IV - 2.10 - Policies on Institutional Review Board (Human Subjects)

I. Purpose

The purpose of the Institutional Review Board ("IRB") is to:

A. Review applications requesting permission to conduct research involving human subjects for compliance with Bowie State University (BSU) guidelines and federal regulations regarding the protection of human subjects (Title 45 Code of Federal Regulations Part 46); and

B. Assist applicants with the actions taken to meet BSU's guidelines and federal regulations regarding the protection of human subjects.

II. Applicability

A. Scope:

This policy applies to:

1. Individuals or groups planning to conduct research that affects humans affiliated with BSU.

2. Campus-based individuals or groups submitting a proposal for external funding.

3. Campus-based individuals or groups conducting research off-campus.

B. Eligibility:

1. Faculty, staff and students affiliated with BSU.

2. Individuals or groups not affiliated with BSU who wish to conduct research involving BSU's constituents.

C. Responsibility:

The BSU IRB is responsible for the implementation of this policy. The IRB meets monthly during the academic year to review applications.

III. Guidelines and Standards

Researchers must submit the following:

A. A statement of project approval from the academic department of the researcher;

B. Approval of the faculty advisor in writing (if a student is conducting research);

C. One (1) original and nine (9) copies of the typed IRB Proposal Submission Form;

D. One (1) original and nine (9) copies of the proposed Consent Form; and

E. One (1) original and one (1) copy of the typed IRB Proposal Submission Form, if the project is exempt from IRB review.

IV. Results

Applicants will receive written notification of approval or suggestions for modification of the proposal. Applications that have not been approved may be resubmitted.

V. Exceptions

Research that does not involve human subjects is exempt from this policy. Categories for exempt research are listed on the IRB Proposal Submission Form.

VI. Definitions

(Source: 45 CFR 46.102 Definitions)

Institutional Review Board: A committee established to review and approve research protocols involving human beings. This committee operates under the rules and regulations of the Code of Federal Regulations, 45 CFR 46, Protection of Human Subjects (Revised June 18, 1991) and the policies and procedures of BSU. The IRB is comprised of faculty representatives from departments with graduate programs where research is conducted with human subjects, the Director of the Office of Research and Sponsored Programs, a representative from the School of Graduate Studies, a community representative and other individuals as deemed necessary by the IRB or the Dean of the School of Graduate Studies. Decisions are made based on a two-third (2/3) majority vote of those in attendance. A tie is broken by the Chair.

IRB means an institutional review board established in accordance with and for the purposes expressed in this policy (45 CFR).

IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.Human Subject: A living individual about whom an investigator (whether professional or student) conducting research obtains:

1. data through intervention or interaction with the individual; or

2. identifiable private information.

Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Sponsored Research: All research and development activities that are sponsored by federal and non-federal agencies or organizations. This term includes activities involving training of individuals in research techniques where such activities utilize the same facilities as other research, for the purposes of this document, shall be combined with sponsored research under the function of organized research.

Effective Date: 05/01/1999 Revised Date: 06/25/2012