Human Research Protection Program - Education and Training in Research Ethics
Ethical Practices in Research Involving Human Subjects: Education & Training
Human Subjects Tutorial
SDSU offers a web-based training for faculty, students and key personnel who are involved in human subjects
research. This tutorial REPLACES the tutorial launched in 2002.
The new SDSU Human Subjects Tutorial focuses on ethical principles and practices when conducting research involving human subjects and basic issues relevant to protection of participant rights and welfare. These include, for example, the informed consent process, confidentiality, identifying and managing risks, protocol development, protocol adherence and ethical conduct.
All investigators who submit a protocol for review by the Institutional Review Board AND who have not completed the SDSU training since 2004, must obtain training certification USING THIS TUTORIAL prior to developing and submitting an IRB protocol. Likewise, key personnel associated with NIH-funded research must also complete this training. Certification of completion is obtained by reviewing all sections of the tutorial which takes about 1 hour. Certification is sent to you by electronic notification upon satisfactory completion. To verify completion of the training for an IRB application, upload a copy of the certification message to your vIRB application. Certification is valid for 2 years.
Human Subjects in Research: Workshops & Lectures In support of the IRB, the Division of Research Affairs offers ongoing training for the SDSU research community. Lectures focus on issues relevant to human subjects protections to include, for example, ethical issues and accepted principles/practices, compliance with federal regulations and institutional/investigator responsibilities. Please contact the IRB office (619-594-6622) to request information or a list of upcoming events.
Project TRES
Training in Research Ethics and Standards is a culturally tailored, content-appropriate, Spanish-translated
research ethics curriculum that targets Community Health Advisors/promotores delivering research to
Hispanic/Latino communities. Promotores are members of the research team and have direct involvement in
research conducted within the Hispanic/Latino communities.
This curriculum emphasizes awareness of ethical, legal and social aspects of conducting research. The application of ethical practices associated with research is stressed (e.g., selection, recruitment, informed consent, privacy and confidentiality).
Additional Resources
• Institutional Review Board Guidebook provides clarification of the policies and interpretation of the ethical principles that underlie the regulations governing research with human subjects and increase awareness of relevant issues. http://www.hhs.gov/ohrp/irb/irb_guidebook.htm
• Code of Federal Regulations TITLE 45 PART 46 (45 CFR 46) PROTECTION OF HUMAN SUBJECTS http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
• The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research provides a summary of basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
• Office for Human Research Protections (OHRP) OHRP has the primary responsibility within the federal government for developing and implementing the policies, procedures, and regulations to protect human subjects involved in HHS-sponsored research. http://www.hhs.gov/ohrp/
• U.S. Food and Drug Administration (FDA) INFORMATION SHEETS includes guidance for Institutional Review Boards and Clinical Investigators, 1998 Update. http://www.fda.gov/oc/oha/IRB/toc.html
• IRB Discussion Forum promotes the discussion of ethical, regulatory and policy concerns with human subjects research.List-Post: irbforum@irbforum.org, http://www.irbforum.org/discussion List-Subscribe: http://www.irbforum.org/user
• Public Responsibility in Medicine and Research (PRIM&R) PRIM&R is dedicated to creating, implementing, and advancing the highest ethical standards in the conduct of research. http://www.primr.org./resources/human.html
The Office for Human Research Protections (OHRP) is pleased to announce a new page on its website, The Belmont Report Historical Archive. We encourage everyone to visit the site and review this important part of the history of human subject protections.
The Belmont Archive includes:
• Belmont Report Oral History Interviews - transcripts of interviews with members, staff and consultants of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78); OHRP will soon add the video versions of these interviews.
• Training Video - a 9-minute educational/training video with highlights from the Oral History interviews.
• Commemorative Program Video - a one-hour edited version of the November 16, 2004 Department of Health and Human Services (HHS) ceremony honoring the members, staff and consultants of the National Commission.
• History of the Belmont Report - a short history of the Belmont Report and the current human subject protection regulations.