Research Ethics Review

1. All research that involves living human subjects requires review and approval by an REC in accordance with this Policy Statement, before the research is started, except as stipulated below.
2. Research about a living individual involved in the public area, or about an artist, based exclusively on publicly available information, documents, records, works performances, archival materials or third-party interviews, is not required to undergo ethics review.  Such research only requires ethics review if the subject is approached directly for interviews or for access to private papers, and then only to ensure that such approaches are conducted according to professional protocols and to Article 2.3 of this Policy.

1. The REC shall satisfy itself that the design of a research project that poses more than minimal risk is capable of addressing the questions being asked in the research.
2. The extent of the review for scholarly standards that is required for biomedical research that does not involve more than minimal risk will vary according to the research being carried out.
3. Research in the humanities and the social sciences which poses, at most, minimal risks shall not normally be required by the REC to be peer reviewed.
4. Certain types of research, particularly in the social sciences and the humanities, may legitimately have a negative effect on public figures in politics, business, labour, the arts or other walks of life, or on organizations. Such research should not be blocked through the use of harms/benefits analysis or because of the potentially negative nature of the findings. The safeguard for those in the public arena is through public debate and discourse and, in extremis, through action in the courts for libel. 

1. Ongoing research shall be subject to continuing ethics review. The rigour of the review should be in accordance with a proportionate approach to ethics assessment.
2. As part of each research proposal submitted for REC review, the researcher shall propose to the REC the continuing review process deemed appropriate for that project.
3. Normally, continuing review should consist of at least the submission of a succinct annual status report to the REC. The REC shall be promptly notified when the project concludes.

1. Research governed by this Policy (see Article 1.1) may begin only if (1) prospective subjects, or authorized third parties, have been given the opportunity to give free and informed consent about participation, and (2) their free and informed consent has been given and is maintained throughout their participation in the research. Articles 2.1(c), 2.3 and 2.8 provide exceptions to Article 2.1(a).
2. Evidence of free and informed consent by the subject or authorized third party should ordinarily be obtained in writing. Where written consent is culturally unacceptable, or where there are good reasons for not recording consent in writing, the procedures used to seek free and informed consent shall be documented.
3. The REC may approve a consent procedure1 which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent, provided that the REC finds and documents that:
1. The research involves no more than minimal risk to the subjects;
2. The waiver or alteration is unlikely to adversely affect the rights and welfare of the subjects;
3. The research could not practicably be carried out without the waiver alteration;
4. Whenever possible and appropriate, the subjects will be provided with additional pertinent information after participation; and
5. The waivered or altered consent does not involve a therapeutic intervention.
4. In studies including randomization and blinding in clinical trials, neither the research subjects nor those responsible for their care know which treatment the subjects are receiving before the project commences. Such research is not regarded as a waiver or alteration of the requirements for consent if subjects are informed of the probability of being randomly assigned to one arm of the study or another.

1. Information that the individual is being invited to participate in a research project;
2. A comprehensible statement of the research purpose, the identity of the researcher, the expected duration and nature of participation, and a description of research procedures;
3. A comprehensible description of reasonably foreseeable harms and benefits that may arise from research participation, as well as the likely consequences of non-action, particularly in research related to treatment, or where invasive methodologies are involved, or where there is a potential for physical or psychological harm;
4. An assurance that prospective subjects are free not to participate, have the right to withdraw at any time without prejudice to pre-existing entitlements, and will be given continuing and meaningful opportunities for deciding whether or not to continue to participate; and
5. The possibility of commercialization of research findings, and the presence of any apparent or actual or potential conflict of interest on the part of researchers, their institutions or sponsors.

1. the research question can only be addressed using individuals within the identified group(s); and
2. free and informed consent will be sought from their authorized representative(s); and
3. the research does not expose them to more than minimal risks without the potential for direct benefits for them.

1. The researcher shall show how the free and informed consent will be sought from the authorized third party, and how the subjects' best interests will be protected.
2. The authorized third party may not be the researcher or any other member of the research team.
3. The continued free and informed consent of an appropriately authorized third party will be required to continue the participation of a legally incompetent subject in research, so long as the subject remains incompetent.
4. When a subject who was entered into a research project through third-party authorization becomes competent during the project, his or her informed consent shall be sought as a condition of continuing participation.

1. The type of data to be collected;
2. The purpose for the which the data will be used;
3. Limits on the use, disclosure and retention of the data;
4. Appropriate safeguards for security and confidentiality;
5. Any modes of observation (e.g., photographs or videos) or access to information (e.g., sound recordings) in the research that allow identification of particular subjects;
6. Any anticipated secondary uses of identifiable data from the research;
7. Any anticipated linkage of data gathered in the research with other data about subjects, whether those data are contained in public or personal records; and
8. Provisions for confidentiality of data resulting from the research.

1. Identifying information is essential to the research; and
2. They will take appropriate measures to protect the privacy of the individuals, to ensure the confidentiality of the data, and to minimize harms to subjects;
3. Individuals to whom the data refer have not objected to secondary use

1. The informed consent of those who contributed data or of authorized third parties; or
2. An appropriate strategy for informing the subjects; or
3. Consultation with representatives of those who contributed data.

1. Where research is designed to survey a number of living research subjects because of their involvement in generic activities (e.g., in many areas of health research or in some social science research such as studies of child poverty or of access to legal clinics) that are not specific to particular identifiable groups, researchers shall not exclude prospective or actual research subjects on the basis of such attributes as culture, religion, race, mental or physical disability, sexual orientation, ethnicity, sex or age, unless there is a valid reason for doing so.
2. This article is not intended to preclude research focused on a single living individual (such as in a biography) or on a group of individuals who share a specific characteristic (as in a study of an identifiable group of painters who happen to be all of one sex, colour or religion, or of a religious order which is restricted to one sex).

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