Institutions and researchers must comply with internally and externally imposed requirements related to the management of research projects. We must assure that our researchers and administrative staff follow best practices for sound research management.
This section covers the topics listed on the bulletin board to the right. To review all of the materials, scroll through this page. To jump to particular sections, click the linked sub-section titles on the bulletin board or click on the menu bar at the top of the screen.
The purpose of the Institutional Review Board (IRB) is to protect the rights and welfare of human research subjects.
The IRB reviews all research projects at NCSU that use human subjects to ensure that we meet this goal and are compliant with the related federal regulations.
There were a number of significant historical events that preceded the formulation of the regulations that govern our use of human subjects in research here at the University.
The following are three of the more significant events. Note that even though these are all medical examples, the resulting regulations apply to behavioral and social research, also.
The medical experiments conducted by German doctors and prosecuted in the so-called Doctors' Trial led to the creation of the Nuremberg Code, a set of research ethics principles for human experimentation.
The Nuremberg code includes such principles as:
Henry Beecher Article
Henry Beecher was an important figure in the history of anesthesiology and medicine, receiving awards and honors during his career. His 1966 article on unethical practices in medical experimentation within the New England Journal of Medicine was instrumental in the implementation of federal rules on human experimentation and informed consent.
In this 1966 paper, Beecher described 22 published medical studies where patients had been experimented on with no expected benefit to the patient. In one study, for example, patients infused with live cancer cells had been told they were receiving "some cells" without specifying that they were cancer. Though identities of the authors and institutions had been stripped, the 22 studies were later identified as having been conducted by mainstream researchers and published in prestigious journals within the previous decade.
The paper has been described as "the most influential single paper ever written about experimentation involving human subjects." The Office for Human Research Protections credits this paper as "ultimately contributing to the impetus for the first NIH and FDA regulations."
Beecher also worked both in defining the rules and conditions for informed consent and in establishing institutional review boards as an additional layer of oversight regarding research protocols.
Tuskegee Syphilis Experiment
The Tuskegee syphilis experiment (also known as the Tuskegee syphilis study or Public Health Service syphilis study) was an infamous clinical study conducted between 1932 and 1972 in Tuskegee, Alabama by the U.S. Public Health Service.
The experiment was conducted to study the natural progression of untreated syphilis in poor, rural black men who thought they were receiving free health care from the U.S. government. When the press exposed the study, the US Congress appointed a panel that determined that the PHS Syphilis Study should be stopped immediately and that overseeing of human research was inadequate.
The Tuskegee Syphilis Study, cited as "arguably the most infamous biomedical research study in U.S. history," led to the 1979 Belmont Report and the establishment of the Office for Human Research Protections (OHRP) within the US Department of Health and Human Services (HHS).
The main regulation that governs our research conduct involving human subjects is 45 CFR 46, a set of federal regulations for Institutional Review Boards called the "Common Rule." It applies to all research projects at an institution, regardless of the funding source.
For us that means that any research we conduct at the University involving human subjects must be compliant with this federal regulation and must be reviewed by the Institutional Review Board. IRB approval must be obtained before any contact with potential subjects is made.
Review the University definitions on the right that are fundamental to our basic understanding of the broad scope of research and the way we categorize "human subjects" in a research setting.
In addition, note that continued analysis of identified data that was collected previously is considered ongoing research and is subject to review and approval by the IRB committee just as the original collection of the data is classified as research.
To clarify further, the following notes also expand on two of the terms under the Human Subject Definition:
Anonymity vs. Confidentiality
Anonymous data means that not even the researcher can trace a subject from his or her data. Coded data is not anonymous because there is a traceable link between the subject and his or her data.
3rd Party Subjects
3rd party subjects are people about whom information is gathered, but who are not actually participating in the study. For example, if a study asks about a subjects' family members, those family members are considered 3rd party subjects and they must have their confidentiality protected also.
The cornerstone of research ethics when working with human participants is the idea of informed consent. It is a legal requirement that we give complete information to every potential research subject about the research – including any potential risks. The potential research subjects have the right to make their own decisions about whether or not to participate. If they decide to participate in the research, they must sign a consent form.
Review the following overview information on IRB responsibilities and processes and note the contact information in the "Further Exploration" links for any questions you may have.
Remember the following important fact: IRB approval must be obtained before any contact with potential subjects is made.
The following are the basic components of an IRB review:
The IRB also ensures that additional safeguards are in place for research involving vulnerable populations including:
After the IRB reviews each research protocol, they will make one of four possible decisions:
Level of Risk
The IRB has some flexibility regarding research involving human subjects. The amount of flexibility is based on the risk of the research – the riskier a project is, the less flexibility is allowed. Those studies deemed "minimal risk" can receive simpler, faster reviews, and have more flexibility than other research. The IRB rather than the PI makes a determination of the risk of the research and flexibility of the rules.
Minimal risk is defined by the regulations as "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
IRB Review Process
Review the notes in the following chart regarding the IRB review process.
Submitting Research Details to the IRB for Review
The researchers' IRB submissions are the blueprints for their research. They must describe all study activities and components on the IRB form, including full details about their research along with specific, practical information on how procedures will be carried out, confidentiality protected, etc. Any research activities that deviate from the details described in the IRB submission are not approved and are considered noncompliant.
Review the following overview of the steps researchers must take to get IRB approval:
You can find further details including forms and access to further training in the "Further Exploration" section that follows.
To explore further than the overview information presented on this IRB topic, click the SPARCS IRB web site pictured below (opens in a new tab or window).
Note the menu items accented below by the red box including forms and policies.
For more information, you may also access an online tutorial on Human Subjects in research by clicking on the SPARCS site illustrated below. You will need to enter your Unity ID and password to access the tutorial.
The USDA logo below illustrates just one of the governing bodies responsible for the rules and regulations that exist to ensure that we respect and treat animals humanely when used for research here at the University.
The federal regulations and policies ensure that the following occurs when animals are used in research:
The University provides guidance, oversight, monitoring and a mandated committee review and approval process to help maintain our high standards of ethical and humane treatment and conditions.
Review the topics that follow for a broad overview and explore or save the links to more information on each segment if you are involved in this area of the University's research projects.
You may choose to watch the following optional video (less than 2 minutes) for a brief introduction to one of our research facilities here at the University. The center conducts research studies that benefit human health as well as animal health. (Take a moment before clicking the play arrow to grab your ear buds or adjust your computer's volume up or down to listen to the audio track in your work environment – also has closed captioning text to view without sound).
The best practices, rules, and regulations surrounding humane animal treatment in the field of research as it is today evolved from scientific study as well as historical events and "front page news" that brought past animal mistreatment issues into the public view.
The following are some historical events that were important milestones in this area:
Animal care issues that made headlines such as the following also brought animal care research to the forefront, leading to public outcries and pressure for oversight and regulations:
The University must comply with numerous rules and regulations regarding animal use and care. The two main governing regulations are these:
The SPARCS Animal Care and Use Division web site linked in the "Further Exploration" segment at the end of this section contains links to all of the policies and supporting regulations.
The following FAQ page also contains a specific question and answer related to the changing nature of the guidelines we must follow.
All research universities must have this type of committee to ensure that all of the regulatory requirements are met. Our University committee has these mandated duties and criteria:
The IACUC reviews and approves all research, teaching or testing activities that involve animals before our researchers begin their experiments.
The committee must ensure that all of the following conditions or requirements are met:
The committee also makes sure that the animals' living quarters are inspected at least twice per year to ensure that all of the following conditions or requirements are met:
To explore further than the overview information presented above, click the SPARCS Animal Care and Use Division web site pictured below (opens in a new tab or window). Note the menu items accented below by the red box including forms and policies.
For more information, you may also access an online tutorial on Animal Care and Use by clicking on the SPARCS site illustrated below. You will need to enter your Unity ID and password to access the tutorial.
As the magnifying glass on the COI sign implies, our projects' federal and non-federal sponsors "closely scrutinize" our sponsored projects for real or potential conflicts of interest. So, we must follow their requirements to closely look into our research staffs' potential conflicts of interest that could bias the design, conduct, or reporting related to the research projects.
To meet this requirement, the university has established standards and procedures that include a mandatory disclosure requirement for all covered employees. We remind our faculty and staff that the COI disclosure is not a "bad thing" but rather a way to manage any potential problems. By disclosing any possible conflicts in advance and having an approved management plan in place, the University and our researchers have protections in place in case any questions arise.
For this topic, review the following "Who, What, When, Where, Why, and How" segments to get a clear understanding of how to manage this requirement for faculty and staff who work on our sponsored projects.
NOTE: The specific instructions for completing the online COI disclosure are in "Section 9: Systems" of this RAMP Guide.
The following employees are required to complete the COI declaration:
The potential Conflicts of Interests that must be disclosed include:
What is a Management Plan?
If any of the circumstances listed above exist, the disclosers may be required to file a management plan to ensure optimal objectivity in carrying out their project related activities. The management plan is included in the COI disclosure process. The plan details the actions and safeguards that the staff and department will undertake to ensure that their objectivity is maintained.
Click the screen shot below to access this section of the SPARCS web site for specific guidance on writing the plan:
Annual Disclosure Period
The COI disclosure period is August 16th through August 15th of each year, so a new disclosure is required annually. Covered employees are asked to complete the COI each year by October 1st.
As circumstances change, our faculty and staff are required to update the COI system disclosure information with any new potential conflicts of interest that arise during the year.
College and Department Research Administrative staff should keep the following in mind to facilitate this updating requirement:
The university uses an electronic COI system to record and approve any potential conflicts of interest. The specific instructions for completing the online COI disclosure are in "Section 9: Systems" of this RAMP Guide.
Once the on-line form is complete, the COI system electronically routes the disclosure to the employee's Department Head, Director, Dean or Vice Chancellor for review and approval. If the employee completes the declaration with nothing to disclose, the approver is only notified that the declaration has been completed.
We use this electronic certification process in our COI system as our signature authority under the following categories:
The Right Thing to Do
The university's mission to transfer knowledge also includes an entrepreneurial spirit to encourage faculty's outside endeavors. At the same time, we are upholding our obligation to assure our objectivity by guarding against any biases (or perceived conflicts) due to potential competing interests of faculty who "wear two hats" in university research and private business pursuits.
Preserving the Public Trust
We comply with the regulations that require us to declare any potential conflicts of interest for a number of reasons including:
Regulations Require It
The original language of the federal 1995 regulations includes this phrase: "that the design, conduct, or reporting of research is not biased by any conflicting financial interests of the investigator." There are a number of regulations that adhere to this basic concept including:
Acknowledge It, Then Manage It!
Our attitude centers around managing any potential conflicts of interest rather than any unsound practices of discouraging private partnerships to the detriment of progressive research. We manage potential conflicts as we have described in this RAMP Guide section on COI as well as specific COI guidance and references on the SPARCS web site.
Department and College or Division staff are responsible for the oversight and management of the COI process by carefully reviewing, monitoring, and approving COIs
Review the following information to make sure that you are aware of these issues:
The University not only encourages external professional activities of our EPA professionals and faculty but expects these outside activities. Why? Because they provide opportunities for our faculty and staff to add "real-life" knowledge to their intellectual and research base of knowledge. It is a privilege enjoyed by academics that must also be carefully monitored to remain in compliance with our governing regulations.
The State of North Carolina and University regulations require that the University monitor our EPA professionals' and faculty's potential conflicts of commitment (time) or External Activities for Pay (EPAP) that could impact their responsibilities to the University.
To assess any potential issues, the university has established standards and procedures that include a mandatory disclosure requirement using our "Notice of Intent" system to record and get approval for any EPAP or potential conflicts of time commitments for outside consulting or similar activities.
For more information on this topic, review the following "Who, What, When, Where" segments to get a clear understanding of how to manage this requirement for faculty and staff who work on our sponsored projects.
NOTE: The specific instructions for completing the online NOI disclosure are in "Section 9: Systems" of this RAMP Guide.
All EPA and faculty members who are planning to do some consulting or engage in any other activities outside the University for pay (EPAP), must complete the online Notice of Intent to get prior approval from their department heads.
Note the prior notice requirements in the "When" section below for more information on the specific time frame and process.
Engaging in external professional activities for pay is a privilege of serving in an EPA Professional or Faculty position. The Board of Governor's policy and NC State University regulations require faculty and EPA staff to provide prior-notification of their intent and get approval by their Deans or Department Heads.
When completing the required fields in the NOI system, they will be asked to provide the following information:
10-Day Notice Requirement
All EPA and faculty members who plan to do some consulting or engage in any other activities outside the University for pay (EPAP), are required to complete the online Notice of Intent at least 10 calendar days prior to the start date.
If faculty or staff cannot meet the 10-day rule for some unforeseen circumstance, they should submit the request as soon as possible. In rare cases where they did not submit the NOI before beginning the outside work, they must complete the NOI after the fact with an extra-ordinary justification clearly noted.
The university uses an electronic NOI system to record and get approval for any consulting or work outside the University for pay (EPAP). The specific instructions for completing the online NOI disclosure are in "Section 9: Systems" of this RAMP Guide.
Once the on-line notice is complete, the NOI system electronically routes the disclosure to the employee's Department Head, Director, Dean or Vice Chancellor for review and approval.
Researchers who run across the words "Export Controls" may skip that reference because they immediately think that they don't export anything. You can help the researchers that you work with realize that they could be dealing with less evident forms of Export Controls as part of their research and a dismissive attitude toward Export Controls is not the best way to approach this subject!
Knowingly or unknowingly violating Export Control laws can result in extreme penalties that can include:
Review the basic overview information that follows and be sure to visit and bookmark the Export Controls section of the SPARCS web site for specifics. Keep in mind, also, that the introductory information in this Export Controls section of the RAMP Guide applies to all university business and activities, not just research-related functions. For example, shipping a controlled substance without a license is illegal whether or not the shipment is related to a research project.
The following are examples of situations that we might commonly find in our Sponsored projects that may be subject to Export Controls:
To better understand the examples above, review the following definitions.
The good news is that approximately 95% of the research activities performed at the University are exempt from Export Controls.
Federal regulations include exemptions for the University under these categories:
The bad news is that penalties for violating Export Controls that are not exempt are severe as described in the introductory paragraphs of this section. Remember also that these potential penalties (including fines and incarceration) are applied to individuals rather than just the University.
The following cases are real situations involving penalties in university settings. The last example relates to one of our own (former) private business partners on Centennial Campus.
In September, 2008, Dr. J. Reece Roth was convicted on 18 counts of conspiracy, export control violations, and wire fraud. Roth utilized foreign nationals from Iran and the PRC to work on a controlled Air Force-sponsored SBIR research project without prior authorization and licenses. He was sentenced to 48 months in prison for violating the Arms Export Control Act by conspiring to illegally export, and actually exporting, technical information relating to a U.S. Air Force (USAF) research and development contract.
The illegal exports by Dr. Roth of military technical information involved specific information about advanced plasma technology that had been designed and was being tested for use on the wings of drones operating as a weapons or surveillance systems. The Arms Export Control Act prohibits the export of defense-related materials, including the technical data, to a foreign national or a foreign nation.
In March 2004, Dr. Tom Butler was sentenced to 2 years imprisonment, 3 years supervised release, and a $50,000 fine. He had reported to the FBI that vials of a potentially deadly plague bacteria were missing and presumed stolen from his university research lab. The report sparked a bioterrorism alert in the western portion of his state.
The investigation proved that Dr. Butler had illegally shipped the vials of bubonic plague bacteria to Tanzania without the required export licenses. Among the numerous charges of which Dr. Butler was found guilty at trial, two were export control related: making false, fraudulent and fictitious statements regarding the exports to federal agents and making an unauthorized export to Tanzania.
Allied Telesis Labs Inc., based on the University's Centennial Campus, was sentenced to two years probation and a $500,000 fine in August, 2008 after pleading guilty to one count of conspiracy to export to Iran.
Specifically, ATL and its related corporate entities conspired to acquire and execute a $95,000,000 contract with the Iranian Information Technology Company to rebuild and upgrade the telecommunications systems of approximately 20 Iranian cities, including Tehran.
The University severed its ties with Allied Telesis Labs, Inc. in 2008.
Review the information presented here and on the Export Control section of the SPARCS web site linked below so that your awareness level is advanced to notice any red flags or potential issues that need further clarification.
Be sure to save the web site linked below and note the "Decision Tree" option in the menu. That section provides a step-by-step set of questions to help research staff analyze their projects in relation to any Export Control issues.
Encourage faculty to check yes if they have any doubt related to the three Export Control related questions in the PINS record illustrated below. Checking yes will alert the SPARCS Export Controls expert to get involved early in the negotiations phase to investigate any potential problems.
The SPARCS Export Control expert looks at all online foreign Travel Authorizations submitted by faculty and sends them a one-page information sheet of information including locations of consulates as well as information on the country's specific requirements related to laptops, cell phones, etc. For this reason, it is important to remind faculty in your college to submit their online travel information well in advance to receive this important trip-specific information before departure.
A Quick Call Is Best!
Whether you are involved with travel, shipping, or other issues that could be related to Export Controls, encourage your faculty or colleagues to call before taking action. They can make sure that shipping that item overseas does not violate any laws or signing for that UPS delivery will not land anyone in jail!
Keep in mind that even although 98% of such actions are probably okay, the severe penalties for violating the law in the other 2% of the situations are not worth taking a chance.
Click the "Call or E-mail Us" image on the right to access an e-mail link or contact Richard Best in SPARCS at 919.515.0158 or via e-mail at firstname.lastname@example.org.
NCSU's Environmental Health & Safety department is dedicated to helping us manage health, safety, and environmental aspects of our research projects at the University. As a member of the research community, you can help our researchers comply with the safety rules and regulations by learning more about these requirements as well as how to direct PIs and other research staff to valuable online and campus resources.
For this topic, review the following "Who, What, Where, and Why" segments to get a clear understanding of how to manage these health and safety requirements for faculty and staff who work on our sponsored projects.
Beyond Sponsored Projects
Although this RAMP Guide is focused on managing sponsored projects, it is important to understand the overall importance and critical nature of Environmental Health and Safety awareness on campus.
The following are a few facts to keep in mind:
Research Compliance Regulations
Beyond our need to support all Environmental Health and Safety "best practices" on campus, we are required under federal, state, county, and university regulations to maintain ongoing committee reviews of our documentation and procedures.
The following chart lists our committees and their associated authorities:
Generally, the following types of campus facilities that use hazardous materials, hazardous processes, and storage of these items must file Safety Plans and comply with the associated health and safety requirements:
Materials or Equipment
Staff who work on research projects that involve any of the following types of materials or equipment must comply with their prescribed protocol and safe handling requirements:
In some colleges, research administrative staff are involved in coordinating or submitting safety approvals.
Review the following chart for more specifics. You may also click any of the links in the chart for more information.
You can easily access the Environmental Health and Safety forms and information through MyPack.
Log on to MyPack using your Unity ID and then click the "Environmental Safety" folder under the "My Projects" tab as illustrated below for direct links to each section of the Environmental Health and Safety web site.
Access Through the Environmental Health and Safety (EHS) Web Site
You may also use the A to Z index on the EHS web site to access the same information as illustrated in the site linked below (opens in new tab or window).
Unfortunately, the number of research misconduct investigations in universities across the nation is increasing. Accusations of misconduct can produce disruptive to devastating results or repercussions for all parties involved.
It is important for our research administrative staff to understand what constitutes research misconduct and what our responsibilities are in this area.
Some potential misconduct actions are intentional and others may be errors in judgement by researchers under tremendous pressure or time constraints. If the potential misconduct is unintentional, we may be able to help our research staff recognize when they are treading into unsafe territory and possibly help prevent potential misconduct allegations.
Review the following information to explore this important topic, thinking about how you can support and encourage our NCSU scholars in the area of research integrity by:
What if You Suspect that Research Misconduct May be Occurring?
NC State's administrative regulation 10.00.2 requires requires reporting of observed, suspected, or apparent research misconduct. The university's Research Integrity Officer encourages concerned staff to report observed, suspected, or apparent research misconduct to the senior administrator responsible for research programs within the college, school or unit where the alleged misconduct is occurring.
Review the SPARCS Whistleblower and Respondent Obligations and Protections web page for more detailed information on the various responsibilities, confidentiality requirements, protections, and resources.
What is Research Misconduct?
After reviewing the following definitions and potential contributors to misconduct accusations, roll your mouse pointer over the image to view the common terminology that often applies to these issues.
The following are examples of the types of actions that would fall under the category of misconduct:
Research Misconduct – The Video
Click on the screen shot below to open a Federal Office of Research Integrity web page (opens in a new tab or window), and then click the "Play Full Video" button circled below to watch a 3-minute introductory video. It is an excellent portrayal of an instance of research misconduct. Pay particular attention to the reference to "people with responsibility for oversight who did not properly exercise their responsibility" to note how you could potentially become part of a research misconduct investigation in your Research Administration role.
Optional Follow-Up: If you decide to continue at the end of the introductory video, you can select the role of the Research Integrity Officer, the PI, the Lab Assistant, or the Grad Student to "play out" their part of the scenario, selecting what actions you would take in their situations and discovering what the results might be. Taking any one of the roles will probably take 30 minutes or more, so you may want to bookmark the site to come back to it later if necessary. Completing the entire video interaction section is optional, but highly recommended for a compelling and valuable learning experience.
Note: Take a moment before clicking the play arrow on the web site to grab your ear buds or adjust your computer's volume up or down to listen in your work environment. The video starts playing automatically when you click the "Play Full Video" button. (If you need to stop, pause, or go back, roll your mouse pointer over the bottom of the screen to activate a play bar.)
Our University's Misconduct Investigations
Review the following list of common misconduct allegations and the underlying problems that have contributed to the allegations. As you review the list, think about how you might be able to observe, take note of any potential issues, and express your concerns appropriately in your work environment. Your proactive attention might raise awareness and possibly prevent or diffuse misconduct that may be eminent or emerging.
What Can We Do on Campus?
Here are several topics on best practices for our researchers to note and review further on the SPARCS site linked below:
For more information on maintaining Research Integrity here at the University, click the web page image below to visit the SPARCS Research Integrity web page (opens in new tab or window).
Click the RAMP link below to return to the RAMP Guide Table of Contents.