INFORMATION FOR
The IRB reviews all research involving human subjects to ensure that risks to participants are minimized and balanced with the benefits to society. The extent of IRB review is based on the level of risk and defined terms within federal regulations.
Minimal risk is defined as 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.
There are three levels of IRB review:
Research activities may be classified as exempt when the only involvement of human subjects falls within one or more of the Federally-defined categories, the study represents not greater than minimal risk to its participants.
Category 1
Research conducted in established or commonly accepted educational settings that 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, including:
Category 2
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:
Category 3
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:
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; or
Category 4
Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
Category 5
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 and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs.
Category 6
Taste and food quality evaluation and consumer acceptance studies:
*Note: These exempt review categories do not apply to research involving prisoners or involving children, except for Category 1, and Category 2 in the following circumstances:
Federal regulations permit the use of two additional categories of exempt review that apply only to research covered under a broad consent process. Adopting the use of broad consent procedures requires an infrastructure for the secure storage of Biospecimens that is not currently available university wide. In addition, the tracking requirements are burdensome for both the investigator and the IRB. Because of this, WPUNJ does not utilize the broad consent position at this time and therefore:
Exempt Categories 7 and 8 are not included in the list of exempt categories. There are several other options for researchers using Biospecimens which these research protocols can be reviewed under.
Federal regulations allow certain research activities to be reviewed by a subset of the IRB (Chair and/or their designee). This review type occurs on a rolling basis and may be submitted for initial review at any time.
Research activities may be reviewed through Expedited Review when the only involvement of human subjects falls within one or more of the Federally defined review categories (OHRP 1998) and the study represents no greater than minimal risk to participants.
Clinical studies of drugs and medical devices only when condition (a) or (b) below is met:
(a) Research on drugs for which an investigational new drug application 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.); or
(b) Research on medical devices for which
(i) an investigational device exemption application 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:
Prospective collection of biological specimens for research purposes by noninvasive means.
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.)
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.
Category 7
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.)
Review categories 8 and 9 only apply to continuing review
Category 8
Continuing review of research previously approved by the convened IRB as follows:
Category 9
Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories (2 - 8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
In the case where the risk to a study participant may be greater than the risks encountered in everyday life or participants fall into certain vulnerable subjects categories, the study must be reviewed by the IRB at a full board meeting. The meeting must include a majority of board members.
Research activities that do not meet the definition of research involving human subjects and activities that are not reviewed by the IRB considered “non-human subjects research” and are not reviewed by the Instructional Review Board.
Non-human subjects determinations are conducted and issued by the IRB upon request from Investigators wishing to obtain a written determination of if their activities require IRB review.
IRB applications are reviewed on a rolling basis as received. The duration of the review process will vary according to the protocol review category and specifics of the research project.
1. Protocol Category Exempt Review – a minimum of two weeks; submissions are reviewed on a rolling basis.
2. Protocol Category Expedited Review - a minimum of three weeks; submissions are reviewed on a rolling basis.
3. Protocol Category Full Board Review – protocol must be submitted to the IRB a minimum of two weeks prior to the next occurring scheduled IRB meeting.
