Applying Ethics and Integrity to Human Research.
IntegReview reviews the following types of research: Phase I-IV drug/biomedical, medical device, social and behavioral, Investigator-sponsored, single and multiple investigator as well as research conducted in academic and hospital settings, expedited review for research that qualifies, expedited review of additional Investigators, research determined to be exempt, research conducted in Latin America and Canada.
IntegReview Ethical Review Board
3001 S. Lamar Blvd., Suite 210
Austin, TX 78704
Phone: 512-326-3001
Fax: 512-697-0085
Email:
IntegReview Training Campus
Belmont Report
Declaration of Helsinki
The Nuremberg Code
Center for Drug Evaluation and Research
Clinlaw
Code of Federal Regulations, Title 21, Part 50
Code of Federal Regulations, Title 21, Part 54
Code of Federal Regulations, Title 21, Part 56
Code of Federal Regulations, Title 21, Part 312
Code of Federal Regulations, Title 21, Part 812
Code of Federal Regulations, Title 21, Part 814
Guidance on Good Clinical Practices
FDA Information Sheets
Office for Human Research Protections (OHRP)
Code of Federal Regulations, Title 45, Part 46 (OHRP)
HIPAA Privacy Rule
FOR RESEARCH CONDUCTED IN CANADA
TCPS 2 – 2nd Edition Tri-Council Policy Statement – Ethical Conduct for Research Involving Humans
Division 5 – Regulations Amending the Food and Drug Regulations – Health Canada
Natural Health Products Regulations, Part 4
