Research Ethics
General Principles of Research Ethics
All research conducted on human subjects must be performed in accordance with universally recognized ethical principles, namely:
The principle of autonomy is implemented through the process of free and informed consent, which can be revoked at any time. A potential research participant must be provided with appropriate, accurate, and understandable information about the research project before deciding whether to participate in the study.
The principles of beneficence include a moral obligation for the research to maximize potential benefits and minimize potential harm. The design of the research project must be sound and meet accepted criteria for scientific quality, while researchers must demonstrate competence, conduct research in accordance with relevant professional obligations and standards, and ensure proper protection of research participants.
Selection criteria should be directly related to the purpose of the research and not merely based, for example, on the ease of obtaining consent.
Reviewing research ethics should facilitate minimizing risks and maximizing benefits, while simultaneously ensuring respect for the individual and providing the best possible response to prevent unwarranted harm without impeding potentially beneficial research.
The research proposal should detail the level and type of risks participants might face.
Identification of Anticipated Risks
The committee must determine the nature, characteristics, and magnitude of risks according to the research plan submitted to the Research Ethics Committee. The committee should carefully consider the description of risks provided in the plan, but should not assume that this description is necessarily accurate or complete.
Identification of Anticipated Benefits
Research interventions that are expected to yield useful scientific information for society in the future must be reasonable in relation to the importance of the knowledge to be gained, compared to the associated risks.
When Assessing Risks to Research Subjects, the Following Should Be Considered:
Risks to physical integrity, including risks associated with experimental drugs, treatments, and other interventions used in the study.
Psychological risks: for example, a questionnaire may pose a risk if it addresses traumatic events or particularly stressful events.
Social, legal, and economic risks: for example, if confidential information collected during the study is accidentally disclosed, participants may face the risk of discrimination and stigmatization.
When Assessing Risks to Society, the Following Should Be Considered:
As a result of the research, certain ethnic or population groups may experience discrimination or stigmatization, especially if members of these groups are identified as having a higher-than-usual risk for a specific disease.
The research may impact the existing healthcare system: for example, human and financial resources allocated to the research might divert attention from other pressing healthcare needs in the community.
Autonomy
The principle of autonomy is implemented through the process of free and informed consent, which can be revoked at any time. A potential research participant must be provided with appropriate, accurate, and understandable information about the research project before deciding whether to participate in the study.
Beneficence
The principles of beneficence include a moral obligation for the research to maximize potential benefits and minimize potential harm. The design of the research project must be sound and meet accepted criteria for scientific quality, while researchers must demonstrate competence, conduct research in accordance with relevant professional obligations and standards, and ensure proper protection of research participants.
Justice
Selection criteria should be directly related to the purpose of the research and not merely based, for example, on the ease of obtaining consent.
Reviewing research ethics should facilitate minimizing risks and maximizing benefits, while simultaneously ensuring respect for the individual and providing the best possible response to prevent unwarranted harm without impeding potentially beneficial research.
The research proposal should detail the level and type of risks participants might face.
Risk/Benefit Assessment Phases Are:
Identification of Anticipated Risks
The committee must determine the nature, characteristics, and magnitude of risks according to the research plan submitted to the Research Ethics Committee. The committee should carefully consider the description of risks provided in the plan, but should not assume that this description is necessarily accurate or complete.
Identification of Anticipated Benefits
Research interventions that are expected to yield useful scientific information for society in the future must be reasonable in relation to the importance of the knowledge to be gained, compared to the associated risks.
When Assessing Risks to Research Subjects, the Following Should Be Considered:
Risks to physical integrity, including risks associated with experimental drugs, treatments, and other interventions used in the study.
Psychological risks: for example, a questionnaire may pose a risk if it addresses traumatic events or particularly stressful events.
Social, legal, and economic risks: for example, if confidential information collected during the study is accidentally disclosed, participants may face the risk of discrimination and stigmatization.
When Assessing Risks to Society, the Following Should Be Considered:
As a result of the research, certain ethnic or population groups may experience discrimination or stigmatization, especially if members of these groups are identified as having a higher-than-usual risk for a specific disease.
The research may impact the existing healthcare system: for example, human and financial resources allocated to the research might divert attention from other pressing healthcare needs in the community.
Research Ethics Committee Application Form
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Research Ethics Committee Application Form | Download |
