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Compliance

Conflict of Interest

What is a conflict of interest?

A conflict of interest in research is significant financial interests or other personal considerations that may compromise or could appear to compromise a researcher's professional judgment or integrity.

Who reviews financial disclosures?

The campus Conflict of Interest Committee is a panel of faculty members from disciplines across the campus. They review positive disclosures of financial interests to determine whether these interests constitute significant conflicts of interest that must be eliminated, reduced or managed before research support can be accepted. If they determine that the research support may be accepted, the Committee, Department Head and the PI then determines an appropriate strategy for management of any significant conflict.

What happens after University Personnel have completed and submitted the financial interest disclosure forms to the Office of Research?

Once your disclosure forms are completed and submitted to the Office of Research, a preliminary review of the forms will be performed to determined whether a financial conflict of interest exists. If the Office of Research  determines that an actual or potential financial conflict of interest exists, the disclosure will be referred to the Conflict of Interest Committee for further evaluation and a final determination.

Animals

What is Post Approval Monitoring?

Post Approval Monitoring is a thorough examination of key elements of an approved animal use protocol (laboratory, animal procedures, animal health monitoring records, training, use and handling of test articles, safety). The reviews are conducted to ensure animal subjects are cared for and used in compliance with the protocol.

What are the goals of the PAM process?

The primary goal of the PAM program is to ensure animal well-being and to maintain regulatory compliance. Associated with this, the process will facilitate the science by serving as a resource to the researchers. The PAM process is positioned to convey IACUC policies on matters of animal care and use, identify opportunities for improvement and make recommendations on how to achieve improvement. Ultimately, the PAM process will confirm that the manner in which animal procedures are performed and conducted under an approved protocol is consistent with what the IACUC approved.

What are the benefits that an Investigator may gain from the PAM process?

When scientific research involves animals, reliable and meaningful results depend on proper and consistent animal care and use. Animal protocols are reviewed and approved with the principles of humane care and use of animals in mind. Compliance with these principles is mandatory. Some benefits that may be gained from a PAM review, but are not limited to, are:

  • Increased understanding of the regulations that guide our research projects
  • Increased communication concerning Federal regulations and University policies
  • Access to an individual to clarify the Federal regulations and University policies

How does the PAM process protect my research?

The PAM process enables correction of protocol issues or procedural inconsistency, internally, so that regulatory agency inspectors are less likely to find problems. It is in the best interest of the IACUC, DU and researchers to correct any issues in this way.

What are DU’s obligations to regulatory bodies?

In response to increasing oversight and consequences imposed by regulators, PAM has become a standard practice in laboratory animal program oversight. The IACUC is responsible for conducting a continuing review of approved protocols in accordance with Public Health Service Policy (IV.C.5) and Animal Welfare Regulations (Sec 2.31(d)). Drexel’s Institutional Official must sign an Animal Welfare Assurance Statement for OLAW annually, promising that DU will conduct animal research in accordance with federal policy, and the Guide for the Care and Use of Laboratory Animals. In addition, DU must send a yearly record of its acquisition and disposal of animals by December 1st to the USDA. The USDA conducts unannounced inspections of animal care facilities and has the authority to stop research if it determines that investigators do not treat animals in accordance with the law. The records of the USDA reports and inspections are available to the public through the Freedom of Information Act.

Why do we need continuing AAALAC, International accreditation?

Many private funding sources strongly recommend that grantees receiving support have animal programs with AAALAC accreditation. It is generally recognized in the laboratory animal care and use community as commitment to excellence and an international symbol of quality. AAALAC accreditation requires that the program for animal care and use at Drexel meets the minimum standards required by law, but also that extra steps are taken to achieve excellence in animal care and use, which promotes scientific validity.

How are protocols selected for a PAM review?

The most common way is that protocols are selected from the pool of all approved protocols, randomly, based on risk criteria to some degree. Animal welfare risk factors include, but are not limited to; species, pain categories, survival surgery, food and fluid restriction, prolonged restraint, hazardous agent use, use of satellite facilities, breeding and previous compliance history. If a protocol has been selected for PAM review, it does not necessarily mean that something is wrong. Protocols can be selected for cause from a complainant and/or unexpected outcomes reporting.

How long will a PAM review take?

If documentation is complete and organized, the PAM checklist review will take approximately an hour or less. However, depending on the complexity of the protocol procedures, subsequent appointments may be required to observe procedures to complete a comprehensive assessment of the level of protocol compliance.

As the PI, what should I expect?

The PI/designee will be asked to provide records of the regulatory file, data collected and/or source documents that demonstrate the protocol is/was followed as approved. The QA/QI reviewer will ask questions about the protocol conduct and procedures. The PI or designee should report any problems or adverse events, if not already reported to the IRB. The scope of the review varies depending on the research and may include:

  • A tour of the clinic, unit , laboratory, or procedure spaces

What are the possible outcomes?

There are several outcomes that could result from a QA/QI review. They include, but are not limited to:

  • All procedures and documentation is compliant, no further action required
  • Minor deficiencies were identified and recommendations for resolution are made. These are communicated to the PI and/or designee at an exit briefing and outlined in a report sent to the PI from QA/QI / Office of Research. The PI will then send a response back to QA/QI with a plan and timeline to address the issues. QA/QI will verify implementation of the action plan.
  • Significant deficiencies were identified and recommendations for resolution are made. These are communicated to the PI and/or designee at an exit briefing and outlined in a report sent to the PI from the QA/QI/Office of Research. The PI will then send a response back to QA/QI with a plan and timeline to address the issues. QA/QI will follow up within a specified time frame to assure compliance.

When will I know the outcome?

The QA/QI reviewer will make every effort to communicate any concerns or deficiencies, and the severity level, at an exit briefing with the PI and/or designee. If this is not possible, the issue(s), recommendation for resolution, and timeline for completion will be sent in a report from the QA/QI/ Office of Research within 10 business days from the QA/QI review date.

When will I know the outcome?

The PAM reviewer will make every effort to communicate any concerns or deficiencies, and the severity level, at an exit briefing with the PI and/or designee. If this is not possible, the issue(s), recommendation for resolution, and timeline for completion will be sent in a report from the QA/QI/ Office of Research within 10 business days from the PAM review date.

Human

What is human subject QA/QI monitoring?

QA/QI Monitoring is a thorough examination of key elements of an IRB approved protocol. The reviews are conducted to ensure human subjects are safe and used in compliance with the protocol.

What are the goals of the QA/QI process?

The primary goal of the QA/QI program is to ensure a human subject safety, to maintain regulatory and institutional compliance, and support the strive for research excellence. Associated with this, the process will facilitate the science by serving as a resource to the researchers. The QA/QI process is positioned to convey IRB policies, identify opportunities for improvement and make recommendations on how to achieve improvement. Ultimately, the QA/QI process will confirm that the manner in which research is conducted under an approved protocol is consistent with what the IRB approved.

What are the benefits that an Investigator may gain from the QA/QI process?

Reliable and meaningful research results depend on proper and consistent processes that support regulatory compliance and human subject safety. Compliance with these principles is mandatory. Some benefits that may be gained from a QA/QI review but are not limited to are:

  • Increased understanding of the regulations that guide our research projects
  • Increased communication concerning Federal regulations and University policies
  • Access to an individual to clarify the Federal regulations and University policies

How does the QA/QI process protect my research?

The QA/QI process enables correction of protocol issues or procedural inconsistency, internally, so that regulatory agency inspectors are less likely to find problems. It is in the best interest of the DU, the IRB, and researchers to correct any issues in this way.

How are protocols selected for a QA/QI review?

The most common way is that protocols are selected from the pool of all approved protocols randomly based on risk criteria to some degree. Human subject risk criteria includes, but is not limited to complex interventional protocols, high enrolling protocols, researcher teams with high turnover rates, new PIs, or sponsored studies with the potential for FDA audits. If a protocol has been selected for QA/QI review, it does not necessarily mean that something is wrong. Protocols can be selected for cause from a complainant and/or unexpected outcomes reporting.

How long will a QA/QI review take?

If documentation is complete and organized, the QA/QI checklist review will take approximately an two hours or less (Checklist is available on website under study management tools). However, depending on the complexity of the protocol procedures and subject enrollment, subsequent appointments may be required to observe procedures to complete a comprehensive assessment of the level of protocol compliance.

What if the PI is unable to attend the scheduled QA/QI review meeting?

preferred option is to meet at a mutually agreeable time for both the QA/QI reviewer and the PI and research staff. If the PI is not able to attend, he/she may designate a representative for the QA/QI review.

Can I obtain informed consent over the telephone?

An oral approval over the telephone is not satisfactory. However, you can send the informed consent document to the legally authorized representative (LAR) of the subject and conduct the consent interview with the LAR by telephone when the LAR can read the consent as it is discussed over the telephone. If the LAR agrees, the LAR can sign the consent and return the signed consent document to the investigator. The consent document can be faxed before and after LAR signs the document.

Can the subject sign his own consent without a witness?

Yes. However, to be on the safer side, in general, many investigators obtain witness’s signature to make sure that the consent has been properly obtained.

Can we obtain consent with the use of electronic signatures?

Yes, but additional safeguards must be in place to validate the signature is authenticated.

 

Does the IRB ever waive consent?

Yes.  It depends upon several circumstances such as:

·         When the principle risks are those associated with a breach of confidentiality concerning the subject’s participation in the research (sensitive topics like drug abuse, sexual deviance)

·         The consent document is the only document linking the subject with research

·         Record or chart reviews

·         If the IRB is satisfied that the information contained in the files is not particularly sensitive

·         The research is no more than minimal risk

·         The waiver or alteration would not adversely affect rights and welfare of subjects

·         The results of study must be likely to bring social benefits of significant nature

·         You have devised procedures to protect the confidentiality of information to be collected

·         Your study could not be carried out if consent was required

 

During consent, should I discuss appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject?

To enable a rational choice to participate in the research study, you should discuss with the subject the range of alternate options that are available to them. Consent documents should briefly explain any pertinent alternatives to entering the study. But consent document need not contain an exhaustive list of options.   

How do I close out a study?

Complete the “FORM: Continuing Review Progress Report (HRP-212 embedded in the COEUS Lite platform), and attach all requested supplements.

Maintain electronic copies of all information submitted to the IRB in case revisions are required. If you fail to submit a continuing review form to close out Human Research, you will be restricted from submitting new Human Research until the completed application has been received. If the continuing review application for closing out a Human Research study is not received by the date requested in the approval letter, you will be restricted from submitting new Human Research until the completed application is received. 

How do I get additional information and answers to questions? 

This document and the policies and procedures for the Human Research Protection Program are available on the IRB Web Site at www.research.drexel.edu/compliance. If you have any questions or concerns, about the Human Research Protection Program, contact the Office of Regulatory Research Compliance at: 

Office of Regulatory Research Compliance 

1505 Race Street 

Bellet Building   7th Floor 

Philadelphia. Pa 19102 

hrpp@drexel.edu  

If you have questions, concerns, complaints, allegations of undue influence, allegations or findings of non-compliance, or input regarding the Human Research Protection Program that cannot be addressed by contact the Office of Regulatory Research Compliance, follow the directions in the “HUMAN RESEARCH PROTECTION PROGRAM PLAN (HRP-101)” under “Reporting and Management of Concerns.” 

How do I submit a Reportable New Information?

Complete the HRP 214 Reportable New Information form located on the website. Be sure to include the corrective action plan to prevent future recurrence of the event. Submit via the COEUS platform as an "FYI" and attach the HRP 214 form as well as any other relevant documents. 

How do I submit continuing review?

Complete the “FORM: Continuing Review Progress Report (HRP-212) (embedded in the COEUS Lite platform and ,” attach all requested supplements. 

If the continuing review application is not received by the date requested in the approval letter, you will be restricted from submitting new Human Research until the completed application has been received. If the approval of Human Research expires all Human Research procedures related to the protocol under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information. Continuing Human Research procedures is a violation of federal regulations. If current subjects will be harmed by stopping Human Research procedures that are available outside the Human Research context, provide these on a clinical basis as needed to protect current subjects. If current subjects will be harmed by stopping Human Research procedures that are not available outside the Human Research context, immediately contact the IRB chair and provide a written list of the currently enrolled subjects and why they will be harmed by stopping Human Research procedures. 

How do I submit new Human Research to the IRB?

All IRB submissions are ONLY accepted via the COEUS Lite platform.

    HRP-211 Application for Initial Review 

    HRP-212 Continuing Review Progress Report Form 

    HRP-213 Modification of Approved Research Form 

    Letter of Determination Application 

    Case Reports and Case Studies Application 

Forms are now embedded in the COEUS lite platform and do NOT need to be completed or attached EXCEPT for researchers st St Christopher’s Hospital for Children. 

The HRP  503 protocol , HRP 502 Consent and all other forms when applicable are attached into COEUS submission. 

How do we consent if the subject does not speak English?

If you anticipate subjects who primary language is not English, you will need to submit the consent in both English and the identified language. A letter of attestation noting the translation is accurate must accompany the submission to IRB. 

If you do not anticipate a non-English speaking population as subject and one subject does not speak English, the short form consent may be used.

Short Form Consent Guidance [DOCX]

I know most new drugs and new investigational devices will have some risk or induce some discomfort. How should I describe those risks to the subjects?  

The risks associated with each research protocol has been reviewed and approved by the IRB and is clearly outlined on the consent form. Use the informed consent as your guide. Explain those risks to each subject. Do not minimize the risk(s). If there is any information available on the morbidity/mortality whether it was related to humans or animals, describe those findings so that they can make a decision on whether or not to participate in such a study. Please always inform each subject that their participation is entirely voluntary. Assure them that if they refuse to participate in the study, it will not affect the quality of care they are receiving.

If I have a sponsor-prepared informed consent document, can I use that? 

Generally, most sponsors provide a sample or draft consent document. They are useful in preparing the consent document. Drexel does have mandatory language which must be inserted into the sponsor's template. This language is posted on the website with the consent templates.

Once I have obtained consent, should I always give a signed copy of the consent to the subject? 

The person who signed the consent form must be given a copy as a reference and reminder of the information conveyed in the consent document.. Please remember that by giving this form the subject is now aware of not only the contents of consent document he/she signed, but also will have the written information on when to schedule an appointment to see the study doctor or for a study-related test. 

What appropriate procedures should I use to consent a research subject?

To obtain informed consent, use your consent document as a guide for the verbal explanation of the study. The consent document contained regulatory required elements for all human subject research Give adequate opportunity for the subject to exchange information with you. Open the discussion with a concise summary of key information- the prospective subject or legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.

All of the information contained in the consent is critical since subjects need to understand what is being done to them. Describe to them how this research project distinguishes itself from routine care they receive from their doctor. 

 

What are some of the applicable laws and regulations pertinent to Informed Consent? 

For studies that meet DHHS (e.g., NIH) policy, Federal regulation 45 CFR part 46.116 states that “no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.    An investigator shall seek such consent only under circumstances that provide the prospective subject or his representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.  The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.  No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence”.     Basic elements of informed consent are also described under this regulation.   
 
For studies that are subject to FDA regulations (clinical trials of drugs or devices), the informed consent documents should meet the requirements of 21 CFR 50.20 and contain information required by each of the eight basic elements of 21 CFR 50.25(a) and each of the six elements of  21 CFR 50.25(b) that is appropriate for the study.   
 
There are some differences in DHHS and FDA applicable laws and regulations. 

 

 

What is a Clinical Trial?

"Clinical trial" is "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. 

 

What is the purpose behind obtaining informed consent? 

The Nuremberg Code developed by International Military Tribunal that tried Nazi physicians for the “experiments” they performed on un-consented inmates of concentration camps, was the first widely recognized document to explicitly deal with the issue of informed consent and experimentation on human subjects. 

Informed consent is the primary ethical requirement underlying research with human subjects. It emphasizes the basic principle rights of individuals and respects for persons. Informed consent is an ongoing process. It assures that prospective human subjects will understand the nature of research and individuals can voluntarily and knowledgeably decide whether or not to participate in a study.This voluntary consent is absolutely essential. This assurance protects all parties, the research subject whose autonomy is respected, the investigator(s), the sponsor and the institution where the proposed research is being conducted.   

What training does my staff and I need to conduct Human Research?

Investigators and staff conducting human subject research must complete the Relevant Group Specific online Collaborative Institutional Training Initiative (CITI) human subjects”. Access the site at CITI Program . Please note that all members of the research team involved in the design, conduct, or reporting of the research are required to complete training. IRB approval will not be granted for proposed research in which members of the research team have not completed human research protections training.  

Where can I get help to write the informed consent for my study in our university?

The DU IRB website has a template of informed consent that contains standard language/or a standard format that must be used in consent documents.  They are developed for those elements that deal with confidentiality, compensation, voluntary nature of participation, pregnancy/pregnancy waiver, statement on no apparent benefit, who is responsible for costs in case of injury, contact information for questions on research project, in case of injury  and adverse reactions. Please be aware that these are some standard statements that may or may not directly apply to your study, but may help organize your study information. 

Who can sign the consent if a research subject is unable to give consent because he/she has diminished mental or medical capacity to consent?

If an adult research subject is unable to consent on his/her own behalf due to medical or mental incapacity, only the subject’s legally authorized representative (a court appointed conservator or guardian, an attorney-in-fact pursuant to a durable power of attorney) may consent on his/her behalf.

Family members (also called "next-of-kin") who do not meet the definition of legally-authorized representative may not provide consent for a related adult to be enrolled in research.

 

If there is no legally-authorized representative, and the adult patient cannot consent, the patient may not become a human subject in a medical experiment unless the federal requirements for waiver of consent have been met.

 

Minors cannot give consent, but sign an assent if they are seven years or older.  If a minor (emancipated?) is unable to consent on his/her own behalf due to medical or mental incapacity, a parent or legal guardian may provide consent for research. (Note: under normal circumstances, enrollment of minors as subjects requires permission by the parent or legal guardian and assent by the minor).

 

Who has the ultimate authority for assuring the adequacy of informed consent document? 

It is your IRB that has the final authority to ensure that the informed consent contains appropriate and adequate information in the informed consent that will safeguard the subject, the investigator, the sponsor and the institution where the research being conducted.

Export Control

What is an "export"?

Normally, an export is considered a tangible item shipped outside of the United States. In addition to actual shipment of a commodity out of the country, an export may also be the transfer, release or disclosure to foreign persons in the United States of technical data about controlled commodities. This release of controlled technical data or commodity is considered a "deemed export." The “deemed export” regulation states that a transfer of "technology" or "technical data" to the foreign person is "deemed" to be an export to the home country of the foreign person. Accordingly, for all controlled commodities, a license or license exception is required prior to the transfer of "technology" or "technical data" about the controlled commodity to foreign persons inside the U.S.

What is "fundamental research" and why is it important?

The export control regulations exempt from licensing requirements technical information (but not controlled items) resulting from "fundamental research." Fundamental research is defined as basic and applied research in science and engineering conducted at an accredited U.S. institution of higher education where the resulting information is ordinarily published and shared broadly within the scientific community. Such research can be distinguished from proprietary research the results of which ordinarily are restricted for proprietary reasons or specific national security reasons.

Research conducted by scientists, engineers, or students at a university normally will be considered fundamental research. The fundamental research exemption permits U.S. universities to allow foreign members of their communities (e.g., students, faculty, and visitors) to participate in research projects involving export-controlled technical information on campus in the U.S. without a deemed export license. Further, technical information resulting from fundamental research may be shared with foreign colleagues abroad and shipped out of the United States without securing a license.

What is "technology" or "technical data"?

The phrases refer to technical information beyond general and basic marketing materials about a controlled commodity. The terms "technology" and "technical data" mean specific information necessary for the development, production, or use of a commodity, and usually takes the form of blueprints, drawings, photographs, plans, diagrams, models, formulae, tables, engineering specifications, and documentation. The "deemed export" rules apply to transfer of such technical information to foreign nationals inside the U.S. They do not refer to the controlled equipment/commodity itself, or to the type of information contained in publicly available user manuals.

What is "published" information?

Information is "published" (and therefore not subject to export controls) when it becomes generally accessible to the interested public in any form, including: (1) publication in periodicals, books, print, electronic, or other media available for general distribution (including websites that provide free uncontrolled access) or to a community of persons interested in the subject matter, such as those in a scientific or engineering discipline, either free or at a price that does not exceed the cost of reproduction and distribution; (2) readily available at libraries open to the public or at university libraries; (3) patents and published patent applications available at any patent office; and (4) release at an open conference, meeting, seminar, trade show, or other open gathering held in the U.S. (under ITAR) or anywhere (under EAR). Note, a conference or gathering is "open" if all technically qualified members of the public are eligible to attend and attendees are permitted to take notes or otherwise make a personal record of the proceedings and presentations.

What is the fundamental research exemption?

The fundamental research exemption originated from the U.S. National Security Directive 189 (1985) which states: “It is the policy of this Administration that, to the maximum extent possible, the products of fundamental research remain unrestricted. It is also the policy of this Administration that, where the national security requires control, the mechanism for control of information generated during federally funded fundamental research in science, technology and engineering at colleges, universities and laboratories is classification. Each federal government agency is responsible for: a) determining whether classification is appropriate prior to the award of a research grant, contract, or cooperative agreement and, if so, controlling the research results through standard classification procedures; b) periodically reviewing all research grants, contracts or cooperative agreements for potential classification. No restriction may be placed upon the conduct or reporting of federally funded fundamental research that has not received national security classification, except as provided in applicable U.S. statutes.”

What kinds of controls in a government-sponsored research project would compromise the fundamental research exemption?

If the U.S. Government funds research and specific controls are agreed on to protect information resulting from the research, then information resulting from the project will not be considered fundamental research. Examples of "specific controls" include requirements for prepublication review by the Government, with right to withhold permission for publication; restrictions on prepublication dissemination of information to non-U.S. citizens or other categories of persons; or restrictions on participation of non-U.S. citizens or other categories of persons in the research.

What are “deemed exports”?

In addition to actual shipment of a commodity out of the country, the export regulations also control the transfer, release or disclosure to foreign persons in the United States of technical data about controlled commodities. The “deemed export” regulation states that a transfer of “technology” or “technical data” to the foreign person is “deemed” to be an export to the home country of the foreign person. Accordingly, for all controlled commodities, a license or license exception (such as the fundamental research exemption) is required prior to the transfer of “technology” or “technical data” about the controlled commodity to foreign persons inside the U.S.

What is not subject to the “deemed export” regulations?

Technical data that is "in the public domain" under ITAR or "publicly available" under EAR, including "fundamental research", is not subject to deemed export controls. Accordingly, the compliance plan at Drexel is based largely upon insuring that research results generated at the University meet the standards for "publicly available" thereby avoiding the necessity of securing a license prior to dissemination of information to foreign nationals involved in the research, including graduate students, post-doctoral scholars, and visiting scientists. For University-based research, there are three different ways that the technical information may qualify for an exemption from the deemed export regulations. It is exempt if it:

  • Is published or disseminated
  • Arises during, or results from, fundamental research or
  • Is educational information (as described at 15CFR734.9 and 22CFR120.10(a)(5)) released by instruction in catalog courses or associated teaching laboratories of academic institutions.

What must Drexel researchers do to adhere to the university’s export compliance plan?

Drexel faculty and staff must take the following steps to assure that they do not violate the export regulations and become personally liable for substantial civil and criminal penalties:

  • Prior to shipment of any commodity out of the U.S., determine if the commodity requires an export license and assist in securing such license, when required.
  • Secure license approval or verify license exception PRIOR to shipment for all controlled items. Contact Julie Ford (x2947 or jjf47@drexel.edu) in the Office of Research for guidance on verifying license exceptions and submission of license applications.
  • Assure that all technical data about export-controlled commodities qualify as "publicly available" under the above-described criteria (e.g., publish early and often).
  • Do not accept publication controls or access/dissemination restrictions (such as approval requirements for use of foreign nationals), enter into 'secrecy agreements', or otherwise agree to withhold results in research projects conducted at Drexel or that involve Drexel facilities, students, or staff.
  • Do not accept proprietary information from another that is marked "Export Controlled." Return to the manufacturer any materials they provide to you about export-controlled equipment that is marked "Confidential." Review any Confidentiality/Non-Disclosure Agreements to insure that Drexel and you are not assuming the burden of restricting dissemination based on citizenship status or securing export licenses.
  • Do not attend meetings that foreign nationals are prohibited from attending. Do not sign the DD2345, Militarily Critical Technical Data Agreement, as a condition of attending a conference or receiving materials from the government.
  • Do not travel to conduct research or educational activities to embargoed countries without first checking with the Office of Research to ascertain whether a license from the Department of Treasury, Office of Foreign Assets Control, is required. The list of currently embargoed countries can be found at the Treasury Department's Office of Foreign Assets Control (OFAC) website. 

What are the penalties for violating the export control regulations?

Violations of the export control regulations can result in both civil and criminal penalties for the individual and for the institution. In addition to a civil penalty not to exceed $10,000 for each violation of the export regulations, there are criminal penalties that may be imposed, including a fine of up to $1 million against the university and a fine of up to $250,000, or imprisonment of not more than 10 years, or both against the individual. Penalties apply to each individual violation, which means that if a violation relates to more than one controlled material or item or occurs on more than one occasion, each item or incident may trigger a penalty. Contact Julie Ford in the Office of Research immediately if you think you have an issue.