Forms, Policies & Procedures

Here you will find a repository of forms, policies and procedures related to research at the University of Delaware. This repository draws on sources throughout campus to provide quick and easy access to these resources in a variety of formats, such as html, MSWord and Adobe PDF. We encourage you to explore and use the tools provided to narrow your search by word, resource type or category in order to learn more about the content that governs research at UD.
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RO Forms, Policies, and Procedures Search 2019

Animal Subjects in Research

For Forms, Policies and Procedures pertaining to Animal Subjects in Research and other resources

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Conflict of Interest
Contracts and Grant Management
Effort Certification
Export Regulations (ITAR/EAR/OFAC)
Human Subjects in Research
Intellectual Property
Internal Funding
Material Transfer
Reporting Misconduct
Research Administration
Research Agreement Templates
RO Forms, Policies, and Procedures Search 2019
Forms, Policies and Procedures (36 Procedures Entries)
Procedure: Human Subjects in Research
Administrative Review
Procedure

Administrative Review

Please review the material carefully and if there are any questions, please refer to the Regulatory Affairs page.

In addition to the types of review listed above, the Institutional Review Board (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.

 

Procedure Details:

OWNER: UD Research Regulatory Affairs

RESPONSIBLE OFFICE: Research Office

Procedure Source Open Procedure



Procedure: Conflict of Interest
Conflict of Interest Disclosure Procedure
Procedure

Conflict of Interest Disclosure Procedure

Log in to the Conflict of Interest (COI) Disclosure webform

  • The form describes the different categories of significant financial interest (SFIs) that are required to be disclosed. A table of examples below is provided as a reference. Please know this is not an all inclusive reference, rather, just few examples for illustrative purposes.
  • If answering ‘Yes’ to any of the listed questions, a pull down menu of information required will show. Please provide enough detail to facilitate its assessment.
  • COI web forms will be automatically routed to the chair or direct supervisor and the dean for review and approval.

Faculty and professional staff must complete a new COI disclosure every year, even when they do not have any SFI to disclose. COI disclosures must be submitted, via web form, on an annual basis or within 30 days of any change to previous disclosures. Please click on the link below, and login using your UDNet ID and password. If the link does not take you directly to the form, look for “Conflict of Interest Disclosure Form” under the tab “Blanks.”

Significant Financial Interest (SFI) Must Be Disclosed Does NOT Need To Be Disclosed
Publicly traded entity(ies) Any remuneration from the entity during the previous 12 months that, when aggregated, exceeds $5,000; and/or any equity interest that represents more than 5 percent ownership in a single entity Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles
Non-publicly traded entity(ies) Any remuneration during the previous 12 months received from the entity that, when aggregated, exceeds $5,000; and/or any equity interest  
Intellectual property(ies) Royalties, inventions, discoveries and patents under NOT assigned to UD Royalties, inventions, discoveries and patents under assigned to UD through Policy 6-6, and/or Policy 6-7
Consulting activity(ies) Any arrangements that involve a consulting agreement, or other outside professional activities Seminars, lectures, teaching engagements or income from service on advisory committees or review panels sponsored by a federal, state or local government agency, or an institution of higher education
Entity(ies) related to employee’s institutional responsibilities Participation in, or personal sponsorship from, any entity that invests in, or provides financial support for, activities related to the employee’s University areas of responsibility.  
Commercial enterprise(s) An appointment as an officer, director or any other managerial position in a commercial enterprise; participation in the day-to-day operations, including serving on the scientific advisory board, of a commercial enterprise.  
Potential conflict(s) of interest Situations where students are directed into research areas or other activities from which the employee intends to realize personal financial gain.  
Reimbursed or sponsored travel   Travel reimbursed or sponsored by a federal, state or local government agency, or an institution of higher education

 

Related Links

 

Procedure Details:

OWNER: Research Office

RESPONSIBLE OFFICE: Research Office

Procedure Source Open Procedure



Procedure: Conflict of Interest
Conflict of Interest Management Procedure
Procedure

Conflict of Interest Management Procedure

  • If a COI is determined to exist, a COI management plan is to be developed by the chair and/or dean in agreement with the employee.
  • Please use the template for the COI management plan.
  • Examples of conditions or restrictions that might be imposed to manage a COI include, but are not limited to:
    1. Public disclosure of the conflict (e.g., when presenting or publishing affected research);
    2. Appointment of an independent monitor capable of taking measures to protect against bias resulting from COI;
    3. Change of personnel or personnel responsibilities, and/or modification of the research plan;
    4. Reduction or elimination of a financial interest;
    5. Severance of relationships that create the conflict(s).
  • In addition, please see a detailed guidance for the development of COI management plans in the context of SBIR/STTR awards.
  • Additional information on UD’s COI disclosure and management procedures can be found in the UD COI training module.
  • Further details on reporting requirements specific to PHS-funded research can be found in the Financial Conflict of Interest (FCOI) tutorial provided by NIH.
  • Inquiries concerning Institutional Conflict of Interest should be directed to udresearch@udel.edu

Related Links

NIH Conflict of Interest Tutorial

 

Procedure Details:

OWNER: Research Office

RESPONSIBLE OFFICE: Research Office

Procedure Source Open Procedure



Procedure: University
Cost Accounting Standards Guidelines
Procedure

Cost Accounting Standards Guidelines

The University of Delaware, as an Institution of Higher Education, must comply with a number of regulations and guidelines that restrict the ways in which sponsored funding may be spent. This document is intended to clarify the federal constraints regarding the direct and indirect charging of expenditures to federal awards. It is also intended to provide instructions regarding how to charge costs that are determined to be unallowable, as those charges must never be charged to a federal award.

Related Links

Online Guidelines

 

Procedure Details:

OWNER: Research Office

RESPONSIBLE OFFICE: Research Office

Procedure Source Open Procedure



Procedure: Effort Certification
Effort Certification Procedures
Procedure

Effort Certification Procedures

Each department assigns an effort administrator who has the procedural responsibility to oversee the reports for that department.

A. Each department assigns an effort administrator who has the procedural responsibility to oversee the reports for that department.

B. Reports are required from every employee whose salary is either directly charged to a sponsored project or used as match/cost sharing for a sponsored project during a particular effort reporting period.

C. For faculty on academic contracts, there are three effort reporting periods. Period 1 includes effort provided during the fall semester of the academic year. Period 2 includes effort provided during the spring semester, and Period 3 includes summer research activity performed during the months of June through August. The following chart describes the three periods for academic faculty: Click to view the sample chart.

D. Following each reporting period, a web based electronic application will produce web views for review. This application will allow interaction (via web journal) to modify transactions through cost transfer submissions. Every certification must be reviewed by a designated Effort Administrator (each unit has one assigned staff member for this role) and the employee personally (unless that employee has terminated or retired from employment with the University in which case an employee with suitable means of verification evaluates effort in lieu of the particular employee). If an employee has an active HR status but is not capable of certifying their own report, the report may be completed by providing certifications (with suitable means of verification) from both the Effort Administrator and the Effort Manager or another Research Office

designee.

E. To facilitate accuracy in initial payroll allocations, the Labor Allocation Module (LAM) allows for timely changes made to an employee’s payroll distribution plan. A LAM calculator exists to assist in the accuracy of percentages to distribute.

F. It is expected that all certifications will be in “completed” status within 90 days of the end of the reporting period. Electronic copies are retained in the Research Office for the retention period required by the sponsored agreement, usually three years after the closeout or final payment of the project.

G. Email notification will be sent to effort administrators listing reports 40 days old in an effort to remind administrators of this responsibility. Notification of delinquent reports still outstanding beyond the 90 day certification period and again at 120 days past the last day of the effort certification period will escalate to the Department Chair, Assistant Dean and Dean. If any reports remain incomplete 150 days past the end of a reporting period, notification will be sent to the Associate Deputy Provost for Research Administration for review and action as necessary. If any reports remain incomplete 180 days past the end of a reporting period, notification will be sent to the Deputy Provost for Research & Scholarship for review and action as necessary. The effort administrator is responsible for completing these reports. Cost disallowances on sponsored projects resulting from the failure to complete an effort report will be removed from the sponsored project to a non-sponsored project.

H. In the event that an error was made during the routing process, the research office has the authority to create revised effort reports which must be completed within 30 days of release. These will be stamped with ‘[REVISION]’ so as to identify the report as such. In order to request a revision the effort administrator must have an adequate justification. Any changes must comply with all other UD policies and federal regulations.

University of Delaware Effort Certification Procedures

I. Routing is as follows:

a. Research Office creates the report (in batch three times annually, or one at a time as needed) (report is now in ‘UNSENT’ status)

b. Effort Administrator reviews and ‘forwards’ to employee (report is now in ‘IN PROGRESS’ status

c. Employee reviews and either clicks yes, I agree (‘review and certify’), or no I do not agree (‘forward’), and the system will require a comment stating what is wrong with the report. Either way it is routed back to the effort administrator.

d. Effort administrator selects ‘review and certify’ (if approved by employee in c.) or takes necessary action to correct the errors identified by the employee (if not approved in c.).

e. If approved in c and ‘review and certify’ in d., the system will set the certification report to ‘COMPLETE’status.

f. Once action is taken in step ‘d’, effort administrator will ‘forward’ back to the employee until the employee is satisfied that this report reflects the effort expended during that effort reporting period.

Revised July 2013

*If employee is terminated or otherwise incapable, someone with suitable means of verification may act as a substitute.Employee will REVIEW AND CERTIFYProxy* will REVIEW AND CERTIFY for otherwise incapable employeesEmployee supervisor * will REVIEW AND CERTIFY for Terminated employeesEA FORWARDS to Effort ManagerWith request for exceptionEffort Manager REVIEWS & CERTIFIES

 

Procedure Details:

OWNER: Research Office

RESPONSIBLE OFFICE: Research Office

Procedure Source Open Procedure



Procedure: Human Subjects in Research
Exemptions
Procedure

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.
  6. 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.

     

    Procedure Details:

    OWNER: UD Research Regulatory Affairs

    RESPONSIBLE OFFICE: Research Office

    Procedure Source Open Procedure



Procedure: Human Subjects in Research
Expedited Review
Procedure

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.
  10.  

    Procedure Details:

    OWNER: UD Research Regulatory Affairs

    RESPONSIBLE OFFICE: Research Office

    Procedure Source Open Procedure



Procedure: Export Regulations (ITAR/EAR/OFAC)
Export Compliance Program Manual
Procedure

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 retransfer 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
URC– University Research Counsel
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

 

Procedure Details:

OWNER: Research Office

RESPONSIBLE OFFICE: Research Office

Procedure Source Open Procedure



Procedure: Safety
Fire Prevention/Fire Protection Programs
Procedure

Fire Prevention/Fire Protection Programs

The University of Delaware Fire Prevention/Fire Protection Program was established to protect students, employees, and visitors from the perils of fires, explosions, hazardous gas releases and other types of emergencies which may cause injury to persons or damage to University facilities. This program is designed to ensure the University of Delaware is in the forefront of fire safety by maintaining compliance with Federal Laws, State of Delaware Fire Prevention Regulations and local laws governing basic life safety and building protection.

RESOURCES

Questions regarding the fire prevention/fire protection program may be addressed to Kevin McSweeney or call 302-831-6847.

 

Procedure Details:

OWNER: Environmental Health & Safety

RESPONSIBLE OFFICE: Environmental Health & Safety

Procedure Source Open Procedure



ASSISTANCE

Compliance Hotline
Phone: (302) 831-2792

UD Research Office
210 Hullihen Hall
Newark, DE 19716
Phone: (302) 831-2136
Fax: (302) 831-2828
Contact us

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