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, training 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, training 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?

Projects involving Risk Group 2 or Risk Group 3 microorganisms 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 CITI? I noticed that this was a requirement that needed documentation on the AUP.

This is the Collaborative Institutional Training Initiative, 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, training, 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 module titled "Working with the IACUC." Individuals who will be working at CLAF (Central Laboratory Animal Facility) or ENRC (Engineering Research Center) are also required to complete the module titled "Post-Procedure Care of Mice and Rats in Research:  Minimizing Pain and Distress." To complete the training, go to the CITI website  and log in under the University of Arkansas Fayetteville using your university ID and password.
 

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 required CITI training (see above).

 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 later in the month.

Protocols must be submitted electronically no later than noon on 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 can I do?

 While the IACUC prefers to reviewall 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 designated member review (DMR). After the AUP or MR is submitted to the IACUC Program Manager, the IACUC Chair (or his/her representative) 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 DMR is not a guarantee that a project can be approved before the next scheduled IACUC meeting. Also, DMR does not mean that the review will be completed immediately. You should allow at least a week for the DMR process to be completed.

When do I need approval from the Institutional Biosafety Committee?

Activities which involve Risk Group 2 or Risk Group 3 microbiological agents (bacterial, viral, fungal, and certain multicellular parasites), biological toxins, recombinant and/or synthetic nucleic acid molecules (rDNA), human or non-human primate blood or tissues, and cell cultures must have the approval of the IBC.  Please see the University Biological Safety Manual for more information.
 

How do I get IBC 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 (ibc@uark.edu, or (479) 575-2671).
 

Where do I get the IBC Forms?

The fillable PDF forms are available here.

 

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 ibc@uark.edu. 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 him at jrhogan@uark.edu. 
 

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 you  of the time and location of the next IBC meeting. You must 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 renewal or confirm that the protocol can be terminated.
 

When should I submit a request for a protocol renewal?

Renewals 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. 

 

 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 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 ibc@uark.edu. 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.

 A. Protocol Submission and Review

 What is the deadline for submitting a protocol?

All  studies are reviewed on a first-come, first-served basis. The only “deadline” that exists is for studies that require full board review. One IRB meeting is scheduled each month during the academic year. During the summer, meetings are held as needed and if a quorum can be attained. Protocols must be submitted at least one week before the meeting to allow time for thorough review of the protocol. Typically, less than 3% of all  studies submitted to the IRB require full board review. On average, about 75% of the 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 Coordinator (irb@uark.edu) 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. Decision charts  (see link below) can assist you in determining whether your protocol qualifies for an exemption or for expedited review.

Decision Charts

 

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. At that time a notification is sent to the investigator(s) with an approval or a request for changes.

If a study does not fit into an exempt category, but presents no more than minimal risk to the participant and can fit into one of the expedited review categories, then it is assigned 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 a notification to the investigators with an approval or the information/stipulations requested by the reviewer.

  How do I submit a protocol for IRB review?

The IRB review process is conducted through the Streamlyne system. Instructions on how to create, complete, and submit a new IRB protocol can be found here.  There is also a link to login to the Streamlyne system on the right-hand side of the RSCP webpage.

Under Streamlyne Help Documents, click on the red bar labeled “Streamlyne: IRB Protocols. Beginning with Module 6.1, Initiating a New Protocol." The modules will take you through each step of the submission process. 

Once you have logged in to Streamlyne and clicked on Main Menu -> IRB, you should see a + symbol next to the words IRB Protocol. If you do not, please contact the IRB Coordinator at irb@uark.edu, as your permissions will need to be updated to allow you to use the system properly.

  What "Protocol Role" so I use for my Faculty Supervisor?

A Faculty Supervisor should be listed as a Co-Investigator. This will allow the study to show up for the faculty member when looking at the “All My Protocols” search, or when a study is searched for by investigator name.

  How do I determine which Protocol Role to use for the personnel on my study?

The options for Protocol Role for any study personnel are Co-Investigator, Data Integrity Manager, Principal Investigator, and Study Personnel.

There can only be one Principal Investigator. If, for example, you have a faculty member and three students working on a protocol, and you generally refer to the study as “Student-A’s research”, then Student-A should be designated the Principal Investigator.

Study Personnel is most often used when there are multiple student researchers who are primarily assisting on the study. They are not necessarily integral to the research process.

Most people associated with your study will likely be added as Co-Investigators. The primary difference is that Co-Investigators are required to approve submissions, while Study Personnel are not. A faculty member doing research who has multiple graduate assistants, for example, might wish to list them all as Study Personnel, so as not to tie up the submission process waiting for everyone to login and approve the submission before it is sent for review.

A Data Integrity Manager is usually listed when a study is conducted by several groups of investigators over multiple research sites. This person would be the one to oversee the entire data collection process and compile all the data.

 What should I include in the Attachments to the protocol?

That depends on the study. A simple rule of thumb is that the IRB needs to review everything that a participant will see. Examples include recruitment flyers, introductory emails, radio announcements, or Newswire advertisements, the consent process (whether it is a script, an introductory sheet, or a form that requires a signature) and, if applicable, assent forms for minor participants, 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 at that facility with the authority to allow you to conduct research at that site. For example, research conducted at a school would require the approval of a principal or vice principal; teacher approval would not be sufficient. 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.

 My advisor is out of town. Do I have to wait until s/he returns before I can submit my protocol?

No. Once you submit a protocol via the Streamlyne system, it will automatically prompt any co-investigators, including your Faculty Supervisor, to login and approve the submission before it is routed to the IRB for review, which can be done from anywhere with an internet connection.

Under no circumstances can you start a project until you have received approval from the IRB to begin the study.

I received approval for my protocol but I need to make changes to it. How do I do that?

Amendments to exempt studies only need to be submitted if there is a change that may affect the level of risk to participants. These can be done by opening the protocol in Streamlyne, going to Protocol Actions -> Request an Action and choosing the option to Notify IRB.

If your study was approved under Expedited or Full Board review, you will need to open the protocol (login to Streamlyne and click on Main Menu -> IRB -> All My Protocols, wait for the search to finish, and then click 'edit' on the line for the study you wish to update), then click on Protocol Actions -> Request an Action -> Create Amendment. You will see several checkboxes: check whichever sections of your protocol you wish to update. (If you wish to add more participants, for example, you would check the Participant Type box; if you wish to update a consent form or survey materials, you would choose Add/Modify Notes & Attachments.) Check as many boxes as applicable, then click 'create'.

Once the amendment is created, you can go to the various sections of the protocol you have marked, and update the sections you wish to change.

Once your changes are complete, click on Protocol Actions -> Request an Action -> Submit for Review. Complete the drop-down and checkboxes, and then click 'Submit'.

Amendments 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.

 

B. Completing the Protocol Questionnaire

 How do I answer the question, “Are you collecting data through intervention or interaction with these individuals,” if I’m conducting surveys over the internet, and never see my participants?

Interaction does not have to be physical. Any communication between you and a participant, including email exchanges, is an interaction. Examples of collecting data without interacting with people would include public observation (whether in a physical public place, such as watching people in front of the Student Union, or on the internet, such as looking through public posts on social media) where participants do not know data is being collected, or obtaining an existing dataset from another investigator or third party. For interviews or surveys, you would need to answer YES to this section of the Questionnaire.

 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 information on 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 a protocol amendment.)

 C. Duration of Protocol Approval

 How long is my project approved for?

The regulations require that all studies be reviewed once a year, and therefore the maximum approval time given is one year. Studies involving a high level of risk may be approved for a shorter period.

To extend the approval period, you must submit and receive approval for a Renewal prior to the expiration date. Given that reviews generally take one to two weeks, it is recommended that renewals be submitted a month before the study will expire, to ensure there is no lapse in the approval.

 

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 s/he 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 confict of interest disclosure form prio 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 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?

University of Arkansas System 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.

³A 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.

What is Research Misconduct?

Research Misconduct is defined by the U.S. Department of Health and Human Services Office of Research Integrity as fabrication, falsification, or plagiairism in proposing, performing, or reviewing research, or in reporting research results.

1) Fabrication - making up data or results and recording and/or reporting them

2) Falsification - manipulating research materials, equipment, or processes, or chaning or omitting data or results in such a way that the research is not being accurately represented.

3) Plagiairism - the appropriation of another person's ideas, processes, results, or words without appropriate attribution. 

Are author disputes considered research misconduct?

No, disputes regarding authorship, including order of authors or inclusion on/exclusion from an article submission do not constitute research misconduct.

Are disagreements over the interpretation of data considered research misconduct?

No, when two or more parties disagree over how research data should be interpreted, this is not considered research misconduct.

What is self-plagiarism?  Is that misconduct?

Self-plagiarism refers to authors who reuse their own previously published content and attempt to pass it off elsewhere as new, unpublished content, usually with no explanation that the content had been previously disseminated. While this does not meet the definition of research misconduct, it is a practice that is widely discouraged and frowned upon. Refereed journals set their own standards, but generally do not look to favorably upon self-plagiarism and may refuse to accept submissions from authors found to have engaged in it.

How can I ensure that I don't unintentionally commit plagiairism? 

SafeAssign, available on the University of Arkansas Libraries webpage (UA Libraries) is a plagiarism checking software. This may be used by faculty, staff, and students.

What should I do if I suspect an incident of research misconduct?

Contact the Office of Research Compliance to discuss your concerns. If a formal allegation of misconduct is warranted, the Director of Research Compliance will assist the Research Integrity Officer in reviewing the incident and conducting the inquiry and investigation as appropriate.

Are incidents of research misconduct reported to project sponsors?

The Office of Research Compliance files an annual report to the Office of Integrity. Included on this report are all allegations, inquiries, and investigations involving research sponsored by any PHS agencies. Notification to other sponsors is made in accordance with their reporting requirements.