IRB Application Guidelines
The Pace University Institutional Review Board (IRB) is mandated by the Federal Government and is appointed by the President of the University. Its purpose is to review and certify the ethical acceptability of all research involving human participants conducted at Pace University and by its employees. All studies, except certain projects, must be approved by the Pace University IRB. This includes all studies conducted by Pace students, faculty, and staff either on or off campus, as well as all research by outside investigators on Pace students, faculty, and staff through the auspices of Pace University. To receive approval, follow the instructions below. Note, before you can submit your proposal and associated materials, you must first determine the level of review through which your project will be processed. Below are brief descriptions of the four levels of research projects:
1. Class Projects / Workshops / Teaching Evaluations. For these projects, implied (verbal or cover letter) consent may be acceptable and no IRB packet need be submitted. Generally, most master’s theses, dissertations, and independent research projects would not fall into this category.
a. Key characteristics of such studies:
i. Participants are subjected to no risk
ii. Results are not submitted for publication consideration by a refereed journal or conference
iii. The investigator is responsible for maintaining all participant safeguards as outlined in these instructions
b. Examples of such studies:
i. Classroom projects not to be submitted to a refereed journal or conference
ii. Evaluation of teaching techniques
iii. Evaluation of student performance
iv. Market research (not to be submitted to a refereed journal or conference)
v. Journalistic surveys (the results of which are presented journalistically and not to be submitted to a refereed journal or conference).
2. Exempted Studies. Participants are subjected to no risk. Implied (verbal or cover letter) consent may be acceptable. Investigators must submit an application packet. A detailed description can be found below.
3. Expedited Studies. Participants are subjected to very low risk. Signed consent is required and the investigator keeps signed consent forms. Investigators must submit an application packet. A detailed description can be found below
4. Full Review Studies. Participants are subjected to some risk or the project involves populations with special consent considerations (e.g., prisoners, minors, or individuals who are not legally competent). All externally funded studies must receive full review. Investigators must submit an application packet.
How Do I Know What Level Of Application To Submit?
Below are detailed descriptions of the Exempt and Expedited review categories. If your study does NOT fall into either of these categories, then it must undergo a Full Review. After deciding which level of review your study requires, complete the necessary forms in the application packet. The level of review will dictate which forms need to be completed and the number of copies submitted.
1. Research Projects that May Qualify for Exemption Status
Below is a description of research projects that may qualify for exempted review process.
If an investigator believes that his/her project qualifies for exemption, he/she should submit one copy of the completed signed Proposal Form (included in application packet) and associated materials. A designated member of the IRB must "concur" that the project qualifies for exemption. An investigator cannot exempt him/herself. Exemptions and/or expedited approvals may not be requested in person or by telephone. A research project cannot start until after the "concurrence" by a designated member of IRB. Retroactive "concurrence" or review cannot occur. If identifiers that can be linked directly to an individual research subject (Names, Social Security Number, Hospital Admission Number, Specimen Number, etc.) are to be collected, the research project does not qualify for Exemption and the investigator must submit the project for Expedited or Full Board review (see below).
A. Exemption Categories
Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from review by the IRB:
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, or
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’ 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.
Note. When a study uses subjects who are MINORS, category 2 only applies as follows: Studies using educational tests involving minors as subjects are exempt. Studies using survey or interview procedures with minors as subjects are NOT exempt. Studies using observations of public behavior involving minors are NOT exempt unless the investigator does NOT participate in or contrive the activities being observed.
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 category 2 above, if:
a. the human subjects are elected or appointed public officials or candidates for public office; or
b. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
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. (Note: To qualify for this exemption the data, documents, records, or specimens must be in existence before the project begins.)
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:
a. public benefit or service programs, or
b. procedures for obtaining benefits or services under those programs, or
c. possible changes in or alternatives to those programs or procedures,
d. possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies if:
a. wholesome foods without additives are consumed, or
b. 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.
2. Categories of Research That Qualify for Expedited Review Process
An expedited review procedure consists of a review by the IRB chairperson and one or more experienced IRB members designated by the chairperson. The applicability of this review is as follows:
A. Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
B. The categories in this list apply regardless of the age of subjects, except as noted.
C. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
D. The expedited review procedure may not be used for classified research involving human subjects.
E. IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or full--utilized by the IRB.
F. Categories one (1) through seven (7) pertain to both initial and continuing IRB review.
1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(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.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(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 children1, 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.
3. Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a nondisfiguring 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.
4. 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.
5. Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch 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.)