University of Delaware
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Protocol Review and Approval Procedures

IRB Review Types

The University of Delaware (UD) requires that ALL research activities involving human subjects, bio specimens and/or tissue samples from humans, and/or private identifiable data be reviewed and approved by the IRB prior to their start. All submissions to the UD IRB must be made using IRBNet. Depending on the research proposed the IRB may issue different types of review as prescribed in the pertinent regulations and policies:


Exemptions

There are six defined categories of research exempt from the regulatory requirements imposed by the “Common Rule’. Exempt review determinations MUST be made by the IRB office and require the submission of a research protocol to 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.

Exemption 2 does not apply to children except for research involving observations of public behavior when the investigator does not participate in the activities being observed.

(3) Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior that is not exempt under category 2, 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.

(5) Research and demonstration projects that are conducted by or subject to the approval of department or agency heads and that are designed to study, evaluate, or otherwise examine (a) public benefit or service programs, (b) procedures for obtaining benefits or services under those programs, (c) possible changes in or alternatives to those programs or procedures, or (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, (a) if wholesome foods without additives are consumed, or (b) 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.

Exempt reviews are conducted as projects are submitted. Review times may vary depending on the overall volume of projects to be reviewed by the IRB at any given time. In most cases exempt reviews are completed within two weeks from the submission date. A project determined exempt does not require annual continuing reviews. Informed consent forms of projects determined to be exempt will not be stamped by the IRB. The IRB office should be consulted about proposed changes that could affect the exempt classification.

Expedited Review

Expedited review procedures may be used for certain research activities described in the federal regulations. Expedited reviews are done by one or more experienced reviewers designated by the chairperson from among members of the IRB. Projects approved by the expedited review process are subject to the same regulatory requirements as those approved on a full board review and must be periodically reviewed by continuing review before the expiration date set on approval (no longer than one year since approval). Informed consent forms associated with projects reviewed by expedited review will be stamped by the IRB with the approval and expiration dates. IRB-stamped documents are posted in IRBNet after approval and must be used when obtaining the informed consent of research participants. Protocols eligible for expedited review are evaluated on a rolling basis as they are submitted to IRBNet. Review times for expedited reviews vary depending on the total IRB submissions load at any given time and may take on average about two weeks from the time of complete submission.

(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 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.

(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.)

(6) Collection of data from voice, video, digital, or image recordings made for research purposes.

(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.)

(8) Continuing review of research previously approved by the convened IRB as follows:

(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.

(9) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (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.

Full Board Review

Review of non-exempt research that does not qualify for expedited review or that may present more than minimal risk to the subjects must be reviewed at a convened meeting of the University’s IRB. At the University of Delaware (UD) the IRB meets once every month and investigators proposing new protocols are usually invited to attend the IRB meeting to present their research and address any questions the Board members may have. Students having protocols reviewed at a convened meeting and presenting to the IRB must be accompanied by their faculty advisor.

The meeting dates for the IRB as well as the submission deadline for protocols to be considered for full board review at each month’s meeting are set well in advance and can be found in the Research Office Calendar of Events. The number of protocols to be reviewed at each meeting may be limited due the constraints of time and the complexity of other items on the agenda. Protocols will be accepted for review in the order received. If the board is not able to review a protocol in a particular month, it will be given priority for review in the following month.

Investigators submitting new projects are normally invited to attend the IRB meeting to present their project to the Board and answer any questions or concerns IRB Members may have. The results from the meeting are later communicated to the PI and any conditions the IRB may have set before approval can be effective will be addressed then. If a student-led new project is to be reviewed by the full board the academic advisor responsible for the student and project must accompany the student to the meeting.

Projects approved at a convened full board meeting must be periodically reviewed by continuing review before the expiration date set on approval and no less than once a year. Informed consent forms associated with projects reviewed at a full board will be stamped by the IRB with the approval and expiration dates. IRB-stamped documents are posted in IRBNet after approval and must be used when obtaining the informed consent of research participants.

Administrative Review

In addition to the types of review listed above the IRB may provide administrative reviews when appropriate. Administrative reviews are used in cases in which the University of Delaware needs record of research with human subjects in which UD is engaged but for which review and approval are not issued by the UD IRB. This is the case, for example, when UD investigators are part of a research team performing research at another institution. Depending on the nature of the research and the collaboration arrangement UD IRB may rely on the review and approval from the other institution’s IRB. UD keeps record of that reliance via an administrative review.

All UD investigators involved in collaborative research with human subjects must consult with UD IRB and submit that proposed effort to the UD IRB regardless of other IRB reviews sought after.