The key personnel will receive a notification through email and via their Action List on the Streamlyne Portal Index page. 

The department chair, college dean and the college division chief will be notified by email only once during the proposal sign-off approval process. However if a PI submits a proposal, the PI can decide whether to receive future sign-off approval requests or not. If he/she does wish to receive future requests, he/she will be notified via email.

If the PI chooses not to receive future requests, he/she will not be notified via email. The approval will also be acknowledged upon the PI’s submission into workflow.

Yes, both the Pre-Award and Compliance modules include the ‘Copy to New Document’ functionality in order to copy both Proposals and Protocols.

You must report all personal financial interests from external sources, including travel. This would include any interest in a company, business, foundation or other organization that:

• Provides products or services in your academic, clinical, or research discipline or area of study. An example would be a manufacturer that has products in your professional discipline, clinical practice area, or area of research;
• Will likely make use of your scholarly work or research – either directly or indirectly. For example, could the company, foundation or organization use your scholarly work or research in its own product line, or could it be used by a competitor?
• Is a member of an industry, trade, advocacy group or professional association that funds scholarly work, research or is an advocate for funding in your professional discipline or area of study or expertise;
• Has some other relationship not described above that could reasonably appear to impact your research or other obligations to the University;
• You receive royalties directly from intellectual property that you have licensed to an external entity.

A "financial interest" is any monetary value that belongs to you, your spouse or partner, or your dependent children. The financial interest becomes "significant" if it meets ANY of the following conditions:

• All income from a publicly-traded entity received during the 12 months prior to disclosure plus the value of any equity interest in the entity as of the date of an annual disclosure, when combined, exceeds $10,000 or represents more than 5% ownership interest in any single entity. Examples of income include consulting fees, honoraria, or paid authorship. Equity interest includes any stock, stock option, or other ownership interest;
• ANY equity interest held in a non-publicly traded entity, or more than $10,000 in income from a non-publicly traded entity received during the 12 months prior to disclosure; or
• Income from intellectual property rights and interests received from an entity other than NJIT that exceeds $10,000 during the 12 months prior to disclosure.

Please note that the U.S. Public Health Service (PHS) and its agencies define a "significant" financial interest (SFI) at a lower level than do other federal agencies, such as the National Science Foundation, and the university’s longstanding level of $10,000 described above.

Specifically, if you have worked on PHS funded research in the past year, or expect to work on PHS-funded projects this year, a financial interest becomes “significant” if it meets ANY of the following conditions:

• All income from a publicly-traded entity received during the 12 months prior to disclosure plus the value of any equity interest in the entity as of the date of an annual disclosure, when combined, exceeds $5,000. Examples of income include consulting fees, honoraria, or paid authorship. Equity interest includes any stock, stock option, or other ownership interest;
• ANY equity interest held in a non-publicly traded entity, or more than $5,000 in income from a non-publicly traded entity received during the 12 months prior to disclosure; or
• Income from intellectual property rights and interests received from an entity other than NJIT that exceeded $5,000 during the 12 months prior to disclosure.

PHS agencies include the National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Indian Health Service (IHS), Health Resources and Services Administration (HRSA), Substance Abuse and Mental Health Services Administration (SAMHSA), Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare & Medicaid Services (CMS), Administration for Children and Families (ACF), or Administration on Aging (AOA).

Federal regulations and university policy do not require you to disclose the following types of financial interests:

• Reimbursement or payment of travel paid by NJIT, or covered by a sponsored program agreement managed through the Office of Research;
• Royalties received from NJIT for intellectual property owned by the university;
• Royalties resulting from traditional academic publishing activities such as the publication of text books or other educational materials;
• Any salary or other remuneration paid to you by NJIT.

Faculty, staff, and students are required to disclose the occurrence of any reimbursed or sponsored travel paid for directly or reimbursed by an external entity.

However, this disclosure requirement does not apply to:

• Any travel reimbursed, sponsored or paid for by a U.S. government agency, a U.S. higher education institution, a U.S. academic teaching hospital, medical center, or a U.S. research institute affiliated with a U.S. higher education institution; and
• Any travel reimbursement or payment of travel made by NJIT, a university college, department or unit, or travel covered by a sponsored program agreement managed through the Office of Research.

For research purposes, if it is determined that a significant financial conflict of interest exists that may directly and significantly affect the design, conduct or reporting of a specific research project, then the case will be reviewed by the Vice Provost for Research.

NJIT uses the Citi Training programs.

Financial conflicts of interest disclosures made for research purposes will be reviewed by the Executive Director, Sponsored Research Programs Administration, for compliance with applicable regulations.  Determination that a conflict exists will require the PI to work with the Chair and Dean to provide a mitigation plan that will be reviewed and approved by the Executive Director, Sponsored Research Programs Administration.

No, you cannot hire a relative to assist you on a research project supported by federal funds. According to Part 310 § 310.102 of Title 5 of the Code of Federal Regulations, a “relative” includes a wide range of family members such as parents, siblings, spouses, and in-laws. Federal agencies and institutions have strict policies against nepotism to ensure fairness and avoid conflicts of interest in employment practices. Both the National Institutes of Health (NIH) and the National Science Foundation (NSF) explicitly prohibit non-federal employees working on research projects supported by their funds from hiring, supervising, promoting, or advancing their own relatives. These policies also extend to training opportunities. The goal of these policies is to prevent the use of insider access or influence to sway decisions in favor of family members.

The policy is located on the Office of Research website at: http://www.njit.edu/research/compliance/export-control.php

Research in export restricted science and engineering areas – examples include:

• Military or Defense Articles and Services
• High Performance Computing
• Dual Use Technologies (technologies with both a military and commercial application)
• Encryption Technology
• Missiles & Missile Technology
• Chemical/Biological Weapons
• Nuclear Technology
• Nuclear Technology
• Space Technology & Satellites
• Medical Lasers

Traveling overseas with high tech equipment, confidential, unpublished, or proprietary information or data – Traveling with certain types of high tech equipment including but not limited to advanced GPS units, scientific equipment, or with controlled, proprietary or unpublished data in any format may require an export license depending on your travel destination.

Traveling with laptop computers, web-enabled cell phones and other personal equipment – Laptop computers, web-enabled cell phones, and other electronics containing encryption hardware or software and/or proprietary software can require an export license to certain destinations. In general, an export license will be required to take any items to or through any U.S. sanctioned country (e.g., Iran, Syria, Cuba, Sudan, and North Korea).

Use of 3rd Party Export Controlled Technology or Information – University activities involving the use of export controlled information, items, or technology received from outside the university are not protected under the Fundamental Research Exclusion and all research involving the use of export restricted technology is subject to all export controls.

Sponsored research containing contractual restrictions on publication or dissemination – The vast majority of research done at the university is shielded from export controls under the Fundamental Research Exclusion. However, this protection is lost whenever the university or the researcher agrees to allow any restrictions on the publication, dissemination, or access to the research by foreign nationals.

Shipping or Taking Items Overseas – University activities that involve the transfer of project information, equipment, materials, or technology out of the U.S. by whatever means will be subject to export controls and may require export license(s) depending on the item, destination, recipient, and end-use.

Providing Financial Support/International Financial Transactions – University activities that involve the international payment of funds to non-U.S. persons abroad need to be verified to ensure that the university is not inadvertently providing financial assistance to a blocked or sanctioned entity. Examples include providing support via a subcontract to a non-U.S. university or providing payments to research subjects in other countries.

International Collaborations & Presentations – University activities that involve foreign national faculty, students, staff, visiting foreign scientists or collaborator(s), or other foreign entities (e.g., non-U.S. company, university or other organization) or research that will include travel to international conferences to present unpublished results may be subject to export controls especially if any of the foreign nationals are from embargoed or sanctioned countries.

International Field Work – Research projects where any part of the research will take place outside the U.S. (e.g., field work outside the U.S.) may not qualify under the Fundamental Research Exclusion and may be subject to export controls.

International Consulting – Providing professional consulting services overseas, especially to embargoed or sanctioned countries (e.g., Iran, Syria, Cuba, Sudan and North Korea) is, in most cases, strictly prohibited.

Penalties for violating U.S. export control laws (EAR, ITAR) or trade sanctions (OFAC) can be severe. The penalty for unlawful exports of items or information controlled under the ITAR is up to two years imprisonment, or a fine of $100,000, or both. The penalty for unlawful export of items or information controlled under the EAR is a fine of up to $1,000,000 or five times the value of the exports, whichever is greater; or, for an individual, imprisonment of up to ten years or a fine of up to $250,000 or both.

Yes, export controls apply to all international activities regardless of funding status or source.

Yes, export controls apply to all international research activities. In general, basic research conducted at the university is not subject to export controls under the Fundamental Research Exclusion as long as it is not in an export restricted area and there are no restrictions on publication or access by foreign nationals. However, in cases where NJIT research involves collaborations with foreign nationals, the university must perform a review of the research and document that the Fundamental Research Exclusion or other exclusion does or does not apply.

An export occurs whenever any item (i.e., any commodity, software, technology, or equipment) or information is sent from the U.S. to a foreign destination or provided to a foreign national here or abroad. The manner in which the transfer or release of the item or information occurs does not matter. Some examples of export activities include: the shipment of items, written or oral communications, hand-carrying items when traveling, providing access to or visual inspection of equipment or facilities, and providing professional services.

A deemed export refers to the release or transmission of information or technology to any foreign national in the U.S., including students, post-docs, faculty, visiting scientists, or training fellows. A deemed export is treated as an export to that person’s home country. Deemed exports are a primary area of export control exposure for the university.

A foreign national is defined as any natural person who is not a U.S. citizen, or is not a lawful permanent resident of the U.S. (i.e., does not have a green card), or who does not have refugee or asylum status.

A foreign entity is any corporation, business, or other entity that is not incorporated to do business in the U.S. This includes international organizations, foreign governments, or any agency of a foreign government.

A dual use item is any item that can potentially have a military application as well as a commercial or civilian purpose (e.g., GPS units).

ITAR stands for the International Traffic in Arms Regulations (22 CFR §§120-130) and they are administered by the Directorate of Defense Trade Controls under the U.S. Department of State. The ITAR governs all military, weapons, and space related items and services as enumerated on the U.S. Munitions List (USML).

EAR stands for the Export Administration Regulations (15 CFR §§730-774) and they are administered by the Bureau of Industry and Security (BIS) under the U.S. Department of Commerce. The EAR governs the export of most items in the U.S., especially dual use items as enumerated on the Commerce Control List (CCL).

The EAR controls all items (commodities, software, or technology) that are 1) of U.S. origin; or 2) are made with U.S. materials, technology, or know-how; or 3) are located in the U.S. AND that are NOT under the exclusive jurisdiction of another regulatory body (e.g., ITAR or Nuclear Regulatory Commission) or that are NOT shielded from export controls under the Fundamental Research, Educational Information, or Public Information exclusions.

OFAC stands for the Office of Foreign Assets Control (31 CFR §§500-599) and is an office under the U.S. Department of the Treasury. OFAC is responsible for enforcing the foreign policy of the U.S. government, including all trade sanctions, embargoes, and financial interactions with prohibited or blocked individuals or entities. For more information, see a listing of OFAC Country Sanction programs.

Fundamental Research is defined by the National Security Decision Directive 189 (NSDD189) as “any basic or applied research in science and engineering, the results of which are ordinarily published and shared broadly within the scientific community…” In order to qualify as Fundamental Research, the research must be conducted free of any publication restrictions and without any access or dissemination restrictions.

Research that qualifies as Fundamental Research is NOT subject to export controls as provided for under the federal regulations (15 CFR§734.8). It is critical to note that the Fundamental Research Exclusion will be lost if a researcher agrees to any “side-deals” allowing sponsors the ability to review and approve publications or to control access to the project or project results.

Loss of the Fundamental Research Exclusion can quickly put your research in jeopardy of non-compliance with export controls.

Maybe. To qualify as Fundamental Research, research must be based at an accredited institution of higher education located in the United States.

If your research includes work done outside the U.S., it may not qualify for the Fundamental Research Exclusion. This does not automatically mean that export licenses will be required, but it does mean that an export control determination needs to be done before the work begins.

Not automatically. While research results developed or generated under the Fundamental Research Exclusion are exempt from export controls and can be freely shared with foreign nationals both here and abroad, any materials, items, technology, or software generated as a result of the research ARE NOT exempt from export controls.

Before shipping or taking any item abroad, an export control determination needs to be done to determine if an export license is required to take or transfer the item.

Information that is normally taught or released by the university as part of the normal instruction in a catalog course or in an associated teaching laboratory is considered Educational Information and, as provided for under the federal regulations (15 CFR§734.9), is NOT subject to export controls.

Information that is already published or is out in the public domain is considered public information and, as provided for under the federal regulations (15 CFR§734.7 and 15 CFR§734.10), is NOT subject to export controls. Examples of information in the public domain include:

• Books, newspapers, pamphlets
• Publically available technology and software
• Information presented at conferences, meetings, and seminars open to the public
• Information included in published patents
• Websites freely accessible by the public

The following are examples of the types of university activities that may trigger the need for an export license or deemed export license:

• Research in controlled or restricted areas (e.g., defense items or services, missiles, nuclear technology, satellites, chemical/biological weapons, encryption)
•  
• Research involving the use of export restricted information obtained from external sources
•  
• Research involving collaborations with foreign nationals here at NJIT or overseas
•  
• Research involving travel or field work done overseas
•  
• Research involving the transfer or shipment of tangible items or equipment overseas
•  
• Presentations at meetings or conferences of unpublished information not protected under the Fundamental Research or Educational Information exclusions
•  
• Research involving the provision of financial support or services outside the U.S.

Determining when you need an export license can be very complicated. Consult the SRA Office.

An Export License Exception is a special authorization that allows you to export or re-export, under very specific conditions, items that would otherwise require an export license. Export License Exceptions are detailed in EAR§740.

Yes, in most cases, low-end items that are commercially available do not require export licenses. There are some important exceptions including items containing strong encryption technology or software (e.g., laptop computers, web-enabled cell phones), items that have dual use applications (e.g., high end GPS units), or that are restricted under other regulations or sanctions

Research conducted at NJIT that includes or uses export controlled or restricted information or items obtained from an outside entity does not qualify under the Fundamental Research Exclusion and would be subject to all export controls.

Yes, export controls apply to all U.S. persons, at all times. It is important that you understand and comply with your obligations under export control regulations. If you are consulting in a restricted technology area (e.g., on dual-use technologies or select agent work), then you may need an export license depending on where you are going, what information you are providing, who you are providing it to, and what they intend to do with it.

If the destination or end-user is a foreign national of a sanctioned country (especially Iran, Syria, Cuba, Sudan, or North Korea), then in most cases any consulting activities would be prohibited regardless of the subject matter. For more information, see a listing of OFAC Country Sanction programs.

Yes, under the current federal regulations, Federal Register vol. 72, 50047-50052 (see section 560.538), all activities normally incident to publishing are allowed with Iranian citizens as long as the Iranian author is not a governmental official or working on behalf of the government of Iran.

Academic and research institutions in Iran and their personnel are not considered governmental employees or representatives for the purposes of the regulations. This would be true for citizens from the other sanctioned countries as well.

NJIT provides access to the Citi training programs. For more information, go to: http://www.njit.edu/research/compliance/citi-software.php.

According to NJIT Policy, research is defined as "…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

Activities which meet this definition constitute research for this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Human subjects are "...living individuals about whom an investigator (whether professional or student) conducting research obtains

1. data through intervention or interaction with the individual, or
2. identifiable private information."

Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes (e.g., providing stimuli to gauge reaction and response).

Interaction includes communication or interpersonal contact between investigator and subject (for example, surveys and interviews).

Private information includes

• information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and
• information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).

Private information must be individually identifiable (i.e., the identity of a participant is associated with the information or may readily be ascertained by the investigator) in order for obtaining the information to constitute research involving human subjects.

If you are unsure about your research project’s involvement with human subjects, please consult with the IRB Chairperson who can provide guidance in making this determination.

All research projects that will involve human subjects must be submitted for review and approval before beginning the study. This includes proposed research involving existing data as well as any advertising or other recruitment procedures.

Yes, if the study meets the definition for research with human subjects, as explained above. Written approval from the IRB must be in place before any interventions or interactions with human subjects (e.g., recruitment) actually begin.

Yes. If your research project involves active data collection, federal regulations and NJIT policy require that ALL research involving intervention or interaction with human subjects, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the research study.

However, if your research project involves use of existing information collected from human subjects (e.g., secondary datasets), that do not have any identifiers, then the activity may not require IRB review.

Yes. Projects conducted by NJIT undergraduate and graduate students need IRB approval if they fit the definitions of “research” and “human subjects” as described above. If the project is to be used in classroom setting only to teach research methods, the project may not constitute human participant research.

However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation or other research purposes. Therefore, students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary.

Yes, researchers can be subjects in their own studies. However, NJIT policy regards this type of research (investigator self-experimentation) as research with human subjects, and generally requires the same review and approval as research that recruits other people as subjects.

Under certain circumstances, human participant research activities may be granted exempt status. Technically, exemption means that all the research activities fall under one or more of the exemption categories specified by the federal regulations.

The significance of exempt status is that the research activity is not monitored by the IRB. Assuming the project does not change, it also is not subject to continuing IRB oversight. Exempt status does not, however, lessen the ethical obligations to subjects. Thus, depending on the circumstances, investigators performing exempt studies may need to make provisions to obtain informed consent, protect confidentiality, minimize risks, and address problems or complaints.

In order to have a research project recognized as exempt, investigators will need to request an exemption. The IRB Chairperson will evaluate the exemption request and notify investigators if their projects are eligible.

Please note that for each change that is proposed or occurs during the execution of the research activity, the investigator may need to consult to determine if the change affects the eligibility of the research activity to continue to be exempt from IRB review and approval.

Yes. The Federal Regulations do make certain categories of research exempt from IRB review. However, NJIT policy does not allow investigators to self-exempt their human participant research projects. Instead, determining if a project is exempt from IRB review is an administrative review process handled by the IRB staff.

If you are a member of the NJIT faculty or staff, or a NJIT student, and you are the person responsible for the conduct of the study (PI), you must get NJIT IRB approval to conduct your research regardless of where the research takes place. Investigators should contact the IRB office whenever collaborative research is occurring. Separate applications for each institution may be necessary.

Studies that use multiple case studies to draw conclusions that are applicable in a generalizable context, or to address a hypothesis, meets the federal definition of 'human subjects research' and requires review by the IRB committee. Other case studies may not require IRB review.

You must receive written approval from the IRB before beginning participant recruitment, data collection, or data analysis. An email will be sent to you when your project has IRB approval.

Applications need to be submitted to the IRB via Streamlyne at least  10 days before the next scheduled meeting date for inclusion. For applications requiring full board review, you should allow at least 3-4 weeks for review and approval of your study.

No. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted. If data was collected for purposes that the IRB determines to be non-research (e.g., program evaluations for library or educational programs not initially intended to be used for research), IRB approval can be sought for the data analysis going forward.

The IRB committee is available to provide assistance to investigators who are engaged in research with human subjects. Dr. Eric Hetherington and Dr. Britt Holbrook, IRB Co-Chairs, are your resources for any general questions.

You can also explore the IRB website for detailed information about the IRB policies and procedures, forms, meeting schedules, committee members, and other important information.

To start your protocol, review the information on IRB Submissions & Protocols. Once you are familiar with the process and requirements, you will utilize the Streamlyne system to submit your materials for review. Training information for IRB submissions can be found here.

The IRB evaluates every research protocol according to the ethical principles described in the Belmont Report (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html).

Basically, this means the IRB considers whether the risks and benefits of a study are acceptable and managed appropriately, and whether individuals being asked to participate are adequately informed about the research and its possible risks.

Considered another way, investigators could look at their plans from the point of view of a subject, or an observer concerned about responsible research. Who are the subjects and how are they recruited? Could they be lured or coerced to participate? Is it through an institution that may have responsibilities toward them (e.g., a school or hospital) and should be consulted? Do they understand, in advance, what they are agreeing to participate in and give their consent willingly? What will they actually do, and what is done to them, during the study? Is it possible that the experience might be injurious, painful, uncomfortable, needlessly boring, embarrassing, offensive, or otherwise stressful? Might there be long-term consequences? Could the subject be endangered, compromised or embarrassed if information collected leaked out? There are many possible considerations, but they should not be difficult to understand if one assumes the subject's perspective.

The IRB’s role is to look at the study from this perspective and to ensure that proper precautions are taken to protect individuals when they agree to participate in research.

Fully informing subjects of the risks, benefits, and procedures involved in a study is a standard requirement in research with human subjects.

Ethically and legally, consent is not considered to be "informed" unless the investigator discloses all the facts, risks, and discomforts that might be expected to influence an individual's decision to willingly participate in a research protocol.

This applies to ALL types of research including surveys, interviews, and observations in which subjects are identified, and other experiments, such as exercise studies.

The informed consent process can take on various forms:

• Signed informed consent is the standard expectation in research with human subjects. This is in the form of a document with the elements of informed consent, signed and dated by the participant and kept as a record by the researcher.
• In research with children (individuals under 18 years old), assent of the child and parental permission are standard requirements.
• In some circumstances, investigators can seek alternatives to standard informed consent procedures, such as:
  1. A waiver of using a signed consent form (e.g., giving subjects an information sheet but not collecting signatures)
  2. A waiver of written consent (e.g., using oral consent procedures)
  3. A waiver of some or all of the elements of informed consent (e.g., in research that involves deception)

It is not uncommon for a research project to involve one or more of the above scenarios.

Both consent and assent involve informing potential subjects about the research and its risks and benefits, and documenting their understanding and agreement to participate.

The reason the different terms are used has to do with the age of the subjects. In research involving adults, "consent" is obtained from individuals to participate in the study.

In research involving minors, a parent must give permission to allow the child to participate in the research, and children who are able to understand information about participation are asked to "assent" or agree to participate as well.

In general, yes, but there are some limited exceptions.

The NJIT IRB is responsible for ensuring that basic ethical principles are abided by in all research. The expectation that the informed consent of research subjects be obtained is based upon the principle of respect for persons, and regarded as extremely important in conducting ethical research.

The IRB has the authority to waive some or all of the federal requirements for informed consent in certain extenuating circumstances. A request for waiver of informed consent must be specifically justified by the researcher in the proposal to the IRB.

Used most commonly, signed informed consent allows prospective subjects to document their agreement to take part in research activities by signing and dating the consent document.

A waiver of documentation of informed consent is a request whereby a signed consent document is not required.

Examples include implied and verbal consent. Consent will still be obtained from subjects; however, they will not be required to sign the consent form. There are only two circumstances when the IRB may waive the requirement to obtain a signed consent form:

• The only record linking the research participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (participant must be asked if he/she want documentation) OR
• The research presents no more than minimal risk of harm to subjects and involves no procedure for which written consent is normally required outside of the research context (for example, no risk surveys or interviews)

PLEASE NOTE: The IRB will take into consideration the risks and potential harms involved in the research and consent process before granting a waiver of documentation of informed consent.

Yes. If the proposed study is truly "anonymous" - no coding for identifiers (e.g., names, social security numbers, driver’s license numbers, etc.), a modified informed consent form (often called an information sheet) may be used. That is, all of the elements of consent must be documented for the participant, but the signature line is replaced with a statement informing the participant that completion and return of the survey is considered implied consent.

If, however, the procedures involve risk or biological sample collections, written consent may be required.

Implied consent is the tacit indication that a person has knowingly agreed to participate in research by performing a research activity or task. By completing the research task (e.g., completion of a questionnaire, interview, survey, etc.), the participant has provided consent to participate in the research.

Implied consent is actually a type of a waiver of documentation of informed consent. Before granting such a waiver, the IRB may require the researcher to provide the subjects with a written summary or an information sheet about the research, including:

1. purpose of research
2. time involved
3. assessment of minimal risk
4. statement regarding benefit to subjects
5. contact for questions about the research
6. contact for questions about rights as a research participant

There are a number of instances where this type of consent is helpful. For example, you wish to mail out a survey. The survey does not ask for any identifiable information. The cover letter accompanying the survey could be written in such a manner as to serve as the "implied" informed consent form.

The letter would need to contain a statement indicating that completion and return of the survey implies consent to participate in the research.

For Internet-based surveys, it is sometimes appropriate to use implied informed consent. Subjects would still need to be presented with the consent information, but would be informed that their consent is implied by submitting the completed survey.

If, for study design purposes, the researcher needs to keep track of who participated or if the IRB determines that some sort of documented consent is required, instead of "signed" informed consent, the researcher may email the consent form to subjects who may then type their name and the date into the spaces provided on the consent form, and return it to the researcher via email.

This process may be appropriate for data collected via email, chat rooms, online interviews, etc. Alternatively, some Internet-based survey vendors and/or software packages provide a means to record whether a respondent has consented to participate before beginning a survey (e.g., a date/time stamp feature).

For protocols involving oral consent, the following information is required to be communicated to the participant:

• study purpose and procedures involved
• what will participant be asked to do - as well as the amount of time participant will spend
• the voluntary nature of participation in the study
• the participant is free to withdraw at any time
• the information collected will remain confidential
• offer the participant contact information for the researcher and the IRB

It may be pertinent to request the PI to offer additional information depending on the nature of the study. It is up to the IRB Committee to suggest additional information to be included in order to further protect the participant.

At NJIT, all investigators and research staff (including external collaborators) must successfully complete the on-line course for Human Subjects Protection given either by OHRP or CITI and update it every three years. All NJIT investigators and research staff also must successfully complete the CITI on-line course on Responsible Conduct of Research.

Additionally, investigators and research staff must be qualified by training and experience for the research they will be conducting. It is important to understand that the responsibility for the welfare of subjects lies with the principal investigator, even when subjects have given consent. Investigators and research staff must have the necessary training and expertise to:

• Ensure the rights, welfare and safety of subjects are protected
• Comply with regulations concerning IRB review and approval, including
  1. Informed consent requirements
  2. Reporting requirements
  3. Maintenance and retention of records (keep complete files during and 5 years after research ends)
• Supervise research conduct
• Apply relevant professional standards that are applicable to the research

All faculty, students, and external collaborators proposing to use human subjects in research under the auspices of NJIT are required to complete the human subjects training.

Approvals for including human subjects in proposed research projects will be not be granted until this training has been completed and verified by the IRB Committee.

NJIT faculty, staff and students can access required compliance training modules via the NJIT CITI program portal which offers web-based training courses to fulfill research compliance training needs. For more info, go to: http://www.njit.edu/research/compliance/citi-software.php.

The IRB may accept alternate training in lieu of the OHRP course if the researcher can produce documentation related to the training courses, the institution offering the training, the date of completion and the score received. Such documentation should accompany the proposal submission or be sent to the IRB committee upon request.

Any and all changes to an approved research study must be submitted for review and approval prior to implementing the change(s) into the research study. Investigators with approved projects must submit an Amendment application if there are significant changes involving any of the study protocols, study design, informed consent procedures, or principal investigator team.

Investigators with approved projects must submit an Amendment application if there are significant changes involving any of the study protocols, study design, informed consent procedures, or principal investigator team. The administrator and chair of IRB review all amendment applications. Go to Streamlyne for IRB for guidance on Modification (Amendment) Training.

If IRB approval of the human research expires, all study procedures related to the protocol under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection of private identifiable information. Continuing human research procedures after expiration of an approved protocol is a violation of federal regulations. To avoid lapses in approval, continuing review submissions should be submitted at least 30 days before the expiration date.

You need to receive continued approval from the IRB in order to continue research.This can be requested through Streamlyne using the renewal procedures detailed in the training materials.

It is the responsibility of the principal investigator (PI) to ensure continued approval of his or her human participant research study. For the renewal process and more information visit  IRB Submissions and Protocols.

Serious adverse events must be reported to the IRB immediately, with a written report by the PI following within 24 hours of the PI’s becoming aware of the event.

A serious adverse event is an adverse event that: 

• results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or 

• requires, based on a reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above

All other non-serious unanticipated problems should be reported to the IRB within 2 weeks of the first awareness of the problem by the Protocol PI or another researcher, ORIA, or a member of the IRB. Prompt reporting is important, as unanticipated problems often require some modification of study procedures, protocols, and/or informed consent processes. Such modifications require the review and approval of the IRB.

Notifications for such events can be made via Streamlyne. Go to Streamlyne Training and review the training on Modifications.

Yes. If an unanticipated problem poses a risk(s) to the subjects or others, the IRB may temporarily discontinue a research project until a thorough investigation has been conducted. Dependent on the investigation, the IRB may request changes to a research study or permanently discontinue the research study.

Yes. As a result of the IRB's investigation of the unanticipated problem, revisions to the approved research study and the informed consent form may be requested.

The Family Educational Rights and Privacy Act (FERPA) is a Federal law administered by the U.S. Department of Education; 34 CFR Part 99. FERPA aims to protect the privacy of Student Education Records. Student education records are often accessible to and used by instructors, teachers, and administrators for the purposes of conducting the duties of their job. However, this natural access cannot automatically be used for other intents and purposes, such as research.  If a researcher wants to use student data for research purposes, FERPA applies and consent is required, unless one of the exceptions to consent as outlined in FERPA is met. More information about FERPA.

Upon award notification, Pre-Award Services staff will review the sponsoring agency award budget against the internal sign-off of budget. If fringe rates have changed since the time of award the new rates will apply and the PI will need to adjust the budget accordingly.

Once the PI returns the current updated budget to Pre-Award Services, a request to create a new index number will be provided to Post-Award Management to be generated within three business days.

An award letter and/or a final executed award agreement from the agency approving the project. The award documents must contain:

1. Start and end date of the award performance period
2. Total funding amount of the project
3. Terms and condition of the award

If the award is not yet finalized, in addition to the above information, the PI must submit an advance account request form and a letter from the sponsor with language indicating that they are authorizing NJIT to start incurring expenses.

The PI will received an e-mail notification from grant accountant in the Post-Award management team containing details of the awarding/sponsoring agency, index number, project dates, and additional information as necessary. This email will indicate the index is ready and available for use.

Please see the Post-Award Management Team Contact List.

If the award is not yet finalized, the PI must submit an advance account request form and a letter from the sponsor with the following:

1. Starting date of project
2. Total amount of the project
3. NJIT budget for pre-award, as required on the advance request form
4. Language that they are authorizing NJIT to start incurring expenses

Once the advance request form is approved by the Office of Research and Finance, it will be provided to Post-Award for index setup within three business days.

Financial obligations are when funds are committed for a specific use and are documented and defined in writing. Examples include a purchase order, an employee contract, a signed contract or other agreement, outstanding invoices, or other commitments to expend the funds.

Grant funds may not be obligated prior to the starting date of the grant or after the ending date of the grant.

The Principal Investigator and departmental support can access the Grant Budget Summary, actual expenses details, expense backup documents, and commitments on the specific award in Banner Self Service. For training and information on how to access, please visit Finance Website-Banner Finance Resources.

Expenditures on an award must be incurred within the performance period of the grant or contract. Any expenditures prior to the start date require sponsor approval and any expenditures after the end date require a no cost extension from the sponsor prior to expenses being incurred.

The award agreement provides the terms and conditions of the award. All eligible expenses would have been listed in the budget narrative submitted with the proposal, the final approved budget, and must be allocable to the objectives of the program. Depending upon the type of expenses, prior written approval from the sponsor may be necessary before the purchase can be initiated.

Direct costs are those costs that can be identified specifically with a particular final cost objective, such as a Federal award, or other internally or externally funded activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. Examples of direct costs include your grant salary and benefits, subcontracts, equipment, travel, and the cost of materials and supplies used to implement the project.

Indirect costs are charged to the project based on a percentage that is approved by the sponsor or was approved by the federal government. They represent an estimate of the university’s overhead on providing research facilities and administrative support. This percentage is calculated on direct costs and automatically charged to the project. 

Costs incurred for the same purpose in like circumstances must be treated consistently as either direct or indirect (F&A) costs.

Carry forward of funds from budget year to budget year varies depending on the terms of the award and sponsor regulations. The award agreement would provide requirements on whether carry over approval of funds is needed or it is automatic.

If approval for carryover of funds is required, the PI must work with Pre-Award Services to obtain official notice of sponsor approval

A cost (expense) transfer – is an after-the-fact movement of costs (labor and non-labor) from a sponsored or non-sponsored award to another sponsored award.  This is completed when expenses need to be reallocated retroactively from one index to another whereby one or both of these is a sponsored award.

Cost transfers may be necessary to (a) distribute clearing account expenses; (b) correct salary distribution estimates; or (c) correct clerical, bookkeeping, or data entry errors.

Examples of unallowable cost transfers are:

•    To cover cost overruns or deficit balances in other non-grant or grant funds
•    To utilize unexpended funds of a sponsored award
•    To use for cost management strategy
•    Used any other reason of convenience

A cost transfer form must be completed and the following information must be provided:

1. the index and account number for which you are requesting the charges be transferred to/from
2. ledger detail and support for the date and description of the original charge
3. an explanation of why the transfer is being requested is required.

Generally, explanations for cost transfers should address why the expense was originally charged to an account or line item, why the charge needs to be transferred to/from the grant account, and if the charge is being transferred, whether the charge is allowable and allocable based on the terms and conditions of your award.

In addition, further justification/explanations are needed for transactions greater than 90 days.  Any adjustments done greater than 90 days, give the perception that grants aren’t being monitored regularly and are an audit flag. These instances require additional documentation, clear explanations and corrective actions to prevent future errors.

Grants should be reviewed monthly or at least quarterly to identify if any adjustments are needed.

The principal investigator must make sure that the charges being transferred are appropriate and allowable expenditures on the grant or contract according to the terms of the award. If so, the PI must complete a cost transfer request form.

The post-ward unit will then review and process the cost transfer if they are eligible with regards to the terms of the award. Post-Award Management has full authority to request more information or to reject the recording of a cost to a grant fund if there is inadequate evidence to support the allowability of the cost. In this case, the cost must be recorded to a departmental or University fund.

Examples of unallowable cost transfers are:

•    To cover cost overruns or deficit balances in other non-grant or grant funds
•    To utilize unexpended funds of a sponsored award
•    To use for cost management strategy
•    Used any other reason of convenience

Federal regulations govern the amount of time that cost transfers are allowed to be made. In order to comply with these regulations, NJIT policy is that all cost transfers must be made within 90 days of discovering any errors.

•    Justification/explanation are needed for transactions greater than 90 days.  Any adjustments done greater than 90 days, give the perception that grants aren’t being monitored regularly and are an audit flag.

•    These instances require additional documentation, clear explanations and corrective actions to prevent future errors.

Given that a timely review of monthly grant payroll reports is expected, labor transfers should occur infrequently and must include detailed documentation as to why the transfer is required. Written justification and PI approval for the labor transfer for sponsored awards is required and must be provided on the cost transfer form upon request from the grant accountant.

Once this transfer is approved by Post-Award Management, the PI will need to work with the labor redistribution initiator in their college to process the labor redistribution. Please see Labor Redistribution-Finance Site for more information.

The PI must confirm from the award agreement what are the re-budgeting conditions and/or restrictions on the award.

Some budget transfers will require additional levels of approval if they have the following impact and PI must obtain chair and dean approval if they are requesting:

•    Transfer of academic year release time to summer salary or to any other category.
•    Reduction in student support (stipend and/or tuition)
•    Reduction in F&A (Indirect/overhead costs charges)

Sponsor agency approval may be required for the following examples and will only be transferred when said approval is documented:

•    Changes in scope or objective of the project
•    Changes in indirect costs
•    Changes in PI and/or PI and other key personnel percentage effort (25% increases or decreases)
•    Absence of PI for a significant length of time (usually in excess of 3 months)
•    Changes in student support (stipend and/or tuition)
•    Exceeds allowable limit threshold for re-budgeting
•    Changes to equipment
•    Changes to subcontracts

Prior approval matrix across multiple federal agencies: Budget Change Approval Matrix

For a copy of the form and submission of budget revisions requests, please contact your assigned grant accountant under Post-Award Management Team Contact List.

Note: If sponsor approval is required, the budget transfer will not be completed until NJIT receives official approval and authorization from the agency prior to the occurrence of the significant change.

Faculty members and certain instructional staff working on sponsored research projects during the summer months are eligible for summer salary.

Employees with a twelve month appointment, some instructional staff and part time employees are normally ineligible for summer research salary.

Faculty members and certain Instructional staff working on sponsored research projects during the summer months are eligible to earn up to 1/3rd of their academic year salary based on their nine month academic contract.

There may be some limitations on this based on additional requirements on the sponsor award and agency regulations.

The summer research period starts the day after the academic year-end graduation date. The total number of summer work hours can be no more than 420, consisting of 12 work weeks at 35 hours per week (70 hours or two weeks equals a pay period).

The senior vice provost for research will send out a summer salary memo in  April with details on the summer pay periods, deadlines for summer PAF submissions, and requirements.

No. Summer salary is earned and paid over the same period as the summer research is performed. Effort expended during the academic year does not qualify for summer salary.

Effort reporting is required in accordance with eCFR 200.430 Compensation-Personal Services.

•    The processes and system in place allow for reasonable approximations of the activity actually performed;
•    The system must recognize the principle of after-the fact confirmation or determination so that costs distributed represent actual costs.
•    Reasonably reflect the total activity for which the employee is compensated by the non-Federal entity, not exceeding 100% of compensated activities (for IHE, this is determined by the IHE's definition of IBS)
•    Salaries and wages of employees used in meeting cost sharing or matching requirements on Federal awards must be supported in the same manner as salaries and wages claimed for reimbursement from Federal awards.

Effort reports are distributed three times a year – once each semester – spring/summer/fall. The senior vice provost will send out notification when the effort reports are available for review and certification.

The anticipated Effort Report deadlines will be approximately:

Spring – Early July (Due to fiscal year end processes and recast deadlines)
Summer – September 24
Fall – March 31

Yes, the traveler’s approver, within his or her school, division, or department must authorize all official business travel.

Please see the finance website for more information on travel.

Travelers are expected to make their own travel arrangements by planning ahead, explore multiple transportation and lodging options, and complete their arrangements in the most cost effective manner as far in advance as possible. You can also use Anthony Travel.

Please see the finance website for more information on travel.

The university will reimburse coach class tickets aboard a regularly scheduled commercial carrier. Travelers must use a US Flag Carrier if paying on research funds. The university complies with the Fly America Act.

Please see Finance Website for more information on Travel.

The University will reimburse for rental car when there is a business justification or there is no other means of comparable transportation (e.g. taxis, limousines, etc.).

Please see Finance Website for more information on travel.

The university will reimburse travelers who use private automobiles on university business at the State’s mileage reimbursement rate in effect at the time of travel.

The University will reimburse travelers for meals in travel status under the following options:

This per diem must be prorated if any meals are provided at a conference, by the hotel or by any other source, or if a traveler begins or ends his/her travel after the start or prior to the end of the business day.

Please see the Finance Website for more information on travel.

University regulations apply to all grant or contract meal and food purchases unless there is a restriction or guidance from the sponsor.

Generally, meal and food purchases are not an allowable expense on grant funds. In those cases in which meal and/or food purchases are an integral part of the grant purpose, the need for such costs should be specifically identified in the proposal and explicitly provided for in the budget.

Entertainment expenses are not allowable on grant/contract funding.

Travelers must submit their Travel Expenses forms and all supporting documents within 45 days after their return to the university. Both the approver and the next higher-level approver must approve Travel Expenses Forms submitted beyond the 45-day time period.

Travel Expense Forms submitted beyond one year after the date(s) of travel will only be reimbursed with a vice president’s approval.

Please see the Finance Website for more information on travel.

The traveler’s supervisor, PI, index/fund responsible person or their designee who does not report to the traveler must approve the reimbursement. Any travel paid for by grant funds will also route to the appropriate grant accountant for review and approval.

Modified Total Direct Cost (MTDC) means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and up to the first $25,000 of each subaward (regardless of the period of performance of the subawards under the award). MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward in excess of $25,000. Other items may only be excluded when necessary to avoid a serious inequity in the distribution of indirect costs, and with the approval of the cognizant agency for indirect costs. (as specified in CFR Section 200.1

Animal use on the NJIT campus is currently managed by Rutgers, the State University. For full information, go to: http://www.njit.edu/research/compliance/animal-care.php.

A fundamental objective of any biosafety program is the “containment” of potentially harmful biological agents.

The term “containment” is used in describing safe methods, facilities and equipment for managing infectious materials in the laboratory environment where they are being handled or maintained.

The purpose of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents. The use of vaccines may provide an increased level of personal protection. The risk assessment of the work to be done with a specific agent will determine the appropriate combination of these elements.

Four “Biosafety Levels ((BSL) have been developed. No BSL4 work is conducted at NJIT.

• BSL-1: Suitable for work involving well characterized agents not known to cause disease in healthy adult humans and of minimal potential hazard to laboratory personnel and the environment.
• BSL-2: Suitable for work involving agents of moderate potential hazard to personnel and the environment.
• BSL-3: Suitable for work with infectious agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation route.

In many countries, including the United States, infectious agents are categorized in risk groups based on their relative risk. Depending on the country and/or organization, this classification system might take the following factors into consideration:

• Pathogenicity of the organism
• Mode of transmission and host range
• Availability of effective preventive measures (e.g., vaccines)
• Availability of effective treatment (e.g., antibiotics)
• Other factors

Risk group classifications are primarily used in the research environment as part of a comprehensive biosafety risk assessment. There are four (4) risk group designations:

• Risk Group 1 (RG1) agents are not associated with disease in healthy adult humans.
• Risk Group 2 (RG2) agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.
• Risk Group 3 (RG3) agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available.
• Risk Group 4 (RG4) agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available.

NJIT provides compliance assurances to the National Institutes of Health. One of these assurances is that laboratory inspections will be conducted periodically for all research involving recombinant DNA and/or biohazards.

Contact or your Environmental Health & Safety Representative to set up an inspection at 973-596-3059. For more information visit the Department of Environmental Health & Safety.

Research conducted at each location must undergo location-specific institutional (e.g., IBC) research risk reviews and grant approval. Grant approval is often dependent on IBC approval.

New applications, responses to deferrals, and any amendments calling for significant changes to approved research require convened committee review and will be discussed at the subsequent monthly meeting.

Deadlines for new applications, responses to deferrals, and any amendments calling for significant changes to approved research are listed on our website.

Read the policies.

Forms can be found on the Office of Research website.

NJIT provides both internal and external training opportunities. The internal training is offered by the NJIT Environmental Health and Safety. For more information, go to: http://www5.njit.edu/environmentalsafety/.

NJIT also makes available the Citi training programs.

The NJIT Responsible Code of Conduct policy is located on the Office of Research website.

RCR Required Training: All NJIT employees including students, staff, post-docs, research associates, faculty and collaborators are expected to be in compliance with NJIT and federal requirements with respect to responsible conduct of research that emphasizes conflicts of interest, professional ethics, collegial and behavioral obligations to serve the basic foundation of a professional academic research workplace. 

RCR training and certification can be obtained through the online software system, CITI (Collaborative Institutional Training Initiative). The NJIT RCR training program includes both interdisciplinary general and program-specific RCR content.  It is intended to provide quality training experiences while offering flexibility for the learner. All those with an NJIT UCID and NJIT email address are able to register for RCR training via the CITI resource.

Only SRA completes and issues and executes all Agreements. No other party could use any template.

The recipient may send the proposed changes to us. SRA would review and negotiate the terms and conditions directly with the recipient. The PI could work only if there is a change in the Scope of Work or Budget.

Yes. The value of the Agreement can be modified (increased or decreased) with the PI sending the revision to SRA. Then a modification would be sent out by SRA. No new Agreement is required in such instance.

Yes. The project end date can be extended provided the extension is within the period of performance of the Prime Contract.

The subcontractor / consultant will be notified in the beginning as to which documents are required; based on the details of the Agreement.

Once the Agreement is executed, the PI would create a Requisition in Banner system.

When an invoice is received, the PI approves it based on the work done. Then the invoice is sent to Accounts Payable department with the PO number written on it.