Institutional Review Board

Any institution participating in research or sponsored programs must have an approval process in place for the use of human subjects.  Please allow up to four weeks for applications to be reviewed. Applications submitted within the first seven days of the month will be reviewed by the end of the month. If the IRB committee has any questions or concerns regarding the proposal, the approval process may take longer than usual.

 

 

COVID-19 GUIDANCE

In the context of the rapidly evolving circumstances regarding COVID-19 and to further the efforts of Arkansas Tech University’s commitment to promote social distancing and protect members of our community, the Institutional Review Board (IRB) has issued the following guidance related to in-person human subject interactions. 

All in-person research must follow the general University guidelines and policies for Covid-19 precautions for safety as described by their unit currently in force at the time the research is conducted.

IRB COVID-19 GUIDELINES

  1. If your protocol does not involve face-to-face contact for recruitment or with enrolled participants (e.g., online surveys, questionnaires, remote interviews or focus groups, etc.), you do not need to submit any modifications and may continue to collect data in accordance with your approved protocol.
  2. If your protocol does involve face-to-face contact for recruitment or with enrolled participants and it is feasible to utilize an online platform (e.g., Zoom/Skype) or other communication method (e.g., by mail) for these interactions, you should consider doing so to maintain research momentum.  A modification application may be required based on whether the protocol was approved as exempt or non-exempt.   
  3. If your protocol does involve face-to-face contact for recruitment or with enrolled participants and it is not feasible to utilize an online platform and does not conform with University or unit guidelines for Covid-19 precautions for safety, you will need to seek approval up through your Vice President.
  4. Modifications for Non-Exempt Protocols 
    If you choose to revise your protocol to allow for remote recruiting, consent, or data collection, submit a Modification of an IRB Approved Research Project form to irb@atu.edu
  5. Modifications for Exempt Protocols 
    If your Notice of Action letter indicates that your study was approved as exempt, you may modify your methods to include remote interactions without submitting a modification.
  6. The IRB will not require a Modification application if you choose to temporarily suspend your research activities approved as Exempt or Non-Exempt. You must, however, communicate this decision via email to irb@atu.edu.
 

 

FREQUENTLY ASKED QUESTIONS

Per 45 CFR 46.102(l), "[r]esearch means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge."

Per 45 CFR46.102(e)(1), "[h]uman subject means a living individual about whom an investigator (whether professional or student) conducting research:

(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens;

(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable specimens.

Per 45 CFR 46.102(j), "[m]inimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
The IRB exists as a body to assure the protection of research subjects in accordance with federal regulations and the ethical principles set forth in the Belmont Report (i.e., respect for persons, beneficence, and justice).

The function of the IRB is to review requests on research involving human participants and to conduct periodic reviews of human participant policies and procedures.

Per 45 CFR 46.111, the IRB “shall determine that all of the following requirements are satisfied: 1) [r]isks to subjects are minimized...; 2) [r]isks to subjects are reasonable in relation to the anticipated benefits...; 3) [s]election of subjects is equitable...; 4) [i]nformed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by, 45 CFT 46.116; 5) [i]nformed consent will be appropriately documented or appropriately waived in accordance with 45 CFT 46.117; 6) [w]hen appropriate, the research plan makes adequate provision for monitoring data collected to ensure the safety of subjects; and 7) [w]hen appropriate, [ensure that] there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data."

If the IRB determines that benefits of a proposed research study outweighs the risks, they review the consent process to ensure that all potential risks and benefits are clearly identified to prospective participants and that participation is voluntary.

After the review, the IRB may elect to approve, table, or reject the research application. The committee may require protocol revision(s) and resubmission. In the event of requested revisions, the proposal must be resubmitted for IRB review and approval.

There are several activities that may involve human subjects but that are not classified as research. As such, these activities do not fall under the IRB's policies and jurisdiction. All of the types of activities listed below do not require IRB applications or approvals.

  1. ATU teacher and student evaluations;
  2. Program evaluation research to benefit ATU and carried out by ATU administrative officials and/or their designees;
  3. Projects designed to enhance or improve curricula offerings;
  4. ATU employee performance evaluations;
  5. State of Arkansas mandated program evaluations;
  6. Marketing research (designed to market the institution as a product).

 

QUESTIONS

If you have further questions about whether or not your research must be reviewed by the IRB, please consult the Human Subject Decision Charts:  2018 Requirements. If the decision charts do not address your question, please contact the IRB at irb@atu.edu for further guidance.

 

 

 

COLLABORATIVE INSTITUTIONAL TRAINING (CITI)

Researchers must complete the CITI training prior to beginning their project. IRB Applications will not be reviewed without inclduing proof of CITI course completion. The Collaborative Institutional Training (CITI) is an online training module teaching research methods. 

CITI TRAINING COURSECITI COURSE ENROLLMENT INSTRUCTIONS

 

 

 

IRB LINKS 

 

 

INSTITUTIONAL REVIEW BOARD

Appointments 2020-21

Alternate Members