The Research Ethics and Governance Information System (REGIS) will support ethics and governance management of human research projects within all NSW public health organisations.
REGIS is a joint initiative between eHealth and the Office for Health and Medical Research. It is already being used by most NSW sites for local single-site research projects. Canberra based F1 Solutions have been contracted to build REGIS on their OmniEthics platform. Guided by ongoing stakeholder feedback, the REGIS team is progressively working with F1 solutions on the system build.
For more information and regular monthly updates on the REGIS transition, please visit the REGIS website.
Clinical trial risk category: REGIS Project Registration Question B8
In REGIS, the applicant completing Project Registration is asked to assign an overall risk category for all clinical trials (question B8). This page provides additional guidance for the completion of that question, and for the use of the information for the HREC and institution.
International risk assessment guidance from the Office of Economic Cooperation and Development recommends an overall risk category is assigned to clinical trials. This categorisation is based on the:
- potential risks of the use of the investigational product/device in the trial relative to standard of care for the clinical condition
- level of clinical experience with the intervention
OHMR has expanded the scope of the risk assessment to all interventional trials. Risks should be assessed relative to the standard of care and the level of clinical experience with the intervention rather than the patients’ underlying illness or the recognised adverse effects of the intervention.
By assigning each trial with a pragmatic risk category, the institution can use this information to plan an appropriate level of oversight (e.g. to inform a trial audit plan). In addition, collection of these data will enable the institution to build an overall risk profile based on the clinical trials that it conducts.
Risk types for drug trials
|Risk type||Drug Trials|
|Type A: Risk comparable to standard medical care||
Trials involving a drug entered onto the Australian Register of Therapeutic Goods (ARTG) if:
|Type B: Risk associated with modified use of an existing product/intervention||
Trials involving a drug entered onto the ARTG if:
Trials involving a drug not entered onto the ARTG if:
|Type C: Risk associated with use of an unlicensed product/novel intervention||Trials involving a drug not entered onto the ARTG.|
Risk types for device trials
|Risk types||Device trials|
|Type A: Risk comparable to standard medical care||Trials involving a medical device used within the terms of its marketing approval if knowledge derived from controlled trials already exists.|
|Type B: Risk associated with modified use of an existing product/intervention||
Trials involving a medical device used:
A Type A grading may be justified if there is extensive use/clinical experience with the therapeutic good and no reason to suspect a different safety profile in the trial population.
|Type C: Risk associated with use of an unlicensed product/novel intervention||
Trials involving a medical device not entered onto the ARTG.
A grading other than ‘TYPE C’ may be justified for therapeutic goods not on the ARTG but which have been approved in other jurisdictions and for which there is extensive clinical data.
Risk types for interventional trials
|Risk types||Interventional trials|
|Type A: Risk comparable to standard medical care||The use of an established intervention in line with local or national protocols.|
|Type B: Risk associated with modified use of an existing product/intervention||Risk associated with modified use of an established intervention.|
|Type C: Risk associated with use of an unlicensed product/novel intervention||Risk associated with the use of a new/novel intervention and/or where no knowledge from prior studies exists.|
Guidelines: completing research team information in REGIS for the NSW SSA and HREA
Applicants for ethical and governance review in NSW can enter research team member details, such as contact, study role, and employment information, in three places in the Research Ethics and Governance Information System (REGIS): at Project Registration, on the Human Research Ethics Application (HREA), and on the NSW Site Specific Assessment (SSA) application.
These guidelines explain which research team members should be listed where, based on which information needs to be seen and reviewed by the Human Research Ethics Committee (HREC) on an ethics application, versus the governance officer (on an SSA application).
For all applications in REGIS and in forthcoming NSW Health policy document revisions, the following terminology applies:
The Coordinating Principal Investigator (CPI) is, in relation to research conducted at a single site, the investigator for that site; or, in relation to research conducted at more than one site, the individual, whether or not they are an investigator at any particular site, who takes primary responsibility for the conduct of the research.
A Principal Investigator (PI) is the person responsible, either individually or as a leader of the researchers at a site, for the conduct of research at that site. In a single site research project or when a project does not require the appointment of a NSW Health PI, the CPI may also be the PI.
An Associate Investigator (AI) is any individual member of the team at the study site, designated and supervised by the site PI, to perform significant study-related procedures and/or to make important study-related decisions.
Who is responsible for reviewing which team listings?
The National Statement, the NHMRC Research Governance Handbook, and current NSW Health research ethics and governance policy recognise the need for human research to be “conducted or supervised by persons or teams with experience, qualifications and competence that are appropriate for the research,” (NS 1.1), and that the institution and the reviewing HREC have responsibility for ensuring these requirements.
For clinical trials conducted under Good Clinical Practice, and other research conducted per GCP principles, the investigator is responsible for ensuring that study teams are “qualified by education, training, and experience,” and that they have “an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial.” The sponsor is also responsible for selecting qualified investigators/institutions with adequate resources. In effect, these are clearly shared responsibilities.
However, since the implementation of single ethical review in NSW and the expansion of the National Mutual Acceptance (NMA) scheme from clinical trials to all research, HRECs are no longer necessarily located within the institution where the research will be conducted. Furthermore, for clinical trials, the research site isn’t always the study sponsor. Thus, there is some duplication of the review of study team listings by the reviewing HREC, the RGO on behalf of the institution hosting the study, and the “institution-as-sponsor.”
Draft NSW Health policy states that PHOs are expected to develop an effective research governance framework that, among other recommendations:
- enables all checks and approvals to be undertaken without duplication or unnecessary delay; and
- clarifies the roles and responsibilities of all stakeholders.
As early adopters of single ethical review, Australia and the UK have had to delineate all aspects of the ethics and governance roles, and are setting examples world-wide for multi-centre research reviewed by a single ethics committee.
Applicant guidelines: listing research team members
For all new applications entered into REGIS, regardless of the number of sites:
At Project Registration and on the HREA
The applicant is to list the people outlined in table 1 at Project Registration – these details will be pre-populated into the HREA (if required). The CPI and each site PI must have a REGIS account and profile in order to proceed past project registration.
Important: Associate Investigators and other team members at the site are to be listed on the SSA only; not at Project Registration.
If the CPI wishes for additional contacts to have access to the study at the project level, those people should create profiles in REGIS, and the CPI should share the project with them. Table 1 also shows which role to select from the drop-down in HREA question 1.9.1, for which people.
Table 1: Study team members to list in Project Registration and on the HREA in REGIS
|Team member role||Where to list in Project Registration||Where to list on the HREA||HREA Q1.9.10 drop down selection|
|Coordinating Principal Investigator details||Part D||Q1.9.1 – Q1.9.13 (pre-populated from registration)||Co-ordinating Principal Investigator|
|Site names and Principal Investigator details||Part C||Q1.9.1 – Q1.9.13; M188.8.131.52.6 if applicable||Principal Investigator|
|Details about key members of the study management group/ CPI’s team||Do not include at Project Registration||Do not include at Project Registration.||No need to include on Project Registration|
On the NSW SSA(s)
The applicant is to list the people outlined in table 2. These people need not have a REGIS account and profile. The applicant does not list members of the CPI’s project management team on the SSA unless they also meet the definition of one of roles in table 2.
Table 2: Study team members to list on the NSW Health SSA in REGIS (Part B)
|Team member role||SSA B2 project team member role drop-down selection|
|Coordinating Principal Investigator details||N/A; pre-populated from project registration|
|Site names and Principal Investigator details||N/A; pre-populated from project registration|
|Other site-level administrative contact for the project at this site to receive copies of notification and other correspondence (optional)||N/A; separate fields provided|
|Associate Investigator details||Associate Investigator|
|Details about any other research personnel requiring physical access to the site who are not NSW Health staff at that site/location (This is used by the research office to determine whether any additional human resources/workforce checks are required.)||Investigator/Researcher (label to change in future version of REGIS SSA)|
NSW research office guidelines: who reviews which team members?
These guidelines are an extension of the roles and responsibilities established by the Australia-wide Clinical Trials Project Reference Group (CTPRG); formerly, the Clinical Trials Jurisdictional Working Group (CTJWG) (see figure 1). For NSW HRECs and sites, per the Matrix of Shared Responsibilities:
- Assesses the suitability of the CPI and key members of the study management group. This includes whether the CPI and if applicable, key members of the CPI’s team have sufficient expertise to undertake all research activities, including, where relevant, GCP training.
- Examples of study management group roles include protocol co-authors, study statistician, and members of the study advisory committee.
- Is aware of the number and type of sites covered by the ethics approval and the name of the PIs at those sites.
The Research Governance Officer/Public Health Organisation
- Must be satisfied that HoDs have assessed whether the local PI and their study team have the necessary training and experience to undertake their role as described in the protocol/project description.
- Does not need to assess the study management group (unless they are the study sponsor and have reviewed this; for example, by reviewing the HREA, as part of the sponsor operational activities).
Per forthcoming NSW policy clarifications, NSW PHOs may verify, through the declarations of relevant department heads and the PI involved in the research, that the investigators at the PHO have the necessary skills, training and experience to undertake their role.
What's new in the new NSW Site Specific Assessment form?
In early 2018, an updated NSW Site Specific Assessment form (SSA) was introduced in the Research Ethics and Governance System (REGIS).
This form facilitates a more streamlined and targeted SSA process, for the applicant, Heads of Departments (HoDs), and the Research Office.
The summary table below provides an overview of all changes, compared to the NSW SSA form that is in Online Forms.
Forthcoming policy changes reflected in new SSA form
While some of the changes to the SSA – such as the ability to reduce duplication of answers already provided within the Human Research Ethics Application (HREA) – have been necessary to support REGIS, many of the changes reflect forthcoming policy updates.
Important: All policy documents will be updated to reflect these changes. In the meantime, applicants should accept any policy-related changes in the REGIS SSA form rather than current policy.
Key SSA changes and rationale
On the SSA, the applicant lists:
1. Details of all Associate Investigators
An Associated Investigator (AI) is defined as any individual member of the team at the study site, designated and supervised by the site Principal Investigator (PI), to perform significant study-related procedures and/or to make important study-related decisions.
For clinical trials with at least one AI, the PI must select an AI who will act as a substitute (back-up) for the PI when unavailable. This is optional for other types of studies, and is different from the administrative contact person.
2. Details of any additional member of the study team that is ‘external’ to NSW Health
The SSA should capture personnel who require access to the site/location but who are not NSW Health staff at that site/location, so that the research office can determine whether any additional human resources/workforce checks are required.
Applicants should select the label “Investigator/ Researcher” to indicate these team members in REGIS. Departmental head sign-off on the SSA is not required for these people.
3. An administrative contact person (optional).
Associate Investigator definition: A standard definition for AI ensures applicants are clearer on which site-level study team members to include on an SSA. As outlined in PD2010_056 (http://www1.health.nsw.gov.au/pds/Pages/doc.aspx?dn=PD2010_056) sections 3.3 (i) and 3.4.2), the requirement has not changed, for Public Health Organisations (PHOs) to be satisfied that HoDs have assessed whether the local PI and their trial team have the necessary training and experience to undertake the trial.
Separate listing for external personnel: This requirement has been added to trigger the human resources/workforce checks that may be required. Early identification of these individuals enables the Research Office to provide advice on the process for obtaining these checks.
OHMR is developing a separate guidance on which researchers to list at Project Registration, on the HREA, and on the SSA.
The SSA form no longer requires AI signature declarations. Declarations from the site PI and relevant HoDs/ Supporting Department(s), including Authority for Data Provision, are still required.
AI declarations are not required per state policy or guideline, and the NSW Operations Manual: Research Governance Officers <https://www1.health.nsw.gov.au/pds/Pages/doc.aspx?dn=GL2010_015> will be revised to reflect this.
AI SSA application declarations do not reduce risk any more than other good practice safeguards, such as AI review of and signature on a project description/protocol, and appropriate training.
The PI is responsible for study team assurances. For clinical trials, Good Clinical Practice (GCP) ( https://www.ich.org/products/guidelines/efficacy/efficacy-single/article/integrated-addendum-good-clinical-practice.html ) states that “the investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and functions conducted at the trial site.”
Finally, AI declarations may unnecessarily delay application submission and thus, study start-up.
The study team and the PHO should decide how to document in the site and/or sponsor files that the study team is appropriate, agrees to conduct the study in accordance with the protocol/project description and relevant regulations, and is qualified and trained. Relatedly, the PHO as a study sponsor and/or administering organisation should decide how to monitor and review study team listings.
1. Maintaining delegation of authority and training logs at the study site, which are monitored periodically and/or annually. While these logs are common for clinical trials, they can also be adapted for other types of research. Samples are available in various researcher toolkits and SOPs online.
2. Maintaining a protocol/project description signature sheet at initial submission, which is re-signed whenever there are significant study amendments.
Ultimately, the internal business decisions to meet and document study team declarations and listings should not hold up the site authorisation application process.
Currently, the new SSA in REGIS collects student information about any team members listed. An academic (question B15) and/or a clinical supervisor (question B16) may be listed for each student.
Although the system is currently set up so that both sets of fields must be answered before the SSA may be submitted, REGIS will be revised later in 2018 so that the applicant may select “not applicable” for one out of the two student supervisor listings.
Which supervisor should be listed?
An academic supervisor is the person who supervises the student through the student’s academic course of study.
A clinical supervisor is an on-site representative employed by that site who is involved in the research. It does not refer to the individual who supervises the student’s clinical activities at the site, per se.
If the student is participating in any clinical activities with participants at the site (e.g. direct medical treatment, observation or testing of patients or participants), the applicant should list a clinical supervisor and obtain their declaration. An academic supervisor declaration is not necessary.
If the student is not conducting clinical activities at the site (e.g. is merely conducting medical record reviews, tissue analysis at the site, non-clinical interviews or focus groups) and there is no clinical supervisor at the site, the applicant should list an academic supervisor and obtain their declaration.
In cases where the clinical and academic supervisor are the same person, the applicant should list them under SSA question B16 clinical supervisor.
The PI, sponsor and host organisation will be ultimately responsible for agreeing the most appropriate arrangements in each case. However, any requirements to obtain multiple student supervisor declarations before the SSA may be submitted should not hinder the progress of site authorisation.
How do I complete the student supervisor questions today?
Until the N/A options are added to SSA questions B15 and B16, the applicant can enter “N/A” into the fields for the appropriate supervisor if it does not meet the criteria above, and is not otherwise required by the site.
All student research must be supervised, and the supervisor is responsible for the conduct of the research.
At least one supervisor must declare/sign a declaration confirming that they are taking responsibility for the student’s conduct during the project at that site.
The 2011 NHMRC Research Governance Handbook ( https://nhmrc.gov.au/sites/default/files/documents/reports/research-governance-handbook.pdf ) says that for a multi-centre human research project, the credentialing and supervision of proposed researchers is one of the components of an institutional research governance framework that occurs prior to study start. Under this component, institutional administrators and the site principal investigator are responsible for the confirmation of arrangements for the supervision and mentoring of student/junior investigators.
The HREA similarly asks for student information, but the study personnel listings application guidelines ensure that different categories of people are listed on the HREA and the SSA. Student information is therefore only duplicated in the rare case where site PIs, who are listed on both applications, are students.
In Online Forms, the former application portal, Heads of Departments did not require a system account for the SSA to be completed and submitted, although it was an available option. REGIS requires Heads of Departments to review a project and make a declaration online using the system.
By logging into REGIS, Heads of Departments may be assured that they are reviewing the right versions of the SSA application and related documents. Electronic processing of Head of Department review and comments will allow the applicant and research office to track the progress of an application real-time.
Each Research Office has provided a list of Heads of Departments to the REGIS team.
Departments should update the REGIS team (firstname.lastname@example.org) about any changes to Heads of Departments as soon as possible, to ensure accounts are up-to-date.
In REGIS, the option will exist for the applicant to ‘manually’ submit the SSA where there is one or more Head of Department who has either not supported the research, or has not yet replied. In this instance, the applicant must add a note as to why the application is being submitted without support.
In Online Forms, SSAs could be generated before the parent HREA was complete.
In REGIS, it is not necessary for an applicant to wait for the outcome of ethical and scientific review of the project before preparing and submitting an (SSA) application, but the HREA must have been submitted to facilitate SSA generation.
REGIS’ smart form technology includes the sharing of common information between Project Registration, the HREA, and the SSA. It is important that the HREA is finalised before any dependent SSAs are started. While this may be an issue for the drafting of the forms, parallel review is still enabled as submission of the SSAs is not dependent upon approval of the HREA.
While waiting for the SSAs to be generated in REGIS, PIs should contact the relevant student supervisor(s) and HoDs that need to provide declarations, to ensure they are registered in REGIS and that they have the appropriate information to make an informed declaration.
If the project is a clinical trial, PIs should submit the Clinical Trial Research Agreement (https://www.medicalresearch.nsw.gov.au/clinical-trial-ethics-governance) to the RGO for review at the earliest possible opportunity, particularly if there are non-standard agreements or clauses. Clinical trial budget negotiation between the PI and sponsor should also begin early in the process. These early reviews should occur, where possible, before SSA submission. They often occur external to REGIS.
Summary of all SSA form changes
For a summary of what’s new in the NSW SSA form in REGIS compared to the NSW SSA form that is in Online Forms, download the summary or review the table below.
|Section||New SSA||Old SSA|
|Part A: Project-wide information||
|Part B: Project team||
|Part C: Departments and services||
|Part D: recruitment, records, tissue and data||
|Part E: site costing and funding||
|Part F: attachments – site specific documents||
|Part G: declarations||
Updated 7 months ago