Other than those studies specifically listed and qulaify for Exempt and Expedited levels of review, these research studies are subject to a full committee review. Applications for full board review are reviewed at a convened meeting of the IRB. Studies assigned to full board review are reviewed by members ahead of time, and then discussed at the meeting. The Committee then votes on whether or not to approve the study. Investigators are requested to attend the scheduled Board meeting to make a brief presentation about the protocol and answer any questions the Board may have.
General examples of research conducted at UMBC to help plan a study may be found here.
Student investigators performing independent research or conducting senior theses, master's projects and doctoral dissertation research - please review the application and review information found here.
The following are instructions for preparing an application for Full Board Review:
2) List all members of the research team (if applicable) who will be involved in the study. If not known at the time of the application, these names may be forwarded to the ORPC when hired. All members must have completed the CITI training before engaging participants in the study.
3) Complete the below appropriate forms that are applicable to your project; at the minimum complete the Application for Approval of Use of Human Participants and Informed Consent documents. When completing the application forms, please keep the use of jargon or technical terms at a minimum. Otherwise, provide an explanation of these terms within the body of the proposal. Review of protocols are performed by someone who may not be familiar with the investigator's field or discipline. Be sure to follow all instructions on the forms.
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When completing an Application for Approval of Use of Human Participants for full board review:
a) provide an evaluative summary of relevant literature on the topic of the protocol. If adverse effects have been documented, indicate how the research addresses or attempts to prevent such effects. Complete citations of prior research and, If possible, copies of relevant articles must be included with the protocol application.
b) provide an evaluative summary if the proposed research includes invasive procedure and indicate which databases have been consulted (e.g., Medline). Investigators are required to summarize these findings, including findings of adverse effects and steps to be undertaken prevent such events from occurring in the protocol.
c) provide a list of three experts in the investigator's field who can independently evaluate the proposal and assist the IRB in the review process.
4) Electronically submit the protocol and any accompanying documents to firstname.lastname@example.org. Full board protocols must be received no later than four (4) weeks prior to a regularly scheduled IRB meeting (see the latest schedule here). The ORPC prefers applications submitted in MS Word format, but Adobe Acrobat versions will be accepted also. Please do not submit “hard-copy” or paper documents.
Please be sure to include the applicable pages with the signature of the investigators. A scanned version as a PDF document is acceptable. If that's not possible, fax that page (and that page only) to the ORPC at (410) 455-3868. Protocol applications will not be processed until this face page is received. Copies of approval documentation from collaborating institutions, which must accompany the protocol submission, may be faxed if electronic versions are not available.
Investigators will be notified of the IRB's decision of approval by the ORPC following the scheduled meeting.