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Ethical Review of Observational Research, Audit and Related Activities Discussion Document September 2003 Published in September 2003 for the National Advisory Committee on Health and Disability Support
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How to Fill Out Ethical Review of Observational:

01
Start by clearly stating the purpose of your observational study. Clearly explain the research question or objective and why it is important to investigate.
02
Provide a detailed description of the study design and methodology. Outline the data collection methods, the population/sample you will be observing, and any procedures or interventions involved.
03
Explain how you will ensure the privacy and confidentiality of the participants. Discuss how you will handle and store the data collected to protect the participants' identities.
04
Address the potential risks and benefits of the study. Assess any potential harm that participants may experience and describe the steps you will take to minimize these risks. Additionally, highlight the potential benefits of the study, either to the participants or to society as a whole.
05
Describe your plan for obtaining informed consent from the participants. Explain how you will provide clear and comprehensive information about the study, including its purpose, procedures, potential risks, and benefits. Outline the process for obtaining participants' voluntary consent and ensure they have the option to withdraw from the study at any time.
06
Discuss any conflicts of interest that may arise during the study. Declare any financial, professional, or personal relationships that could potentially influence the study's outcomes or create bias.
07
Provide information about the qualifications and expertise of the researchers involved in the study. Highlight their experience in conducting observational studies and any relevant training or certifications they possess.

Who Needs Ethical Review of Observational:

01
Researchers conducting observational studies in any field, including social sciences, healthcare, psychology, biology, and more, need to undergo an ethical review.
02
Institutions and organizations that oversee research, such as universities, hospitals, and research foundations, require researchers to go through an ethical review process before conducting observational studies.
03
Funding agencies that provide financial support for research often have ethical review requirements in place. Researchers seeking funding for their observational studies will need to submit their study protocols for ethical review.
04
Scientific journals and publishers often require researchers to have obtained ethical approval for their studies before accepting their manuscripts for publication. Meeting the ethical review requirements is crucial for disseminating research findings in reputable journals.
05
Regulatory bodies and government agencies may also require ethical review to be conducted for certain types of observational studies, especially those involving human participants. Compliance with ethical guidelines is necessary to ensure the rights and welfare of the participants are protected.
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Ethical review of observational studies is the process of evaluating the ethical considerations involved in conducting research that involves observing individuals or groups in their natural environment.
Researchers conducting observational studies are required to file for ethical review to ensure the protection and well-being of study participants.
Researchers can fill out the ethical review of observational by providing detailed information on study design, data collection methods, informed consent procedures, and measures taken to protect participant confidentiality.
The purpose of ethical review of observational studies is to ensure that research is conducted in an ethical manner, with the principles of respect for participants, beneficence, and justice being upheld.
Researchers must report information on study objectives, study population, data collection methods, risks and benefits to participants, informed consent process, and measures taken to protect participant confidentiality.
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