- Health Care, Drugs & Insurance
How to Join the NCI CIRB
This article is written for clinical research sites who currently utilize a local Institutional Review Board.
The National Cancer Institute Central Institutional Review Board (CIRB) has been established over ten years ago to try to alleviate most of the administrative work required by local Institutional Review Boards (IRB).
All of the responsibilities of the CIRB and the local IRBs are outlined in the NCI CIRB Handbook for local sites located on the NCI CIRB website (please find a link below this article). The application process is also located in this handbook. Read more to learn about some of the requirements in order to participate in the CIRB initiative...
Institutions that enroll patients into Cooperative Group clinical trials are encouraged to apply to the CIRB by completing the NCI CIRB enrollment form. They must meet eligibility requirements such as having their own IRB with a Federal Wide Assurance Number. Enrollment assistance can be found on the NCI CIRB website: http://www.ncicirb.org/
There are responsibilities required of local IRBs if an institution chooses to utilize the NCI CIRB:
- The local IRB must ensure that
research is conducted at their institution under the local requirements in the
best interest of protecting human subjects.
- All local serious adverse events, unanticipated problems, and protocol violations are managed under the local IRB.
- Local IRBs must also conduct facilitated reviews. There are
specific guidelines as to how the facilitated review must be done all stated in
the CIRB handbook.
During facilitated reviews, the local IRB reviews the protocol and they make small changes to the consent form under local policies and state laws and must be compliant with HIPAA regulations. Translation of the consent form is done by the local IRB. Any significant changes to the consent form may require full board review. If an investigator wants to enroll a prisoner on a cooperative trial they must undergo full board review of the protocol at their local institution.
My Other Hubs
- How to Report a Serious Adverse Event
This guide is written for CRCs or other people who want to learn how determine if the event is considered a serious adverse event (SAE) or an adverse event (AE). In clinical studies, the investigator is...
- How to Advance as a Clinical Research Professional
It is never too late to consider a different career path in the clinical research industry. The multitude of choices is based on a persons experience level and education. The room for advancement and earnings potential is high in this field. Read mo
- How to Write SOPs Using the FDA Guidance Document
The U.S. Department of Health and Human Services Food and Drug Administration developed a procedural document Finalized October 2009 titled Guidance for Industry -Investigator Responsibilities ...