The Brookdale Community College Institutional Review Board (IRB) is responsible for protecting the rights and welfare of human subjects who participate in research activities conducted by College faculty, staff or students. The IRB is also responsible for safeguarding the rights and welfare of members of the College community who participate in research conducted by those outside of the Brookdale community (see Board Policy and Board Regulation).
Unless the research is considered “exempt” (defined below under “Exempt Research”), any faculty, staff, or student who would like to engage in research involving the use of human subjects must have the project reviewed and approved by the IRB. Researchers not affiliated with Brookdale Community College who conduct research with Brookdale students, faculty members, or staff members also must have their research projects approved by the IRB. This policy applies to all non-exempt research regardless of methodology (e.g., surveys, interviews, observational studies, experiments).
Individuals requesting authorization to conduct research must complete Brookdale’s “Application for the Use of Human Subjects.”
Application for the Use of Human Subjects
Categories of Review
There are two categories for IRB review: Expedited and Full Committee Review. These categories are based on an evaluation of the risks and benefits of the study and protection of confidentiality of participants. Researchers must submit the “Application for the Use of Human Subjects” and the IRB Chair will decide which type of review is appropriate.
IRB approval is required before data collection can begin. The IRB cannot approve a proposal submitted after research is initiated. Brookdale’s IRB meets regularly throughout the academic year. Proposals qualifying for Expedited Review are reviewed on an ongoing basis
Studies which involve no more than minimal risk to the participants may be eligible for an expedited review process. 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)). Expedited review will be conducted by the IRB chairperson and one or more IRB members designated by the chairperson to conduct the review. The IRB member(s) conducting the expedited review may approve a research project; however, the reviewer(s) may not disapprove the research. Instead, the reviewer(s) will refer any research protocol which the reviewer(s) would have disapproved to the full committee for review.
Full Committee Review
Research that involves more than minimal risk, recruits from special populations, seeks waivers from informed consent procedures, or lacks the guarantees of confidentiality, must apply for full review. Studies in which a guarantee of anonymity cannot be provided, will require participants be provided with the opportunity to sign an Informed Consent Statement. The full review process can only occur at regularly scheduled meetings of the IRB, and the application must fully address all the requirements for submissions prior to consideration.
In accordance with the Federal Policy for the Protection of Human Subjects, certain research activities may be exempt from review by the IRB.
Research that Qualifies for Exemption from Federal Regulations for the Protection of Human Subjects – Code of Federal Regulations, Title 45 CFR 46.101
Click here for link to electronic Code of Federal Regulations concerning the Protection of Human Subjects
45 CFR 46.101 (b)(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
45 CFR 46.101 (b)(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
45 CFR 46.101 (b)(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
45 CFR 46.101 (b)(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
45 CFR 46.101 (b)(5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
45 CFR 46.101 (b)(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Exemptions at 46.101(b)(1) and (b)(3) through (b)(6) are applicable to research studies that use children as subjects. The exemption at 46.101(b)(2) regarding educational tests is also applicable to research involving children as subjects. However, the exemption at 46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research involving children as subjects, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed (45 CFR 46.401 (b)).
The following research activities do not qualify for exemption:
- Surveys or interviews of children or minors (subjects under the age of 18).
- Research studies that use prisoners, pregnant women, the cognitively or mentally impaired, or other “vulnerable” subjects.
- Recorded audio or taped data that presents potential harm to subjects if revealed.
- Studies in which data, documents, or records are labeled in such a manner that subjects can be identified, directly or indirectly, through identifying links (e.g., codes).
- Research studies that involve more than minimal risk to subjects.
- Surveys or interviews collecting sensitive data such as illegal activities, sexual orientation or behavior, memories of physical abuse, etc., that may be painful or embarrassing to reveal.
- Studies involving deception where an investigator does not disclose the true purpose of the research.
- Observational studies involving sensitive aspects of subjects’ behavior or in settings where subjects have a reasonable expectation of privacy.
Contact the Chair of the Institutional Review Board (below) if the exemption status of proposed research is unclear.
Institutional Review Board Members
Dr. Laura Longo (Director, Institutional Research & Evaluation) firstname.lastname@example.org
Members (There are currently two vacancies):
Dr. James Crowder (Professor, Biology) email@example.com
Dr. Eugene DeRobertis (Professor, Psychology) firstname.lastname@example.org
Ms. Lisa Hailey (Professor, Engineering & Technology) email@example.com
Ms. Eleanor Glazewski (Registrar) firstname.lastname@example.org
Dr. David Wiseman (Professor, Psychology) email@example.com