Frequently Asked Questions
How do I know if I need to submit an Animal Use Protocol (AUP)?
If you are a faculty member or a student at the University of Arkansas, Fayetteville (UAF) and are obtaining live animals for projects (research or teaching) or will be doing field research that requires interaction with the study population (trapping, banding, attaching radio collars, etc.), an AUP must be submitted to the IACUC for review. The AUP must be approved prior to initiating any such research (or teaching). In the case of student (undergraduate, graduate or post-doctoral) projects, the AUP must be submitted under the supervising faculty member’s name.
I want to do a research project that involves only lab analysis of tissue samples.
Do I need to submit an AUP?
If you must obtain live animals in order to obtain the tissue samples after appropriate euthanasia, an AUP must be submitted to the IACUC and approved before you proceed. If you arrange to obtain the tissues from animals (after euthanasia) from another investigator (operating under a current approved protocol), then an AUP is not required.
For a class project, I want to take a group of students to a wildlife sanctuary to
count the number of bird species in a particular area. Do I need to submit an AUP?
As long as the group of students will not interfere with the natural behavior of the animals, an AUP is not required.
I want to do research that involves infecting mice with a microorganism potentially
harmful to humans. How do I proceed?
The project must be reviewed and approved by both the IACUC and the Institutional Biosafety Committee (IBC). There is no particular order in which this must be done. However, to save one’s time and effort, it is recommended either to submit the protocol (using each of the committees’ appropriate forms) to the IACUC and IBC concurrently or to make a judgment as to the committee which will have the most stringent requirements and pursue acquiring its approval first.
What is LATA? I noticed that this was a requirement that needed documentation on the
This is the Laboratory Animal Training Association, a commercial company which provides on-line training materials and documentation of such training for the use by such institutions as the UAF. Various regulations require the IACUC to assure that personnel proposing to use animals in research and teaching projects are qualified to do so. In part, this means that they have a basic understanding of humane principles of animal care and use and the regulations and policies with which they must comply. The IACUC requires all personnel named in an AUP to complete the two base modules, Humane Principals of Laboratory Animal Care and Use and Policies and Procedures. Other topics are also available, and animal users are encouraged to avail themselves of all modules they may find helpful. There is no cost to the persons completing the LATA modules.
I have an approved protocol but have recruited a new graduate student who will be
working on the project. I understand that I have to notify the IACUC of this. How
should I proceed?
Whenever the Principal Investigator (PI) finds that changes to need to be made to an approved protocol (changes include personnel changes, a need to increase the number of animals needed, refinements or additions of procedures that do not significantly alter the original objectives of the study) a Modification Request (MR) form must be completed and sent to the IACUC for review and approval prior to initiating any of the changes. NOTE: New personnel will not be approved until they have completed the mandatory LATA Training.
When does the IACUC meet? How far in advance of the meeting should I submit the AUP?
The IACUC generally meets on the first Friday of each month, although this is subject to change. Investigators are encouraged to contact the IACUC Program Manager if they have questions about a particular month’s meeting date. Often the IACUC does not plan to meet during the summer session (July and August) or in January. If there is a January meeting it is usually at a later than customary date.
As stated in the instructions for the AUP, protocols must be submitted electronically no later than noon of the Monday prior to the scheduled Friday meeting. It is recommended, especially for those submitting an AUP for the first time, to submit the protocol a week or more earlier so there the Program Manager has time to review it and give feedback as to any additional information or revisions that may be required. This can save the investigator time in getting a particular project approved.
I missed the deadline for the scheduled monthly meeting of the IACUC, but I really
need to have my protocol approved before the next meeting. What should I do?
While the IACUC prefers to review all protocols and modification requests at a scheduled meeting, the members understand that circumstances can prevent an AUP or MR from being submitted in time for such review. Another method for review and approval is known as the expedited review. After the AUP (MR) is submitted to the IACUC Program Manager, the IACUC Chair (or his/her representative; i.e., the IACUC Program Manager) can appoint two IACUC members to act for the Committee to perform the review. The AUP (or MR) is distributed to all of the committee members and they have seven (7) working days to voice comments to the reviewers or to call for the document to be reviewed at the next convened meeting. Therefore, the PI needs to be aware that expedited review is not a guarantee that a project can be approved before the next scheduled IACUC meeting. Also, “expedited” does not mean “immediate". You should allow at least a week for the expedited review process to be completed before the desired start date of the study.
Institutional Biosafety Committee (IBC)
When do I need approval from the Biosafety Committee?
Activities which involve microbiological agents (bacterial, viral, fungal, and certain multicellular parasites), biological toxins, recombinant DNA molecules, human or non-human primate blood or tissues, and cell cultures must have the approval of the Biosafety Committee. Prior approval is required in most cases. Please see the Biological Safety Policy for more information.
How do I get Biosafety Committee approval?
Submit the appropriate forms at least one week prior to a scheduled meeting. To find out the date of the next meeting, contact the Compliance Coordinator (firstname.lastname@example.org, or (479) 575-02671).
Where do I get the IBC Forms?
The forms are available on the Environmental Health and Safety website, http://ehs.uark.edu/FormsPage.aspx.
Why am I having problems entering data in these forms?
Forms are available in two formats, Microsoft Word and PDF. For Word forms, you will need Microsoft Word (2007 version, or newer) on your PC. The Acrobat (PDF) version works a little differently. You can complete and print them using the free Acrobat Reader, but you will not be able to save the completed form with data. If you have Adobe Acrobat Professional, , you can complete, save (with form data) and print the form within the browser window. You may want to save the blank form to your hard drive, exit the browser, and open the saved form with Acrobat Professional. When the form is completed use "Save As" to save it to a different name. The completed form will be available for further editing and printing. NOTE: If you save the blank forms to your PC, remember to check for form updates before using the same blank forms again.
To whom, and how, do I submit the completed forms?
An electronic copy of the forms should be sent to the IBC Compliance Coordinator at email@example.com. Fax: (479) 575-3846, or email the signature page to the Compliance Coordinator.
Whom do I contact for technical advice and/or assistance in completing the forms?
Contact the Biological Safety Officer by calling 575-5448 or emailing her at firstname.lastname@example.org.
How often does the committee meet?
The IBC meets once a month depending on submission of protocols. Please note that meetings may be cancelled if no protocols are received at least one week prior to the scheduled meeting date.
When will my protocol be approved?
The Compliance Coordinator will send you a confirmation of receipt and inform you of any readily identifiable problems or issues. If there are none, the Compliance Coordinator will notify of the time and location of the next IBC meeting. You or a representative of your lab should attend to describe the proposed work and answer any questions about the protocol.
Once I have an approved protocol, how often do I need to renew it?
Protocols are approved for a three (3) year period. You will be notified by the Compliance Coordinator approximately two months prior to the expiration date, asking that you either submit a request for renewal or confirm that the protocol can be terminated.
When should I submit a request for a protocol renewal?
Requests for renewal must be submitted at least one month prior to expiration of the approved protocol in case a member requests that the renewal be reviewed by the whole Committee. (See FAQ #11 for more information.)
If I want to renew my current protocol will I need to attend another IBC meeting?
The IBC Compliance Coordinator sends requests for renewals of approved protocols (due every three years) to the full committee. Any committee member can request a full review of the protocol, with the investigator or a representative in attendance at the meeting to answer questions. If no member requests full committee review, the Chair and Biological Safety Officer may approve the renewal administratively. In this case, you need not attend another meeting.
I want to make a change in personnel and/or another modification to an approved protocol.
Do I need to inform anyone?
Yes, please notify the IBC Compliance Coordinator at email@example.com. Include the protocol number and title and the changes to be made. Personnel and minor changes will be approved administratively by the Chair of the IBC and the Biological Safety Officer. For major changes, the Chair and Biological Safety Officer may request review by the full committee. If full review is considered necessary, you will be notified and the protocol placed on the agenda of the next scheduled meeting.
Institutional Review Board (IRB)
A. Protocol Submission and Review
What is the deadline for submitting a protocol?
We review all incoming studies on a first-come, first-served basis. The only “deadline” that exists is for studies that require full board review. We have one meeting each month during the academic year. During the summer, meetings are held as needed subject to our ability to convene a quorum of the voting members of the Board. Protocols must be submitted at least one week before the meeting to allow time for thorough review of the protocol. However, less than 3% of all the studies submitted to our IRB require full board review. On average, about 75% of our studies qualify for exempt review, and another 20% require expedited review, both of which are done on a continuous basis.
When is the next IRB meeting?
The meeting schedule is posted on the RSCP website each semester. Note that these dates are subject to change because we cannot approve protocols unless a quorum of the voting members is in attendance. Please check with the IRB administrator (firstname.lastname@example.org) to confirm the next scheduled meeting date.
Do I need to ask for my protocol to be considered for expedited review?
No, that decision is made by the IRB Coordinator based strictly on the categories of review listed in the Code of Federal Regulations. These can be found on the OHRP website: http://www.hhs.gov/ohrp/policy/expedited98.html.
How long does the review process take?
The initial administrative review is completed within a week. If the study fits one of the exempt categories, the IRB Coordinator reviews it administratively. An email is sent to the investigators with an approval or a request for changes at that time.
If a study does not fit into an exempt category, but is no more than minimal risk
to the participants and can fit into one of the expedited review categories, then
it is sent by email to one of our Board members for review. Expedited reviews are
sent to Board members every Friday. If a protocol is received by close of business
Wednesday, it will be sent out for review that Friday. Otherwise, it will be sent
out with the next week’s protocols. Expedited reviews, again, are usually returned
within a week of being sent to the reviewer. When the review is received, the IRB
Coordinator will send an email to the investigators with an approval or the information/stipulations
requested by the reviewer.
Where can I find the forms?
The Humans as Subjects in Research page of the Research Compliance website can be found here.
What do I need to send in besides the protocol form?
That depends on the study. A simple rule of thumb is anything that the IRB needs to review everything that a participant will see. Examples are recruitment flyers, introductory emails, radio announcements, or Newswire advertisements, the consent and, if applicable, assent forms, the survey, the interview questions, and any debriefing you give out. If you are conducting your research at another facility, such as a school or a place of business, you must get a letter of approval from someone in authority over that facility to allow you to conduct your research at that site. For a school, this would mean the Vice-Principal or Principal, not a teacher. For a business, an owner or a manager can give permission, but not a store clerk. Permission must be obtained from an individual with the authority to contractually obligate the research site.
Can I submit electronically?
Yes. The protocol form needs to be signed by all investigators (and their Faculty Advisor if the investigators are students). However, if you scan the protocol form, you can email the documents to email@example.com. You can, if you prefer, email the documents and then fax the signature page to 575-3846. You must include the title page of the protocol form in the fax to ensure the signature page gets matched up to the right study.
My Advisor is out of town. Do I have to wait until s/he gets back to submit?
No. You can send your protocol to the IRB as soon as the documents are finalized. However, approval cannot be released until all the signatures are received. Similarly, if you are conducting your research at an outside facility, you can go ahead and submit your study while you are working on getting approval from the site authorities. In this case, you will need to submit the signed permission from the facility before final approval will be given. Under no circumstances can you start a project until you have received approval from the IRB to begin the study.
I received my approval, but I need to make some changes. How do I do that?
To modify an existing study, send an email to firstname.lastname@example.org describing the changes clearly and attach any documents that must be changed (the protocol form if you changed your procedures in any way, the consent form, survey questions, etc.).
Modifications to exempt studies are usually reviewed within a week (5 work days).
Modifications to studies that required expedited review will also need expedited review,
so they will be sent out for review each Friday. Changes to studies that were reviewed
by the full board may be able to be reviewed by the expedited review method, or might
be scheduled for the next full board meeting, depending on the changes being made.
We will let you know which level of review will be used.
If I’m doing research with kids, can I send a parental consent that says, “return
this if you don’t want your child to participate?”
Ordinarily this is not acceptable. When dealing with participants who are minors, our IRB allows “passive consent”, that is, giving consent by doing nothing, only if a study fits into Exempt Review Category 1:
45 CFR 46.101(b)(1): Research conducted in established or commonly accepted educational
settings, involving normal educational practices, such as (i) research on regular
and special education instructional strategies, or (ii) research on the effectiveness
of or the comparison among instructional techniques, curricula, or classroom management
B. Completing Protocol Forms
If I’m using existing data, what do I put for number of participants?
The regulatory definition of a research “subject” includes collection of private data about individuals as well as interaction with individuals. Even if you never see them or talk to them, every person about whom you have personal, identifiable data is a “participant” in your research. If you’re getting an existing dataset that includes 20 people, you have 20 participants. If the dataset has 13,522 people, then that is also how many participants you have. If you’re unsure how many people are in a dataset, you should always estimate high. (To exceed the number of participants stated in an approved protocol, you must submit a request for protocol modification.)
In Question 8, what do I put for “First Contact” with participants if I’m using existing
The date you intend to start using the data is your “First Contact” with those subjects.
In Question 12, what is the difference between H, “Research involving participants
in institutions,” and J, “Research that must be approved by another institution or
Item H refers to institutions in which participants cannot leave at will – a prison or a psychiatric facility, for example. Item J refers to any outside institution or site where you are conducting your research – a school, a place of business, a Boys and Girls Club, etc. You must get approval from that institution to conduct your research on their premises or with their data. (See See Question A.5. for additional information on obtaining permission.
C. Duration of Protocol Approval
How long does my approval last?
Protocols are approved for a period of one year. To extend the approval period, you must submit and receive approval for a Request for Renewal prior to the expiration date.
What if I forget to renew my protocol before the expiration date?
You must stop all data collection and analysis until you submit a new protocol and get approval from the IRB. Any data collected after the expiration date must be excluded from your dataset.
I am finished collecting data. Can I let my protocol expire and continue to analyze
No. You must have an approved protocol in effect during data collection and analysis.
Conflict of Interest (COI)
Do I have to report all externally sponsored travel? Is there a monetary threshold
for reporting such travel?
You are required to report only externally sponsored travel which is related to your institutional responsibilities. This affirmative disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an institution of higher education, a philanthropic organization, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education, provided that no travel costs supported by any other entity shall be charged to the University.
Reporting is required only for those sponsors whose sponsorship exceeds $5,000, in aggregate, over the course of a given calendar year.
The new campus policy on conflict of interest (404.0) states: “For all full‐time faculty
(both 9‐month and 12‐month) and non‐classified staff, outside employment requires
prior approval.” Assuming a faculty member expects to return in the fall, is prior approval required for summer outside employment when the faculty member will not be on UA appointment? What about employment during
breaks (such as winter break) during the academic year?
With regard to breaks during the academic year, because 9‐month faculty are compensated for the entire period from the beginning of the appointment in August to the end of the appointment in May, including during breaks and holidays, prior approval is required for all outside employment during university breaks and holidays under Board of Trustees Policy 450.1.
If a 9‐month faculty member seeks to undertake outside employment during the summer (when he or she is not on appointment) 1) that will involve or relate to “University Research” as defined in Board Policy 210.1(B)(2) 1 and which may involve or relate to any “Invention” as defined in Board Policy 210.1(B)(4) 2 , or 2) which may involve an actual or potential conflict of interest as defined in Fayetteville Policies and Procedures 404.0(1) 3 , then the faculty member must submit a conflict of interest disclosure form prior to undertaking the outside employment, and an approved conflict of interest management plan may be required in order to engage in the employment. Furthermore, an agreement with the University may be required regarding disclosure, ownership and licensing of any “Invention” conceived or reduced to practice during the outside employment.
Does the University have an ownership interest in intellectual property developed
in the summer when the faculty member is not on University appointment ‐‐ for example,
if the faculty member is consulting for a third party? Must such intellectual property
be disclosed to the University? May such intellectual property be assigned by the
faculty member to the third party, rather than to the University?
A: Board Policy 210.1 requires that any invention by a faculty member must be timely disclosed to the University, regardless of whether it occurs at a time that the faculty member is not on University appointment, and regardless of any contrary contractual obligations imposed by a third party, unless a specific agreement to the contrary has been negotiated in advance with the University. If the University determines that the invention is unrelated to the activities for which the faculty member is employed by the University and it was not made or conceived under circumstances involving University facilities or personnel, then the University will make no claim to such invention.
Recall that Board Policy 210.1(D)(2) provides as follows: “Employees engaged in external consulting work or business are responsible for ensuring that agreements emanating from such work are not in conflict with this policy or with contractual commitments of the University. Such employees should provide affirmative notice to the other parties to such agreements, informing them of the obligations of the employees to the University and the possible applicability of this policy to such agreements.”
1 “University Research” means any research or development activity which is directly
related to the duties and responsibilities for which a person has been compensated
by or through the University or for which facilities owned, operated, or controlled
by the University are used.
2 "Invention" refers to any material capable of legal protection arising out of University Research and includes any discovery, invention, process, know‐how, design, model, computer software (if patentable), strain, variety, or culture of an organism, or portion, modification, translation, or extension of these items but excludes Works [protectable by copyright] as defined [in the Board Policy] which are not patentable.
3 A conflict of interest is a situation in which a faculty or staff member may have the opportunity to influence University administrative, business, or academic decisions in ways that could lead to personal gain, give improper advantage to self or others, or interfere with objective preservation, generation, or public dissemination of knowledge.