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Queen's University
 

Overview of Approval Process

CONTENTS

1. Ethics Boards at Queen's
2. Unit REBs (where available)
3. The GREB
4. Expedited Reviews
5. Evaluation of Level of Risk and Ethics Concern
6. Exclusions for Expedited Review
7. Research Ethics Principles

1. Ethics Boards at Queen's

All research proposals,funded or not,that involves humans requires review and approval. Research whose primary application is in the biomedical disciplines will be referred to the Health Sciences REB. Research whose primary application falls in any other discipline at Queen's University will be directed to the GREB. If a proposal could fall under either Board, the two chairs may agree to reassign a protocol from one Board to another if it is deemed that the proposal would be more properly reviewed by the alternate research ethics board.

2. Unit REBs (Where Available)

a) For course-based research projects (either undergraduate or graduate courses), the Unit REB, if one exists, will normally approve the protocol unless it is of medium or high risk and higher ethics concern. In these cases, the course-based research project will be forwarded to the GREB for review. The project approval must be communicated to the researcher in writing. Note: All projects involving Aboriginals Peoples must be forwarded to the GREB for review.

b) All protocols of Faculty, Graduate Theses and Post Graduate Student will be reviewed by the Unit REB, if one exists. After the researcher has satisfied the Unit REB's questions or concerns, the application is approved and sent to the GREB with either a recommendation for expedited or full review. The GREB Chair will review the file and, based on an Evaluation of Level of Risk and Ethics Concern, will recommend either expedited review or full review. Note: All projects involving Aboriginals Peoples must be forwarded to the GREB for review.

3. The GREB

a) Course-based research is reviewed and approved by the Unit REBs. Once a year, all applications are forwarded to the GREB for audit and storage purposes. All projects involving Aboriginals Peoples must be forwarded to the GREB for review.

b) All Graduate and Faculty protocols may be considered for expedited review it is deemed to be of low ethical concern and minimal risk based on an Evaluation of Level of Risk and Ethical Concern . If any of the researcher, Unit REB, Chair of the GREB or delegate determines that the research is deemed to be greater than of low ethical concern and minimal risk, the protocol will undergo full review by the GREB.

4. Expedited Reviews

If an expedited review is warranted, normally the GREB Chair and at least one other member of the GREB will review the application. If no Unit REB exists, at least the Chair and two other members will review the application. Expedited reviews are conducted on an ongoing basis independent of meeting dates. All expedited reviews will be brought to the GREB at the next scheduled meeting for information and, if necessary, discussion. An expedited review will be conducted if the project consists of research that is of low ethical concern and minimal risk based on the principles set out in the Tri-Council Policy Statement.

5. Evaluation of Level of Risk and Ethics Concern

Any project which is deemed to be of greater that minimal risk may require a full review at a monthly GREB meeting. Based on Article 1.6 of the Tri Council Policy Statement "The standard for minimal risk is commonly defined as follows: if potential participants can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research then the research can be regarded as within the range of minimal risk". (Tri-Council Policy Statement Article C1).
For examples of research studies which may cause concern with regard to the level of risk involved please see Evaluation of Level of Risk and Ethics Concern.

6. Exclusions from Ethics Review

Review is not required for:

  •  Research about a living individual involved in the public arena, or an artist, that is based entirely on publicly available information, documents, records, works, performances, or archival materials. Such research requires review when it is based in part or in whole on third party interviews, or if the subject is approached directly for interviews or for access to private papers.
  •  Quality assurance studies, performance reviews or testing within normal educational requirements.

7 . Research Ethics Principles:

The following principles that form the bases of all ethics reviewsare extracted from the Tri-Council Policy Statement(i-4) under Context for an Ethical Framework.

Respect for Human Dignity: The cardinal principle of modern research ethics, as discussed above, is respect for human dignity. This principle aspires to protecting the multiple and interdependent interests of the person -- from bodily to psychological to cultural integrity. This principle forms the basis of the ethical obligations in research that are listed below. In certain situations, conflicts may arise from application of these principles in isolation from one other. Researchers and REBs must carefully weigh all the principles and circumstances involved to reach a reasoned and defensible conclusion.

Respect for Free and Informed Consent: Individuals are generally presumed to have the capacity and right to make free and informed decisions. Respect for persons thus means respecting the exercise of individual consent. In practical terms within the ethics review process, the principle of respect for persons translates into the dialogue, process, rights, duties and requirements for free and informed consent by the research subject.

Respect for Vulnerable Persons: Respect for human dignity entails high ethical obligations towards vulnerable persons -- to those whose diminished competence and/or decision-making capacity make them vulnerable. Children, institutionalized persons or others who are vulnerable are entitled, on grounds of human dignity, caring, solidarity and fairness, to special protection against abuse, exploitation or discrimination. Ethical obligations to vulnerable individuals in the research enterprise will often translate into special procedures to protect their interests.

Respect for Privacy and Confidentiality: Respect for human dignity also implies the principles of respect for privacy and confidentiality. In many cultures, privacy and confidentiality are considered fundamental to human dignity. Thus, standards of privacy and confidentiality protect the access, control and dissemination of personal information. In doing so, such standards help to protect mental or psychological integrity. They are thus consonant with values underlying privacy, confidentiality and anonymity respected.

Respect for Justice and Inclusiveness: Justice connotes fairness and equity. Procedural justice requires that the ethics review process have fair methods, standards and procedures for reviewing research protocols, and that the process be effectively independent. Justice also concerns the distribution of benefits and burdens of research. On the one hand, distributive justice means that no segment of the population should be unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are vulnerable and unable to protect their own interests in order to ensure that they are not exploited for the advancement of knowledge. History has many chapters of such exploitation. On the other hand, distributive justice also imposes duties neither to neglect nor discriminate against individuals and groups who may benefit from advances in research.

Balancing Harms and Benefits: The analysis, balance and distribution of harms and benefits are critical to the ethics of human research. Modern research ethics, for instance, require a favourable harms-benefit balance -- that is, that the foreseeable harms should not outweigh anticipated benefits. Harms-benefits analysis thus affects the welfare and rights of research subjects, the informed assumption of harms and benefits, and the ethical justifications for competing research paths. Because research involves advancing the frontiers of knowledge, its undertaking often involves uncertainty about the precise magnitude and kind of benefits or harms that attend proposed research. These realities and the principle of respect for human dignity impose ethical obligations on the prerequisites, scientific validity, design and conduct of research. These concerns are particularly evident in biomedical and health research; in research they need to be tempered in areas such as political science, economics or modern history (including biographies), areas in which research may ethically result in the harming of the reputations of organizations or individuals in public life.

Minimizing Harm: A principle directly related to harms-benefits analysis is non-maleficence, or the duty to avoid, prevent or minimize harms to others. Research subjects must not be subjected to unnecessary risks of harm, and their participation in research must be essential to achieving scientifically and societally important aims that cannot be realized without the participation of human subjects. In addition, it should be kept in mind that the principle of minimizing harm requires that the research involve the smallest number of human subjects and the smallest number of tests on these subjects that will ensure scientifically valid data.

Maximizing Benefit: Another principle related to the harms and benefits of research is beneficence. The principle of beneficence imposes a duty to benefit others and, in research ethics, a duty to maximize net benefits. The principle has particular relevance for researchers in professions such as social work, education, health care and applied psychology. As noted earlier, human research is intended to produce benefits for subjects themselves, for other individuals or society as a whole, or for the advancement of knowledge. In most research, the primary benefits produced are for society and for the advancement of knowledge.

 

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