Institutional Review Board

IRB Guidelines

Introduction

These Guidelines are intended to assist NCTC researchers, NCTC IRB members, and the Office of Institutional Research by answering some of the most frequently asked questions about human subjects research and briefly explaining the procedures involved in the IRB review process. These Guidelines also include a summary of the administrative rules relating to operation of the NCTC IRB.

If the information you are seeking is not contained in these Guidelines, please contact the IRB Chair or the Director of Institutional Research at the e-mail addresses or phone numbers listed on the IRB website.

What is research on human subjects?
The regulations define research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge." The regulations further clarify that "activities which meet this definition constitute research... whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities." (45 CFR 46.102(d))

Human subjects are living individuals "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." The following additional guidance is included in the regulations to help in determining whether the research involves human subjects:

• Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

• Interaction includes communication or interpersonal contact between investigator and subject.

• Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. (45 CFR 46.102(f))

Only projects meeting both definitions (research and human subjects) come under the jurisdiction of the NCTC IRB. All NCTC surveys conducted should be approved by the IRB, along with questions that will be used in focus groups.

Why is your research subject to review?
The federal Office for Human Research Protections (OHRP) has issued a Federal-wide Assurance (FWA) to NCTC. According to the terms of this assurance, it is NCTC's responsibility to reasonably ensure that the rights and welfare of human subjects are adequately protected in all human subjects research conducted at NCTC and all human subjects research conducted by NCTC faculty, staff or students at any other location.

Submitting an IRB Request

To submit a request or proposal for review by the Institutional Review Board, or to request more information on the process or potential supporting documentation, please send an Email to irb@nctc.edu.

IRB Membership

The Common Rule regulations specify that the NCTC IRB must have at least three members. The membership must represent a variety of backgrounds in order to promote complete and adequate review of the research activities commonly conducted by the institution. Also, the IRB must be sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.

In addition to possessing the professional competence necessary to review specific research activities, the IRB must be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. Therefore, the NCTC IRB must include persons knowledgeable in these areas.

The IRB must include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. Initial and continuing reviews of research requiring Full Board approval must be reviewed at a convened meeting of the IRB at which a majority of the voting members are present, including at least one non-scientific member.

Every nondiscriminatory effort should be made to ensure that the IRB does not consist entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. The IRB may not consist entirely of members of one profession.

The IRB is authorized to invite individuals with expertise in specific areas to assist in the review of issues that require expertise or perspective beyond or in addition to that available on the IRB. Although these individuals may attend meetings and take part in the discussion of research protocols, they may not vote. Prospective IRB members may also be invited to attend one IRB meeting to learn about the IRB review process, but they may not vote at that meeting. An investigator may be invited by the Chair to present additional information to the IRB members about a proposed study, but the investigator may not remain in the meeting for the deliberation and vote. Due to the confidential nature of the IRB proceedings, the IRB members, the IRB staff, an invited investigator, an ad hoc member invited for special expertise, and invited prospective IRB members are the only persons authorized to attend any convened meetings of the NCTC IRB."

NCTC Institutional Review Board 

• Dr. Magen Bunyard - Chair

• Dr. Roxanne Del Rio

• Erica Thompson

• Diane Neu

• Kate Richardson

• John Gonzalez

• Jennifer Beal