R E S O U R C E S
Principal IRBs FAQs
Educational resources for irb members & Staff
Please CLICK HERE for access to The Office for Human Research Protection Training and Self Assessment for IRB members and staff.
The Office for Human Research Protections has created an excellent list of resources to help IRB administrators and staff learn about and succeed in their role in protecting research subjects.
Please CLICK HERE for access.
Please CLICK HERE for all Office for Human Research Protection sponsored Research Community Forums (RCFs) and Educational Workshops for 2020.
Protecting research participants is a shared responsibility!
Interested in learning more about the importance of protecting research participants and avoiding research misconduct?
CLICK HERE to check out this interactive video simulation from The Office of Research Integrity, The Research Clinic.
Please CLICK HERE for Revised Common Rule Educational Materials from the Office of Human Research Protection.
Please CLICK HERE for the Recommendations on the Notice of Proposed Rulemaking entitled: "Federal Policy for the Protection of Human Subjects," from the Office of Human Research Protection.
Please CLICK HERE for the GCP Comparison of FDA and HHS Human Subject Protection Regulations.
resources for Participants
Considering joining a clinical trial but have questions? Please contact us! CLICK HERE.
To review frequently asked questions by research participants or potential participants, CLICK HERE.
Please CLICK HERE for a list of helpful links for research participants.
resources for audits
There are two types of audits in research; routine audits and for-cause audits.
Routine audits are often performed by the IRB, Sponsor, FDA or internally.
The goal of an audit is to review and verify the ethical conduct of research for human participants, to see if the study protocol was followed, check the integrity of the data and the state and federal regulations. Most audits review the informed consent, the consent process, regulatory documents, source documents to ensure protocol compliance and drug accountability records. The internal auditor may want to review the site’s SOPs and the research team’s credentials and documentation of training.
For-cause audits may be conducted during the monitoring process if a Sponsor has continued documentation of possible noncompliance and concerns over the ethical conduct of the study by the P.I.
The Sponsor may contact the FDA and report these concerns which could result in a for-cause
FDA audit. Research participants could also report to the FDA their concerns and this could also result in an FDA for-cause audit.
The IRB and the Sponsor can also perform a for-cause audit. Items reviewed in a for-cause audit are very similar to those reviewed in a routine audit.
HHS 45 CFR 46 Protection of Human Subject, please CLICK HERE.
FDA E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry, please CLICK HERE.
FDA 21 CFR 50 Protection of Human Subjects, please CLICK HERE.
regulatory guidance and Helpful Links
The U.S. Department of Health and Human Services YouTube Channel, CLICK HERE to view or subscribe!
The U.S. Food and Drug Administration YouTube Channel, CLICK HERE to view or subscribe!