Please note:

The Human Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans has been revoked. This information is kept here for archival purposes only. For the current guidelines, Human Research Ethics Committees should refer to the National Statement on Ethical Conduct in Human Research 2007.

A Research Ethics Collection

EXPLANATORY NOTE

This is a collection of opinions on recurrent issues of ethics relevant to research involving humans. It is not an exhaustive collection and suggestions for additional topics are welcome. The opinions have been written by some of the contributors, who are listed at the front of this Handbook, and the views they express are not all necessarily shared by NHMRC. Nonetheless, they do serve the purpose of fostering an open and reflective discourse in ethics relating to research involving humans.

Contents

How can risks be minimised?

Children and Young People, Research Involving

Consent
Consent process
Risks, benefits and the research participants' best interests
United States guidelines

Children, Clinical Trials Involving

Clinical Trials

Drug trials
Protocol and study design
Inclusion and exclusion criteria
Study endpoints and outcome measures
Analysis of results
Testing 'generic' drugs and marketing disguised as research
Safety issues

Published procedures
A cooperative climate
Receiving complaints about the conduct of research
Responding to complaints about the conduct of research
Procedures for responding to complaints
Procedures for investigating complaints
Allegations and complaints of serious research misconduct
Natural justice and due process
Complaints concerning Human Research Ethics Committee review processes
Sanctions
Appeals and review of Human Research Ethics Committee decisions

Conflicts of Interest

Conflicts of interest and Human Research Ethics Committee members
Conflicts of interest and the researcher

Trust
Forms of consent
Consent and inducement
Consent, refusal and withdrawal

Deception, Research Involving

Emergency and Intensive Care Research

Employees, Research Involving

Epidemiology Research

Epidemiological study designs
Epidemiological research and public health surveillance

Gay Men And Lesbians, Research Involving

Relevant considerations

General Practice Research

Coercion and consent
Confidentiality
Intrusiveness

Genetic Research

Overview of ethical issues raised in relation to human genetic research
Other risks and research involving children
Research involving gene therapy or cloning
Research involving stored material

Highly Dependent on Medical Care, Persons, Research Involving

Relevant international standards

Research involving HIV/AIDS
Clinical trials and HIV/AIDS
Vaccine trials and HIV/AIDS

Human Participants, Justification of Research Involving

Human Research Ethics Committees

Historical, sociological and ethical background
The 1996 IEC Report
The place of HREC review in ethical research
Membership
Subcommittes and other human research ethics committees within the institution
Workloads
Network support
Frequency of meetings
Policies in relation to frequently reviewed ethical issues
Meeting agenda
Application format for research protocols
Applications, preliminary review of
Approval of research
Minutes and recording decisions
Expedited review

Human Tissue, Research Involving

Factors for consideration
Commercial development of tissue samples and consent
Avoiding and limiting injury
Consent
Storage of tissue and consent
Waiver of consent
Privacy and confidentiality

Humanities and Social Sciences Research Methods

Intellectual or Mental Impairment, Research Involving

Decision-making capacity
Consent

Impaired Capacity for Communication, Research Involving People With

International Research

Placebo use in developing countries

Selection and recruitment of research participants
Balancing justice and respect for persons

Monitoring Research

Monitoring research in progress
Management of adverse events

Multi-Centre Research

Scientific and ethical review
Human Research Ethics Committee jurisdiction
A model for conducting multi-centre research

Neonatal Intensive Care Research

Pharmaceutical Industry, Physicians and

Prisoners, Research Involving

Psychiatric Research

Introduction
Respect for persons
Balancing risks and benefits
Informed consent
Confidentiality and privacy
Conflicts of interest

Qualitative Research

Ethical issues in qualitative research

Radiation, Research Involving

Use of radioactive materials
Measurement and regulation of radiation exposure
Risks of radiation
Consent

Research - Analysis of Data

Analysis and interpretation of data
Bias in quantitative empirical research
Bias in qualitative research

Research - Communication of Results

Participants' rights
Commercial-in-confidence

Research Design And Purpose

Choice of research method: qualitative and quantitative techniques
Observational and experimental studies
How can HRECS assess research design?

Research Question, Statement of

What are the criteria for an acceptable research question?
The context of the research question
How are research questions assessed?

Respect for Persons

Schools, Research In

Students, Research Involving

Terminally Ill People, Research Involving

Unconscious People, Research Involving

Women, Clinical Trials Involving

Exclusion of women of child-bearing age from clinical trials

Women, Research Involving

Women, inclusion in research
Women, exclusion from research
Women, inclusion of vulnerable women

Footnotes for all page in this section

| Handbook TOC | Abbreviations | Commentary on the National Statement |
| A Research Ethics Collection | A Research Law Collection |
| Bibliography | Appendices | Downloads |