The Institutional Review Board (IRB) is responsible for ensuring that all individuals involved in research studies have received appropriate education and training on the ethical conduct of research with human subjects. The IRB oversees the training requirements and ensures that researchers, including principal investigators and study personnel, have completed the necessary Human Subjects Training before engaging with participants.
By requiring Human Subjects Training, the IRB ensures that researchers are knowledgeable about the ethical principles, regulatory requirements, and best practices for conducting research with human subjects. This training helps researchers understand the importance of informed consent, the protection of participant confidentiality, the identification and mitigation of potential risks, and the overall ethical considerations throughout the research process.
What is Human Subjects Training?
Human Subjects Training programs are designed to educate individuals involved in research studies about the ethical principles, regulations, and best practices for conducting research with human subjects. This training aims to ensure that researchers are well-informed about the rights and welfare of participants, the appropriate procedures for obtaining informed consent, minimizing potential risks, maintaining privacy and confidentiality, and adhering to ethical standards throughout the research process.
Human Subjects Training at SKERI covers topics such as the historical context of research ethics, regulatory requirements, the importance of informed consent, considerations for vulnerable populations, data protection, and the role of Institutional Review Boards (IRBs) in overseeing research involving human subjects.
In addition to completing a Human Subjects Training Course, individuals will also be required to read several documents available on the SKERI Wiki page. These documents include but are not limited to:
- The Bellmont Report
- The SKERI IRB Policies and Procedures Manual
- The HIPAA Privacy Rule
- The Revised Common Rule (46 CFR 45)
- The Experimental Subject's Bill of Rights (State of California Health and Safety Code 24172)
- State of California Health and Safety Code 24173 - Informed Consent
Who needs Human Subjects Training?
Any researcher or member of a project team who will participate in human subject research needs to have training.
How do I get Human Subjects Training?
All SKERI personnel who require Human Subjects Training will be contacted by the IRB prior to their start at the Institute with instructions on how to complete their required training.
Researchers and SKERI personnel conducting research with human participants are required to complete Human Subjects Training every five years. This is to ensure that all SKERI personnel conducting research stay updated on the evolving ethical guidelines, regulations, and best practices in research involving human subjects. The field of research ethics is dynamic, with new insights, regulations, and approaches emerging over time. By undergoing periodic training, personnel can stay current with the latest standards and ensure that their practices align with the most recent ethical considerations.
Additionally, the periodic training requirement serves as a reminder for researchers and study personnel to revisit and reflect on the ethical responsibilities inherent in working with human subjects. It helps SKERI to promote a culture of continuous learning and improvement, encouraging researchers to stay informed about emerging ethical issues, changes in regulations, and advancements in research methodologies.
Questions?
Please contact the IRB with any questions or concerns via email, at IRB@ski.org.