The BSU Institutional Review Board (IRB) Chair accepts research proposals involving the use of human subjects (primary research) or secondary research for review by the Board. No research project can begin until a written approval letter is received by the investigator from the BSU IRB Chair or co-Chair.There are three different types of review that can be requested depending on the type of study and the judgment of the IRB. These are as follows:
|II.||Expedited Review |
|III.||Full Board Review |
All proposal application submitted by faculty/student researcher based on type will be reviewed by the Board for either approval or denial. In accordance with the BSU IRB regulations and standard, the description of an exempt, proposal is clearly stipulated in the last page of the proposal application submission form. Type of research must be indicated in the application form; however, the IRB Chair determines the review category of a proposed research. This means that IRB decides a category under which a submitted proposal will be reviewed should a disagreement arise. Definitions: Proposed Research that are not Exempted from Review
1 Proposed research that involves a signed inform consent process, the project does not qualify for exempt review.
2 Proposed research that involves more than minimal risk to the potential subjects does not qualify for exempt review.
3 Proposals that involves the collection of data that contains identifiers that can be directly linked to individual research subjects, does not qualify for exempt review.
4 Proposals that involves collecting audiotape or videotaped data sets, does not qualify for exempt review.
5 Proposals that involves minors, prisoners, pregnant women, handicapped or mentally disabled persons, requires a full BSU Board review.
Expedited Review: A considerable circumstance might result in categorizing a proposal to be expedited such as serious ill-health (with doctor’s certification), relocation, and tragedy.
Full Board Review: A full review is conducted when a research proposal is using human subjects where a full survey is used (primary subject). All faculty/student researchers submitting proposals to BSU IRB should consider the identified definitions in determining the type of review they are requesting:
Definition of Human Subject: Human subject as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information (DHHS Regulations under 45CFR46.102 (f).
Definition of Research: Research is defined as any systematic investigation, including research development, testing, evaluation, designed to develop or contribute to generalizable knowledge (DHHS Regulations under 45 CFR 46 102 –f)
This definition therefore implies that Thesis or dissertation projects conducted to meet the requirement of a graduate degree are usually considered generalizable, and require IRB review and approval. A "systematic investigation" is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question. No research involving human subjects can be conducted without the written approval from the BSU IRB. If you are uncertain if your proposed research falls within the categories listed above, please contact Prof. Cosmas U. Nwokeafor at firstname.lastname@example.org or 301-860-3406 for assistance.
Submission Guidelines: For all research and research-related activities involving human subjects, please download the "BSU Proposal Application Form" under the "Forms" in the BSU Graduate School link. The proposal submission form also contains all application instructions, an "Exemption reasons" on page three to make sure you have a complete submission. The IRB requires a researcher to submit a completed three copies of the application form with all supporting documents to: Prof. Cosmas U. Nwokeafor. If you have any additional questions concerning the status of your submission, you may contact him at: 301-860-3406.
Please allow four weeks for a full committee review, and two weeks for an Exempt/Expedited review and/or notification of approval. A written e-mail notification with an approved/rejected letter will be promptly sent to the primary investigator/advisor for a student investigator through the e-mail address provided in the application form. Please allow four weeks for a full committee review. Be advised that a final approval must be received in a letter form from the Chair or co-Chair of IRB before your research can advance to another level.
Please be advised that the above specified timelines for proposal (protocol) approval are strictly dependent on the completion and receipt of all properly submitted application materials which includes (1) application form, (2) consent forms, (3) surveys, tests, and advertisements (where applicable), (4) approval notices from outside institutions (where applicable) and (5) a letter of advisor support, (6) reference page at the current stage of the research. Any Changes and/or modifications to the submitted proposal or any missing information will delay the review/approval process.