ETHICS APPLICATION 101
Overview of the ethics approval process for health research, emphasizing the importance of conducting research ethically to benefit participants and minimize risks. Explains the role of ethics committees in evaluating and minimizing potential risks. Describes the establishment of the Health Research Ethics Authority and the requirement for approval in NL. Provides insights on completing the application and setting up a ROMEO account for research submissions.
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ETHICS APPLICATION 101 Rebecca Cole MSc Canidate rjc255@mun.ca
OUTLINE 1. Overview of ethics approval 2. Applying for Health Research Ethics Board (HREB) approval 3. Tips on completing an application
ETHICS APPROVAL In order for research to result in benefit, and minimize risk of harm, it must be conducted ethically The aim of ethical reviews are to protect participants AND researchers The role of ethics committees is to identify the possible risks in a project, and then assess whether the research team is: aware of the risks taking appropriate steps to minimize them
Established by the Health Research Ethics Authority Act HEALTH RESEARCH ETHICS AUTHORITY (HREA) Health research involving human subjects: activities whose primary goal is to generate knowledge in relation to human health, health care and health care systems, and involving human beings as research subjects, health care information respecting human beings or human biological material (The Act) All health research conducted in NL requires approval from the HREB or another ethics body approved by HREA
Health Research Ethics Board Non-Clinical Trial Subcommittee Clinical Trial Subcommittee
SET UP A ROMEO ACCOUNT
CHOOSE WHICH APPLICATION YOU ARE REQUIRED TO COMPLETE
TIPS ON COMPLETING THE APPLICATION Get organzaized Focus on privacy & consent Use your resources Review before you submit
GET ORGANIZED Start early it will take longer than you think! Have your protocol, research instruments, variable lists, etc., available to use as a reference Keep track of your progress Checklist Question list
FOCUS ON PRIVACY & CONSENT Consent Privacy Who will approach/recruit the participants Ensuring the research team knows their responsibilities in protecting participants privacy How you will get consent Consent forms Data retention Note any possible risks/discomforts/inconveniences to participants Who will have access Safeguards Waiver of consent Destroying the data after the project is complete
USE YOUR RESOURCES Don t be afraid to ask questions! Talk to those who are familiar with the process Supervisor Other students Dr. Aslanova Ethics officers TCPS guide HREA site & guidelines
REVIEW Make sure the application is consistent & aligns with your protocol Use detailed answers do not leave the reviewers with questions about your project Understand reviewers may not be an expert in your area of research make it easy to understand Spending more time on your application for the original submission can save you unnecessary work later on
HREA https://www.hrea.ca TCPS 2 https://ethics.gc.ca/eng/policy-politique_tcps2- eptc2_2018.html HELPFUL LINKS Common ethics application mistakes https://uwaterloo.ca/research/office-research- ethics/research-human-participants/application-process/top- 10-problems-can-delay-review-ethics-application-and
REFERENCES 1. Newfoundland and Labrador Health Research Ethics Authority [Internet]. 2020. Available from https://www.hrea.ca/ 2. Memorial University Research Grant & Contract Services: Health Research Ethics Board [Internet]. 2020. Available from https://rpresources.mun.ca/human-ethics/hrea/ 3. Memorial University Research Portal [Internet]. 2020. Available from https://rpresources.mun.ca/ 4. University College London Research Ethics Committee: The Main Reasons why Ethical Approval is Required [Internet]. 2020. Available from https://ethics.grad.ucl.ac.uk/why-is-ethical-approval-required.php
