Institutional Review Board
Institutions participating in research on human subjects for data collection and analysis are 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 (IRB) 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, or disapprove research activities conducted by or through the College using human subjects.
In order to conduct research on STCC's campus or with STCC students, faculty, or staff, there must be a STCC faculty member (or appropriate level staff member) who leads the research locally (even if it is initiated off-site), completes the IRB forms, and is available to the IRB Chair and members. In this and other IRB documents, for the purpose of brevity, this local liaison is referred to as the Principal Investigator/Program Director (PI/PD). Also, in order to conduct research on the STCC campus or with STCC students/employees, it is expected that each member of the study staff with a substantive role will be trained in the ethics of human subject's research. At a minimum, the NIH PHRP course will be required (or evidence of completion of a similar training such as CITI). See link below.
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.
- Institutional Review Board Bylaws
- IRB Initial Application for Research Involving Human Subjects
- IRB Continue Review Closure
- IRB Modification Form
- Informed Consent Guidelines
- IRB Training Link to NIH Protecting Human Research Participants
Please submit all completed forms to Tracey Trottier, STCC IRB Chair at email@example.com.
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 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.
Those who agree to participate on the IRB board will require formal online training. IRB members must obtain a Training Verification Form and forward to the IRB Chair for recordkeeping purposes.
Types of IRB Review
There are three categories of IRB Review for new projects:
- Exempt Research Review
- Expedited Review
- Full Committee Review
Applicants are asked to submit the Initial Application form and the committee will make a determination concerning the appropriate type of review. The Chair of the Committee or their designee will be in touch to request more information if needed.
The majority of research conducted at community colleges falls either into the exempt or expedited categories. Research that continues for more than a year (or whatever duration less than a year that the IRB approves) will require a Continuing review. Any changes to the research or study personnel will require a Protocol Modification to be reviewed by the Chair or the Full Board.
There are six categories of Exempt review, but they can be distilled for our purposes into two categories:
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.
If the project is expected to require an exempt research IRB review, the STCC liaison/principal investigator (PI/PD) still needs to complete the full STCC Initial Application. A determination will be made by the Chair of the IRB (it does not require full Board review) and communicated back to the STCC PI/PD.
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.
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/PD submits an Initial Application to the IRB Chairperson. 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 who reviews the documentation, signs the form indicating approval, and returns it to the Principal Investigator/Project Director.
A review of the proposed research by the full IRB must be conducted on research activity involving more than minimal risk or research involving vulnerable human subjects. The latter include: minors, mentally disabled, elderly, high school students, and prisoners.
The principal investigator/project director submits a full review protocol with the Initial Application form to the IRB committee. After review, the committee notifies the PI/PD 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 will provide a written statement of the reasons for its decision and give the PI/PD an opportunity to respond in person or in writing.
Projects are generally approved for an initial period of one year. Annually, PI/PDs complete and return to the IRB Chair a Continuing Review form. PI/PDs are notified of the action taken (e.g., approved, approved subject to restrictions, etc.). It is important to start the continuing review process well in advance of the year anniversary (calculated as 364 days after the initial approval date). Projects that do not have an annual review within this time frame will be suspended and any data collected may have to be purged. It will be up to the STCC PI/PD to keep track of when the Continuing review must be completed.
Informed Consent Forms
The PI/PDs 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 or otherwise signify their willingness to participate and their understanding of the project. Approved consent forms are kept on file by the Principal Investigator/Project Director; only approved forms can be used.