- Institutional Review Boards (IRBs): IRBs are independent bodies responsible for reviewing and approving research involving human subjects. They assess research proposals to ensure they meet ethical standards, protect participants' rights and welfare, and comply with relevant regulations and guidelines.
-Informed Consent: Researchers must obtain informed consent from potential participants before they can participate in research. Informed consent involves providing participants with clear and accurate information about the study, including its purpose, risks, and benefits, and answering any question they may have. Participants must give their voluntary consent before taking part in the research.
-Confidentiality and Data Security: Researchers are required to maintain the confidentiality of participants' information and data. This includes protecting their privacy and ensuring that their information is not shared or used in ways that could cause harm. Data security measures are implemented to safeguard participants' data and prevent unauthorized access or breaches.
-Conflict of Interest: Researchers must disclose any potential conflicts of interest that could influence the conduct or outcome of their research. This includes financial or non-financial interests that might affect their objectivity or judgment.
-Ethical Review: Research involving human subjects must undergo ethical review by an IRB. The IRB evaluates the risks and benefits of the study, considers ethical issues such as informed consent, privacy, and potential for harm, and ensures compliance with ethical guidelines and regulations.
- Continuing Review: IRBs may require ongoing review of research studies over time to ensure that ethical standards are being maintained and any changes to the study are approved.
-Reporting and Auditing: Researchers are required to report any unexpected or adverse events that occur during research involving human subjects. IRBs and regulatory bodies conduct audits and inspections to ensure compliance with ethical guidelines and regulations.
These protections are aimed at safeguarding the rights, well-being, and privacy of research participants, and at ensuring that human subject research is conducted ethically and responsibly.