Research Compliance Overview
Research Compliance: An Overview
It is often necessary to use human subjects for research to obtain results that are not able to be secured any other way. However, it is vital that we satisfy certain moral, ethical and legal standards with regard to human subjects. There are three basic principles that must be addressed with any human subject research:
- Autonomy - voluntary informed consent
- Beneficence - good science and favorable benefit to risk ratio
- Justice - equal opportunity to participate and to not participate
At Gallaudet University, as at all institutions of higher education and research in the US, an Institutional Review Board (IRB) has been established to review all proposed research projects involving human subjects and to monitor their progress after approval. For more information about the IRB and the protection of human subjects, visit their website. All researchers (faculty, staff or student) planning to use human subjects must complete online training through the Collaborative Institutional Training Initiative (CITI) at the University of Miami. Please visit the IRB website's CITI page for more information.
Many research projects use animal subjects before using human subjects. This allows the researcher to project what could happen in humans without exposing people to higher risks. There are a lot of ethical considerations when using animal subjects. Institutions of higher education and research where vertebrate animal subjects are in use must have an Institutional Animal Care and Use Committee (IACUC). This committee functions similarly to the IRB for human research but does have some additional responsibilities, including annually inspecting animal care and use facilities. At this time, no researchers at Gallaudet are participating in vertebrate animal studies and there is no IACUC established. If you are considering using vertebrate animals in your research, please contact the Office of the Provost.
Biosafety refers to the use of laboratory facilities, laboratory practices and safety equipment when dealing with potentially biohazardous materials in a research setting to maintain the safety of laboratory personnel, research subjects, the environment, and public health. Biohazardous materials include items such as radioactive materials, viruses or other pathogens, and toxic chemicals. You can contact the Environmental, Health, and Safety Manager for Gallaudet University for more information.
Gallaudet University has a duty to maintain the privacy of our students, research subjects and healthcare clients. The category an individual falls into determines which regulations govern their privacy rights. Some individuals may be part of all three categories.
· FERPA - Family Educational Rights and Privacy Act (students)
o A federal regulation which protects the privacy of student education records
o Provides students 18 and older with the ability to decide who can and cannot see their educational records (including their parents)
o Places limits on what information can be shared without written consent of the student (or their parent if the student is under 18)
o Specifies which entities can request information without written consent (for example: other schools to which a student is transferring or appropriate individuals in connection with student financial aid for which the student has applied)
· HIPAA - Health Insurance Portability and Accountability Act (healthcare clients)
o A federal regulation which protects the privacy of individually identifiable health information
o Provides individuals with the ability to decide who can and cannot see their healthcare records
o Places limits on who can request identifiable health information without written consent
· The Common Rule - Code of Federal Regulations (CFR) Title 45 Part 46 (research subjects)
o Defines human subjects as living individuals about whom a researcher obtains:
§ data through intervention/interaction with the individual, or § identifiable private information.
o Protecting data is the key to protecting privacy. The common rule is clear that these data need to be protected. As stated in CFR 46.117(7), "when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data."
· Food and Drug Administration (FDA) Regulation: CFR Title 21 Part 21 Protection of Privacy (research subjects)
o Requires statements on the Informed Consent Form that:
§ describe the extent to which confidentiality of records that can identify the participant in the research will be maintained, and
§ inform the participant that the FDA may view the research records
Confidentiality is the process of maintaining privacy for our students, research subjects, and healthcare clients. Data should be depersonalized wherever possible and stored securely. How the information is stored and accessed determines who you should contact for help maintaining confidentiality. Paper records should be stored in accordance with the University's Document Retention Schedule (A&O manual section 1.18 Appendix A). Gallaudet Technology Services (GTS) can help with retention and destruction (when applicable) of electronic records. It is important to remember, particularly in a visual language environment, that confidentiality includes signed/spoken conversations as well. Care should be taken to avoid discussing confidential information in public spaces.
How data is recorded, stored, disseminated and destroyed are key components of data management. Data must be maintained in a secure manner that still allows for ease of access for authorized individuals. Privacy and confidentiality (see previous section) must be maintained while allowing research data to be shared in accordance with sponsor and/or governmental guidelines. In addition, it is important to store your data in a format that will allow for future access as technologies and formats change.(GTS) can assist you in making sure your data is stored appropriately and destroyed, as needed, in accordance with Gallaudet University retention policies ( .
Export Controls refers to the regulation of shipment or transport of controlled items, data, software, technology or services outside of the U.S. Also included are restrictions on the release of the same to foreign nationals on U.S. soil, referred to as "deemed export". This can be very important to universities who have foreign students or researchers. Below you will find a list of examples which might trigger export controls. Working with or developing these technologies may require licenses or waivers from one of the government agencies responsible for regulating export. You can read more about export controls on the OSP Pre-Award Policies page. Please contact the OSP if you think you need export control assistance. 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) - see the Commerce Control List found in 15 CFR 774
• Encryption Technology
• Missiles & Missile Technology
• Chemical/Biological Weapons
• Nuclear Technology
• Select Agents & Toxins
• Space Technology & Satellites
• Medical Lasers
International travel can also bring up export control issues. Scientific equipment, research data, proprietary information, and even laptops or cellphones may require a license to carry them to certain countries. OSP and GTS can work with you to make sure you are compliant with export control regulations when traveling overseas. For more information on taking technology overseas visit the Higher Education Information Security Council (HEISC) - Security Tips for Traveling Abroad: https://www.educause.edu/focus-areas-and-initiatives/policy-and-security/cybersecurity-program/resources/information-security-guide/hot-topics/security-tips-for-traveling-abroad or on securing a laptop before crossing the border from the Canadian Bar Association visit http://www.cba.org/cba/practicelink/tayp/laptopborder.aspx. You can contact the Information Security Officer in GTS for questions, cleaning/inspection of the laptops, or other issues related to technology or data security.
Sometimes innovative technology is created or developed during a grant-supported research project that can then be patented, marketed commercially, and/or used by others for further research. Gallaudet wants to facilitate the transfer of such technology when applicable while still protecting the intellectual property rights of the university and our researchers while still adhering to any sponsor stipulations agreed to by the University. Gallaudet faculty are not authorized to give away Gallaudet intellectual property resulting from grants and contracts. The Business Office and OSP can help you with Materials Transfer Agreements (MTA), Non-Disclosure Agreements (NDA), and other documentation necessary to share your technology and protect your rights.
In addition to technology, various materials may be created or developed during research that can be used by other institutions for research. Materials may include cell lines, plasmids, nucleotides, proteins, transgenic animals, plant varieties, bacteria, pharmaceuticals, and other chemicals. The NIH and other federal funding sources require "unique research resources" arising from funded research to be made available to the scientific research community. The Business Office and OSP can help you with Materials Transfer Agreements (MTA), Non-Disclosure Agreements (NDA), and other documentation necessary to share your materials and protect your rights.
Please review section 1.09 of the Administration & Operations Manual for Gallaudet University's policies on copyrights, patents, and royalties. Questions regarding this section should be directed to the Office of Risk Management and Insurance. For grant-sponsored copyrightable materials, refer to the award notification document from the sponsor for publication rights and restrictions specific to your grant.
Patentable items which are invented or discovered must be reported to the appropriate university administrator per section 1.09 of the A&O manual. For grant-sponsored, patentable items, refer to the award notification documentation from the sponsor for patent rights and restrictions specific to your grant.
The Digital Accountability and Transparency Act (DATA) was passed in 2014. It calls for all government agencies to standardize how their financial data is presented. The purpose is to make it easier for taxpayers to understand where their tax dollars are being spent. The Treasury Department and Office of Budget and Management are in the process of establishing financial data standards for all federal spending. Because Gallaudet University is a federally-funded institution and we receive federal grant dollars, we will be required to begin reporting our financial data in accordance with the DATA Act once it is implemented. More information will be provided to the campus community when available.
The Office of Research Integrity (ORI), part of the Department of Health and Human Services, defines research misconduct as "fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results." Fabrication refers to making up data or results and recording or reporting them. Falsification is manipulating equipment, processes or materials and/or changing data or results such that the research is not recorded or reported accurately. Plagiarism is using someone else's words, ideas, results, or processes without giving them credit. Re-use of your own published work without due credit is referred to as "self-plagiarism". The Gallaudet policy on misconduct in research can be found in several sections of the A&O manual: section 1.15, Policy on Reporting Suspected Misconduct (Whistleblower Policy) and section 2.10, Objectivity in Research and Investigator Financial Disclosure. Another important resource is the University's Institutional Integrity Policy. This policy explains Gallaudet's research misconduct policy and the procedure for contacting the Research Integrity Officer (RIO).
The United States Office of Government Ethics website offers information on Procurement Integrity. Following proper procurement procedures assures fair treatment of bidders, offerors, and contractors, and preserves the integrity of federal spending. With all purchases, whether grant funded or university funded, it is important to avoid conflicts of interest, both financial and otherwise. The Gallaudet procurement policy can be found in the A&O manual, section 2.06. For additional information on procurement, please visit the Contracts and Purchasing Department website.
A conflict of interest is a situation that has the potential to undermine partiality. Conflict of interests can be financial or non-financial. Please view the A&O Manual, sections 1.12 and 2.10 to see the Gallaudet University policy on financial conflicts of interest and financial disclosures. Non-financial conflicts of interest can be due to personal relationships, strongly held beliefs (political or religious), or desires for career or academic advancement. While most research emphasizes financial conflicts of interest, non-financial conflicts can be just as damaging to research integrity. It is important to avoid even the appearance of a conflict of interest.
Please view the Finance Office policy on Subrecipient Monitoring. Gallaudet is responsible for making sure subrecipients on grants are compliant with the same rules and regulations that the university is following. The OSP will assist PIs in identifying subrecipients during the proposal stage and the Contracts and Purchasing Office will work with you to create the contracts after the grant is awarded. The Finance Office monitors subrecipients' financials during the grant period, while the PI monitors subrecipients' work and deliverables.
The Gallaudet University policy on Whistleblower Protection can be found in the A&O Manual, Section 1.15. The university expects its employees to perform their duties in accordance with applicable laws and regulations and encourages good-faith reports of observed or suspected misconduct. This section of the A&O Manual lists who to call to report suspected misconduct for each category of university employee or student. A Whistleblower Hotline has been set up through EthicsPoint.com. This system allows you to make reports by phone or internet and can be anonymous. The university does not permit retaliation against anyone reporting suspected misconduct in good faith. Any person making an accusation they know to be false can be subject to disciplinary or other appropriate actions. The Office of Risk Management and Insurance is responsible for the Whistleblower Protection policy.
The False Claims Act, which was enacted in 1863, prohibits individuals, organizations, or companies from falsely requesting money from the Federal Government or its pass-through entities. For example, you can't request reimbursement on a grant for equipment you didn't buy or work you didn't perform. The Department of Justice has more information on their website with The False Claims Act: A Primer.
Debarment and suspension refer to punishments for fraud against the government. Debarment and suspension mean you cannot contract with the Federal Government or pass-through entities; no grants, no contracts, no subcontracts. Suspension is short-term, usually one year, while pending the outcome of an investigation. Debarment happens after a finding of fraud and usually lasts three years. More information can be found on the General Services Administration (GSA) website.
The Buy American Act requires that purchases made with federal money be for products made or produced in the USA, except in cases where no product of the same kind is made in America. For assistance with Buy American questions, contact the Contracts and Purchasing Department. Similarly, the Fly America Act requires that travel paid for by federal funds must be on US carriers. There are some exceptions, known as Open Skies Agreements, and more information can be found on the Department of Transportation's website. For assistance with Fly America Act questions, contact the Gallaudet representatives for Travel-On.
Whether you are presenting the results of your grant-supported research at a conference or publishing in a journal, book, blog, or website, essentially any time you report on your research you must acknowledge the supporting agency. Most agencies have standard wording you need to use. A typical statement might be, "Research reported in this [publication/press release] was supported by [name of the agency] under award number [specific grant number(s) in the agency's preferred format]." Some sponsors also request a disclaimer such as "The content is solely the responsibility of the authors and does not necessarily represent the official views of the [funding agency]." Other agencies require that the dollar amount of the award or the percentage of the project the award supported is listed. Make sure to check your agency's website and your award documents for their preferred wording.
The America Competes Act was enacted in 2007 and reauthorized in 2010. ACA was included in the American Innovation and Competitiveness Act (AICA) (S. 3084) on January 7, 2017. ACA is intended to:
- 1. increase research investment,
- 2. strengthen educational opportunities in science, technology, engineering, and mathematics from elementary through graduate school, and
- 3. develop an innovation infrastructure.
It calls for more science, technology, engineering and mathematics (STEM) education and gives federal scientific agencies, such as the National Aeronautics and Space Administration (NASA), National Oceanic and Atmospheric Administration (NOAA), and National Science Foundation (NSF), specific targets for funding STEM research. The Act also required the establishment of several committees dedicated to furthering STEM education and jobs in the US.
In order for a vendor or grantee to receive federal funds, they must make certain representations and certifications including, but not limited to: small business status, minority-owned or economically-disadvantaged women-owned status, lobbying certification, Buy American certification, and delinquency on federal debt. At Gallaudet, the Office of Sponsored Programs is responsible for completing this section of grant proposals.
The Uniform Guidance, which became effective in 2014, combined the rules and regulations governing federal grant and contract funds. This replaces the previous OMB circulars, A-21, A-87, A-110, A-122, A-89, A-102, and A-133. The Uniform Guidance consolidates the administrative, accounting and audit requirements for expenditure of federal funds into one document. This document covers topics such as allowable costs, indirect and direct charges, auditing, and much more. Contact the Office of Sponsored Programs for more information about the Uniform Guidance.
The Cost Accounting Standards Board (CASB) was established to create cost accounting standards designed to ensure consistency and uniformity in spending of federal funds by contractors. There are 19 standards adopted by CASB including: consistency in estimating, accumulating, and reporting costs; consistency in allocating costs incurred for the same purpose; accounting for unallowable costs; allocation of direct and indirect cost; and more. Contact the Finance Office for more information about Cost Accounting Standards.
The Single Audit, also known as the OMB Uniform Guidance, is typically performed by an independent certified public accountant and encompasses both financial and compliance components. This is an organization-wide audit on an entity that expends $750,000 or more in Federal assistance received for its operation. For more information about audits, please contact the Finance Office.
The Uniform Guidance establishes principles for determining costs applicable to Federal grants, contracts, and other sponsored agreements. Previously, OMB Circular A-21 applied to educational institutions but this has been replaced by Uniform Guidance. The Cost Principles section of Uniform Guidance is designed to ensure that federal awards bear their fair share of costs. For additional information on cost principles, please contact the Finance Office.
Indirect (or Facilities and Administrative (F&A)) costs (sometimes known as overhead) are defined as expenses that benefit more than one cost objective and cannot be allocated to a specific sponsored project. This includes items such as building maintenance, equipment and capital improvements, personnel, space, and accounting. Each entity receiving federal funds has a negotiated Indirect Cost rate (or F&A rate) although some grant opportunities have a maximum allowable indirect rate. It is important that the university receive reimbursement for the maximum allowable indirect rate to cover common services and assets used by the sponsored program. For more information about Gallaudet's indirect rate, please contact the Finance Office.
The Federal Acquisitions Regulation System was developed to ensure uniform policies and procedures for acquisition for all federal agencies. The guiding principles are:
- 1. to satisfy the customer in terms of cost, quality, and timeliness of the delivered product or service by, for example-
- a. to maximize the use of commercial products and services;
- b. to use contractors who have a track record of successful past performance or who demonstrate a current superior ability to perform;
- c. to promote competition;
- 2. to minimize administrative operating costs;
- 3. to conduct business with integrity, fairness, and openness; and
- 4. to fulfill public policy objectives.
Nearly all federal agencies must comply with the FAR, although a few have their own acquisition regulations. The FAR affects sponsored programs because it outlines specific certification requirements, notifications and instructions directed at entities that are seeking federal contracts. For more information about the FAR as it relates to Gallaudet, please contact the Office of Sponsored Programs.
Time and effort reporting refers to certifications made by people working on sponsored projects about the amount of their working time that is spent on their project. It is very important that federal funds are accounted for correctly and that only time (and all time) spent working on the sponsored project is charged back to that specific project. The Finance Office will send documentation for signature to each PI for all personnel charged to their project each semester. Only the person who has done the work or the PI who can verify the amount of time spent on the project can sign to certify the hours. For more information about time and effort reporting, please visit the Finance Office website.
The Historic Preservation Act (HPA) requires federal agencies to evaluate the impact of federally funded projects on historic properties (buildings, archeological sites, etc.) Both Chapel Hall and House One are registered historic places and any sponsored project which might impact one of them would be subject to HPA evaluation. The Office of Campus Design and Planning is responsible for historic preservation on campus. For information about how the HPA might affect off-campus sponsored projects, please contact the OSP.
The Clean Air Act, which was enacted in 1970 and revised in 1990, gives the Environmental Protection Agency (EPA) authority to implement and enforce regulations reducing air pollutant emissions. Specifically, EPA implements a variety of programs that focus on:
- reducing outdoor, or ambient, concentrations of air pollutants that cause smog, haze, acid rain, and other problems;
- reducing emissions of toxic air pollutants that are known to, or are suspected of, causing cancer or other serious health effects; and
- phasing out production and use of chemicals that destroy the stratospheric ozone.
Any research or sponsored project which causes the release of air pollutants would be regulated by the Clean Air Act
The Clean Water Act, which was enacted in 1948 as the Federal Water Pollution Control Act and reorganized and expanded in 1972, establishes the basic structure for regulating discharges of pollutants into the waters of the United States and regulating quality standards for surface waters. Permits are required to discharge any pollutant from a point source into navigable waters.
The Safe Drinking Water Act was enacted in 1974 and amended in 1986 and 1996 to protect public health by regulating the nation's drinking water. Originally, the act focused on water treatment but the 1996 amendment expanded the focus to include source water protection, operator training, funding for water system improvements, and public information as important components of safe drinking water.
 Concepts from the Belmont Report https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html retrieved 12/06/217  Concepts from the U.S. Department of State http://www.state.gov/strategictrade/overview/ retrieved 3/31/2015  List retrieved from http://orc.osu.edu/regulations-policies/exportcontrol/ - 03/31/2015  Concepts from Acquisition.gov "Federal Acquisitions Regulation" retrieved from https://www.acquisition.gov/browse/index/far 05/06/2015
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