Forms, Policies & Procedures

Exempt Determination Tool

A tool to help determine if research is eligible for exempt status under the Common Rule.

Exemptions

There are five 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.

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.

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

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Procedure Details:

OWNER: UD Research Regulatory Affairs

RESPONSIBLE OFFICE: Research Office

Procedure Source Email https://research.udel.edu/forms-policies-procedures/?entry=51461

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 eight week period and collection may not occur more frequently than two 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 eight week period and collection may not occur more frequently than two 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.
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Procedure Details:

OWNER: UD Research Regulatory Affairs

RESPONSIBLE OFFICE: Research Office

Procedure Source Email https://research.udel.edu/forms-policies-procedures/?entry=51462

Export Compliance Program Manual

The U.S. export control system generally requires export licensing for defense items, for items that have both commercial and military applications, and for exports to sanctioned persons and destinations. U.S. national security, economic interests and foreign policy shape the U.S. export control regime. The export laws and regulations aim at achieving various objectives, such as preventing the proliferation of weapons of mass destruction, advancing the U.S. economic interests at home and abroad, aiding regional stability, implementing anti-terrorism and crime controls, and protecting human rights.

These controls generally restrict the export of products and services based on the type of product and the destination of the export. In both the defense and high-technology sectors, the U.S. Government tightly regulates the export not only of equipment and components, but also of technology. Technology includes technical data, such as blueprints and manuals, as well as design services (including the transfer of “knowledge”) and training. U.S. laws assert jurisdiction over U.S.-origin equipment and technology even after it is exported (i.e., restricting the re-export or re- transfer to third parties). In addition to general export licensing, the United States maintains economic embargoes against a number of countries whose governments consistently violate human rights or act in support of global terrorism. Such embargoes bar most transactions by U.S. persons with these countries. Finally, the U.S. Government maintains lists of Specially Designated Nationals or persons and entities that are barred from conducting export business because of previous activities.

Three principal agencies regulate exports from the United States: the U.S. Department of State Directorate of Defense Trade Controls (“DDTC”) administers export control of defense exports; the U.S. Department of Commerce Bureau of Industry and Security (“BIS”) administers export control of so-called “dual-use” technology exports; and the U.S. Department of the Treasury Office of Foreign Assets Control (“OFAC”) administers exports to embargoed countries and specially designated entities.

DEFINITIONS:

APRRA– Associate Provost for Research & Regulatory Affairs
BIS– Department of Commerce Bureau of Industry and Security
CCL– Commerce Control List
CJ– Commodity Jurisdiction
DDTC– Department of State Directorate of Defense Trade Controls
EAR– Export Administration Regulations
ECCN– Export Control Classification Number
EO– Empowered Official
DRRA – Director of Research Regulatory Affairs
ITAR– International Traffic in Arms Regulations
OFAC– Department of the Treasury Office of Foreign Assets Control
RO– Research Office
PI– Principal Investigator
SDN– List Specially Designated Nationals and Blocked Persons List
TCP– Technology Control Plan
USML– United States Munitions List
UD– University of Delaware

Export Control Certification for I-129 Form

This export regulations form deals with standards from the United States federal government regarding the transport of research material and project staff across national borders. If there are any questions regarding these standards, please review the Research Office’s Regulatory Affairs page.

Export Controlled Project Staff Eligibility Form

This export regulations form deals with standards from the United States federal government regarding the transport of research material and project staff across national borders. If there are any questions regarding these standards, please review the Research Office’s Regulatory Affairs page.

Export Controls and Trade Sanctions

1. POLICY

   The University shall comply with EC&TS regulations governing applicable Sponsored Projects, as provided in the University of Delaware Export Compliance Program Manual. By delegation from the Provost, the Deputy Provost for Research & Scholarship serves as the final authority in any dispute resolution, and designates the Associate Deputy Provost for Research & Regulatory Affairs the EO.

   1. The EO is responsible for EC&TS policies and procedures and will oversee the EC&TS compliance program including the signing of Technology Control Plans (TCPs) (which prescribe required training and handling), license and disclosure requests, auditing of controlled Sponsored Projects and reporting of any EC&TS violations to the appropriate agencies.
   2. The EO develops appropriate procedures and is responsible for implementing and maintaining EC&TS compliance procedures including TCP management, auditing and documentation.
2. SCOPE OF POLICY
   This policy addresses the requirements to ensure compliance with U.S. Export Control and Trade Sanctions (“EC&TS”) regulations governing research at the University of Delaware (“UD” or “University”) and applies to all University departments, units, faculty, staff and students.

Related Links

• Export Controls and Trade Sanctions Memo PDF
• Export Regulations Web Policy
• Export Regulations for Online Courses Web Policy

The complete policy and more can be found on the General Counsel’s web site.

Export Controls and Trade Sanctions Memo

MEMO

While federal regulations restricting the export of goods and technologies related to national security interests have been in existence for decades, these regulations have become more restrictive and enforcement has become increasingly rigorous in the years following the events of September 11, 2001. The purpose of this memo is to remind the University community that the University of Delaware must comply with all U.S. government export control regulations. While the vast majority of the work carried out on our campuses falls within the several exemptions to export licensing requirements, it is nonetheless necessary for researchers to be aware of how these laws may apply to their activities.

It is important to recognize that the U.S. Government defines exports to include not only tangible or “physical” items such as biological materials, chemicals, and equipment, but also intangible information, which may include research data and ideas. Furthermore, an export is defined not only as the actual physical shipment, but also includes electronic and voice transmissions out of the United States (e.g., email to colleagues at foreign institutions or even a phone call) as well as the release of technology to foreign nationals within the U.S. These exports are controlled by multiple federal agencies including the Department of State, the Department of Commerce, and the Department of the Treasury. Violation of the export control regulations can result in significant institutional and personal penalties including fines of up to $1,000,000 per violation, incarceration for up to 10 years, and loss of future exporting privileges.

The University of Delaware remains committed to the preservation of academic freedom. Fortunately most, but not all, research activities on campus fall under the “fundamental research exemption,” which provides that basic research activities NOT subject to publication or access restrictions will not be subject to export controls. Other exemptions apply to technology and information shared in the conduct of teaching activities on campus and to information already generally publicly available. However, the export regulations are complex and continually changing, and it is important to consider each activity on an individual basis.

The Research Office will be happy to assist members of the university community with export control compliance. Please contact Dr. Cordell Overby, Associate Deputy Provost for Research and Regulatory Affairs (overbyc@udel.edu), if you need help in assessing the impact of the regulations on your activities or to schedule training on this important issue.

Related Links

• Export Controls and Trade Sanctions Web Policy
• Export Regulations Web Policy
• Export Regulations for Online Courses Web Policy

Export Regulations

University research is subject to U.S. Export Control laws that protect national security and trade, including the International Traffic in Arms Regulations (ITAR), implemented by the U.S. Department of State, and the Export Administration Regulations (EAR), and the Commerce Control List (CCL) implemented by the U.S. Department of Commerce. The Office of Foreign Asset Control (OFAC), which is part of the U.S. Department of the Treasury, also is responsible for administering and enforcing economic and trade sanctions against certain nations, entities, and individuals.

These regulations control the export of strategic information, technology, and services to foreign countries as well as to foreign nationals inside the United States. Temporary export of controlled items, including laptop computers with controlled technologies, such as encryption software or technical project data also falls under the regulations. Failure to comply with these laws can result in serious consequences, including penalties of up to $1 million in fines and up to 10 years in prison per violation.

It is important for members of the University of Delaware research community to be aware of the University of Delaware Policy on Export Controls (Research Policy 6-17). Additionally, the following tools are available to help researchers become more aware of the issues surrounding Export Controls and to assist them in determining when the regulations are applicable:

• The Memo on Export Controls and Trade Sanctions gives general information about the Export Control regulations as they apply to the academic research community
• The Travel with or Transportation of Research- Related materials and Data Memo explains the issues and steps for compliance when traveling.
  Note: University personnel traveling to OFAC sanctioned/embargoed countries, which at the time of this writing include Cuba, Iran, North Korea, Syria, and Sudan, should contact the Research Office – Associate Deputy Provost for Research and Regulatory Affairs, Cordell Overby, overbyc@udel.edu , or University Research Counsel Sean Hayes, hayes@udel.edu – for guidance prior to travel. UD personnel should travel with a “clean” laptop that contains software and data that are not export controlled. In this way, previously utilized and generated export controlled software and unpublished research data will remain at home or work and therefore are neither exported nor deemed-exported.
• The Export Control Decision Tree may be used to help determine if projects are subject to the Export Control Regulations and how to obtain further project-specific information to make sure the work remains in compliance with the laws.
• Our Export Control FAQ ‘s provide basic information to help you understand the Export Control regulations and how they might apply to you.

The Research Office will work with individual researchers to make all necessary checks of the ITAR, EAR, and OFAC regulations to determine when licensing is necessary for shipment or disclosure to foreign countries or nationals. Please contact Dr. Cordell Overby, Associate Deputy Provost for Research and Regulatory Affairs (overbyc@udel.edu) for assistance.

Related Links

• Export Controls and Trade Sanctions Web Policy
• Export Controls and Trade Sanctions Memo PDF
• Export Regulations for Online Courses Web Policy

Export Regulations for Online Courses

Online Courses

Export controls and trade sanctions must be considered and, unless specifically excluded, applied to online courses. As is generally the case with universities, UD online courses possibly may be excluded from export control and trade sanction regulations.

• Per EAR regulations, information and software that “are released by instruction in a catalog course or associated teaching laboratory of an academic institution” are not subject to the EAR. 15 CFR 734.3(b)(3)(iii). Please note that some encryption technology is excluded from this EAR exclusion.
• Per ITAR regulations, the definition of Technical Data subject to ITAR “does not include information concerning general scientific, mathematical or engineering principles commonly taught in schools, colleges and universities.” 22 CFR 120.10(b).2
• OFAC legislation provides in 50 USC 1702(b)(3):
  (b) The authority granted to the President by this section does not include the authority to regulate or prohibit, directly or indirectly—
  (3) the importation from any country, or the exportation to any country, whether commercial or otherwise, regardless of format or medium of transmission, of any information or informational materials, including but not limited to, publications, films, posters, phonograph records, photographs, microfilms, microfiche, tapes, compact disks, CD ROMs, artworks and news wire feeds.

  UD courses generally may be classified as “information and informational materials.” The online presentation does not alter this characterization. Therefore, pursuant to the OFAC legislation cited above, online courses typically are not OFAC-prohibited.

• Exclusions do not apply to all subject matter that may be presented in online courses. The provision of principles not commonly taught in schools, colleges and universities, defense services, ITAR technical data, encryption technology and nuclear technology may not be excluded from control. Online-course instructors of such topics shall complete the export control training found at: http://www1.udel.edu/research/swf/UD-export-controls-training/
• Online courses cannot be taught to students from OFAC-sanctioned countries without a license. Currently comprehensive or selective sanctioned countries include the Balkans, Belarus, Burunda, Central African Republic, Cuba, Democratic Republic of Congo, Iran, Iraq, Lebanon, Libya, North Korea, Somalia, Sudan and Darfur, Syria, Ukraine/Russia, Venezuela, Yemen and Zimbabwe. The list of sanctioned countries is updated periodically – https://www.treasury.gov/resource-center/sanctions/Programs/Pages/Programs.aspx.

Guidance for Foreign On-Line Education

*This column refers to foreign nationals of the identified nationality participating in on-line education in that country.
Sanctioned countries include the Balkans, Belarus, Burunda, Central African Republic, Cuba, Democratic Republic of Congo, Iran, Iraq, Lebanon, Libya, North Korea, Somalia, Sudan and Darfur, Syria, Ukraine/Russia, Venezuela, Yemen, and Zimbabwe. The list of sanctioned countries is updated periodically – https://www.treasury.gov/resource-center/sanctions/Programs/Pages/Programs.aspx.

Questions regarding UD online course compliance with export controls and trade sanctions should be directed to UDresearch@udel.edu.

Related Links

• Export Controls and Trade Sanctions Web Policy
• Export Controls and Trade Sanctions Memo PDF
• Export Regulations Web Policy

Extension Cords

1. PURPOSE
   To establish a uniform policy regarding the use of extension cords.
2. POLICY
   All extension cord use shall comply with NFPA 70 (National Electric Code).
   1. Extension cords shall not be used as a substitute for the fixed wiring of a facility, laboratory or shop.
   2. Extension cords shall not be used for permanent or semi-permanent installations, ie, must be less than 30 days. Exception: Extension cords designed for use with portable equipment.
   3. Extension cords shall be listed by the Underwriters’ Laboratory (U.L.) and bear the U.L. label.
   4. Extension cords shall be a minimum of 16 gauge copper wire and rated for not less than 13 amperes, shall be of the grounding type (three wire) and shall not be used in excess of their rated capacity.
   5. Extension cords shall be used only in continuous lengths without splice or tap. Terminals and insulation shall be free of defects such as cracked, split or nicked insulation; exposed wires; knots; burn marks; loose connectors; or other damage that may present a fire or electrocution hazard. Destroy any extension cords showing defects.
   6. Extension cords shall not be connected in series.
   7. Extension cords shall not be used in bathrooms. Extension cords used in wet or damp areas shall be connected to a ground fault interrupter device or GFCI circuit only.
   8. For three wire extension cords, the ground prong shall not be removed. Departments shall request the installation of three prong type wall outlets where not provided.
   9. Proper polarization shall be maintained at all times.
   10. For extension cords equipped with single plug-in capability, a multiple plug adapter may be utilized provided the adapter is U.L. listed and rated for not less than 125 volts/15 amperes. Multiple plug adapters are not otherwise permitted in conjunction with an extension cord.
   11. Extension cords shall not be covered by carpeting, clothing, furniture, or other objects that could prevent adequate air circulation and cooling of the cord.
   12. Extension cords shall not be tacked, stapled or otherwise affixed in semi-permanent or permanent manner. Major appliances such as refrigerators, television sets, or other devices drawing currents for starting motors shall not be connected to an extension cord.
   13. Multi-plug devices may be used for: computer equipment, televisions, stereos, radios and similar devices. They may not be used with refrigerators, microwaves, coffee pots, hot plates toaster ovens and similar devices. Multi-plug devices must be Underwriters Laboratory approved or approved by a similar nationally recognized testing laboratory and they must contain an integral circuit breaker.

For more information regarding this policy, contact either the Department of Environmental Health and Safety at extension 8475 or the Supervisor of Electrical Services at extension 2621.

The complete policy and more can be found on the General Counsel’s web site.

External Sponsorship and Grant

1. POLICY
   It is important that the long-range implications of the acceptance by the University of any external grant be carefully considered. In the past, the University has sometimes found itself in a position where the acceptance of these grants has resulted in serious budgetary commitments which extended far above and beyond the grant income. This has been particularly true in the case of federal, departmental, or program developmental grants which have involved continuing financial commitments for staff, equipment, and other items.
2. SCOPE OF PURPOSE
   To insure that acceptance of external grants by faculty members does not create unforeseen and unrealized financial burdens for the University.

ALL proposals and awards with the exception of those that fall within the limits of delegated authority must be approved and signed by the Vice Provost for Research or his or her designee.

The complete policy and more can be found on the General Counsel’s web site.