IRB’s Independent Institutional Review Board in Latin America

ESTERN Medical provides you with guidance over independent ethical review of your drug and/or device trials when review of protocols for the protection of human research subjects by an on-site board is not available across Latin America.

Independent IRB across Latin America has provided this service to a growing national clientele of investigators and sponsors.

ESTERN IRB guidance provides independent ethical review of your drug and/or device trials when review of protocols for the protection of human research.

The Independent IRB operates in compliance with federal regulations governing Institutional Review Boards set forth in 21 CFR Part 56, federal regulations governing informed consent set forth in 21 CFR Part 50, as well as ICH guidelines for good clinical practices. The Independent IRB can review studies for a single investigator or serve as a central IRB for multi-center trials across Latin America.

Confidentiality

The confidentiality of information contained in the documents submitted to the Independent IRB is carefully preserved. Protocols, investigator drug brochures, informed consent documents, IND’s, NDA’s, PMA’s IDE’s 510K’s safety reports, and other records are safeguarded in locked files, with access strictly limited to the IRB staff. In addition, each Board member signs an agreement to treat all reviewed material as confidential.

The overriding objective is to ensure that the privacy of individuals, industries and institutions involved in the protocol is respected.

Meeting Schedule

The IRB meetings are usually twice a month during the year. Specific meeting dates can be provided upon request. In addition to the schedule above, ad hoc sessions are convened to meet a client's special needs.

Turn-Around Time

The protocol, IDB, informed consent, and any proposed advertising should be submitted to the IRB no later than one week before the next scheduled IRB meeting. After review by the board, the investigator and/or sponsor will be notified of the outcome within 24 hours. Expedited reviews are handled within 24-48 hours.

Quick IRB Review

The IRB meets twice a month or special meetings can be arranged. Approval letter for full-board review items are sent approximately 48-72 hours after the IRB meeting, and expedited review items are sent approximately 24-48 hours from their submission.