What is the IRB? [+/-]
The Institutional Review Board (IRB) is an independent body consisting of a diverse group of health care professionals, scientists, and members from the local community. The IRB has the legal mandate to 1) advocate for the protection of the rights and welfare of human subjects who participate in research projects; 2) review and approve the scientific merit of research involving human subjects; 3) oversee the informed consent process; and 4) monitor ongoing biomedical and behavioral research studies. The United States Food and Drug Administration, the Department of Health and Human Services, and the State of Maryland empower the IRB to insure that all federal, state, and local regulations are met. These regulations represent minimal acceptable standards, and the IRB has the authority to require higher standards whenever human subject autonomy or safety appear not to be maximized. The IRB performs this critical oversight function to insure that all participants in research are treated justly, and with respect and benevolence.
What is the difference between IRB (A) and IRB (B) [+/-]
Due to work load and time constraints, the IRB was divided into two committees:
IRB (A) meets the 2nd Wednesday of the month and oversees human research for the following departments or divisions:
- Radiation Oncology
- Rehabilitation Medicine
- Orthopedic Surgery
- Women’s and Children’s Services
IRB (B) meets the 4th Wednesday of the month and oversees human research for the following departments or divisions:
- Patient Care Services
- Infection Control
- Medicine and Subspecialties
- Social Work
- Surgery and Subspecialties
What is the Administrative Review Board (ARB)? [+/-]
The ARB is charged with overseeing the financial aspects of all research conducted on LBH properties or patients. ARB responsibilities include: 1) Reviewing financial details of all LBH research activity and ensuring that all research costs are appropriately accounted for and reimbursed; 2) Identifying and evaluating potential conflict of interest scenarios and suggesting appropriate management solutions; 3) Ensuring that ancillary departments required to support research endeavors are aware of demands on personnel, equipment, and supplies, and that these resources are available and accessible when required by the research protocol; and 4) Ensuring that third party payers are not billed for any services provided during a clinical research study over and above the routine care normally provided in the absence of research.
If I miss the submission deadline, can we still be on the agenda for the next scheduled Administrative Review Board (ARB) or IRB meeting? [+/-]
Any new applications submitted after the deadline will be placed on the agenda for the following month’s ARB or IRB Meeting. Exceptions may be granted if patient welfare is an issue. The meeting schedules and deadlines are listed on the Department of Research website.
If I submit an IRB application do I have to submit an ARB application also? [+/-]
Yes, unless your study is determined by the ARB to warrant exempt status both applications must be submitted and approved before you can begin any research activity.
Where can I find the applications to submit a research study? [+/-]
When does CITI training need to be completed? [+/-]
CITI training will need to be completed prior to the Institutional Review Board approval.
The CITI training program can be found at http://www.citiprogram.org/. Create a username
and password and click on "LifeBridgeHealth" as the Participating Site. For more information click on CITI training program.
How do I know if my study requires full IRB review? [+/-]
You don’t. Each application must be evaluated by either the IRB chairman or his designee. In general, if your study is associated with greater than minimal risk, i.e., involving invasive procedures, investigational drugs or devices, multiple blood sample collections, or vulnerable populations including subjects under 18 years of age, pregnant women, or cognitively disabled subjects, then your study will certainly require full board review.
What determines whether the review of my study can be expedited or not? [+/-]
An expedited review is reserved for studies that pose no more than minimal risk to the participants, and do not utilize minors or other vulnerable participants. Medical record reviews and studies using questionnaires, surveys, and interviews may be eligible for expedited review. Although expedited reviews are typically done by one or two members of the IRB, and usually occur more rapidly than full board review, there are no guarantees that this will be the case.
I think that my study can be expedited but I’m not sure how this submission differs from a full board submission. [+/-]
It all comes down to the level of risk a human subject is potentially exposed to. An expedited study has minimal risk. This means that there are no serious adverse events anticipated beyond that which would normally be encountered in daily living. Studies involving observation, behavior, survey/questionnaire and routine psychological testing are usually considered minimal risk, as are studies involving venipuncture, exercise testing, EKG’s, and ultrasound scans. However, the subject population studied may affect review status, and studies focusing on potentially vulnerable subjects (e.g., pregnant women, children, or mentally-challenged individuals) may require full board review. To be on the safe side, the IRB chairman or his designee should always make the final determination as to the review status of any human subjects research project.
Can I submit an ARB application for a new study without signatures? [+/-]
No! The principal investigator, the chief of the department in which the research is being conducted, the department director, and any other directors of departments involved in the study. A vice president’s signature is also required, but only after the application has been approved by the ARB.
Who has to sign the IRB application before it can be submitted for review? [+/-]
The principal investigator and the chief of the department.
Should every Adverse Event be reported to the IRB? [+/-]
The LBH IRB only requires submission of internal Adverse Event (AE) Reports when the event is serious, unexpected, and related or possibly related to a study drug, biologic, or device. Otherwise the AE should be documented and included in your annual report. Deaths are an exception: All deaths must be reported, regardless of the relationship to study drug, biologic, or device or disease progression including those in long-term follow-up studies. However, there is one exception to the exception: Subject deaths occurring in non-interventional studies (i.e., surveys, interviews and observational-only studies) do not need to be reported.
Is it necessary to submit a copy of an advertisement that I would like to use for my study? [+/-]
Yes. Any information concerning a research study that is seen by the public via flyer, poster, newspaper, radio, or TV must be approved by the IRB. Remember that LifeBridge Health has video screens at various places in each facility and ads appearing on these screens must also be reviewed and approved by this committee. Those wishing to use LBH video screens must submit the ad in PowerPoint to the IRB, and should note the ad’s start and end date for viewing. Once approved by the IRB, the research office will make the final arrangements for its display.
Are sponsors allowed access to IRB written procedures, minutes and membership rosters? [+/-]
FDA regulations do not require public or sponsor access to IRB records. However, FDA does not prohibit the sponsor from requesting IRB records. The IRB and the institution may establish a policy on whether minutes or a pertinent portion of the minutes are provided to sponsors.
Are there any regulations that require clinical investigators to report to the IRB when a study has been completed? [+/-]
IRBs are required to function under written procedures. One of these procedural requirements [21 CFR 56.108(a)(3)] requires ensuring "prompt reporting to the IRB of changes in a research activity." The completion of the study is a change in activity and should be reported to the IRB. Although subjects will no longer be "at risk" under the study, a final report to the IRB allows it to close its files.