Institutional Review Board

Overview

Increasingly, institutions receiving federal dollars for grant related research on human subjects for data collection and analysis are being required to oversee the procedures for carrying out the College's commitment to protecting human subjects involved in the research. This is accomplished through an Institutional Review Board whose role is to review proposed research projects that involve the use of human subjects; ensure that the individuals involved in the project are treated ethically; ensure that all subjects are provided with substantial information about the study and consent to be a subject in the study; and that all private information will be handled with confidentiality. The IRB is authorized to review, approve, require modifications in, or disapprove research activities conducted by or through the College using human subjects.

The IRB does not assume the role of evaluating the soundness of the proposed research study, the merits of the research design, nor the potential contribution of the research to the scholarly literature. Rather, the IRB is charged with evaluating each project's compliance with ethical standards in regard to issues such as informed consent, confidentiality, and any risk to the participants.


Membership of the IRB

The IRB is composed of at least 5 voting members with varying backgrounds and expertise in special areas to provide complete and adequate review of the research. Committee members should possess not only broad specific competence sufficient to comprehend the nature of the research, but also other competencies necessary for judgments as to acceptability of the research in terms of STCC regulations, relevant law, ethical standards, and standards of professional practice. Consultants may be used to review proposals for which additional expertise is needed. The IRB must include both men and women, at least one member whose primary concerns are in science areas, one whose primary concerns are nonscientific areas, and at least one member who is not otherwise affiliated (either directly or through immediate family) with STCC.


Membership Training

Those who agree to participate on the IRB board will require formal online training. The training is a brief tutorial and will typically take 10 - 15 minutes to complete. I will email everyone a link to the tutorial in the future. IRB members must then complete the Training Verification Form and forward to the IRB Chair (myself) for recordkeeping purposes.


Types of IRB Review

There are four categories of IRB Review:

  1. Exempt Research Review
  2. Expedited Review
  3. Full Committee Review
  4. Continuing Review

The majority of research conducted at community colleges requires either exempt, expedited or continuing review.


Exempt Review

1. Research conducted in established or commonly accepted educational settings involving normal educational practices, such as: (a) research on regular and special education instructional strategies; (b) research on the effectiveness of or the comparison among instructional techniques curricula, or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects' response outside the research reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

Generally, if the project is expected to require an exempt research IRB review, the principal investigator completes an exempt protocol form briefly describing the participants, the procedures to be used for data collection, whether data will be confidential or anonymous, disposition of the data, who will have access to the data, and actual text for the informed consent form to be signed by participants.

**Exempt research need not be reviewed by the full IRB, but only by the chairperson who reviews the documentation, signs the form indicating approval, and returns it to the Principal Investigator/Project Director for filing and submittal**

Exempt review is not appropriate when:
* Subjects are under the age of 18, or
* Subjects are fetuses, pregnant women, or incarcerated individuals

If the research involves one of the vulnerable populations above, an expedited or full review may be required.


Expedited Review

Research activities that present no or minimal risk to human subjects and involve any of seven specific categories of procedures may be eligible for an expedited review. "Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the 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 tests" (45 CFR 46.102 (i)). The expedited review process is similar to the exempt review process. The PI submits an expedited review form to the IRB Chairperson. The IRB Chair signs off on the form after determining whether or not the research constitutes full review. The Chair returns to the PI for filing and submittal. The US Department of Health and Human Services provides seven categories of research procedures that may be eligible for expedited review. A majority of the research conducted at community colleges involves no or minimal risk to subjects and falls into categories five, six, and seven of expedited research because it is:

  • Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
  • Collection of data from voice, video, digital, or image recordings made for research purposes.
  • Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural believes and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

**Expedited research need not be reviewed by the full IRB, but only by the chairperson (myself) who reviews the documentation, signs the form indicating approval, and returns it to the Principal Investigator/Project Director for filing and submittal**


Full Review

A review of the proposed research by the full IRB must be conducted on research activity involving more than minimal risk to vulnerable human subjects. Human subjects include: minors, mentally disabled, elderly, high school students, and prisoners.

The principal investigator/project director submits a full review protocol form to the IRB committee. After review, the committee notifies the PI in writing of the committee's decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB disapproves a research activity, it must provide a written statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.


Continuing Review

Projects are generally approved for an initial period of three to five years, with the condition that updates of the projects will be submitted and approved in one year intervals. Annually, principal investigators complete and return to the IRB Chair a continuing review questionnaire. Principal investigators are notified of the action taken (e.g., approved, approved subject to restrictions, etc.)


Informed Consent Forms

The PIs of research projects, even those exempt from full IRB review, must comply with the requirements of informed consent. Informed consent helps assure that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether to participate or not. If subjects are below 18 years of age, the investigator needs written permission of parents or guardians. Human subjects involved in research activities must sign consent forms. The forms are kept on file by the Principal Investigator/Project Director.