Full Board application instructions

Full Board Review

Applications for full board review are reviewed at a convened meeting of the IRB. Review at this level depends on the level of potential risk to subjects, if the research project involves more than minimal risk or is not covered by the expedited review categories, detailed in the Application for Approval of Use of Human Participants. Questions of interpretation may be directed to the Human and Animal Protections Research Office (HARPO@umbc.edu).

The following are instructions for preparing an application for Full Board Review:

1) Complete the Collaborative Institutional Training Initiative (CITI) training program

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 Human and Animal Protections Research Office when hired. All members must have completed the CITI training before engaging participants in the study.

3) Download and 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. If applicable, download the waiver of written informed consent request.

· Application for Approval of Use of Human Participants

· Instructions for developing a consent form

· Blank Consent Form

· Parent Consent (permission) Form

· Waiver of written informed consent request

· Instructions and format for assent

4) This research is reviewed at a convened meeting of the IRB; twelve copies of the protocol, informed consent document and any accompanying documents (tools, questionnaires, etc.), must be submitted to the IRB Support Office four weeks before a scheduled meeting. Electronic submission of full board review protocols will not be accepted; please forward all documents to HARPO, 5523 Research Park Drive, Suite 310 Baltimore, Maryland 21228.

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. Therefore, make a notation on your calendar to attend.

Student researchers take note: you must complete the application form, sign and forward to your faculty advisor for review and signature before the submitting to the Human and Animal Protections Research Office . It is expected the faculty advisor will review the application before submission to the IRB. His/her signature on the application indicates the appropriate review has taken place. By signing, the faculty advisor accepts responsibility of the student's activities during the course of the project.

Investigators will be notified of the IRB's decision of approval following the scheduled meeting.

Protocols involving more than minimal risk, defined as: "where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or test". [45 CFR 46.102(i)], require additional information from investigators.

Investigators must, 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). A suggested list of Internet-based resources are found below; investigators are encouraged to use the appropriate resources on hand. 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.

Last updated 04/28/2008