This resource provides guidance on the registration application process for Human Research Ethics Committees (HRECs). It details reporting requirements and what should be included in the HREC terms of reference (ToR) and standard operating procedures (SOPs).
HRECs review research proposals that involve human participants to ensure that they meet ethical standards set out in the National Statement on Ethical Conduct in Human Research (National Statement) and other relevant guidelines.
Section 5 of the National Statement sets out the requirements for the establishment, operation and membership of an HREC.
1. Purpose of HREC registration
The National Health and Medical Research Council (NHMRC) administers the registration scheme for HRECs. Registration means that the HREC has notified NHMRC of its existence and declared that it meets the requirements of the National Statement.
HRECs undertaking the following activities must be registered:
- those reviewing and monitoring clinical trials of unregistered therapeutic goods
- those approving research involving excess human embryos, and
- those applying the Guidelines under Section 95 and Section 95A of the Privacy Act 1988.
In addition, some states and territories may have legislation and/or policies requiring HRECs to be registered.
Even if none of the above activities are undertaken, it is a community expectation that all HRECs operating in Australia are registered with NHMRC.
NHMRC also maintains the National Certification Scheme, which provides certification of institutional ethics review processes based on criteria outlined in the Certification Handbook and guidance in the National Statement. Registration of an HREC is a prerequisite for certification but does not automatically confer certified status.
2. Registration process
The registration process requires institutions to provide evidence that any HREC they support establishes, implements and documents operational procedures that promote good ethics review in line with the requirements of the National Statement.1 The principal documentary evidence for meeting this requirement are the HRECs terms of reference (ToR) and standard operation procedures (SOPs). These documents must meet the requirements set out in Section 5 of the National Statement and must be approved by the institution.
To apply for registration, HRECs must submit their membership list, terms of reference and standard operating procedures via the online application form. A completed ToR and SOP requirements form and Membership profile form must also be submitted. These forms and the application form are available on the Human Research Ethics Committees page. We review these documents and provide feedback to applicants as necessary before making a decision about the application.
3. HREC Reporting (to NHMRC)
An Institution must submit an annual report to NHMRC to assess the continued ability of registered HRECs to meet the requirements of registration. This is assessed against the requirements of the National Statement. Failure of an HREC to address serious or ongoing concerns identified by NHMRC may result in registration being suspended or revoked pending resolution of the concerns.
Institutions are also required to inform NHMRC during a reporting year of any changes to the details of a registered HREC such as changes to:
- committee name,
- institutional name
- HREC mailing or email address
- chairperson’s name or contact details
- contact person’s name or contact details.
4. Terms of reference and Standard operating procedures
Recommended topics to be addressed in the HRECs ToR and SOPs are listed below.
ToR
- Background/Preamble
- Definitions/Abbreviations
- Scope of responsibility
- Membership
- Delegation
- Review of multicentre research
- Access to HREC by unaffiliated researchers
- Administrative support/Roles and responsibilities
- Appeals and complaints
- Accountability and reporting
- Document control
SOPs
- Background/Preamble
- Definitions/Abbreviations
- Appointment of Members
- Induction and Training of Members
- Confidentiality
- Disclosure of interests/Management of potential conflicts of interest
- Submission procedure for new applications and amendments
- Non-HREC review pathway/s
- Review of multicenter research
- Access to HREC by unaffiliated researchers
- Authorised Prescriber applications (if applicable)
- Operations/Meeting processes/Conduct of business
- Records of decision making and communication with researchers
- Project monitoring and reporting
- Safety reporting (including adverse events)
- Suspension or withdrawal of ethics approval
- Receiving and handling of complaints
- Record keeping
- Review fees
- HREC reporting requirements
- Administrative staff training
- Document control
5. Guidance on documentation
The following guidance for HRECs and institutions is intended to help them translate the requirements of the National Statement into their ToR and SOPs.
Guidance is provided for selected topics that are frequently the subject of queries or where practice may vary within or between individual institutions and research sectors.
Applicants can refer to the ToR and SOP requirements form for information on the full set of National Statement requirements.
5.1 Scope of responsibility
The ToR should state what the scope of responsibility for the HREC is. In addition to review of research proposals and monitoring of approved research projects, this may include:
- review of clinical or other ethical issues within the institution/organisation,
- review of applications under the TGA’s Authorised Prescriber scheme
- other responsibilities delegated by the institution/organisation.
It should also clarify:
- whether the HREC review encompasses scientific review or relies primarily on a prior or external scientific review
- whether the HREC is able to conduct review of both single-centre (internal) research proposals and multi-centre research applications (under the NMA or otherwise)
- whether the HREC conducts reviews for external entities, such as other institutions or unaffiliated researchers.
This section should also address subcommittees. The information should include:
- which subcommittees have been established and for which purpose
- how appointments are made to the subcommittees
- what the scope of responsibility is for each subcommittee.
Note that members of subcommittees do not necessarily need to be members of the HREC.
5.2 Membership
HREC membership consists of minimum members and additional members, some or all of whom may be drawn from a pool established by the institution (see National Statement 5.1.30-5.1.35)
Decisions by the HREC that are not subject to delegation (see Delegation section below) must include all minimum members regardless of how many other HREC members are present or absent from the meeting. The views of any minimum members not attending a meeting must be submitted in writing and circulated to all members attending the meeting with sufficient opportunity for consideration before the meeting and not just consideration by the Chair.
Institutions that elect to include the concept of a quorum in their ToR or SOP should note that any quorum must include all minimum members.
All members should undergo induction and participate in ongoing training. Induction can include in person or virtual programming and/or mentoring. Ongoing training can include external research ethics programs and/or in-service training by other HREC members, other institutional staff or invited experts.
5.3 Delegation
Information related to delegation of the HREC’s responsibilities should clarify which responsibilities are delegated and to whom (see 5.2.9-10 of the National Statement). All delegations should be authorised by the institution with responsibility for oversight of the HREC.
5.4 Disclosure of interests/management of potential conflicts of interest
The SOP should include a procedure describing how interests are disclosed and what to do if the institution, HREC member or applicant is determined to have a potential conflict of interest. For further information see the Disclosure of interests and management of conflicts of interest guide supporting the 2018 Australian Code for the Responsible Conduct of Research.
5.5 Non-HREC review pathways
Institutions should have a clearly defined decision-making process for determining whether an activity is research or if it is another activity, such as quality assurance. It should have separate mechanisms or processes for the review and approval and/or authorisation of each activity. These mechanisms or processes should be set out in the institution’s policies and procedures.
The SOP should state how applications will be:
- assessed for risk
- determined to be lower or higher risk
- how they will be reviewed if they are determined to be lower risk.
5.6 Review of multicentre research
The ToR and the SOP should address whether the HREC or other ethics review bodies will review research that is conducted at multiple centres/sites. The documents should include any requirements or procedures that apply to submissions for multicentre review by the HREC or other ethics review body. Note that HRECs that do not conduct a review of a multicentre research project do not have a role in review, approval or monitoring of that project. Acceptance of an external review and subsequent monitoring are institutional responsibilities.
5.7 Access to HREC by unaffiliated researchers
The ToR should reflect institutional policy on the access, if any, of researchers unaffiliated with the institution to review by the HREC and any requirements on external applicants to the HREC.
5.8 Authorised Prescriber applications
If an HREC accepts applications under the Therapeutic Goods Administration’s (TGA’s) Authorised Prescriber (AP) scheme, the Terms of Reference should specify this, and the SOPs should set out any application requirements. Information on the AP scheme is available on the TGA website.
5.9 Records of decision making and communication with researchers
Whenever possible the HREC should include links to specific paragraphs in the National Statement in its rationale for requests to researchers for changes to their project documents. This should be documented in the Minutes or other records of decisions and in the correspondence to researchers.
The SOP should include how the HREC will establish, implement and document working procedures for methods of decision making and for communicating with researchers.
The SOP should indicate that decisions made by the HREC are to be transparent, consistent and promptly communicated.
5.10 Project monitoring and reporting
The SOPs should state how approved projects will be monitored, including submission and review of amendment processes and progress (annual) reporting processes, potential auditing, and so on. This SOP should also include reference to proportionality in determining monitoring requirements and the criteria for mandating additional or reduced levels of monitoring, as may be appropriate for selected research projects.
5.11 Safety reporting (including adverse events)
The SOPs should describe the safety reporting requirements of the institution and HREC (noting any relevant differences) for both clinical trial research and other types of research (noting relevant differences). This SOP should be consistent with current national standards, as set out in NHMRC Safety monitoring and reporting guidance and advice published by the Therapeutic Goods Administration.
5.12 Suspension or withdrawal of ethics approval
The SOPs should describe the potential for suspension of a research project or withdrawal of ethics approval for a research project. We note that suspension is an action taken by an institution with oversight of research and withdrawal of ethics approval is an action taken by an HREC. We note, further, that either suspension or withdrawal of approval may precede or follow the other, as circumstances require.
The SOP should clarify how and to whom any decision about suspension or withdrawal will be communicated, as well as the process and criteria for lifting a suspension or reinstating ethics approval, if relevant.
5.13 Review fees
If fees are to be charged for review of research, the fee schedule should be published in an SOP or a policy referred to in an SOP. The SOP or policy should include whether different fees will apply to researchers affiliated or not affiliated with the institution.
5.14 HREC reporting requirements
This section should outline the various forms of reporting by the HREC. These reporting requirements could include:
- submission of annual reports to NHMRC
- submission of any required state/territory privacy reports
- annual reports to the institution
- reports of issues of significant concern, as may be necessary.
1 As in other NHMRC ethics guidelines and related documents, ‘institution’ refers to a health organisation, academic institution, research institute, government agency or any other body that establishes or has oversight of an HREC.
