Helpful Links for Researchers - HS IRB
A compilation of resources for IRB researchers.
- Tufts University
- Tufts Medical Center
- State
- Federal
- Historical Documents Relating to Human Subject Research
- Tips on Informed Consent
- ORI Training Videos
- IRB Quarterly Newsletters – Do you know someone who would like to receive IRB News? Send their name and e-mail address to irboffice@tuftsmedicine.org and we will add them to the IRB distribution list.
- Convened IRB Meeting Dates
- Continuing Review Submission Deadlines
Tufts University
- Office of the Vice Provost for Research
- Social, Behavioral and Educational Research (SBER) IRB (Medford Campus)
- Institutional Animal Care and Use Committee (IACUC)
Tufts Medical Center
(Please note: user must be connected to Tufts Medical Center intranet to view website)
- Grants and Contracts Office, Research Administration
- Tufts Medical Center Formulary
- Typical Exposure Document: This document lists typical effective whole body radiation doses from common medical imaging procedures, including their related increase in lifetime cancer risk and the period of natural background radiation that delivers the equivalent radiation dose.
State
Federal
FDA
- U.S. Food and Drug Administration (FDA)
- FDA Final Rule on IND Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans (September 2010)
- FDA Human Subject Protection/Bioresearch Monitoring Initiative Update (September 2010)
- FDA Guidance on Financial Disclosure by Clinical Investigator
- FDA Guidance on Investigator Responsibilities (October 2009)
- FDA Guidance on Recruiting Study Subjects
- FDA Guidance on Screening Tests Prior to Study Enrollment
- FDA Federal Regulations
- “Off-Label” Use of Marketed and Investigational Use of Marketed Drugs, Biologics, and Medical Devices
OHRP
- Department of Health and Human Services
- DHHS Code of Federal Regulations
- Office for Human Research Protections (OHRP)
- Office for Human Research Protections (OHRP) – Guidance Topics by Subject
- OHRP Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues
Other
Regulatory and Clinical Research Organizations
- Public Responsibility in Medicine and Research (PRIM&R)
- Regulatory Affairs Professionals Society (RAPS)
- Association of Clinical Research Professionals (ACRP)
- The Institutional Review Board – Discussion and News Forum
- Society of Clinical Research Associates (SoCRA)
Historical Documents Relating to Human Subjects Research
Tips on Informed Consent
- OHRP Informed Consent Form Checklist
- OHRP Human Subject Regulations Decision Charts
- NIH IRB Review Standards
- FDA Informed Consent
Office of Research Integrity (ORI) Training Videos
The Office of Research Integrity (ORI), has developed two interactive video simulations which are fun and informative ways to train individuals and groups about promoting research integrity, protecting human research participants, and avoiding questionable clinical research/laboratory practices. The videos will allow you to assume the role of one of four characters and make choices that will determine the outcome of the story:
These video simulations are not required and do not replace the CITI education requirements.