Institutional Review Board (IRB)
Please log onto IRB Net to submit protocols.
The IRB is guided by ethical principles outlined in the Belmont Report and legal mandates outlined in the Code of Federal Regulations Title 45, Part 46 [PDF].
The Suffolk University Institutional Review Board's (IRB) mission is to protect the rights and welfare of people who take part in research at Suffolk University. Federal regulations and University Policy require prospective review and approval of all human subject research conducted by faculty, staff, or students. The goal of the IRB is to ensure the safe and ethical treatment of human subject’s research participants through the review, approval, modification, or disapproval of research applications submitted by faculty, staff, or students. The IRB is responsible for communication, record keeping, reporting, monitoring, education of the campus community about ethical issues, and the overseeing of all research activity .
The IRB is a committee comprised of faculty, staff, and non-affiliated members who are charged with reviewing all human subjects research conducted by Suffolk University faculty, staff and students in accordance with current HHS and FDA regulations and guidelines
An application must be filled out and submitted via IRBNet, even if the research proposal originates at another institution or organization seeking partnership or a co-investigator. The IRB is available to consult with faculty, staff, or students in the early stages of project development regarding the review process and categories of review.
Is it human subject research?
Follow this decision tree [PDF] to determine if your project meets the human subject research criteria.
A research activity may be declared exempt if it is considered low-risk. "Exempt" means review by one IRB member, sometimes in consultation with others.
The Code of Federal Regulations (45 CFR 46.101 b) sets out the following situations where research may be exempt from regular IRB review listed below:
- Research, conducted in established or commonly accepted educational settings, which specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: (i) information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (ii) any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement or reputation; (iii) the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review.
- Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met: (i) the information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (ii) any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or (iii) the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
- Secondary research for which consent is not required: secondary research uses of identifiable private information or identifiable bio specimens, if at least one of the following criteria is met: (i) the identifiable private information or identifiable bio specimens are publicly available; (ii) information, which may include information about bio specimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; (iii) the research involves only information collection and analysis involving the investigators' use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of "health care operations" or "research" as those terms are defined at 45 CFR 164.501 or for "public health activities and purposes" as described under 45 CFR 164.512(b); or (iv) the research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with applicable federal privacy standards found in the E-Government Act, Privacy Act and the Paperwork Reduction Act.
- Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the head of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waives of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended. Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessibly Federal website or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
- 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.
- Storage or maintenance for secondary research for which broad consent is required: storage or maintenance of identifiable private information or identifiable bio specimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §__.111(a)(8).
- Secondary research for which broad consent is required. Research involving the use of identifiable private information or identifiable bio specimens for secondary research use, if the following criteria are met: (i) broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable bio specimens was obtained in accordance with §__.116(a)(1) through (4), (a)(6), and (d); (ii) documentation of informed consent or waiver of documentation of consent was obtained in accordance with §__.117; (iii) an IRB conducts a limited IRB review and makes the determination required by §__.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent references in paragraph (d)(8)(i) of this section; and 479; (iv) the investigator does not include returning individual research results to subjects as part of the study plan. The provision does not prevent an investigator from any legal requirements to return individual research results.
If your project does not meet an exempt review, it may be eligible for an expedited review. "Expedited" means review by the IRB chair and one or more experienced reviewers.
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
a. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
b. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
a. (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
b. from other adults and children , considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
- Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
- 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). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
- 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 beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
Full Board Review
A full board review is required for research studies not eligible for exempt or expedited review at a scheduled IRB meeting. In short, research that is judged to involve more than minimal risk, or involves protected populations such as children, prisoners, or disabled individuals, must undergo a full board review. Individuals intending to conduct research that requires a full board review should allow ample time to complete the review process. Full board protocols should be submitted prior to the deadline for the full review. Submission dates.
The following categories of research require full IRB approval:
- Projects for which the level of risk is determined by the IRB Chair to be greater than minimal.
- Projects that involve the intentional deception of subjects, such that misleading or untruthful information will be provided to participants.
- Projects that involve sensitive or protected populations (such as children or cognitively disabled individuals).
- Projects that plan to use procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial, or legal).
If you are unsure what category your research falls under please contact ORSP at 617-725-4169 for help.
Convened IRB meetings discuss protocols up for full review and determine whether protocols should be approved, approved with modifications required, or not approved. The IRB chair will e-mail the principal investigator the results of the full review.
How to Submit to the IRB
Visit our Investigators Tool Box to access application forms and instructions.
After completing your application and documents, submit them through IRBNet, our electronic submission platform IRBNet is a suite of tools, accessible via the National Research Network, that brings electronic IRB protocol management, online submissions and many other important research oversight features to Suffolk University’s research community. Instructions on how to use IRBNet, can be found here.
Suffolk University offers the Collaborative Institutional Training Initiative (CITI) program as its human subjects research ethics training curriculum. All individuals working directly with human subjects or data that can be linked back to individual subjects must complete human subjects research training requirements every three years. Research protocols will not be reviewed prior to the completion of training by all study team personnel.
To complete CITI you must first register by visiting the training log-in webpage, clicking on the ‘Register Here’ link and affiliating yourself with Suffolk University as the Participating Institution. Initial training requirements can be met by completing the Basic Course for Social and Behavioral Research Investigators. Full instructions can be downloaded with the CITI Instructions Walkthrough [DOC].
Through the review process and post-approval monitoring the IRB evaluates the integrity of the informed consent process as well as procedures that safeguard the confidentiality of personally identifiable information associated with the collection of data on research participants.
- External Requests to Recruit Suffolk University Students, Faculty or Staff as Research Subjects [DOC]
- Access IRBNet