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.

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.

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.

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.

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.

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

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.

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)) and PAM is an extension of the IACUC oversight.

Drexel’s Institutional Official must sign an Animal Welfare Assurance Statement for OLAW, 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 conduct animal research in accordance with the law. The records of the USDA reports and inspections are available to the public through the Freedom of Information Act.

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.

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.

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.

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

1. All procedures and documentation is compliant, no further action required 
2. 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 the PAM reviewer / Office of Research. The PI will then send a response back to QA/QI with a plan and timeline to address the issues. The PAM reviewer will verify implementation of the action plan. 
3. 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 PAM reviewer/Office of Research. The PI will then send a response back to QA/QI with a plan and timeline to address the issues. The PAM reviewer will follow up within a specified time frame to assure compliance. 
4. If an issue that falls outside of the scope of the animal use and care post-approval monitoring visit is identified (e.g., research integrity, misconduct, biosafety concerns), the PAM Team will notify and collaborate with the applicable offices.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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

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.   

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 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).

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.

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.

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.

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.

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.”

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.

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.

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.

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. 

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.