Frequently Asked Questions

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 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.

• Oral verification from a faculty member to an administrator will not pass the test of “suitable means of verification”.
• Verification, at a minimum should be accomplished by some form of written documentation.
• All documentation used as suitable means must be retained for audit purposes to support certification.
• The means of verification must take into consideration and be consistent with other University documentation in existence.
• Must be sufficient to support a reasonable estimate of effort expended.

How do I certify my Time and Effort?

There is a two-step process completed by the PI:

• Complete a mandatory training course “UTPA-Time and Effort Certification Training” at https://my.utpa.edu/. For more information, please see the Training Section under T&E Services.
• Log into ECRT during the 30 day certification cycle semi-annually.

What is ECRT?

ECRT – 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?

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?

For questions about Time and Effort Certification please send an email to effortcert@utpa.edu or contact J. Lilia Treviño from the Office of Research Compliance at 956-665-8991.
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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.

2. Are there types of proposals/awards that are exempt from the RCR requirement?

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.

3. Who must receive the RCR training?

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.

4. Must RCR training be provided on an annual basis? Is there a minimum content requirement

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.

5. Are there resources for institutions to identify effective materials and practices for RCR training?

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.

6. Does the RCR requirement flow down to any subawardee identified on the project?

Yes. At the time of proposal submission, the Authorized Organizational Representative 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.

7. Does the RCR training plan have to be in place before any award is made, or at the time of proposal submission?

The RCR training plan must be in place at the time of proposal submission.

8. Do undergraduates, graduate students and postdoctoral researchers have to receive RCR training before being identified on a proposal to NSF?

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.

9. What does the term “oversight” mean as specified in the certification language?

“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.

10. Does a subaward to an international organization have to include the RCR requirement?

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.

11. Does NSF require that individuals who receive NSF scholarships or stipends through, for example, the NSF S-STEM or Noyce programs receive RCR training?

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.

12. Who is responsible for assuring the students who receive NSF Graduate Research Fellowships receive RCR training?

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.

14. We were told at a seminar in Washington DC that NSF would publish a final rule on RCR in the Federal Register. Did this happen? If so, can you please provide a citation?

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.

15. Do PIs have to report in annual or final reports on the RCR training?

PIs are not required to report on RCR training in annual and final reports.

16. Is this certification also required for NIH, DOD and other sponsors? Or, is just for proposals submitted to NSF?

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.

17. What are the responsibilities of the PI on the award supporting the students or postdocs in providing RCR training?

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.

18. If the award is transferred to a new institution, would the RCR requirement apply to the new award?

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

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

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:

• A study intended to result in publication or public presentation
• An activity resulting in publication or public presentation, even though it involves only review of existing data that was collected with no intent to publish
• Any use of an investigational drug or device
• Research involving human subjects includes survey and interview research, and other evaluation studies.

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 UTPA 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 UTPA’s Bloodborne Pathogen Exposure Control Plan.

What if my research activities are not associated with my work at UTPA?

If an employee of UTPA is neither conducting research at UTPA nor conducting research as part of his/her institutional duties/employment obligations the research activities are unlikely to require UTPA IRB approval. For example, if the investigator is an employee at UTPA and a graduate student at another institution, UTPA IRB review would not be required if human subjects data were not being obtained at UTPA (however, if subjects are being recruited from UTPA, the PI should first obtain IRB approval from his/her degree-granting institution and then contact the UTPA 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 UTPA 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 UTPA as the author’s institutional affiliation (instead “Private Practice”, or something similar, should be indicated).

Lastly, if a student conducts research outside of a UTPA 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 UTPA IRB approval as long as the research is not conducted at UTPA. For example, a local surgeon who has registered as a UTPA 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, UTPA 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 UTPA IRB approval. The federal regulations are set as a minimum and many institutions, including UTPA, 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, UTPA 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 3^rd 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 1^st Tuesday of each month. Protocols and supporting materials should be submitted to the IRB Office in REIN 1.106

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:

1. Research is limited to adults (18 yrs. or older)
2. Questions do not include legally reportable events (such as child abuse or elder abuse)
3. Researcher is not collecting information that would allow the identity of an individual to be readily ascertained.

What if non-UTPA individuals will be working with me collaboratively on the research?

Our FWA only covers researchers at our institution. If non-UTPA individuals will be involved, they must either:

1. Be from an institution with its own FWA and obtain IRB approval from their IRB. This does not negate the need for the UTPA researcher to obtain UTPA IRB approval for his/her involvement in the study. For many collaborative studies, this is the most common approach to take. It is important to note that different IRBs may handle the same protocol differently, thus approval by one IRB does not negate the need for review by, and approval from, the other IRB. Dual IRB review can add time to the review and approval process, so researchers must plan to submit well ahead of intended start dates.
2. Be from an institution with its own FWA and we sign an Authorization Agreement stating that either UTPA’s IRB or the other institution’s IRB will be responsible for human subjects oversight for the entire project. Note that this process may be time consuming and somewhat impractical for individual projects because it involves revision of the other institution’s FWA to include/designate UTPA’s IRB.
3. be from an institution without an FWA and sign an “Individual Investigator Agreement” and complete human subjects protection (CITI) training.

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 UTPA 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-UTPA individuals want to recruit UTPA staff/faculty/students as participants in their research – can I assist?

Our FWA only covers researchers at our institution. If, as an “agent” of UTPA, 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 UTPA IRB protocol prior to conducting the study.

Additionally, all research that recruits our staff/students/faculty must be locally reviewed by the UTPA 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 UTPA IRB approval.

UTPA 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 UTPA IRB oversight. However, agreeing to allow a researcher to visit UTPA and solicit students for, say, a paper-and-pencil survey research study would require that the non-affiliated PI receive clearance from the UTPA 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, ethnic minority or those who are unable to speak English, people with mental impairment 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:

1. A UTPA IRB New Study Application Form.
2. Informed consent form(s) or simplified consent forms and, if applicable, assent forms for children.
3. Certificate(s) of human subjects protection training (through CITI program).
4. Study materials (e.g. copy of survey/scale/interview questions).
5. A copy of any recruitment materials (such as flyers or advertisements), if applicable.
6. Letters of permission, if applicable (e.g. from school principal, clinic director, etc).
7. A copy of the associated grant proposal and award or fundable score letter if the research
   will be supported through a grant.

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 Consent Forms. 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, this should be clearly stated in the protocol; each RA’s certificate must be submitted before he/she becomes involved in 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 Chair or an appointed IRB member. All informed consent forms must be stamped with IRB approval. The PI will receive an Adobe Acrobat PDF of the stamped/approved form(s) via e-mail from the Office of Research Administration. 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 Administration immediately. The ORA will report adverse events to the Office of Human Research Protections, Department of Health and Human Services, as appropriate.

Other Questions:

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:

• DHHS Office for Human Research Protections (OHRP)
• Human Subject Regulation Decision Charts
• 45 Code of Federal Regulations 46
• 21 CFR 50 and 21 CFR 56
• NIH Guidance: Does your proposed research involve human subjects?
• NIH Guidance: Human subjects research definitions
• Texas state reporting requirements for suspected child abuse
• Texas state reporting requirements for suspected elder abuse or abuse of individuals with disabilities
• Association for the Accreditation of Human Research Protection Programs (AAHRPP)
• http://videocast.nih.gov/ram/ohrp_kaneshiro.ram
• http://videocast.nih.gov/ram/ohrp_carome.ram
• http://www.hhs.gov/ohrp/education/#materials

 What is an export? An export is: 

• The transfer or transmission of oral, written, electronic or visual disclosure and shipment of controlled commodities outside the United States to anyone, which includes U.S. citizens, of any commodity, technology - information, technical data, or assistance or software/codes
• The transfer or transmission of oral, written, electronic or visual disclosure, to any person or entity of a controlled commodities, technology or software/codes with the intention to transfer it to a non-U.S. entity or individual, regardless of where they are located including a foreign student a visiting scholar or other colleagues at UTPA
• The transfer of these items or information to a foreign embassy or affiliate also falls under export control regulations

What is deemed export?
Deemed export involves providing, transferring or disclosing technology, information to a foreign national within the U.S.  The following are examples of transmittals that may constitute deemed export:

• Telephone conversations
• FAX
• E-mail communications
• Computer data
• Tours of labs
• Face-to-face discussions
• Training sessions

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.
What agencies control exports?

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).

EAR is responsible for controlling the export of dual use technologies, items that can be used, or have the potential to be used, for both military and non-military purposes that could compromise national security if exported.

ITAR regulates and enforces military or defense-related articles, technologies, and services.

OFAC regulates and controls the transfer of goods and services of value to embargoed countries and imposes trade sanctions, and trade and travel restrictions for controlling terrorism, drug trafficking and other illegal activities.

What types of projects can raise concerns related to export controls?

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.
Projects in the following areas have a high probability of being subjected to export controls regulation:

• Space sciences
• Engineering
• Computer science
• Research with encrypted software
• Biomedical research with lasers
• Research with controlled chemicals, biological agents, and toxins
• Additional considerations why your research may be subject to export control regulations:
  • Expected physical export of controlled goods or technology
  • Sponsor restricting participation of foreign nationals in the research
  • Sponsor restricting the publication or dissemination of research results
• Actual confirmation from the sponsor that export controlled information or technology will be furnished for export or controlled use in the research

What is technical data? 

• Any information, other than software as defined in 22 CFR 120.10(4), which is required for the design, development, production, manufacture, assembly operation, repair, testing, maintenance or modification of defense articles. This includes information in the form of blueprints, drawings, photographs, plans, instructions and documentation;
• Any classified information relating to defense services;
• Any information covered by an invention secrecy order;
• Software as defined in 22 CFR 121.8(f) directly related to defense articles; 

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:

• subscriptions available without restriction to anyone who may want to purchase the published information;
• sales on newsstands and at bookstores;
• second class mailing privileges granted by the U.S. Government;
• at libraries open to the public or from which the public can obtain documents;
• patents databases at any patent office;
• unlimited distribution at a conference, meeting, seminar, trade show or exhibition that is generally accessible to the public and is in the U.S.;
• public release (i.e., unlimited distribution) in any form (not necessarily published) after approval by the cognizant U.S. government department or agency; and
• fundamental research.

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.

In general fundamental research is excluded from export control regulations. It is worth noting that only the information and not the materials or technology resulting from research may be disclosed to foreign nationals.

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;

2) the research is federally funded and specific access and dissemination controls regarding the resulting information have been accepted by the University in a Sponsored Research Agreement

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.


What constitutes published information?

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:

• Periodicals/Journals
• Books
• Print media
• Electronic or any other media available for dissemination to any member of the general public
  Published materials also include the following:
  • Readily available literature at libraries open to the general public
  • Published patents
  • Dissemination at an open conference, meeting, seminar, or trade show

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.

How do I determine if export control regulations apply to my project/grant or contract?

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.

The following categories of defense articles and services are included on the ITAR Munitions List:

• Tanks and military vehicles
• Military training equipment
• Nuclear weapons, design, and testing equipment
• Military electronics
• Spacecraft systems and associated equipment
• Directed energy weapons
• Submersible vessels, oceanographic and associated equipment
• Classified articles, technical data and defense services not otherwise enumerated
• Auxiliary military equipment
• Vessels of war and special naval equipment
• Aircraft and associated equipment
• Launch vehicles, guided missiles, ballistic missiles, rockets, torpedoes, bombs, and mines
• Fire control, range finder, optical and guidance and control equipment
• Toxicological agents and associated equipment
• Ammunition
• Firearms
• Artillery projectors and armaments
• Explosives, propellants, incendiary agents, and their constituents
• Protective personnel equipment
• Miscellaneous articles not listed above with substantial military applicability and which were designed or modified for military purposes.

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:

1. Nuclear Materials, Facilities and Equipment and Miscellaneous\
2. Materials, Chemicals, ''Microorganisms,'' and Toxins
3. Materials Processing
4. Electronics Design Development and Production
5. Computers
6. Telecommunications and Information Security
7. Lasers and Sensors
8. Navigation and Avionics
9. Marine
10. Propulsion Systems, Space Vehicles and Related Equipment.

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.

 ITAR Penalties:

• Criminal: up to 10 years in prison
• Civil: seizure and forfeiture of articles, revocation of exporting privileges, fines of up to 500K per violation

EAR Penalties:

• Criminal: $50K- $1M or five times value of export, whichever is greater, per violation, up to 10 years in prison
• Civil: loss of export privileges, fines $10K-$120K per violation

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.