Research Ethics & Governance Information System

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).

Rationale
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.

Rationale
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.

Options
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.

Options include:
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.

Rationale
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.

Rationale
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.

Options
Each Research Office has provided a list of Heads of Departments to the REGIS team.

Departments should update the REGIS team (regis@health.nsw.gov.au) 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.

Rationale
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.

Options
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.