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Ethical Review of Research Involving Human Subjects

Last Updated 12 January, 2017

GUIDELINES

Ethical Review of Research Involving Human Subjects

All research involving living human subjects must be carried out in such a way that it protects the welfare and rights of the participants. Every research proposal must also show that the research is justifiable. Consequently research within the Sydney College of Divinity involving living human subjects requires review and approval by the Research Ethics Committee following the principles and guidelines in the most current National Statement on Ethical Conduct in Research Involving Humans. The Ethics Committee will be concerned about the ethical issues arising from the proposed research, including the merit of the proposal.

Research involving living human subjects includes:

• information collected directly from or through a person (e.g. interviews, questionnaires, observations of an individual, focus groups)
• accessing secondary sources or non-public materials (e.g. interviews about an individual, personnel records, student records)
• identifiable private information about a living individual (e.g. private papers)

Researchers include:

• Members of the academic faculty
• Research degree candidates
• Postgraduate students completing a Research Essay or Research Project
• Students in the BTh (Honours) or BMin (Honours) program
• Students in coursework units

The members of the Research Ethics Committee are listed in the SCD Handbook, available on the SCD website.

Confidentiality

All research proposals submitted to the Research Ethics Committee are confidential.

Process for gaining approval

Applications are to be sent to the Dean at the Office of the Dean, either by mail or email. Any electronic versions must contain the necessary signatures. Application forms are available on the website or from the SCD Office.

When to apply for approval

Approval should be sought and granted before any research involving human subjects has begun. Approval will not be granted retrospectively. Applicants need to be aware that the approval process may take some time, depending amongst other things on the scheduling of meetings, the complexities of the issues and the quality of the submission.

For research degree candidates the ethical clearance is required before your thesis proposal can be accepted. Similarly, postgraduate research essays and research projects cannot be approved without ethical clearance.

Merits of the research

The researcher needs to demonstrate that the research is justifiable in terms of its potential contribution to knowledge, and is based in a thorough study of the current literature, prior observation, and approved previous studies.

Conflict of interest

The proposal should contain no actual or potential conflicts of interest between the researcher, participants and participating institutions. All funding, remuneration and incentives are to be transparent, as are any caveats on the findings.

Nature of the research

Approval is required for the following research tools:

• questionnaires and surveys, online
• qualitative methodologies (tapes or notes from focus groups, interviews )
• behavioural observation (whether known or unknown to participants)
• accessing data you, or another individual, have already collected for another purpose (e.g. from a database or archives )
• psychological experiments
• psychiatric or clinical psychological studies
• other similar

Participants in the research

The researcher needs to address any ethical issues concerning the subjects of the research, including information given about the research, consent, age, sample size, recruitment policy relationship to the researcher, freedom to enter the project and freedom to withdraw, possible coercion etc. All participants are to be informed clearly that they have a right to withdraw from the research without fear of any reprisal, and that they have a right to insist that their data be removed from the research.

When the research involves children as subjects the researcher is required to complete and provide documentation of a Prohibited Employment Declaration. If the research involves Aboriginal and Torres Strait Islander individuals then the researcher and supervisor must consult the most recent guidelines from the National Health and Medical Research Council on research involving Aboriginal and Torres Strait Islander individuals.

Risks, benefits and publication of results

The application should contain an analysis of the possible risks and benefits of the research, and the dissemination of the results.

These involve answering such questions as:

• Could participation in the research adversely affect the participants: physical harm, psychological harm, injury to reputation or privacy, invasion of privacy, breach of the law?
• Will the participants be informed of the purpose of the research?
• Is the research expected to benefit the participants directly or indirectly?
• How are the results of the research to be disseminated?

Consent

Researchers require the appropriate consent from the individuals, organizations and groups involved in the study. It falls to the researcher and any supervisor to be up-to-date with the policies and procedures of any institution that is part of the research project. Two particular examples are schools and hospitals.

Research in schools requires the following documentation:

• A single public school: approval of school principal
• Two or more public schools: approval of the Department of Education Training
• Private and independent Schools: approval of the school principal
• Catholic systemic schools: approval of the diocesan Catholic Education Office or equivalent

Research in hospitals requires the following documentation:

• For each hospital involved in the study: approval from Hospital or Area Health Service Ethics Committee or equivalent

Consultation

Where research involves particular church, ethnic or community groups the project should be planned in consultation with a representative of the group.

Copyright

Where the research involves original material such as video, diaries or the like, the copyright remains with the participants. All caveats that are placed on viewing the material must be adhered to strictly.

Complaints and queries

Information sheets for participants must contain a contact phone number for the researcher/s so that researchers can respond to queries.

As well, the information sheet must contain the following:

If you have concerns or complaints about the conduct of this research study contact the Dean, Sydney College of Divinity, on phone (02) 9889 1969, email dianes@scd.edu.au.

The role of a supervisor in research degree and postgraduate programs

The supervisor has a responsibility to ensure that the research is carried out following the appropriate ethical procedures in the cases of research by candidates in research degree programs or by postgraduate students under supervision. If the supervisor considers that the application form or the policy are lacking when applied to a project he or she needs to bring this to the attention of the Research Ethics Committee.

Responses and feedback from the Research Ethics Committee

The Research Ethics Committee will contact the researcher and others responsible for the research with the relevant advice, as follows:

Download a Sample Participant Information Statement