The National Statement : A User Guide

This National Statement on Ethical Conduct in Human Research (‘National Statement’) is intended for use by:

• any researcher conducting research with human participants;
• any member of an ethical review body reviewing that research;
• those involved in research governance; and
• potential research participants.

This brief guide describes the structure of the document and suggests how each of these groups might use it. Note that ‘review body’ refers both to Human Research Ethics Committees (HRECs) and to non-HREC review bodies.

The Preamble sets out the historical context of the National Statement. This is followed by a brief explanation of its purpose, scope and limits. The document then has five sections, with multiple chapters in Sections 2 to 5.

• Section 1: Values and principles of ethical conduct sets out values and principles that apply to all human research. It is essential that researchers and review bodies consider these values and principles and be satisfied that the research proposal addresses and reflects them.
• Section 2: Themes in research ethics: risk and benefit, consent discusses the concept of risk in research and the role of participants’ consent – themes in all human research – and is again essential for all users.
• Chapter 2.1 will help researchers and reviewers to understand and describe the level of risk involved in the planned research, and how to minimise, justify and manage that risk, and (with reference to Chapter 5.1) what level of ethical review is suitable.
• Chapters 2.2 and 2.3 will help to identify the information that needs to be disclosed to participants. It will help researchers to draft information for participants and plan the consent process (or develop a proposal for waiver of consent). And it will help reviewers to assess the suitability of the proposed consent process.
• All Section 2 will help participants understand what information they are entitled to receive, and whattheir participation in research will characteristically involve.
• Section 3: Ethical considerations specific to research methods or fields will help researchers and reviewers to identify ethical matters specific to the research methods proposed.
• Section 4: Ethical considerations specific to participants will help researchers and reviewers to identify ethical matters relating to specific categories of research participants. Participants in these categories will also find this Section valuable.
• Section 5: Processes of research governance and ethical review will help those involved in research governance to understand their responsibilities for research ethics and ethical review and monitoring of human research, and provides criteria for their accountability. Chapter 5.2 will help researchers and reviewers to identify their responsibilities in relation to the ethical review of research.

This National Statement does not exhaust the ethical discussion of human research. Even a single research field covers a multitude of different situations about which the National Statement will not always offer specific guidance, or to which its application may be uncertain. Where other guidelines and

codes of practice in particular research fields are consistent with the National Statement, researchers and members of ethical review bodies should draw on them when necessary to clarify researchers’ ethical obligations in particular contexts.