Chapter 5.7: Accountability. National Statement on Ethical Conduct in Human Research (2007) - Updated 2018

Introduction – Chapter 5.7

Responsibility for the ethical design, review and conduct of human research is exercised at different levels, from the detail of research conduct to the more general oversight of review and funding. Accordingly, responsibility is exercised at the different levels by:

• researchers (and where relevant their supervisors)
• Human Research Ethics Committees (HRECs) and other ethical review bodies
• institutions whose employees, resources or facilities are involved
• funding organisations
• agencies that set standards
• governments.

The line of accountability for these responsibilities runs:

• from researchers to review bodies and institutions
• from review bodies and institutions to funders and other agencies
• from agencies to government
• from government to the Australian public.

Typically, this accountability involves reporting from one level to the next.

Guidelines – Chapter 5.7

5.7.1 Researchers have responsibilities for the ethical design and conduct of research. The measures of accountability by which researchers demonstrate, to institutions and to review bodies, fulfilment of those responsibilities appear in Chapter 5.1: Institutional responsibilities, Chapter 5.2: Responsibilities of HRECs, other ethical review bodies and researchers, and paragraph 3.3.22, on the monitoring of approved clinical research. Researchers also have responsibilities under the Australian code for the responsible conduct of research.

5.7.2 Review bodies have responsibilities for the ethical review of research. The measures of accountability by which review bodies demonstrate to institutions their fulfilment of those responsibilities appear in Chapter 5.2: Responsibilities of HRECs, other ethical review bodies, and researchers.

5.7.3 Institutions have responsibilities:

1. (a) to ensure that ethical review of research occurs. These responsibilities are set out in Chapter 5.1: Institutional responsibilities
2. (b) for the conduct of research. These responsibilities are set out in the Australian code for the responsible conduct of research. They include ensuring that research is both sound and lawful, and is conducted or supervised by educated and experienced researchers.

5.7.4 In addition to providing information annually, institutions shall, on reasonable request, provide other information about their ethical review processes to the NHMRC.

5.7.5 Institutions that are in receipt of NHMRC research funding, or intend to remain eligible for it, must be registered with the NHMRC. Registration will include information about any HREC/s or other review bodies which the institution has decided to use or has established.

5.7.6 The deed of agreement attached to any NHMRC funding requires that institutions attest annually to the NHMRC in writing that their research governance and ethical oversight processes remain compliant with this National Statement and the Australian code for the responsible conduct of research.

Authors of this National Statement

This National Statement has been jointly developed by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia (UA). This joint undertaking reflects a widely shared conviction that there is a need for ethical guidelines that are genuinely applicable to all human research and it gives expression to the shared responsibility for ethically good research described above.