 The
Heartland IRB provides 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.
Since 1981, the Heartland IRB has provided this service to a
growing national clientele of investigators and sponsors. The
Heartland 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 Heartland IRB can review studies for a single
investigator or serve as a central IRB for multi-center trials.
Experience
Throughout its existence, Heartland IRB has reviewed
approximately 500 study protocols and has 80 years of combined
ethical review experience. The board brings knowledge and
integrity essential to the sensitive responsibilities of human
subject protection.
During the past 20 years, Heartland IRB has
developed expertise in the areas of:
Phase I-IV Drug Trials
- Analgesics
- Anesthetics
- Antibiotics
- Anti-Platelet
- Anti-Hypertensives
- Asthma
- Anti-Psychotics
- Cancer
- Cholesterol Lowering Agents
- Congestive Heart Failure
- Consumer Taste Test Trials
- Genetic Research Trials
- HIV
Multi-Center Trials
- Obesity
- Osteoporosis
- Post-Marketing Research Trials
- Schizophrenia
Audit History
Heartland IRB has been audited by the FDA several
times. The latest audits were held in May 2007 - with no
findings (no action indicated).
Confidentiality
The confidentiality of information contained
in the documents submitted to Heartland IRB is carefully preserved.
Protocols, investigator drug brochures, informed consent
documents, IND safety reports, and other records are safeguarded
in locked files, with access strictly limited to Heartland 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
Heartland IRB is meeting twice a month during the
year. Specific meeting dates can be provided as requested.
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 Heartland 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
To ensure timely study initiation, Quintiles
Phase I Services has designated Heartland IRB to perform all IRB
functions, which also has on-site administrative and management
staff located at the Quintiles site.
Heartland 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 each meeting,
and expedited review items are sent approximately 24-48 hours
from their submission.
For more information contact us at:
(913) 708-7575 or toll-free (800) 867-5211
Fax: (913) 708-xxxx
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