cancer Immunotherapy
• The Gardisil Story

Navigating the murky waters of data banks & registries and application of the National Statement

Liddy Griffith and Professor Annette Braunack-Mayer
Thursday 27 July 2017

• Presentation by Liddy Griffith
• Presentation by Annette Braunack-Mayer (followed by Q&A session)

For further information regarding applications please contact: epct@bellberry.com.au

Under the EPCT Framework Senior Executives and/or Research Directors from NSW PHOs that are included as part of an application will be invited to attend the HREC meeting during the period the application will be considered by the Committee at a HREC meeting. The nominated Observer can nominate to attend in person or remotely.

Non-commercially sponsored, investigator-initiated research applications submitted by NSW PHOs under the NSW EPCT framework may be eligible for a Bellberry fee reduction and NSW OHMR HREC fee subsidy support. Please contact the Bellberry EPCT team to discuss.

Multi-centre EPCT applications, which will include a NSW PHO, can be reviewed by Bellberry under the NSW Early Phase Clinical Trials (EPCT) Framework with applications made via the following submission pathways:

1. Lead submission is from a NSW PHO – the lead application must be made via REGIS. Private institutions may be included as part of the REGIS application, either in the initial submission or via an amendment, or an application can be submitted directly to Bellberry via our eProtocol platform.

2. Lead submission is from a private institution – where this application has been received via eProtocol, application(s) for NSW PHO’s can be made via eProtocol or REGIS.

Please note the following guidance for submissions made via;

• eProtocol – Bellberry requires an application from each site as part of a multi-centre review.
• REGIS –  the HREA need only include a minimum data set and may reference information contained within the Protocol, IB or lead site application. Site specific information such as the site, investigator and study staff information, participant recruitment and consent practices, participant populations, and data access and management considerations should be detailed within the HREA.

Please note the guidance for the following HREA registration and application questions:

Project Registration A1. Has the project ever received ethics approval or has an ethics application from ever been submitted to an NHMRC registered HREC, for the project? Answer NO so that a HREA application is generated.

HREA Q1.13 Has this research project had prior ethics review? Answer YES. Provide the application ID for the lead site application.

In either circumstance, a lead site can submit amendments or notifications to Bellberry on behalf of all approved sites during the lifecycle of the study.

Please note: each site is required to provide a site-specific annual Progress (Milestone) report. When applicable, such as when the lead site submission is via a platform other than eProtocol, the lead site can submit a collection of additional site Progress (Milestone) reports. Following site closeout, each site is required to provide a site-specific Final Report. Please refer to MAR G4 Progress and final reports and MAR F4.1.1 Progress report (eProtocol questions) for further information.

New applications on behalf of NSW PHOs, which have not previously undergone a Bellberry review, must be submitted via REGIS.

In addition to Bellberry’s submission guidance, please review and include the information in the REGIS application checklist or include the completed checklist with your application.

Please only submit electronic indemnities listing sites that have applied or are due to apply in the coming days. Bellberry will not execute indemnities that list sites that have not applied eProtocol.

If the indemnity is on paper, Bellberry will strike through the sites that haven’t applied in eProtocol.

The lead site only needs to choose a pathway. There may be some situations where updated documentation is required, but it should be rare.

For example, if they pick pathway 2, they do not need to send in site-specific clauses documents if we have already approved their site-specific PICF. Sites approved before the PICF pathways only need update the HREC with a site-specific clauses document if they are changing the wording from an already HREC approved site-specific PICF.

If the lead site chooses pathway 3, the only update required is if the Master PICF does not cover the requirements of the additional site that is being added. E.g. the radiation statement has two options, but the new additional site has different wording that isn’t already covered. The lead site would then need to submit an amendment with an update to the Master PICF. The amendment can come either before or after the additional site is approved. If it comes post-approval, the additional site will be delayed in creating its site-specific PICF. This is a matter for Sponsors and sites to work out what suits them best.

Please contact the Sponsor and get them to confirm with the site that submitted the initial application (lead) which pathway they would like the study to follow. Once you have confirmation, please attach any email correspondence that confirms the pathway and upload it with your application. If there is no correspondence, the HREC administrator will need to contact the lead site and ask which will potentially delay approval for the additional site.

The HREC administration keeps a record of the lead site’s PICF pathway at the initial submission. If a site tries to change the pathway, the HREC administration will return the documentation, along with an explanation that it does not match the study pathway. The only exception to this would be when a single centre study on PICF pathway 1 has changed to a multi-centre study. The Sponsor needs to determine who is responsible for unpacking the PICF and moving the study to PICF pathway 2 or 3. In this case, the submitting site should also explain the change in the pathway to the HREC. Providing as much information as possible will help the administrator understand why the documentation change is being submitted.

The BB website lists the FAQ below:

“If I have an additional site what do I need to submit and when?”

“If the lead site has yet to be approved please submit your site application via eProtocol, however you do not need to attach any study documentation on page 7 of your application. If your lead site has already received HREC approval you will need to submit a full application including all your site’s study documentation on page 7”

 In this context, we define ‘full application’ to mean each site must complete an application in eProtocol and answer all questions. We don’t wish for the definition of ‘full application’ to relate to the uploading of core study documents such as the protocol, IB etc.

The additional sites are only responsible for uploading documents relating to them. The sort of items we would expect to see uploaded:

• CV if not current within 12 months.
• A site-specific form – if applicable.
• Any other site-specific documentation that is not relevant to other sites – e.g. social media plan or local advertising.

No. It only holds up the site/s in question. Suppose it is something minor that could be dealt with swiftly. In that case, we will encourage our team to rectify the issue so approval for all sites can occur on the same day. If it appears that is not likely, sites 1 & 4 would be approved. Then, sites 2&3 would be approved when they have resolved their issues. Sites 2&3 are then provided with any approval letters that have been issued for the other sites if there are documents on there that are relevant to them (e.g. protocol, IB, Master PICF).

1. Does not need to be listed in site-specific clauses document as the wording has been ethically approved in the Master PICF, so site deleting the not applicable section would be a known admin change.
2. Copy and paste the deleted wording into the site-specific clauses template stating that it is not applicable and therefore deleted.

The correct answer is option 1.

Great suggestion – the change has been made and the document has been republished on our website.

No, the site does not reference the version and date. The site only needs to reference which document their wording is going into (e.g. Master Main, Master Pregnancy).

If the lead has chosen pathway two, and each site has submitted a site-specific clauses document, if they never wish to change any ethical content in their site-specific PICF, we will never receive an update to that document for the rest of the study.

The clauses document is approved, and each time the Master is updated, they include their approved clauses in their site-specific version, which is approved via whatever mechanism they choose for their own site (e.g. Clin Trial Manager go-ahead, CRO sign off etc).

Yes, if the lead selects pathway 2.

It is for the following reasons:

• The sites are submitting it to confirm they aren’t making changes.
• If there are ethical changes, then the RGO/other institutional representative has a point of reference that the HREC has reviewed the wording, and it is OK for inclusion. We hope that it can help with making the line clear between what is ethics and what is governance. Governance is then about adding administrative items (headers, footers, logos, local site complaints).
• The real value in the document is post-approval. If the site is not changing any site-specific content, they are free to create a site-specific PICF on the same day as the Master is approved. Historically, they may have created it, but they would then need to submit it to the HREC and await approval. In discussion with sites, we found our former approach caused issues when a Master PICF had urgent safety updates, and sites were then waiting for their site-specific PICFs to be approved post Master.

When we audit a study, if we find ethical changes to the site-specific PICF that were not submitted in the site-specific clauses document, we will bring it to the PI’s attention. We recognise there is no clauses document for historical studies, so we would go by the previously approved site-specific PICF.

The Committee will want to see the radiation report (if above standard of care) and the wording from that report placed in the site-specific wording doc. The HREC notes the radiation report, whereas they approve the site-specific wording.

If the lead has already imbedded the radiation report wording of multiple sites into the Master PICF, then it would not need to be put in the site-specific doc.

Insurance and indemnities
Insurance and indemnities FAQ
MA Clinical HREC Indemnity (1 Oct 2012)
MTAA Device HREC Indemnity (10 April 2024)
Bellberry non-clinical HREC indemnity

New applications: The first submitting/lead site must consult BA F1.1.17 PICF submission pathways to determine how the master study documentation will be submitted. There are now three submission pathways:

• Option 1 for single centre submission;
• Option 2 is a flexible submission pathway (which is the same as currently in place);
• Option 3 for where the initial submitting/lead site takes submission responsibility.

A question has been added to the application form asking the Principal Investigator to confirm which PICF pathway has been chosen for the submission. Only one pathway may be selected per study for review by a Bellberry HREC. Each additional site will need to align with the study’s nominated pathway, chosen by the first submitting/lead site.

Sites are no longer required to submit tracked and clean site-specific PICFs and other site-specific participant facing documentation to Bellberry. This change allows sites with research governance offices (or other formal institutional arrangements for reviewing site-specific documentation) to go ahead without the need for further HREC review. Sites that do not have a formal institutional arrangement will be responsible for developing a local procedure for document management.

The PICF submission pathway will determine what documentation is required from each site. Major site-based changes (e.g. radiation, pregnancy, reimbursement) to the PICF/participant facing documentation may be written in the master document as placeholders, or by the completion of BA F1.1.12 Site-specific clauses. The content will be reviewed by the HREC in the format determined by the PICF pathway. Minor administrative changes will be the responsibility of the site and do not need to be submitted to Bellberry. These include adding the site name, Principal Investigator details, amending footers, formatting, and other typographical errors.

For current/ongoing studies: Most studies will already be consistent with one of the PICF pathways. If a site has submitted a site-specific PICF/document to Bellberry, the HREC will have already approved the site-specific content and listed it on an approval letter. If the master document is updated, the site can continue to imbed previously approved clauses into the new site-specific PICF/document without the need for further HREC review. If the site wishes to change a clause, the site must submit an amendment using the BA F1.1.12 Site-specific clauses template.

Sponsor representatives are able to help build the applications in eProtocol. See registration requirements under BA G1 Submission requirements and responsibilities

As a reminder, earlier this year, Bellberry removed the requirement to submit the following documents for which the institution is responsible:

• Insurance certificates
• Standard indemnities
• Site approval forms*
• Protocol signature pages
• Professional indemnities

These are still required to be in place, and available at the site.

*Site approval forms, in this context, refer to the procedure of form put in place by the Institution or Organisation conducting the research. The Bellberry site approval form has been retired.

A list of submission requirements is available under Bellberry Applications BA F1.1.1 Submission requirements checklist.

Changes to the administration and approval processes will be monitored through the Bellberry site monitoring programme, in order to assess the compliance with the outlined process changes.  A review of the implementation of these changes will be undertaken to ensure overall suitability.

Bellberry routinely monitors sites and studies. Sites selected for monitoring may be for cause or chosen at random. In 2020, Bellberry has added desktop auditing to the annual monitoring calendar.  (Through 2020 it is anticipated that all monitoring will be undertaken via remote methods, with a return to physical site monitoring when safe to do so.)

From 2021, the changes to administration of additional sites will form part of the monitoring agenda. If your site or study is selected for monitoring (either by desktop or site visit methods), the Bellberry quality team will email all relevant forms for completion to the Principal Investigator and nominated contacts.

Bellberry accepts both electronic and hard copy HREC Only indemnities. If an indemnity is to be sent via an electronic platform such as DocuSign or AdobeSign, please do not complete any fields for the Bellberry signatory.

Please send any electronic HREC Only Indemnities to bellberry@bellberry.com.au. If your processes require it to be sent to an individual, please also copy to bellberry@bellberry.com.au.

Bellberry does not require the submission of Standard Indemnities. Researchers and Sponsors can find information on Bellberry’s requirements for HREC Only Indemnities in BA G15 Insurance and indemnities

For clarity, Bellberry requests files to contain the title, version and date of the document. Please refer to BA G12 Version control and document naming conventions for further information.

Minor changes have been made to the progress report form to incorporate the need for submissions to include an update on any conflict of interest changes for the research team, and for a comment on compliance with any: governance approvals; submission of amendments; safety reporting; annual progress reporting; notification to the HREC of regulatory audits; appropriate use of data; caveats placed on the approval; statutory and licensing obligations. See MAR F4.1.1 Progress reports (eProtocol questions).

Protocol deviations and violations do not need to be reported to Bellberry HREC. The PVR form has been updated to reflect the NHRMC’s serious breach questions. Sites may complete these questions, or upload MAR F3.1.1 Serious breaches report form – sponsor or MAR F3.1.2 Serious breaches report form – third party, as applicable.

Please note, the acknowledgement letter will code the item as ‘PVR’; this is system-generated and cannot be altered.

If an amendment or safety report in a multi-centre study relates to core study documentation (such as the protocol, master PICF or investigator brochure, DSUR, ASR), the submission will be reviewed on behalf of all Bellberry approved sites. In the event the submission does not apply to all of these sites, the submitting site must provide an explanation. Please refer to MAR F1.1.3 amendment pathways flowchart for further information.

When an additional site is approved after the initial study’s approval, Bellberry administration will upload all previous approval letters to eProtocol page 7 of the additional site’s application. The additional site is responsible for checking that the approved documents match the documents on file. If the site has any documents that do not match those approved (e.g. they have a more recent version of the protocol), the site is responsible for contacting the sponsor to determine which of the approved sites will be responsible for submitting an amendment.

Please refer to BA F1.1.7 HREC process flowchart for further information.

Each site is responsible for submitting an initial application. The first submitting/lead site is responsible for submitting all core study documents. Additional sites will not need to submit any study documentation that has been submitted by the first submitting/lead site, irrespective of when the additional site joins. However, additional sites are responsible for submitting documents that have not been submitted by the first submitting/lead site (e.g. documents pertaining to the additional site: CV, social media plan, advertising, etc.). Please refer to BA F1.1.1 Submission requirements for further information.

Additional site submissions will be considered by the Chair/reviewers as the first submitting/lead site enters cycle comments, post-HREC review.  When the first submitting/ lead site is ready for approval, any additional sites that have fulfilled the HREC’s requirements will be included on the first submitting/lead site approval letter.

From the ‘investigator’ home page, Principal Investigators will be able to view a complete list of submissions for projects under their responsibility. Applications will be grouped into ‘applications (in preparation/ submitted), ‘approved applications’, or ‘non-active applications’.

From the ‘investigator’ home page, holding Ctrl+F will display a search bar. Entering an identifier such as the HREC application ID into the search bar will highlight items on the page that match the search criteria.

From time to time a submission may not be visible from the ‘investigator’ home page. This may occur when a new Principal Investigator has taken over responsibility for a project, or when a Co-Investigator/ nominated contact completes a submission on behalf of an investigator.

To access a submission that is not visible on the eProtocol landing page:

1. Hover over the eProtocol tab in the top left-hand corner of the page
2. Move the mouse to hover over ‘investigator’. A list of options will Click ‘search protocol’.
3. Enter the relevant HREC application ID the search box. Click ‘search’.

If uncertain of the specific HREC application ID, type a different identifier into one of the search fields. For example, entering the Principal Investigator’s name into the search box and clicking ‘search’ will display a complete list of all submissions made by, or on behalf of, that investigator. Alternatively, selecting the organisation name and clicking ‘search’ will display a complete list of all submissions for projects occurring at that site.

A combination of search fields may be used, such as:

• study title
• form type (amendment, progress report, protocol violation report)
• organisation name
• committee (panel)
• meeting date

Submission requirements and responsibilities
Submission requirements checklist
eProtocol application questions
HREC process flowchart
Delegation of responsibility template
Site-specific clauses template
PICF submission pathways
EPCT submission pathways 
REGIS application checklist

Protocol development – clinical

Protocol development – non-clinical

Participant Information & Consent Form development
Photographic Release Consent
Sample Consent Form
Third-Party Form
Revocation of consent
Standard Clauses – compensation for injury

Registrations Guidance
Organisational verification of personnel form
eProtocol navigation guide for researchers

Application Fees
REGIS submission HREC fee form

Conflict of Interest

CVs and Investigator Qualifications

Advertising and social media

Participant Payment & Reimbursement

Researcher Data Storage and Retention
Standard clauses – confidentiality and privacy

Version control and document naming conventions

Ionising Radiation
Standard clauses – ionising radiation
Standard imaging – definitions
Standard of care declaration- template
HREC reporting flow chart – radiation

Pregnancy and Sexual Health
Standard clauses – pregnancy & sexual health
Standard template – pregnancy/pregnant partner data release

Discussion of the BIAL/Biotrial Phase 1 trial in France

Dr Brian Creese, A/Prof Michael Wiese, A/Prof Mark Slee & Dr Michael James – Thursday 7 April 2016

Presentations by Brian Creese and Michael Wiese followed by panel Q&A session with Brian and Michael joined by Mark Slee and Michael James. Please see below video footage of the sessions, both with introductions from Kylie Sproston:

• Dr Creese and A/Prof Wiese Presentations
• Panel Q&A Session

Withdrawal or Suspension of Ethical Approval

Site monitoring and desktop auditing

Amending Approved Research
Amendment Form (eProtocol application questions)
Amendment Pathways Flowchart
HREC notification template – change in PI
HREC notification template – change in CPI

Safety Reporting
Safety Reporting (eProtocol application questions)

Serious Breaches
Serious Breaches Report Form – Sponsor
Serious Breaches Report Form – Third Party
Serious Breaches (eProtocol questions – PVR)

Progress and Final Reports
Progress Report (eProtocol)
Final Report (eProtocol)

Batch submissions
Batch submission application

Review Pathways – Higher risk and Lower risk research
AI Research Guidance
Post marketing studies
Multi-stage Phase 1 in healthy volunteers
Extension studies
Taking over ethical oversight checklist
Psychedelic Drug Study considerations
Cannabis Study considerations
Application for Lower Risk Review

We recognise that the sector is enormously busy at present and expect that deadlines will come under pressure. Bellberry will be automatically extending ethics expiry dates to take into account the current situation.

Videos cannot be uploaded directly into an eProtocol application; however, they can be embedded into a document which can then be attached to page 7.

The document should be named as you want the video to appear on the approval letter.

To embed a video into MS Word, PowerPoint or Excel, please refer to the instructions below:

1. On the Insert menu, click Object, and then click the Create from File tab
2. Click Browse and locate the movie (video clip or sound wave) you want to insert
3. Select Movie (video clip or sound wave)
4. Click insert
5. To play media clip, double-click its icon
6. Save using the preferred file

Avoid using your browser’s BACK button 
This will avoid taking you out of the system. Instead, use the menus and links within the application to navigate.

Save Frequently
eProtocol will time out after 60 minutes of inactivity. Only actions which cause the page to refresh or reload (such as saving or navigating to a new section) are indications to the system that your session is active.

Be patient                                                                                                               
Some processes can take a short time to run. Although data is loading, your browser may not indicate activity.

Sign out when done
Always click “Sign Out” and shut down your browser completely (close all browser windows) when you are finished using eProtocol. This will not only help keep your information secure but will also release any edit locks you may have had on protocols and allow your colleagues on the project to open the protocols in edit mode.

Changing a Password
If you wish to change your password, click on the ‘Change Password’ button on the top right-hand corner of the Screen (next to the Sign Out button).  Once on this page, if you cannot remember your hint question, follow the ‘click here’ link. This will take you to a second ‘forgot password’ page where you must enter your UserID and email address. Follow the steps outlined in the email generated by the system.

I can’t see my approved applications
Your approved applications will appear on your eProtocol home page (the page you see when you first log in) in the section labelled ‘applications (approved)’. This section should appear towards the middle of your page. You may need to click on the button located on the right-side of the section header to expand this section.

I can’t find the application I need to amend
Please refer to the instructions for ‘creating an amendment’ if you do not see an application listed in your applications (approved) section, it may be that you were not listed as personnel on the study.

The option to ‘Start Amendment’ is not available; it appears grey
You may not have EDIT access to this application. Select “open in view mode” and click on the left-hand menu option ‘personnel info’. Only those people listed in the first four roles (principal investigator, co-investigator, nominated contacts) have access to edit the study/application.

An amendment or progress report may have already been started or is in-process for this application. Check on your home page in the applications (in-preparation/submitted) section to see if the application is listed there.

I am trying to respond to HREC comments, but it appears as if there are none.
You might be confusing the HREC Return Notes item in the left-hand side of the application form with the HREC Comments page, which is used during the HRECs review cycle.

If you are attempting to access comments from the HREC for an application that has already been assigned to a meeting date, please see the ‘Post HREC meeting & application decision’ instructions on how to respond to HREC comments. If your application was returned, please see instructions for ‘Returned applications’.

Access to eProtocol
Once logged in to eProtocol, you will be able to create a new application, and to view and edit any applications on which you have been listed in the Personnel Information section. You will only have access to edit those studies/applications on which you are listed as either:

• Principal Investigator
• Co-Investigator
• Nominated Contact

If you are a new Co-Investigator or Nominated Contact for an existing study, you will need to ask one of the existing study personnel listed on the Personnel Information page of the Application to create and submit an Amendment in eProtocol to add your details. Following approval of that Amendment you will then have view and edit access for the specific study. Refer to the Amendments section of this guide for details about how to do this.

If you are added during a study, you will not be able to access previous versions of documents. The PI however will be able to (unless they have taken over from another PI).

Home> Approved applications> Application ID> Final report

A pop-up window will open. Within this window select ‘final report’ and click OK

If the final report form does not open when you click OK, then you have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, that are blocking your pop-ups.

Once this form is acknowledged by the Committee the study will be closed in eProtocol, and no further submissions can be made. The application will be able to be viewed in the Non-Active Applications section on the home page

Once completed click SUBMIT FORM

Home> Approved applications> Application ID> Progress report

A pop-up window will open. Within this window select ‘progress report’ and click OK

If a progress report form does not open when you click OK, then you have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, that are blocking your pop-ups.

Alternatively, if this option is still not available, then an amendment submission may be active. Check the ‘Applications (In-preparation/Submitted)’ section to see if the study is listed there. Please note that once the submission of an amendment has occurred, you will not be able to start a progress report application until the amendment has been reviewed and approved. If the ethics expiration date is near, please complete a progress report before creating an amendment. Once processed, you will then be able to submit an amendment

Please attach any documents at the bottom of the form.

Once completed click SUBMIT FORM

Home> Approved applications> Application ID> Protocol violation

A pop-up window will open. Within this window select ‘protocol violation’ and click OK

If a protocol violation form does not open when you click OK, then you have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, that are blocking your pop-ups.

Please attach any documents at the bottom of the form

Once completed click SUBMIT FORM

Creating an adverse event/safety report form

Home> Approved applications> Application ID> Start adverse event/safety report form

A pop-up window will open. Within this window select ‘adverse event/safety reporting’ and click OK

If an adverse event/safety report form does not open when you click OK, then you have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, that are blocking your pop-ups.

On the form select either:

1. Individual Event

OR

2. Summary Report

For an Individual Event, select section 1 and complete the report as required. Ensure that all questions are answered including the details of the event and attach relevant documents.

For Summary reporting, select 2 and attach relevant documents.

Once completed click SUBMIT FORM

Creating an amendment

Home> Approved applications> Application ID> Amendment

A pop-up window will open. Within this window select ‘start amendment’ and click OK

If an amendment form does not open when you click OK, then you have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, that are blocking your pop-ups.

Alternatively, if this option is still not available, then an amendment or a progress report/ submission may be active. Check the ‘Applications (In-preparation/Submitted)’ section to see if the study is listed there. Please note that once the submission of an amendment has occurred, you will not be able to start a progress report application until the amendment has been reviewed and approved. If the ethics expiration date is near, please complete a progress report before creating an amendment. Once processed, you will then be able to submit an amendment.

Please attach documents at the bottom of the amendment form.

Once completed click SUBMIT FORM

Click here for the post meeting process

You can generate an Adobe pdf file of your application form that can be printed or saved on your computer.

• In the left-hand menu of the application form, click on the Print View option

A small window will open:

• Select an option, sections and their orientation, and click OK
• The Adobe pdf file will be created and will open automatically
• You may save it to your computer by clicking File, then Save as located in the upper left-hand corner of the window

If you are having difficulty with this function your Windows software may be blocking it. If this is the case, please go to the application page and use the keyboard short cut ‘Ctrl P’ to print individual pages.

Returned Applications

Sometimes it is necessary to return an application. Return advice will be communicated by email to the contacts on the application. The ‘Application Status’ displayed on your home page will be changed to ‘Submission Returned’.

If you receive an email advising that your application was returned:

• Open the application and click on ‘Return Notes’ in the left-hand menu to view the comments.

This will open a window with information regarding the reason your application was returned and instructions on how to proceed.

Make the necessary changes and additions to the application and attachments. Please note that to make changes to the application you will need to open it in ‘Edit’ mode.

When the application is ready to be resubmitted, click the SUBMIT FORM button.

The HREC Return Notes area is used only for instructions from Bellberry relating to returned applications. The Investigator/Contact cannot add text or respond to a Return Note.

Click here for complete guidance on creating and submitting applications

The Organisational verification of personnel form is to be used to verify an individual and their affiliation with the organisation/site with which they wish to register. All new registrations must complete and submit this form. This form can be found in BA G2 Registration Guidance.

The first step of creating an application is to apply for a User ID and password. For assistance with your registration please view the ‘How to Register’ video tutorial on our website.

Verifying new registrations

Bellberry is committed to maintaining and upholding excellence in privacy and security for all those who use our service, including all who register and use the eProtocol system. To further strengthen the security of the registration process, all new applicants will be required to complete the organisational verification of personnel form (Registrations Guidance BA G2) . This form provides information that allows Bellberry to efficiently and effectively process new applications, while maintaining appropriate security of data.

Authorised representatives

Each organisation must have a dedicated person(s) that assumes responsibility for the authorisation of new personnel registering for eProtocol access from that organisation. The authorised representative should be known by staff as they will need to verify the applicant as part of the registration process.

Larger organisations may choose to delegate this role to a departmental level, e.g. a hospital may select the Clinical Trials Manager in each department. For stand-alone clinics, it may be the practice manager or Principal Investigator. The organisation is responsible for determining the person responsible and declaring this person to Bellberry. Bellberry will maintain a list of authorised representatives, and each new registration for that organisation will be verified with the nominated representative.

New organisations

New organisations registering with Bellberry will be required to provide additional information, including full address, phone number and ABN. This information is to be included within the relevant sections of the organisational verification of personnel form Registrations Guidance (BA G2). Completed organisational verification of personnel forms should be emailed to registrations@bellberry.com.au.

Please do not use acronyms in the organisation field on the registration form. The organisation name and address that you enter will appear on all correspondence from Bellberry.

Please ensure that all people that will be involved in the study, i.e. the Principal Investigator, Co-Investigators and any other nominated contacts are all registered with the same organisation.

Working across multiple organisations

A researcher or nominated contact registering for multiple organisations will be required to register with a different user IDs for each organisation. We suggest using an identifier such as the organisation name and surname or initials.

Nominated Contacts

If authorised by a Principal Investigator, a nominated contact from another organisation, including sponsors, clinical research organisations (CROs), site management organisations (SMOs) etc., may prepare an application on behalf of the Principal Investigator. The nominated contact must be registered with the site at which the study is being conducted. Please note that this may be different from the organisation that the nominated contact is employed by.

User ID

It is suggested that sponsors, CROs and SMOs use their surname, initial and organisation name for the User ID, i.e. ‘SmithJ – organisation name’.

Please note that apostrophes cannot be used within a user ID.

Registering in eProtocol

As for all applicants, the authorised representative of the organisation (see definition above) must verify the nominated contact by signing the organisational verification of personnel form Registrations Guidance (BA G2). This form should be completed and emailed to registrations@bellberry.com.au for each separate organisation, prior to registration.

Following completion and submission of the organisational verification of personnel form, open the eProtocol homepage. Click register > complete registration form > user ID (select a username such as last name, first initial) > organisation name (must be the organisation that the user is to be linked to –

e.g. the PI’s organisation) > click submit.

The registration request will be processed by the Bellberry registrations team and a confirmation email acknowledging receipt of the registration request will be sent to the listed email address.

Once the registration has been processed, the user will receive an automated email from registrations@bellberry.com.au with temporary login details. When the new user accesses eProtocol for the first time, the system will generate a prompt to change the password. This link is time-sensitive and should be accessed as soon as possible.

Passwords are required to be a minimum of 8 characters with a minimum of 3 of the following:

• lowercase
• uppercase
• numbers
• symbols (!,@,#,$,%,^,&,* ).

eProtocol will generate automatic emails whenever a transaction between the site and the HREC occurs, e.g. when an application is submitted, comments are returned, and so on. All contacts listed on the personnel information page will receive these automated emails.

Recommended browser

eProtocol is compatible with most popular browsers. We recommend using the most recent version of the following web browsers:

• Firefox
• Edge
• Chrome
• Safari (if using a Mac)

Disabling Pop-ups

Pop-up blockers prevent the eProtocol application from opening certain windows.

You will need to make sure that your internet browser has all pop-up blockers disabled or pop-up windows allowed for the eProtocol website. You can usually find how to do this in the ‘Settings’ of your browser.

Overseas Access
If you are unable to access eProtocol and are outside Australia, please fill out the form here: LINK TO FORM

We will then contact you to arrange an alternative method of access.

Bellberry Education Weekend presentations

Thank you to the presenters from our May education weekend for making their presentations available to all our Committee Members.  Please click on the heading above to view individual presentations.

• A history of research ethics committees: origins, history, membership and functions – Professor Colin Thomson
• Medical Imaging in Clinical Trials – Dr Martin Caon
• A guide to interpretation of the Investigator Brochure and Protocol – Professor Paul Rolan
• An overview of FDA, EMEA, MHW and TGA – Professor Paul Rolan
• Consent and the National Statement – Professor Colin Thomson
• Clinical Trials – Dr Nikolajs Zeps
• The interface between Ethics and Statistics in Clinical Trial Design – Dr Derek Chew
• Omega-3s for heart health and rheumatoid arthritis: Fish oil or snake oil? – Professor Michael James    (available to be emailed on request)
• Biobanks/Databanks – Dr Nikolajs Zeps
• Member Responsibilities – Trina O’Donnell

As part of our commitment to ongoing training and development, we provide for a number of attendees at Ethics training sessions, conferences/seminars and networking events.  We were pleased to sponsor several Members attendance at the Australasian Association of Bioethics and Health Law Conference, Monash Intensive Research Ethics Course, Australasian Ethics Network Conference and the Monash Intensive Bioethics Course in the later part of 2014.

Thank you to Simon Gill, Sid Baxi, Anne Ozdowska, June Challen and Casey Nottage for representing Bellberry and for providing a summary of the program elements that were of particular interest.  Download reports here: 2014 Conference Feedback (7 downloads )

Member education weekend workshop May 2014 – McCracken Country Club, Victor Harbor

• Pharmacology and Drugs: The Basics – Dr Tom Polasek (12 downloads ) (click here for video)
• Pharmacology – Doug Francis (10 downloads ) (Click here for video)
• Respiratory Disease – Emeritus Professor Dick Ruffin AM (9 downloads ) (Click here for video)
• Biosimilar: Why not Biogeneric? – Dr Michael Ward (7 downloads ) (Click here for video)
• Consent research and the National Statement – Dr Bernadette Richards (6 downloads ) (Click here for video)
• TGA/PBAC – Professor Emeritus Lloyd Samson AO (1 download ) (Click here for video)
• Macular Degeneration – Dr Jim Runciman (1 download )
• Alzheimer’s Disease – Associate Professor Mark Slee (1 download ) (Click here for video)
• Oncology – Associate Professor Dusan Kotasek (1 download ) (Click here for video)
• Stem Cells – Associate Professor Megan Munsie (1 download )
• CEO Update – Kylie Sproston (1 download ) (Click here for video)
• Education Project – Melanie Gentgall (1 download ) (Click here for video)
• Bellberry Items – Trina O’Donnell (1 download ) (Click here for video)

Social Media & Clinical Trials: The Good, Bad and the Ugly – Michelle Gallaher
Kids: Mum has signed up to be part of an Ebola vaccine clinical trial – Michelle Gallaher

Thursday 15th October

Michelle raised some very interesting issues which many people found thought provoking.  We are currently developing guidelines for our HREC members regarding social media and clinical trials to clarify what is within the remit of the HREC.

Please see below video footage of the sessions, both with introductions from Kylie Sproston:

• Social Media & Clinical Trials: The Good, Bad and the Ugly
• Kids: Mum has signed up to be part of an Ebola vaccine clinical trial

Ethical and regulatory challenges generated by surgical innovation – Professor Wendy Rogers & Dr Bernadette Richards
Devices – Professor Guy Maddern

Thursday 30th April

Thank you to our guest speakers for a very informative evening and to Members, Staff and Directors who attended.

Please see below for video footage of the sessions, both with introductions from Kylie Sproston:

• Prof Wendy Rogers & Dr Bernadette Richards
• Prof Guy Maddern

As part of our commitment to ongoing training and development, we provide for a number of attendees at Ethics training sessions, conferences/seminars and networking events.  We were pleased to sponsor several Members attendance at the Australasian Association of Bioethics and Health Law Conference, ACTA International Clinical Trials Symposium, Monash Intensive Bioethics Course and Monash Intensive Research Ethics Course.

Thank you to Kerrin Falconer, June Challen, Sharonne Price, Jenni Hughes and Tracy Mitchell for representing Bellberry and for providing a summary of the program elements that were of particular interest. Member 2015 Conference Reports (1 download )

13 and 14 August

Genetics and Stem Cells/Cell Therapy was chosen as the theme for the third Bellberry Education Weekend given the growth in clinical trial activity in these areas.  The timing coordinated nicely with the recent announcement of Bellberry being selected to pilot the NHMRC National Scientific Committee to review complex genetic research.

We are delighted with the extremely high calibre of presenters who generously donated their personal time to speak at our event, and for their enthusiasm for being involved with Bellberry.

Please click on the individual session name below to view the video footage:

1. Welcome & opening – Kylie Sproston, Bellberry CEO
2. Genetics: General – Prof Graeme Suthers
3. Genetics: Big Data – A/Prof Marcel Dinger
4. Genetics: Personalisation of treatment – Dr Lorraine Chantrill
5. Stem Cells: Oncology – Prof Michael Brown
6. Stem Cells: Manufacture & Commercialisation – Dr Sherry Kothari
7. Stem Cells: General  – Prof John Rasko AO
8. Stem Cells: Q&A Panel – Prof Rasko, Prof Brown & Dr Kothari
9. CEO Update – Kylie Sproston
10. Bellberry Items – Trina O’Donnell

We are pleased to have sponsored several members’ attendance at external educational events during 2016.  Thank you to June Challen, Greg Crawford, Margy Hewetson, Natalie Clark Reynolds, Di Sutton, Andrew Davis, Peter Morel, Tracy Mitchell, Paula Swatman, Michael James and Ian Leader-Elliott for representing Bellberry and for providing a summary of program elements that were of particular interest.

Congratulations to June, Di and Natalie who have successfully completed the PRAXIS HREC Essentials Training Course.

• Masterclass in Clinical Trials: Methodology & Conduct – Masterclass in Clinical Trials: Methodology & Conduct (1 download )
• Australasian Ethics Network Conference – Australasian Ethics Network Conference (1 download )
• Australian Association of Bioethics & Health Law Conference & the Monash Intensive Bioethics Course – Australian Association of Bioethics & Health Law Conference & the Monash Intensive Bioethics Course (1 download )

As part of our commitment to ongoing training and development, we provide for a number of attendees at Ethics training sessions, conferences/seminars and networking events.  We were pleased to sponsor several Members attendance at events during the first half of the year.

Thank you to Sid Baxi, Anne Ozdowska, Cecilie Lander and John Hackett for representing Bellberry and for providing a summary of the program elements that were of particular interest. Click here to view their reports: Member 2016 Conference Reports (1 download )

Intensive Bioethics Course (IBC) & Intensive Research Ethics Course (IREC) – December 2017

We proudly sponsored the attendance of HREC members Paula Swatman at the IBC, and Brian Creese and Andrew Davis at the IREC. Thank you for representing Bellberry and for providing feedback. Member Conference reports – Fourth Quarter (1 download ) . Please click this link to review their individual reports.

Introduction to Economic Evaluation in Health – 31 March 2017

HREC members Ian Roberts-Thomson, David Ng and John Hackett represented Bellberry at this one day course held in Sydney. Our thanks to each of them for providing a summary report of the course. Member Conference Reports – First Quarter (1 download ) Please click this link to view the reports.

Participation that is free of coercion and pressure.

An adverse reaction, the nature or severity of which is not consistent with the applicable scientific information (e.g. Investigator’s Brochure for an unapproved investigational product or Product Information (PI) document or similar for an approved, marketed product).

Intervention directed towards the wellbeing of the individual concerned.

An individual, company, institution or organisation that takes responsibility for the initiation, management, and/or financing of research.

Single ethics review is a process whereby one Human Research Ethics Committee (HREC) provides the ethics review for a research proposal that is accepted by the other institutions participating in the multi-centre research.

A serious adverse event (see definition above) for which there is some degree of probability that the event is an adverse reaction to the administered drug, and the adverse reaction is unexpected.

Any untoward medical occurrence that:

• results in death;
• is life-threatening (NOTE: The term “life-threatening” refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/reaction which hypothetically might have caused death if it were more severe);
• requires inpatient hospitalisation or prolongation of existing hospitalisation;
• results in persistent or significant disability/incapacity;
• is a congenital anomaly/birth defect; or
• is a medically important event or reaction.

The function of the magnitude of a harm and the probability that it will occur.

Recognition that each human being has value in himself or herself.

Includes fabrication, falsification, plagiarism or deception in proposing, carrying out or reporting the results of research, and failure to declare or manage a serious conflict of interest. Also includes failure to follow research proposals approved by a research ethics committee, particularly where this failure may result in unreasonable risk or harm to humans, other animals or the environment. Also includes the wilful concealment or facilitation of research misconduct by others.

Includes at least investigation undertaken to gain knowledge and understanding or to train researchers.

Data from which identifiers have been removed and replaced by a code, but it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets.

Research involving the studied use of empirical materials such as case studies, personal experience, life stories, interview, observations and cultural texts.

A document that provides the background, rationale and objectives of the research and describes its design, methodology, organisation and the conditions under which it is to be performed and managed.

A domain within which individuals and groups are entitled to be free from the scrutiny of others.

A substance not containing an active agent under study, administered to some participants to compare the effects of the active agent administered to other participants.

Information by which individuals can be identified.

Anyone who is the subject of research.

Data that have never been labelled with individual identifiers or from which identifiers have been permanently removed, and by means of which no specific individual can be identified. A subset of non-identifiable data are those that can be linked with other data so it can be known they are about the same date subject, although the person’s identity remains unknown.

Research in which there is no foreseeable risk of harm or discomfort, and any foreseeable risk is of inconvenience only.

A multicenter research trial is a clinical trial conducted at more than one medical center or clinic. Most large clinical trials, particularly Phase III trials, are conducted at several clinical research centers.

The process of verifying that the conduct of research conforms to the approved proposal.

Research in which the only foreseeable risk is one of discomfort.

Not disclosing to research participants all of the aims and/or methods of the research.

Regard for the human sameness shared by all human beings, expressed in a concern for fairness or equity. Includes three aspects of justice: procedural justice, involving fair methods of making decisions and settling disputes; distributive justice, involving fair distribution of the benefits and burdens of society; and corrective justice, involving correcting wrongs and harms through compensation or retribution.

Honesty and probity as qualities of character and behaviour.

Data from which the identity of a specific individual can reasonably be ascertained.

Details attached to data, such as name and/or contact information, that identify an individual. (It may remain possible to identify an individual even after all identifiers have been removed, if a code number has been assigned and there is access to the code, or if the data or tissue can be cross-linked to other data or tissue banks).

The substance, structure, and texture of human organs or body parts when separated from human beings; includes blood, blood components and waste products.

Human Research Ethics Committee.

That which adversely affects the interests or welfare of an individual or a group. Harm includes physical harm, anxiety, pain, psychological disturbance, devaluation of personal worth and social disadvantage.

Any source of DNA or RNA that can be tested to obtain genetic information. It includes cells (whether isolated or as part of tissues) and extracted DNA and RNA.

The concepts of right and wrong, justice and injustice, virtue and vice, good and bad, and activities to which these concepts apply.

Body set up to carry out ethical review of human research.

Review of research by an HREC or other body.

Right or morally acceptable / wrong or morally unacceptable.

A systematic collection of data, whether individually identifiable, re-identifiable or non-identifiable.

Pieces of information

A person’s or group’s agreement, based on adequate knowledge and understanding of relevant material, to participate in research.

In the research context: where a person’s individual interests or responsibilities have the potential to influence the carrying out of his or her institutional role or professional obligations in research;
or
where an institution’s interests or responsibilities have the potential to influence the carrying out of its research obligations.

The obligation of people not to use private information – whether private because of its content or the context of its communication – for any purpose other than that for which it was given to them.

A form of research designed to find out the effects of an intervention, including a treatment or diagnostic procedure.

Close genetic relatives.

Any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not, that includes a clinical sign, symptom or condition and/or an observation of an unintended technical performance or performance outcome of the device.

Any noxious and unintended response to an unapproved medicinal product, related to any dose. The phrase “response to an unapproved medicinal product” means that a causal relationship between the product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. (‘Unapproved medicinal product’ here includes approved products used at levels or in ways that are unapproved)
or
A noxious and unintended response to a drug that occurs at doses of marketed medical products normally used in humans for prophylaxis, diagnosis or therapy of diseases or for modification of physiological function.

A clinical sign, symptom or condition that is causally related to the device implantation procedure, The presence of the device, or the performance of the device system.

• Click on Safari on the upper left of your screen to open the drop down options and choose Preferences. 1. Make sure “Block Pop-Up Windows is unchecked as in the image above. Then click Preferences.
• From the menu, choose Security.
• Make sure Block pop-up windows is NOT selected. If it is selected, click it to deselect.

For Safari 12

• Select “Safari” > “Preferences“, then select on “Websites” at the top of the window.
• Select “Pop-up Windows” on the left side.
• Use the “When visiting other websites” drop-down menu to one of the following:
  • Block and Notify
  • Block
  • Allow

To turn Pop-up Blocker on or off.

1. Open Internet Explorer, select the Tools button, and then select Internet options.
2. On the Privacy tab, under Pop-up Blocker, select or clear the Turn on Pop-up Blocker check box, and then select OK.

In Google Chrome, pop-up blocking is enabled by default.

To disable the Google Chrome pop-up blocker:

1. Click the Google Chrome wrench icon to access browser settings.
2. Select ‘Options’ to open the Options dialog box.
3. Click Under the Hood.
4. Click Content settings.
5. In the Pop-ups section, check the Do not allow any site to show pop-ups (recommended) radio button and then click the Manage Exceptions…
6. Add the location of your BMC FootPrints Service Core instance or instances to the Pop-up Blocker exception list (either the Distinguished Name or the IP address will work) in the Add a new exception pattern field.
7. Make sure Allow is selected from the Action drop-down list.
8. Press the Enter key.
9. Close the Content Settings tab to exit the Options The task is complete.

In Firefox, pop-up blocking is enabled by default.

1. Select Tools–>Options. The Options window is displayed.
2. Click on Privacy & Security on the left hand side.
3. Scroll down the page to Permissions.
4. Go down to Block Pop-up window and click on the Exceptions… box.
5. Add the site you want to allow pop-ups by typing in the URL (https://eprotocol.bellberry.com.au) in the box under ‘Address of website:’ and then clicking Allow.
6. Click Close. The Allowed Sites window closes.
7. Click OK. The Options window closes and this task is complete.

You might be confusing the HREC Return Notes item in the left-hand side of the application form with the HREC comments page, which is used during the official review cycle. If you are attempting to access comments from the HREC for an application that has already been assigned to a meeting date, please see the instructions on how to respond to HREC comments. If your application was returned, please see the Return Notes on the left-hand navigation which will explain what you need to do before returning your application.

Your application was left idle for longer than 60 minutes and has timed out. Close all of your browser windows and log back in to eProtocol.

You have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, etc. that are blocking your pop-ups. See instructions for additional information.

• An amendment or Ethics Approval Extension (renewal) may have already been started or is in-process for this application. Check on your HOME page in the Applications (In-Preparation/Submitted) section to see if the application is listed there.

If you do not see an application listed in your Applications (Approved) section, it may be that you were not listed as personnel on the study.  You will need to get one of the nominated contacts to add you to the application.

Your approved applications appear on your eProtocol HOME page (the page you see when you first log in) in the section labelled Applications (Approved). It should appear towards the middle of your page. You may need to click the at the right-side of the section header to expand this section.

You have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, etc. that are blocking your pop-ups. See this page for further information.

The Medicines Australia Standard form of Indemnity and HREC Review Only form of Indemnity can both be found at the Medicines Australia website along with the Clinical Trials Compensation Guidelines.

Bellberry does not require the submission of Standard Indemnities. Researchers and Sponsors can find information on Bellberry’s requirements for HREC Only Indemnities in BA G15 Insurance and indemnities

Our HREC Committee meetings are usually held on a Wednesday. A Principal Investigator can expect to receive comments detailing the committee’s deliberations two business days following the HREC meeting. Comments are provided via eProtocol.

Refer to BA G1 Submission requirements and responsibilities

When you register for eProtocol for the first time you will be asked to enter a user ID. We recommend that for your unique user ID you use your surname followed by your first name initial, for example SmithJ.

Refer to BA G2 Registrations Guidance

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