Regulatory and Ethical Research Conduct References
Resources, Reference Materials, Guidelines, and Regulations for the
Ethical Conduct of Human Subjects Research:
- Quality Assurance & Audits
- SWOG Policies
- SWOG CRA Workbench, including the SWOG CRA Manual for Oncology Research Professionals
NIH and NCI Resources:
Institutional Review Board Review (IRB) and
Utilization of a Single Central IRB (CIRB) in Cooperative Group Research:
- Utilization of a Single IRB for Cooperative Group Research
- IRB Submission Procedures for SWOG Cancer Research Network Protocols
- NCI CIRB Studies list
- NCI CTSU (Cancer Trials Support Unit) – login with CTEP IAM ID required
- NCI CIRB "How to Open a Study"
- NCI CIRB Contact Information
- NCI CIRB Meeting Schedules
- NCI CIRB FAQs about IRBManager
- NCI CIRB quick guides on how to "Report a Potential Unanticipated Problem or a Serious or Continuing Noncompliance"
- NCI CIRB SOPs on Short Form Consents and Accessibility via CTSU
- NCI CIRB Determinations Pertaining to Waiver or Alteration of Informed Consent
NCI Cancer Trials Support Unit (CTSU) Training Resources:
- Site Staff Orientation Slides
** Login with your CTEP IAM ID at www.ctsu.org and then click on the above link.
This 10-part CTSU training module is a high-level overview of each area of the CTSU website and is intended as an introductory training for site staff that may be new to your institution or to the CTSU.
Ethics and Integrity in Human Subjects Research:
- NIH Research Ethics - Online Course
- NIH Annual Review of Ethics: Online NIH Resource of Research Ethics Case Studies
- NIH Office of Research Integrity: ORI Introduction to the Responsible Conduct of Research
- NIH Department of Bioethics Videocasts of Past Lectures: Extensive video archive of the ethical and regulatory aspects of clinical research
- Institute of Medicine Free Online E-book: "Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct (2002)"
- Institute of Medicine Free Online E-book: "On Being a Scientist: Responsible Conduct in Research, Second Edition (1995)"
- National Academies Free Online E-book: "Responsible Science: Ensuring the Integrity of the Research Process:" Volume I (1992) and Volume II (1993)
Regulations and Related Guidance Governing Human Subjects Research:
- The Common Rule (45 CFR 46)
- WHO Handbook for Good Clinical Research Practice (GCP)
- FDA Regulations Relating to GCP and Clinical Trials (21 CFR)
- FDA Clinical Trials Guidance Documents
- The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
- CMS HIPAA Basics for Providers, HIPAA FAQs for Professionals, HIPAA Guidance Materials, and Special Topics: Research
- Certificates of Confidentiality
- International Compilation of Human Research Standards (2020 Edition)
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidance Documents
FDA Drug Development Overview Presentations:
FDA Overview of Drug Development (non-clinical safety assessment)