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.
facebook
IntegReview Ethical Review Board
3001 S. Lamar Blvd., Suite 210
Austin, TX 78704
Phone: 512-326-3001
Fax: 512-697-0085
Email:

Principal Investigator Regulation & Guidance Documents

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