Functions and terms of reference
November 2017
– Functions and terms of reference
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Contents
1.Purpose
2.Functions
3.Scope of responsibility
4.Relationships and reporting
5.FSS-HEC composition and appointment
6.FSS-HEC procedures
7.References
8.Legislation
Purpose
The Forensic and Scientific Services Human Ethics Committee (FSS-HEC) is registered with the National Health and Medical Research Council (NHMRC) (registration number EC00305) and is constituted and functions in accordance with the National Statement on Ethical Conduct in Human Research (NHMRC, 2007 updated May 2015) and complies with the Australian Code for Responsible Conduct of Research (2007) and the Queensland Health Research Management Policy and Framework (QHRMP, 2015).
The FSS-HEC provide the Queensland Health Forensic and Scientific Services (FSS) Executive with independent advice on human ethical issues and ensures that all activities involving the non-diagnostic use of human tissue and other confidential data are conducted in a safe, ethical and scientifically robust manner.
Key objectives of the FSS-HEC are to:
- safeguard the mental and physical welfare, rights, dignity and safety of all participants involved in forensic and health research.
- facilitate and promote a high standard of ethically conducted research through efficient and effective review processes.
- ensure that all research is conducted responsibly and in the interests of the wider community.
- Functions
2.1The FSS-HEC aims to:
(a)provide balanced, independent and timely review of research activities involving human participants and/or their data in respect to their ethical acceptability and scientific merit.
(b)oversee approved research activities through to completion, to ensure compliance with approved ethical standards, legislation, codes of practice and policies.
(c)obtain expert opinions (internal or external) to provide scientific/technical assessment and safety evaluation of research activities along with compliance with regulatory requirements.
(d)register all activities requiring human ethical oversight along with any monitoring and reporting requirements in an institutional approved database.
(e)establish sub-committees and/or working groups as required to perform its functions in accordance with the National Statement (section 5).
- Scope of responsibility
3.1The FSS-HEC will:
(a)review written applications involving:
- the retention and use of autopsy tissues, organs and fluids for research and other non-diagnostic purposes under the Transplantation and Anatomy Act1979.
- the use of primarily diagnostic/evidentiary material held by FSS (i.e. human tissues etc. originating from coronial autopsies, forensic cases, public health testing and other sources) for research and other non-diagnostic/non-forensic purposes
- use of documents, records, reports and statistical data held at FSS (including those relating to coronial cases) for research and other purposes not originally envisaged.[SB1]
(b)provide advice about the level of review required for the use of human material and data [SB2]for quality assurance and process improvement activities.
(c)establish a framework to review proposals for use of human tissue and data involving no more than low risk that meets the requirements of the National Statement 5.1.18-21.
(d)where necessary, consider options for and recommend a procedural framework within which (a), (b) and (c) will operate. This will include oversight and monitoring of ongoing projects (National Statement 5.5); and determining the manner in which applications to the FSS-HEC should be submitted.
(e)consider options for, and make recommendations on, procedural guidelines for any FSS activities which raise difficult human ethical issues. These may include autopsies generally, the handling of human tissues, complaints, policy implementation and responding to commissions of inquiry (e.g. whether to test items referred by concerned relatives for illicit drugs; disposal methods for human tissues). It is expected that such matters would be referred in writing, for example by the appropriate Manager on behalf of the FSS Executive.
3.2The FSS-HEC may require applicants seek legal advice to ensure that proposed research complies with relevant regulatory requirements.
3.3The FSS-HEC will refer applications to the FSS Research Governance Office where additional approvals are required. Examples include:
(a)projects involving coronial cases/material which require approval from the State Coroner.
(b)where access to coronial documents is required for research, approval under s.53(7) of the Coroners Act 2003as a ‘genuine researcher’ must be obtained.
(c)disclosure of confidential health information for research requires approval under Chapter 6, Part 4 of the Public Health Act 2005 (PHA) if consent is not obtained and the information is identifiable or potentially re-identifiable. The PHA does not apply to health information held by Queensland Health if its disclosure is authorised under another Act of law.
(d)where site authorisation or approval of FSS resources is required, or a research agreement or student deed is necessary, approval is facilitated through the FSS Research Office in consultation with the FSS Scientific Support Development Unit (SSDU).
(e)these approvals must be obtained before the project can commence.
3.4FSS expects that applicants submitting projects for FSS-HEC approval will be able to provide assurances and/or undertakings that:
- research is planned to produce clear results intended for publication in refereed literature, and will be conducted or supervised by persons with experience, qualifications and competence appropriate to the research.
- applicants have made/are making conscientious efforts to access all relevant subjects, etc. for the project.
3.5The FSS-HEC may charge fees to recover costs associated with ethical review and monitoring of research projects from applicants external to Queensland Health.
All costs associated with seeking coronial and next of kin consent and retention of autopsy tissues for approved projects must be borne by the projects.
- Relationships and reporting
4.1The FSS-HEC will:
(a)report through its Chairperson to the FSS Executive.
(b)submit an annual report to the FSS Executive and the NHMRC to ensure continuing registration with the Australian Health Ethics Committee (AHEC) as a compliant human research ethics committee.
(c)advise the relevant committee if the FSS-HEC considers that ethical approval for research or other projects involving human material should be withdrawn.
(d)provide advice to researchers about their obligations to ensure that all research involving human material and data complies with the National Statement and relevant legislation.
(e)liaise and consult with the Queensland Health, Health Innovation, Investment and Research Office (HIIRO), other ethics committees, research facilities,other relevant projects and applicants through the Chairperson, Secretary or delegate as required.
- FSS-HEC composition and appointment (National Statement sections 5.1.29 – 5.1.36)
5.1FSS-HEC Chairperson and Deputy Chairperson
5.1.1The FSS Executive Director shall appoint a Chairperson in consultation with the HEC coordinator and other senior staff as deemed appropriate.
5.1.2The Chairperson shall formally designate two members of the Committee to the position of Deputy Chairperson where it is considered necessary to cover the scope of activities required by the FSS-HEC e.g. coronial and microbiological research.
5.1.3A Deputy Chairperson shall act as Chairperson in the event that the Chairperson is unavailable or as requested. Should the Committee Chairperson resign, or be removed from the FSS-HEC, a Deputy Chairperson shall act in his or her stead until such time that the FSS Executive Director appoints a replacement, not exceeding three consecutive meetings.
5.2FSS-HEC Secretary
5.2.1The Secretary to the FSS-HEC will be the HEC coordinator or delegate.
5.2.2The HEC coordinator is an employee of the institution who provides administrative support and advice on the institution’s responsibilities and processes for human ethical review of research activities and related quality assurance activities.
5.2.3The Secretary reports to the Chairperson of the FSS-HEC on matters related to the activities of the Committee.
5.2.4The FSS Research Office is responsible for the administration of applications made by researchers to the FSS-HEC, and for the support of the Committee members, its sub-committees and expert reviewers.
5.3FSS-HEC Members
5.3.1Prospective members of the FSS-HEC may be recruited by expressions of interest, direct approach, nomination or advertisement, and appointed in accordance with the National Statement (5.1.34-36).
5.3.2The appointment of members to the FSS-HEC will be at the discretion of the FSS Executive and considered forreviewat least every three years(National Statement 5.1.34).
5.3.3The membership of the FSS-HEC will be constituted according to National Statement 5.1.30 and will include the following:
(a)‘a chairperson, with suitable experience, whose other responsibilities will not impair the HEC’s capacity to carry out its obligations under this National Statement’.
(b)‘at least two lay people, one man and one woman, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work’.
(c)‘at least one person with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, a nurse or allied health professional’.
(d)‘at least one person who performs a pastoral care role in a community, for example, an Aboriginal elder, a minister of religion’.
(e)‘at least one lawyer, where possible one who is not engaged to advise the institution’.
(f)‘at least two people with current research experience that is relevant to research proposals to be considered at the meetings they attend. These two members may be selected, according to need, from an established pool of inducted members with relevant expertise’.
5.3.4The minimum membership of the FSS-HEC is eight (National Statement 5.1.29).
5.3.5No member may be appointed in more than one of the minimum membership categories. A pool of inducted members may be appointed to attend meetings and provide expertise where required (National Statement 5.1.31).
5.3.6Additional members with specific knowledge and expertise relevant to the role of the HEC may be appointed and should include experience in reflecting and analysing ethical decision-making (National Statement 5.1.32, 5.1.33).
5.3.7Gender balance and multicultural representation are desirable (National Statement 5.1.29(a)).
5.3.8At least one third of the members should be appointed from outside FSS (National Statement 5.1.29(b)).
5.4Conditions of member appointment
5.4.1Members should be appointed as individuals for their knowledge, qualities and experience, and not as representatives of any organisation, group or opinion (National Statement 5.1.35).
5.4.2Before appointment, members should acknowledge in writing their acceptance of the FSS-HEC Terms of Reference and any requirements for confidentiality and conflict of interest required by Queensland Health (National Statement 5.2.4).
5.4.3Members should be provided a letter of appointment including the date of appointment, length of tenure, assurance that indemnity will be provided by Queensland Health in respect of the conduct of their duties as a FSS-HEC member, meeting attendance responsibilities and general responsibilities as a FSS-HEC member (National Statement 5.1.9, 5.1.36).
5.4.4New members should be provided induction material and individual mentoring (National Statement 5.1.28(b)).
5.4.5Each member should become familiar with the National Statement and consult other guidelines relevant to the review of specific research proposals and prepare for and attend scheduled meetings (National Statement 5.2.3 (a) and (b)).
5.4.6Members should attend continuing education and training in research ethics at least every three years (National Statement 5.2.3 (c)).
5.4.7Throughout their tenure, members are given the opportunity to attend conferences and workshops, supported by FSS that are relevant to the roles and responsibilities of the FSS-HEC.
5.4.8All essential and necessary expenses incurred by members in carrying out their FSS-HEC duties will be paid for or reimbursed by FSS on production of original receipts.
5.4.9Parking and refreshments will be provided at FSS to facilitate members’ attendance at meetings.
5.4.10Membership of the FSS-HEC may be terminated at any time without notice or reason either by the member or the FSS Executive.
5.5Indemnity for committee members
5.5.1Queensland Health provides indemnity for members of the FSS-HEC and external expert reviewers for liabilities that may arise in the course of bona fide conduct of their duties in this capacity. Indemnity is provided through the Queensland Government Insurance Fund (QGIF) in accordance with the Public Service Act 2008.
5.5.2The risk of legal liability affecting committee members will be minimised by requiring applicants upon approval of the project to complete a signed declaration agreeing to comply with the conditions prescribed by the FSS-HEC and to accept responsibility for legal liability arising from any aspect of the project.
- FSS-HEC procedures
6.1Standard operating procedures
6.1.1The FSS-HEC operates in accordance with the Queensland Health Standard Operating Procedures (SOP) for Queensland Health HREC Administrators – Version 4, November 2013.
6.1.2All members have access to copies of the SOP and will be consulted with regards to amendments where relevant.
6.2Applications and submissions
6.2.1The FSS-HEC require submissions to be in a standard format using the Human Research Ethics Application (HREA) available on ‘Australia Online Forms for Research’ website
6.2.2The FSS-HEC requires researchers to (i) electronically upload all supporting documents to the online forms website and (ii) email the AU submission number, the HREA, project description/plan and supporting documents to .
6.2.3All other submissions to the FSS-HEC must be in writing e.g. requests for advice on ethical issues and applications for access to human material for non-diagnostic purposes other than research. Advice regarding the format for these submissions should be sought from the Secretary of the FSS-HEC.
6.2.4The Chairperson or Secretary will determine if any expert advice is required.
6.2.5Before giving a favourable opinion, the FSS-HEC should be adequately reassured about the following issues, as applicable:
- scientific design and conduct of the study
- recruitment of research participants
- care and protection of research participants
- protection of research participants’ confidentiality
- informed consent process
- local community considerations.
6.2.6These should follow the values and principles of ethical conduct as described in the National Statement on Ethical Conduct in Human Research (2007):
- Research merit and integrity
- Justice
- Beneficence
- Respect
6.2.7If the research involves Aboriginal and Torres Strait Islander peoples then the researcher should also follow the research values as described in the Values and Ethics: Guidelines for ethical conduct in Aboriginal and Torres Strait Islander health research (NHMRC, 2003)
6.3Levels of ethical review
6.3.1Requests for exemption shall be considered by the FSS-HEC Secretary and noted by the full committee (National Statement 5.1.22-23).
6.3.2Low and Negligible Risk Applications will be delegated to at least two members of the FSS-HEC and the Chairperson and noted by the full Committee (National Statement 5.1.20 (c)).
6.3.3All research that involves more than low risk or is listed under National Statement 5.1.6(b) should be reviewed by the full Committee (National Statement 5.1.6).
6.3.4Amendments and extensions of approval may be reviewed and approved by the Chairperson or Secretary between meetings. Substantial amendments may require full committee review and/or ratification.
6.3.5Related quality assurance and evaluation activities shall be reviewed by FSS-HEC Secretary or delegate and approved by the FSS-HEC Chairperson.
6.4Meetings (National Statement 5.1.37, 5.2.28-31)
6.4.1Meetings will be scheduled monthly, except for January. However, a scheduled meeting may be cancelled if no submissions are received (National Statement 5.1.37).
6.4.2A timetable of meetings will be promulgated by November of the preceding year and published on the FSS-HEC internet site.
6.4.3Notice of meeting will be given at least two weeks before any meeting.
6.4.4An electronic copy of the applications for consideration, including the HREA, information sheet and consent form, questionnaires or other relevant correspondence (where applicable) will be forwarded to all members at least one and preferably two weeks before the meeting.
6.4.5The Chairperson or Secretary may reschedule a meeting and convene additional meetings to consider urgent matters.
6.5Meeting procedures (National Statement 5.1.30, 5.2.2-4, 5.2.28-31)
6.5.1It is the responsibility of each member to decide, independently, whether in his/her opinion, the conduct of each application submitted to the FSS-HEC conforms to established ethical principles and relevant ethical codes and guidelines (National Statement 5.2.2).
6.5.2Members of the Committee must disclose any conflict of interest in relation to matters on the agenda prior to discussion of the item. In such instances the FSS-HEC will determine whether, and to what extent, the member will be excluded from deliberations (National Statement 5.2.4).
6.5.3Decisions by the Committee about whether a research project meets the requirements of the National Statement must be informed by the exchange of opinions from each of the members who constitute the minimum membership of the FSS-HEC. To promote an interactive ‘team spirit’ in the committee and to help apply ethical standards consistently this exchange should, ideally, take place at a meeting with all members present (National Statement 5.2.29). (Please also see 6.5.8 and 6.5.9).
6.5.4Questions or issues raised should be linked by members to the relevant section of the National Statement.
6.5.5Where there is less than full attendance in person of the minimum membership at a meeting, the Chairperson must be satisfied, before a decision is reached, that members from all membership categories have had an opportunity to contribute their views and that these have been recorded and considered in the decision making process (National Statement 5.2.30).
6.5.6Efforts should be made to reach decisions by general consensus (National Statement 5.2.31). Failure to agree may require an extension of time to reconsider the application and its possible modification, especially when any member is not satisfied that the welfare and rights of participants are protected. Dissenting and supporting opinions should be summarised in the minutes, including those submitted by absent members. If necessary, decision will be by simple majority. However, the committee may impose conditions to take into account the dissenting views.
6.5.7To ensure informed consideration of projects/issues the FSS-HEC may invite the applicant to attend the meetingto discuss a proposal. However, the applicantwill be required to leave the meeting before any outcome is decided.
6.5.8Members who are unable to attend a meeting in person may arrange to participate via teleconference and/or forward their reviews in writing to the FSS-HEC Secretary or Chairperson prior to the meeting.