(Click the title to expand each section.)
Frequently Asked Questions (FAQs)
When do I contact OSP if I’m interested in submitting a proposal to an external sponsor?
When are proposals due in OSP?
Who needs to approve my proposal and why do they need to approve it?
I am submitting a proposal with a subaward to another University. What kind of documentation do I need from the other University?
I am submitting a revised budget that needs a signature from an Authorized Organizational Representative. Why does OSP need to process this information?
The agency I am applying to limits indirect costs to 10%. What do I need to do for OSP to accept this rate?
What kind of documentation is required for showing cost share in a proposal?
I am writing a multi-year budget. How much should I increase budget categories each year?
Our department recently was awarded a grant, but we didn’t have enough budgeted for fringe benefits, how can we avoid this in the future?
I plan to propose purchasing equipment in my proposal. What should I look out for?
Now that my grant is over, can I take home the equipment and supplies purchased from the grant?
What is intellectual property?
The terms technology and intellectual property are often used interchangeably, it is the knowledge base regardless of the disciplines that has some utility for the society.
How do we protect intellectual property?
Depending upon the type of intellectual property it may be protected through patents, copyrights, trademarks or trade secrets.
What is Technology Transfer?
It is the transfer of knowledge to the private sector to improve the quality of life in the society. Existing knowledge has been transferred to students in the classroom and laboratory settings for centuries. Students upon graduation use this knowledge to create products and services while employed for businesses. Academic institutions also create new knowledge, the process to transfer this knowledge is different, and it is the transfer of this new knowledge to the private sector that is referred as technology transfer.
Where can I find UTPA’s intellectual property policy?
UTPA operates under the University of Texas System's Intellectual Property Policies.
Who owns the Intellectual Property?
The intellectual property policy explains the ownership rights to various types of intellectual property. However, based on federal laws (Bayh-Dole act) all federal sponsors give the entitlement to the any new intellectual property that result from the project to the university. It is then the responsibility of the university to facilitate the legal protection and transfer to the private sector for the public good.
What are my intellectual property obligations to the University?
The university is required to declare any new inventions that may result from federally sponsored research to the sponsoring agency and the intent that the university plans to legally protect it or return the ownership to the federal government. Thus, according to the UT System intellectual property policy, all faculty members, staff, and students are obligated to disclose the intellectual property to the Office of Technology Transfer regardless of whether you think the invention is patentable or you consider the commercial value questionable.
What is the Bayh-Dole act?
It is a federal law co-authored by two senators, hence “Bayh-Dole” act. It entitles universities to the ownership rights to intellectual property supported by tax dollars, and the university is required to transfer it to the private sector for commercialization. However, the government retails a non-exclusive license to practice the patent.
Can I give my work away?
Only UTPA is authorized to make such a decision on intellectual property owned by UTPA.
What is an invention?
An invention encompasses a new idea for a useful application in the society, new materials, new use of existing materials, a new design, a new process, a new machine, a new article of manufacture, a new asexually propagated plant, or improvements to existing plants, materials, process, designs or machines.
Who should I report the invention/creation to?
According to the UT System intellectual property policy, you should disclose the creation and/or invention to the Office of Technology Transfer. That office will work with you to process your disclosure.
When should I report the invention?
As soon as you think that you have an invention, you should complete the invention disclosure form and submit it to the office of technology transfer. You may call the Office of Technology Transfer to discuss and/or seek assistance in completing the form.
Where can I find the invention disclosure forms?
There are three forms. Select the appropriate form for your invention
Who is an inventor?
Who ever conceives the idea and reduces it to practice is an inventor.
What is a patent?
It is a legal ownership right granted by the U.S. government (or other governments if application filed in other countries) to the inventor to exclude others from making, using and selling said invention.
What are the requirements of a patent?
It must be:
How long is the patent protection term?
20 years from the time an application is filed.
What is a public disclosure?
Any disclosure to the general public through publication, e-mail, published grant proposals, poster presentations, oral presentations at conferences, at the University, to companies, web pages, offer for sale and demonstrations constitute public disclosure. It is recommended that a legal mechanism for protection be implemented before any disclosure. There are several mechanisms that can be implemented without any significant delay in publication.
What is the enabling part of the information?
Any information related to the design, data, drawings, concepts, materials, or any other critical information that describes how an invention is constructed or how it functions.
How does the patent disclosure impact the patent rights?
Any public disclosure will bar the inventor from any patent rights in most of the countries. In the U.S. there is one year grace period; however, it is highly discouraged.
What is a confidential disclosure?
The commercialization of intellectual property requires implementation of legal protection to create barriers for competition. Prior to any legal protection, if the disclosure of the PI is needed, then it must be protected by executing a confidentiality agreement (also know as Non-disclosure Agreement – NDA).
What are the options to protect new plants?
Any asexually propagated (e.g. grafting, budding, and rooting) plants can be protected by patents. The application is filed with the U.S. Patent and Trademark Office.
How long is the plant patent term?
It is 20 years from the date of the application.
How are new sexually reproduced plants protected?
Sexually propagated (through seeds) plants are protected by the Plant Variety protection Act (PVPA). The application is filed with the U.S. department of Agriculture.
How long is the Plant Variety Protection good for?
The protection term for most crops is 20 years and for trees, shrubs and vines it is 25 years.
What is copyright protection?
It is the ownership rights to the “original works of authorship.” The rights include:
How do I know who owns it?
The copyright protection in the U.S. is automatic, no registration is required. Typically you will see a notice such:
© Year of creation followed by the name of the company or individual
What are the examples of copyright protected materials?
Here are few examples:
How long is the copyright protection term?
The original authors life plus 20 years, for “work made for hire” it is 95 years from the date of the publication or 120 years from the date of the creation.
What is a trademark?
It is a word, name, slogan, symbol or device or any combination of these used to identify the source of the goods and to distinguish it from those of others. Examples include Coca-Cola®, Goggle®, Xerox®, Ford automobiles company sign, Chrysler’s diamond.
What is a certification mark?
It is a word, name, symbol, device or a combination used with the owner’s permission by someone other that the owner to certify the quality, material, product or service or if the work is performed by members of an organization. You may have seen UL® mark on appliances, signifying that Underwriter Laboratories conducted the safety testing on the product and they certify that the product meets safety requirements.
What is a service mark?
It is a word, name, slogan, symbol, device or some combination to identify the source of the service as opposed to a product. Examples may include Master Card®, VISA® a financial service.
How long is the trademark protection term?
Trademark protection is granted by the U.S. Patent and Trademark office for 10 years from the registration date, and it can be renewed every 10 years provided it is used in commerce.
What is a trade secret?
Any information that is critical to the success and the competitive advantage of business is considered confidential or sometime referred to as proprietary. This may include information related to product formulation, manufacturing, customers, marketing, financial data, or any other know-how that cannot be protected through patents or copyrights, or trademarks.
How long is the protection term?
As long as the information can be kept confidential and until someone independently discovers the same idea.
MATERIALS TRANSFER AGREEMENT
What is a Materials Transfer Agreement?
Sometimes the research and development efforts require acquisition of materials developed or identified by others. Examples of these materials may include but are not limited to biological materials such as cell lines, microorganisms or antibodies, and chemicals. Typically the transfer of these materials also includes proprietary information. Therefore a legal document called the Materials Transfer Agreement (MTA) is necessary to be executed between the provider and the recipient.
What is the purpose of the Materials Transfer Agreement?
The primary goals of the MTA are to protect and clarify the intellectual property ownership rights, the obligations of both parties and to address the liability issues.
Who executes the MTA?
An MTA is a legal document and it is executed by a designated institutional representative for each part. For UTPA, the Office of Technology Transfer is responsible for the execution of the MTA’s.
Non-Disclosure / CONFIDENTIAL DISCLOSURE Agreement
What is non-disclosure agreement?
A non-disclosure agreement (NDA), sometimes referred to as the confidentiality agreement is a legal instrument used to obligate two parties to protect privileged or proprietary information shared between the parties. Sometimes only one party is disclosing information so it is a one-way agreement, other times both parties share proprietary information, so it is a two-way agreement.
Why is a Non-Disclosure Agreement needed?
The commercialization of intellectual property requires legal protection by appropriate means. Prior to implementing legal means to protect the idea it is necessary to execute a non-disclosure agreement before sharing the enabling part of the intellectual property.
Do we need a non-disclosure agreement if a patent protection is in-place?
An NDA is critical during the period while a patent application is being prosecuted. Once a patent is issued then the information is part of the public domain; however, the ownership rights have been established with the grant of the patent. It is important to note that any additional information not covered by the patent is still protected by the NDA.
What is covered in a non-disclosure agreement?
The NDA is intended to clarify the legal obligations and rights of both parties related to the information exchanged and how long the information will be kept confidential.
What is a license?
It is a legal instrument that allows a licensee certain rights to use the intellectual property under agreed upon terms and for how long.
What rights are typically assigned to a licensee?
The licensing terms depend upon the business needs and the obligations of the university. A licensee’s rights may be exclusive or non-exclusive for a given field of application and for a defined geographical area. The rights may also include some combination of product development, manufacturing, marketing and sales and distribution, again in a defined geographical area for a specific application.
What is Time and Effort Certification or Effort Reporting?
Time and Effort Certification or Effort Reporting is the federally-mandated process by which the salary charged to a sponsored project is documented as being reasonable in relation to the effort expended on that project.
During the course of the year, the University charges salaries to sponsored projects and other accounts based on allocation instructions included in the MOE (i.e., the percentage of salary to be charged to one or more sponsored projects or other accounts based on committed effort) provided by department personnel acting upon instruction from Principal Investigators, Project Directors, and others who oversee those sponsored projects. Federal regulations require that throughout the course of the year, these changes be monitored to ensure that any significant change in effort or workload results in a change of the salary distribution. Time and Effort Certification is required twice a year.
Who certifies Time and Effort?
It is the responsibility of every Primary Individual (PI) in ECRT to certify his/her own Effort Certification report as well as reports for all Supporting Individuals (except PI’s) who have expended Effort on his/her Sponsored Projects every 6 months.
What is a suitable means of verification?
Suitable Means is defined as: Having sufficient or required properties for a certain purpose or task and to denote confirmation by evidence that something that was believed is correct, serving to support or corroborate.
How do I certify my Time and Effort?
There is a two-step process completed by the PI:
What is ECRT?
ECRT – the Effort Certification and Reporting Technology system is an on-line tool that facilitates both semi-annual Time and Effort Certifications and monitoring requirements.
How precise must my certification be?
Federal regulations clearly acknowledge that precise determinations are not expected, and that reasonable estimates are acceptable. To quote directly from OMB Circular A-21, “it is recognized that, in an academic setting, teaching, research, service and administration are often inextricably intermingled. A precise assessment of factors that contribute to costs is not always feasible, nor is it expected. Reliance, therefore, is placed on estimates in which a degree of tolerance is appropriate.” Consistent with the Federal regulations, you are obliged to use your best judgment in your certification, taking into consideration all of the activities that you were engaged in during the course of the fiscal year.
Are there any other obligations related to Time and Effort Certification that I am obligated to fulfill in addition to certifying semi-annually?
Yes. As noted earlier, there is also a monitoring requirement. You should monitor your salary allocation via ECRT or through your monthly statement of accounts to ensure that adjustments are made timely.
What happens if a PI does not certify time and effort?
Failure to certify during the certification period is failure to comply with UT-Pan American, UT System, and federal policy. This can result in having all sponsored projects frozen until the certification is complete. (HOP 4.10.5 - University Payroll Distribution Confirmation for Grants, Contracts and Other Agreements)
When I reviewed my effort card, not all of my salary was there, why not?
With rare exceptions, only your “Institutional Base Salary” or IBS is reflected in ECRT. IBS includes your regular salary and summer salary as well as most other additional compensation received from the University. This includes most additional compensation paid for taking on additional activities, including teaching and administration. The salary reflected in effort reporting may be different from your actual salary if some portion of your salary is excluded from IBS. You still must allocate your effort based on all activities that are part of “Total Effort” or “Total Institutional Activities”.
I didn’t know about these effort rules when I filled out my grant application. Is it too late to fix the problem now?
No. If you have concerns about your grant application, contact the Office of Research Compliance at the Office of Research.
Is the time that I devote to writing grant proposals chargeable to sponsored projects?
If the proposal writing relates to providing budget, technical and other materials on a continuing project (i.e., a non-competing renewal of an existing project), that time is part of the effort devoted to that project. For new proposals, if a portion of the proposal is a summary of work done on another sponsored project, that time may be charged to the other sponsored project. However, all other effort devoted to writing grant proposals for either new awards or competitive renewals of existing awards may not be charged to sponsored projects.
This is a requirement set forth by Federal regulations. As a general rule, a portion of a faculty member’s time devoted to writing proposals should be charged to non-sponsored sources, as is the case for time devoted to teaching and administration.
Where can I go for help?
1. Does the RCR requirement apply to supplemental funding requests?
The RCR requirement became effective for new full proposals submitted or due on or after January 4, 2010. It does not apply to funding amendments on awards made prior to that date. Therefore, if an award was made before January 4, 2010 and a supplement was awarded after that date, the RCR requirement does not apply.
The RCR training requirement applies to new proposals submitted, or due, on or after January 4, 2010, to conduct research, which excludes, for example, conference, symposium, workshop, or travel proposals.
NSF expects institutions to be able to verify that those students (undergraduates and graduates) and postdoctoral researchers who receive NSF funds (support from salary and/or stipends to conduct research on NSF grants) will obtain RCR training. However, NSF anticipates that institutions will develop their RCR training programs in a manner that helps prepare the next generation of researchers, including the consideration of risks or other factors associated with student and postdoctoral researcher participation in research.
Each institution is responsible for the content requirements of its RCR training program, and the frequency with which such training determining must occur. NSF understands that some institutions would like NSF guidance about content for training in responsible conduct of research. However, NSF believes that the research community, encompassing both individual researchers and institutions, is best placed to determine the content of RCR training without a need for NSF-specified standards. Furthermore, NSF recognizes that specific training needs may vary depending on specific circumstances of research or the specific needs of students intending to pursue careers in basic or applied science after completing their education. Therefore, it is the responsibility of each institution to determine both the content and the delivery method for the training that will meet the institution’s specific needs for RCR training in all areas at that institution for which NSF provides support. Furthermore, each institution must decide if development of content or pedagogical method is required, or if appropriate content and training can be provided from some existing sources or capabilities, and take appropriate action to implement their decisions.
A wide array of information exists to help inform RCR training. For example, many professional societies as well as governmental licensing authorities for professional scientists and engineers have adopted policies or best practices that might be usefully considered. In addition, research is illuminating existing practices surrounding ethical issues, and providing an evaluation of pedagogical innovations in ethics education. A recent NSF-funded workshop entitled “Ethics Education: What’s Been Learned? What Should be Done?” was held by the National Academies of Science & Engineering (NAE). Information about the workshop, as well as additional resources, are available at: http://www.nae.edu/nae/engethicscen.nsf/weblinks/NKAL-7LHM86?OpenDocument. The workshop report is available at the NAE’s Center for Engineering, Ethics and Society website. NSF is committed to continue its funding of research in this important area through programs such as Ethics Education in Science and Engineering and to promote the development and implementation of effective practices through its education and training programs. NSF will also continue to promote the development and implementation of effective practices through its education and training programs such as the Integrative Graduate Research and Education Traineeship Program. In addition, NSF has also funded two beta sites (NSF Award 0936857 and NSF Award 0936865) to begin to provide an interactive community online resource on ethics education in science and engineering. These beta sites will provide a foundation for an ongoing on-line RCR resource in ethics education in science and engineering that NSF plans to award through open competition. NSF will also continue to explore other potential methods to support the academic community’s efforts in providing RCR training.
Yes. At the time of the proposal submission, the Authorized Organizational Representative (AOR) of the proposing institution is responsible for certifying that its institution has a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research. The RCR training requirement does flow down to all subawardees, at any tier. The proposing institution must therefore ensure that these RCR requirements are appropriately addressed in the subaward instrument. NSF does not anticipate, however, that such subawards will be negotiated at the time of proposal submission.
The RCR training plan must be in place at the time of proposal submission.
No. It is not required that the training be completed at that time. The institution plan for training should include when individuals are to receive the training.
“Oversight” as specified in the certification language refers to tracking and verification that the requirement has been met. Institutions are responsible for verifying that undergraduates, graduates, and postdoctoral researchers who receive salary or stipend support on the NSF award to conduct research, receive the requisite RCR training.
The RCR requirement flows down to all subawardees, including international organizations. If there are undergraduates, graduates, and postdoctoral researchers supported on the award to conduct research, they must be trained in the responsible conduct of research.
No, students who receive only scholarship or stipend support to enroll in an academic program through such NSF programs as S-STEM and Noyce are not required to receive RCR training. However, students must take RCR training if they receive NSF scholarship or stipend support to engage in research, or if conducting research is included in their academic program.
Institutions that host graduate fellows to conduct research will be required to ensure that the fellows have received RCR training.
13. Can training activities (or salaries for the time period spent taking the training) undertaken by undergraduate students, graduate students or postdoctoral researchers who are working on an NSF award be charged as a direct cost to an NSF award?
The question of whether training activities (or salaries for the time period spent taking the training) undertaken by undergraduate students, graduate students or postdoctoral researchers who are working on an NSF award can be charged as direct cost to an NSF award is dependent on the allocability to the sponsored research activity as follows:
If the training is specific to the NSF sponsored research activity, such as learning how to use a particular research instrument or a specific laboratory technique used in the sponsored research activity, or the presentation and reporting on data sets generated by the sponsored research to meet Research Standards, such training may be appropriate to direct charge to an NSF award.
If the training is more general in nature such as plagiarism, research misconduct, ethical standards, human research, vertebrate animals, etc., then it may be more appropriate to treat such costs as indirect and/or apportion them among the major functions of the awardee institution.
Consideration must be given to Cost Accounting Standard 502, Consistency in the Treatment of Costs, and the awardee’s accounting practices as outlined in the institution’s Disclosure Statement. Therefore, if the institution treats these costs as indirect costs under other major functions, or to other sponsors, it may be more consistent to treat these as indirect costs. For example, it generally would not be appropriate to identify such costs as direct costs on an NSF award and indirect costs on an Office of Naval Research award.
NSF posted its final implementation plan for Section 7009 of the America COMPETES Act (42 U.S.C. 1860o-1) in the Federal Register on August 20, 2009. (See: http://edocket.access.gpo.gov/2009/E9-19930.htm for the full text of the Foundation’s implementation plan.) A revised version of the Proposal & Award Policies & Procedures Guide (NSF 10-1) was issued on October 1, 2009 and formally implements the Foundation’s RCR requirements. The RCR requirement applies to proposals submitted or due on or after January 4, 2010.
PIs are not required to report on RCR training in annual and final reports.
Section 7009 of the America COMPETES Act was directed solely at the National Science Foundation, and the Foundation’s implementation therefore applies ONLY to proposals submitted or due to NSF on or after January 4, 2010. NSF is aware, however, that other agencies may have RCR training requirements.
The institution is responsible for certification that the RCR training plan is in place and verification that the students and postdocs have completed the RCR training. The role of a PI in meeting these institution responsibilities is determined by the institution.
The RCR requirement applies to new proposals submitted or due on or after January 4, 2010. If the original proposal was submitted or due prior to that date, the RCR requirement would not apply to the transferred award.
If the original proposal was submitted on or after January 4, 2010, the RCR requirement does apply, and the new institution becomes responsible for ensuring the training requirements are met for the appropriate individuals at its institution.
What is a Human Subject?
Human subject is defined by the Code of Federal Regulations (CFR) as "a living individual about whom an investigator obtains
The regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects.
What is the definition of research?
Research by CFR is defined as "a systematic investigation designed to develop and contribute to generalizable knowledge." Examples of activities that constitute research include:
What is identifiable information?
Identifiable information is any type of information that can reveal the identity of a participant. This includes, but is not limited to, name, job title, age, fingerprints, biometric data, gender, birth date, ethnicity or race, medical records, and the zip code for a location with small population. Confidentiality of the participants’ identity must always be maintained.
What if I am working with de-identified data that was not collected through intervention or interaction for the purposes of the current research?
OHRP has provided several guidance documents to address whether or not obtaining and analyzing data should be considered human subjects research. If you are not obtaining either identifiable private information or data through intervention/interaction with living individuals, then the research activity does not involve human subjects.
Please be aware that identifiable private information is not limited simply to names or Student ID numbers, etc., but includes circumstances under which data can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.
Is IRB submission required for class “research” activities?
Based on the federal regulations, the issue of whether class exercises involving human subjects “research” activities require IRB review centers on the definition of “research”. In most cases, class research projects are pedagogical learning exercises that DO NOT involve systematic investigation designed to develop or contribute to generalizable knowledge. However, IRB approval cannot be provided retroactively. If a student believes that he/she will want to use the data for research purposes, then he/she should seek prospective IRB approval. If a student completes a classroom research project as a pedagogical exercise and produces some interesting results, IRB approval cannot be obtained retroactively and the student should seek to replicate/extend the study after identifying a faculty mentor and obtaining the necessary approvals. In this latter case, the activities during class have not been “wasted” (e.g., literature review, design, creation of questionnaire or collection of materials/scales, creation of an informed consent document, practice gathering data, etc.) and the student is poised to start data collection early the next semester. Failure to obtain IRB review does not preclude the student from presenting the class research activity at a class/department/college/university level session, as long as the session is represented in terms of pedagogical activities (classroom research activity) rather than as a research study.
What are the requirements for class-based exemption?
A classroom project that is used for “teaching and learning the research tools” in the classroom or for pedagogy and is not intended for publication, or presented beyond the classroom are exempt. These projects must not engage minors or vulnerable populations, and entail no more than minimal risk, must not use deception, and must not use audio and video taping.
Is IRB submission required for independent student research, honors theses, graduate theses, and dissertations?
All human subjects research requires IRB approval, whether it is conducted by UTRGV faculty, staff, or students. If your study requires “research committee” approval (e.g. thesis or dissertation committee), IRB approval should only be sought after committee approval has been obtained (i.e. after approval of the thesis proposal). It is the responsibility of the student investigator AND the Faculty Advisor/ Committee Chair to ensure appropriate human subjects protection. In order to assure sufficient oversight of student studies, IRB proposals from students should include valid human subjects protection certificates from both the student and the Faculty Advisor.
Is IRB submission required for program development, program assessment, or quality improvement studies?
If you are conducting a study or survey that has limited generalizability, it may be exempt from the need for IRB review. Surveys conducted by University personnel for the purposes of developing or improving University services and programs are generally not considered research leading to generalizable knowledge (though such surveys should still follow ethical principles such as voluntary participation, confidentiality, etc.). If the results are likely to be represented as generalizable research rather than local quality improvement/program development/program assessment (i.e. published or presented at a scholarly conference), IRB approval may be required. If there is any doubt, please contact the IRB office.
I am conducting an oral history study. Does this require IRB review?
Whether a study requires IRB review depends on whether or not it meets the definition of human subjects research. Thus, the need for IRB review depends on whether or not the study is a systematic investigation designed to “…develop or contribute to generalizable knowledge”. In many cases, oral histories are not conducted with research intent (at least not based on the federal regulations’ definition of research), but are simply biographical accounts obtained from one or more individuals. However, oral history may at times attempt to develop or contribute to generalizable knowledge and thus may require IRB review. If you are in any doubt, it is best to contact the IRB Chair to discuss your particular situation.
What if I intend to quote statements made by research subjects in my publications/presentations?
If you anticipate including quotes in your research presentations/publications, you must integrate the following statement into your consent form (or something like it): "Your responses may be quoted in whole or in part in publications or presentations about this research. If quotes are used, your real name will be replaced by a made up name (pseudonym) and any additional information that might directly identify you will be removed." Under certain circumstances, the nature and extent of the quotes will not warrant such a statement, thus each study will be evaluated based on the intended use of quotes. It is also possible that attribution of quotes to certain individuals may be an important part of the research. Such activities may be approved if the subjects are made aware of the intended use of identifiable quotes and the IRB determines that such practices would be of minimal risk.
What if my research involves educational or health records?
There are additional regulations covering certain types of research that make use of education and/or health records. The IRB does not review protocols for adherence to these regulations. As a researcher, you are responsible for determining that your study does not violate these regulations. If applicable, familiarize yourself with the FERPA, PPRA, and HIPAA regulations before submitting your IRB protocol so that you can design the study appropriately and avoid the need for a revised IRB submission.
What if my research involves biological specimens or recombinant DNA molecules?
Researchers using or collecting any microbiological/infectious agents (including saliva and/or blood samples) and/or recombinant DNA molecules are responsible for obtaining any necessary approvals from the University’s Institutional Radiation and Biosafety Safety Committee (IRBC) and for complying with UTRGV’s Bloodborne Pathogen Exposure Control Plan.
What if my research activities are not associated with my work at UTPA?
If an employee of UTRGV is neither conducting research at UTRGV nor conducting research as part of his/her institutional duties/employment obligations the research activities are unlikely to require UTRGV IRB approval. For example, if the investigator is an employee at UTRGV and a graduate student at another institution, UTRGV IRB review would not be required if human subjects data were not being obtained at UTRGV (however, if subjects are being recruited from UTRGV, the PI should first obtain IRB approval from his/her degree-granting institution and then contact the UTRGV IRB to determine whether or not additional review/approval is required).
Similarly, a clinical psychologist employee who wishes to conduct research with patients at his/her independent private practice would not require UTRGV IRB review as long as the study is not conducted as part of his/her institutional duties/employment obligation. Under such circumstances, presentations and publications should not list UTRGV as the author’s institutional affiliation (instead “Private Practice”, or something similar, should be indicated).
Lastly, if a student conducts research outside of a UTRGV course requirement (i.e. the research is not part of required coursework, is not overseen by a faculty mentor, is not part of a thesis/dissertation, etc), the student would not need UTRGV IRB approval as long as the research is not conducted at UTRGV. For example, a local surgeon who has registered as a UTRGV student for a research methods class decides to conduct a study with his patients. Assuming that the study is not part of required class coursework, UTRGV IRB approval would not be required.
What if my research is exempt from federal regulations?
Although certain types of human subjects research are considered exempt under the 45CFR46 regulations, the determination of whether a study is exempt must be made by the IRB (normally by the IRB Chair or an appointed IRB member). Even if a study is determined exempt from the 45CFR46 regulations, it still needs UTRGV IRB approval. The federal regulations are set as a minimum and many institutions, including UTRGV, set slightly higher standards for human subjects protection. For example, we generally require some form of informed consent process even if the research is exempt from the federal regulations. In most cases, UTRGV IRB policies allow for a simplified consent process for “exempt” studies.
What if my research is not exempt?
Non-exempt research will either require full committee review or expedited review. Like exempt research, there are certain types of research that can be reviewed as “expedited”. While in most cases expedited review takes less time than full committee review, the term refers to the fact that the protocol does not need to be reviewed at a convened IRB meeting, and a fast turnaround is not guaranteed (the time for expedited review depends largely on the complexity of the study in terms of human subjects protection). There is no specific submission deadline for expedited proposals; protocols are reviewed in the order in which they are submitted.
If a study is not exempt or expedited, it must be reviewed by the full committee at a convened IRB meeting. The committee consists of members from diverse backgrounds. Protocols are discussed in relation to adherence to both regulations more generally to ethical principles. Research is also evaluated on the basis of its “risk to benefit ratio”. Protocols may be approved, not approved, or tabled (generally due to insufficient information or inadequate time for review). Approved protocols may be “approved with contingencies”, meaning that specific issues need to be addressed by the researcher (e.g. modifications to the informed consent form) before the study will be officially approved, but that the review of those contingencies can be performed by the IRB Chair rather than by the convened committee. IRB meetings generally take place around the 3rd week of each month during the Fall and Spring semesters. To allow time for processing and review of the protocol materials, the protocol submission deadline for FULL COMMITTEE REVIEW is the 1st Tuesday of each month. Protocols and supporting materials should be submitted to the IRB via email at email@example.com.
What if my study involves children, prisoners, or individuals from other “vulnerable populations”?
Regulations afford specific additional protections for certain vulnerable populations. These regulations provide additional safeguards. For example, survey research that may be exempt for studies using adult participants is generally not exempt if children are being surveyed. In most instances, parental consent is required for research with children. If the child is capable of understanding the basic study procedures, they will also be given the opportunity to decide whether or not they want to participate – this is known as “assent” and is most often documented through use of a child assent form. Research with vulnerable populations may also necessitate an advocate to be present at the IRB committee meeting, thus such proposals should be submitted as early as possible to provide sufficient time for arrangements to be made. If you will be conducting research with vulnerable populations, you should consider the ethical implications and familiarize yourself with the additional regulations.
What if my research involves payment to participants?
If participants will be paid using University funds (e.g. Faculty Research Council award) or external funds paid through the University’s Grants and Contracts Office or Accounts Payable department it is the responsibility of the Primary Investigator(s) to see that appropriate records of payments to human subjects are maintained. This is indirectly an IRB issue, because it may affect the nature of individually identifiable records maintained as part of research participation. Please contact the IRB for up-to-date policy information on this issue.
What if I am conducting online research?
The use of the internet as a medium for research continues to increase. While it provides many advantages, it can also complicate the process of human subject protection. Research using electronic communication cannot be promoted as anonymous, even if attempts are made to secure the transmission of data. In addition to interception of data, technologies exist for capturing data (e.g., keystrokes and mouse movements/clicks) and remote surveillance of computer use. Please contact the IRB to discuss how to best handle human subjects protection issues in online research, particularly in terms of the process of informed consent. In most cases, documentation of informed consent can be waived, but it should be recognized that no guarantees can be made regarding the tracking or interception of subject responses by third parties. Currently, all consent statements for online research must include the following text:
"All survey responses that we receive will be treated confidentially and stored on a secure server [only state if accurate]. However, given that the surveys can be completed from any computer (e.g., personal, work, school), we are unable to guarantee the security of the computer on which you choose to enter your responses. As a participant in our study, we want you to be aware that certain technologies exist that can be used to monitor or record data that you enter and/or websites that you visit.”
Online surveys that involve collection of “sensitive” data (e.g. sexual behaviors/attitudes, drug use) may still qualify for exempt or expedited review if they meet the following criteria:
What if non-UTPA individuals will be working with me collaboratively on the research?
Our FWA only covers researchers at our institution. If non-UTRGV individuals will be involved, they must either:
If such a collaborative research arrangement is anticipated, it is best to contact the IRB Chair prior to preparing IRB documents. Depending on the specific role of the collaborating investigator, he/she may or may not be considered “engaged in research”. This, in turn, will affect what the UTRGV IRB requires of him/her.
What if my research is conducted off-campus?
Most research conducted in the local community requires Spanish translations of informed consent documents and relevant research material. For community research, if the research is limited to English speaking individuals only, there must be some justification for exclusion of non-English speaking individuals other than one of convenience.
If research is conducted at a site off-campus, such as a business, school, medical clinic, etc., the appropriate permission must be obtained from an individual with authorization to grant access. This permission should be obtained prior to IRB review; the IRB should be provided with a signed letter of permission as part of your IRB protocol submission. The permission letter should be prepared on company/school letterhead and should include specific information about the nature of the research activities for which permission is being granted.
What if my research is conducted outside of the United States?
Research conducted in foreign countries must take the local customs and laws into account. IRB review of research conducted in foreign countries is complicated by this issue. In most cases, it is best (sometimes necessary) to additionally obtain local review of the research through a local IRB or human subjects protections committee. Failing this, the IRB may require consultation with individuals familiar with the local culture and norms and investigation of any additional human subjects regulations particular to the country. Researchers planning to do research in foreign countries are responsible for familiarizing themselves with the country’s human subjects protection laws/regulations (if any) and should be prepared to submit an IRB application well in advance of the anticipated research start date. Researchers should familiarize themselves with the information on the OHRP website regarding International Issues and should check The International Compilation of Human Subject Research Protections for country-specific guidance.
What if non-UTRGV individuals want to recruit UTRGV staff/faculty/students as participants in their research – can I assist?
Our FWA only covers researchers at our institution. If, as an “agent” of UTRGV, your involvement is limited to informing participants (e.g. students) about a research participation opportunity, you are not “engaged in research”. However, if you assist with the informed consent process or with the research activities (including, but not limited to, analysis of individually identifiable private data), then you are engaged in research and would need to submit a UTRGV IRB protocol prior to conducting the study.
Additionally, all research that recruits our staff/students/faculty must be locally reviewed by the UTRGV IRB for appropriate levels of human subjects protection. The level of review depends on the nature of the study. Generally, simple survey studies can be approved quickly, after having reviewed the survey materials and procedures. A letter/memo of IRB approval from the PI’s institution is also required prior to UTRGV IRB approval.
UTRGV IRB approval is limited to the review of research for adequate human subjects protection. The IRB does not have the authority to approve use of university facilities or to provide e-mail lists of students/faculty/staff. Non-affiliated researchers should receive approval at the appropriate level (e.g. Department Chair for recruitment/facility use limited to a department, Dean for recruitment/facility use limited to a college, and Provost for campus-wide recruitment/facility use).
Please note: Simply informing students about the availability of an online research study/survey would not require any UTRGV IRB oversight. However, agreeing to allow a researcher to visit UTRGV and solicit students for, say, a paper-and-pencil survey research study would require that the non-affiliated PI receive clearance from the UTRGV IRB.
What is defined as minimal risk?
Minimal risk is no more than what is normally encountered by healthy individuals in the daily lives.
Who is considered a vulnerable population?
Vulnerable populations include children, pregnant women, and prisoners.
What constitutes a complete IRB application?
Complete IRB application includes, a completed application form, informed consent forms that will be used for the study, interview questions and/or the survey copy, the institutional permission letter, and the Principal Investigator training certificate.
The following materials should be submitted to the IRB:
Why is informed consent necessary?
Informed Consent is intended to allow all human subjects, prior to their participation, the opportunity to understand the nature and scope of the research, issues related to confidentiality and risks associated with their voluntary decision to participate in the research.
Where can I find guidance on Informed Consent forms?
Informed consent forms should be based on our template. The template can be found on the IRB website under Submit a New Application for IRB Approval - Consent Form Templates. For some survey research, if it is exempt from federal regulations, it makes more sense to integrate the important elements of informed consent into a cover letter with a statement that return of the survey indicates the individual’s consent to participate in the research. This negates the need for a signed informed consent. Please note that this is only applicable to certain types of exempt research. In most types of human subjects research, a signature (“documentation of consent”) is required.
Do all studies require a signed consent form?
Many “exempt” survey studies can be conducted using a simplified consent process, generally without the need for a signed consent form. Under certain circumstances, even “non-exempt” (expedited or full review) research may qualify for a “waiver of consent” (standard required elements may be altered or waived entirely) or a “waiver of documentation” of consent (a waiver of the need for a signature). There are specific criteria that must be met in order for such waivers of consent or waivers of documentation of consent to be approved.
Who must complete the online PI Certification training?
PI Certification training is required of all those on the project who will be interacting with human subjects or will have access to the data and/or are involved in the analysis. IRB proposals from student investigators should include valid human subjects protection certificates from both the student and the Faculty Advisor. Research assistants who are interact with participants or who work with research data should complete the online training. If the name of the research assistant(s) is not known at the time of IRB protocol submission, there should be no mention of the RA's. Later once these individuals have been identified, you may submit a modification request to add them to the study.
When is the institutional permission letter required as part of the application?
For a study to be carried out at another institution, the Principal Investigator must seek a written permission letter from an authorized representative of the institution to approve the recruitment of human subjects and to conduct research at the institution.
What happens once my study is approved?
You will receive a letter of approval from the IRB via email. All informed consent forms must be stamped with IRB approvalThe PI will receive an Adobe Acrobat PDF of the stamped/approved form(s) via e-mail from the Office of Research Compliance on behalf of the IRB. These stamped forms are the only ones that may be used in the research study. Any revisions to the approved protocols (including modifications to the informed consent forms) must be reviewed and approved by the IRB prior to being implemented.
Can I make changes to my research protocol after it has been approved?
Changes can be made to an approved protocol, but only after additional IRB review and approval. Any changes to the research protocol (including, but not limited to, study population, recruitment procedures, consent/assent document, survey or test materials, researchers or research assistants) must be reviewed and approved by the IRB prior to implementation of changes. Depending on the nature of the changes (particularly in terms of whether it increases risk to participants), the research may either be reviewed through an expedited review procedure or may require full committee review.
What is required if I want to continue my project beyond the one year IRB approval?
Continuation of research beyond the IRB approved period requires IRB approval. IRB approvals are for one year, and any extension of the research beyond one year requires filing a project Continuing Review Form for IRB’s review and approval.
What events do I need to report to the IRB?
If human subjects involved in research projects approved by the IRB are harmed, including any physical or psychological injury, any adverse events, improper disclosure of private information, economic loss, and other harmful or potentially harmful occurrences, the Principal Investigator(s) must notify the IRB and the Office of Research Compliance immediately. The ORC will report adverse events to the Office of Human Research Protections, Department of Health and Human Services, as appropriate.
What constitutes voluntary participation in research?
Voluntary participation means that all subjects freely choose to participate in the research (without any coercion or undue influence), and participants understand that it is their right to withdraw from the study at any point without any consequences to themselves.
What constitutes complete disclosure?
Disclosure of the scope of the project must be spelled out in plain language in the informed consent forms. It must communicate that participation in the project is voluntary with no consequences for the participant who may decide not to participate or may decide to stop participation at any time during the course of the project.
What if the disclosure of the real objectives is not desirable?
Deception of the scope of the project must not be used for the project. However, in few instances, it may be necessary for an objective research. In those cases the IRB must carefully consider the need and degree of deception and the risks and rewards associated with it in approving the application.
What does “Respect” mean in the context of research?
Respect refers to the principle that all individuals should be treated as autonomous agents (i.e. having ultimate control over their lives), and that persons with diminished autonomy (unable to exercise complete control) are entitled to protection.
What does “Beneficence” mean in light of the human subject research?
The investigators are obligated to protect the principle of beneficence; the wellbeing of human subjects involved in the research by maximizing the benefits and minimizing the harm.
What does “Justice” mean in the context of my research?
Justice obligates the need that all groups must be treated equally in the benefits of any research, and similarly no group should be expected to bear more than their share of the burdens.
What other information is available about human subjects protection?
Please see below for some helpful links:
What is an export? An export is:
What is deemed export?
Why are export control regulations necessary?
For national security reasons, including threats to the U.S. economy. The Export Control Laws are federal regulations that restrict the transfer of certain materials, technology, related technical data, and certain services outside the United States. These laws have been in existence and enforced for many years; however, the events of 9/11 have resulted in heightened concerns and stricter interpretation and enforcement of export control laws.
Majority of export control issues fall under the jurisdiction of the Department of Commerce through its Export Administration Regulations (EAR), the Department of State under the International Traffic in Arms Regulations (ITAR), and the Department of Treasury through its Office of Foreign Assets Control (OFAC).
Any research activity that involves the actual export or "deemed" export of any goods, technology, or related technical data that may have dual use (commercial in nature, but can be used in military applications as well) or inherently military in nature may be subject to export controls.
What is technical data?
Two exclusions are relevant to academic research: the public domain exclusion and the fundamental research exclusion. However, these exclusions cannot be applied, if researchers make side agreements that contain publication restrictions or restriction on who may participate in the research. It is absolutely critical that researchers and faculty do not enter into any agreements without guidance from the Office of Research Compliance.
What is public domain?
Public domain is any information that is published and is accessible to the public through:
How is fundamental research defined under export control regulations?
Fundamental research includes basic or applied research in science or engineering at an accredited institution of higher education in the U.S. where the information is ordinarily published and shared openly with the scientific community or is ready for publication.
It is also important to note that the university research will not qualify for this exclusion if:
1) the University or researcher accepts any restrictions on the publication of the information resulting from the research, other than limited prepublication review by research sponsors to ensure that proprietary information is not inadvertently disclosed in publication or to ensure that publication will not compromise the protection of patent rights of the sponsor;
Note that the Fundamental Research Exclusion only applies to information. However, it does not apply to a sponsor's existing “proprietary information” when some or all of that information is required to be confidential.
It is important to note that this exclusion may not be used for information relating to export-controlled equipment used in research projects and classes. Some researchers assume that they can share such information with foreign nationals without a license, since the information is being used while conducting fundamental research.
Export control regulations generally do not apply to information published in the University catalog of courses offered or in teaching laboratories associated with those courses. This exclusion relies on the fact that in ITAR any information related to the general scientific, mathematical, or engineering principles commonly taught in schools, colleges, and universities, or information that is already in the public domain will not be subject to export control restrictions.
EAR and ITAR regulations differ in declaring what is considered published information. For EAR, information is considered published if it has been, is about to be, or is generally published. The ITAR requirement is that the information has been published.
Information is considered published when it appears or is generally accessible to the public through the following means:
It is important to note that a conference is considered "open" if all attendees are allowed to take notes and/or record the presentations. In all these cases, access to the information in question must be free or for a fixed fee.
If the research topic appears on either the ITAR Munitions List or the, EAR Commerce Control List, the export control regulations will apply. ITAR controls the export of "defense articles" and "defense services." Defense articles include any item or technical data that is on the United States Munitions List (USML), and defense services include providing assistance to foreign nationals, whether or not in the United States, with respect to defense articles, and providing any technical data associated with a given defense article.
Additional details related to the Munitions List
On the EAR Commerce Control List restricted technologies are divided into ten broad categories, and the specific restrictions depend on the specific type of the technology and where it's being exported. The various categories are outlined here:
What are the consequences if the researcher does not comply with export control laws?
There are serious consequences for not complying with export control regulations for both the university and the researcher.
How do I prepare myself to comply with export control regulations?
The researchers and faculty should educate themselves about export control requirements in general and particularly related to their specific project. All faculty, academic administrators, the PIs, and research staff members should have a fundamental understanding of these regulations so that they may alert the Office of Research at UTPA to a possible export control issue. The information on this website is intended to provide some guidance. The Office of Research Compliance strongly encourages the campus community to attend the Export Control workshops conducted by the Office of Research Compliance. Please call the Office of Research Compliance, part of the Office of Research, at (956) 665-2889 if you have questions.
What is involved in seeking an export license?
An export license application must be submitted to the Department of Commerce or the Department of State. Contact the Office of Research Compliance to seek the necessary guidance to address your export control concerns. The key is to start the process early. If you are intending to seek an export license, it can take 3-6 months to secure a license to export controlled materials from the U.S. or to transmit them to a non-U.S. citizen or permanent resident within the U.S.
Who do I contact if I have questions?
You may reach the Office of Research Compliance in the Office of Research at (956) 665-2889 if you have questions about export controls and how they apply to your specific research project.