Human Subjects Research

Important Announcement

REMINDER: Please login to Streamlyne to create and submit your IRB Protocol. For a training schedule click here. For help documents click here and then click the Streamlyne IRB Protocols ribbon.

COVID-19 GUIDANCE: Please click here for guidance on safely conducting human subjects research during the COVID-19 pandemic.

The University of Arkansas is committed to ensuring that researchers use safe, ethical practices when engaging in human subjects research. In accordance with the federal regulations and the institutional policy on human subjects research, the Institutional Review Board (IRB) is responsible for the oversight of all Human Subjects Research (HSR). Where IRB approval is required by University policy or federal or state regulation, researchers must obtain approval prior to the inception of the project. Projects cannot be approved retroactively.

 

 

 

 

 

 

 

Human subjects research is defined  as follows (click here for regulatory definitions):

  • Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
  • Human Subject is a living individual about whom an investigator (whether faculty, staff, or student) conducting research: (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

If the activity you are planning is systematic investigation designed to contribute to or develop generalizable information and involves obtaining data through interaction with an or identifiable private information from a living individual, you are engaged in HSR. You must submit a protocol for review; investigators may not engage in HSR prior to submission and approval of the protocol. HSR is reviewed according to one of three categories into which it falls: Research Which is Exempt From IRB Review; Research Eligible for Expedited Review Procedures; and Research Which Must Be Reviewed At a Properly Convened Meeting of the IRB (Full Board).

Protocols must be submitted through the Streamlyne system. Log into Streamlyne using your university ID and password.

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Submission and Deadlines

Submission deadlines vary according to the type of review required. The IRB Coordinator will make the final determination as to the type of review needed. You may make a preliminary determination based on a review of the Decision Charts available here: IRB Protocol Decision Charts.

  • Exempt - Protocols which qualify for exemption may be submitted at any time. Barring unusual circumstances, results of the review will be provided within one week.
  • Expedited - Protocols which qualify for Expedited Review are are due not later than 5:00 PM on Wednesday of each week. Protocols will be distributed to designated reviewers on Fridays. Reviewers must provide a response within one week. Investigators will be notified of review results within three days of receipt of results by the IRB coordinator. Protocols which miss the deadline will be held until the following week for distribution.
  • Full Board - Protocols which require review at a convened meeting of the IRB must be received at least seven business days prior to the meeting. Protocols will be distributed to the IRB members five days prior to the meeting date. Investigators will be informed of review results within three days.

Data Use Agreements

All data use agreements (DUA) must be sent to the IRB Coordinator with your completed Project Protocol Form.  The DUA  must be reviewed and approved by the Director of Research Compliance. A copy of the signed agreement will be forwarded to you for your records.

Resources for Investigators

Frequently Asked Questions

Research with Children

Research Involving Prisoners

Informed Consent

Investigator Responsibilities

Sample Documents

 Membership

The current IRB roster can be found here.

IRB Summer & Fall Meeting Schedule

The IRB meets monthly during the academic year with the possible exception of the month of December. Days and times may vary from semester to semester. Once your protocol has been scheduled for review, you will be notified of the location of the meeting. 

 Meetings will be held in MLKG 107 on the following dates:

  • Friday, July 10, 10:00 a.m.
  • Monday, August 10, 8:00 a.m.
  • Friday, September 4, 10:00 a.m.
  • Monday, October 12, 8:00 a.m.
  • Friday, November 6, 10:00 a.m.
  • Monday, December 14, 8:00 a.m.

 Resources for IRB Members

Approval of Research with Conditions: OHRP Guidance

Expedited Review Procedures Guidance

Criteria for IRB approval

Smart IRB

The University of Arkansas has joined Smart IRB, which streamlines the reivew and approval process for multisite research protocols involving members. Click here for more detais: Smart IRB

 Researchers conducting projects sponsored by the National Institutes of Health (NIH) must complete training in the responsible conduct of HSR. Otherwise training is voluntary unless specifically required by the IRB. Either of the following training sites fulfills the requirements set forth by the NIH policy on required training.

Online training in the Responsible Conduct of Research is available through the Collaborative Institutional Training Initiative (CITI). Investigators may log in using their university ID and password. At this time, training is voluntary. This is subject to change.

Online training is also available from the NIH Office of Extramural Research.

There is no charge to the trainee for either training activity.

 Concerns about the conduct of human subjects research activities on the UA campus or by UA investigators can be addressed to the Chair, any member of the IRB,  the IRB Coordinator or the Director of Research Compliance. Confidentiality requests will be honored to the extent allowed by the laws of the State of Arkansas and University policies. Individuals who have concerns about their rights as participants should contact the IRB Coordinator or other individual identified in the participant informed consent document. General questions can be sent to irb@uark.edu.

Please note that international students and scholars must comply with all terms and conditions of their current immigration status. Participation in any human subjects research study for compensation  (e.g. cash, gift cards, etc.) meets the definition of "employment" for immigration purposes. Students may contact the Office of International Students and Scholars for assistance prior to participating in any compensated research study.

This applies only to students or scholars who are participating as research subjects. This does not apply to those who are themselves conducting research as part of their studies.

 

 Contact IRB Program Staff

Director of Research        Compliance Jason G. Ramage


108 MLKG 
479-575-2105 ramage@uark.edu 

IRB Coordinator Iroshi (Ro) Windwalker

109 MLKG
        479-575-2208          irb@uark.edu 

IRB Chair  Douglas Adams

222 MAIN
       479-575-7440        djadams@uark.edu 



UPCOMING MEETINGS

IACUC Meeting: Friday, October 9 at 1:00 p.m. via Microsoft Teams. (iacuc@uark.edu)

IBC Meeting: Thursday, October 8 at 2:00 p.m. via Microsoft Teams. (ibc@uark.edu) 

IRB Meeting: Monday, October 12 at 8:00 a.m. via Zoom.

Committee meetings will be conducted via webinar or teleconference until further notice.

 

UPCOMING FALL SEMESTER WORKSHOPS - Register at https://edp.uark.edu/

 October

10/8 - Human Subjects Research 

10/13 - Biological Safety

10/21 - Export Controls

10/22 - Responsible Conduct of Research

10/23 - Conflict of Interest

 November

11/5 - Human Subjects Research

11/9 - Export Controls

11/10 - Biological Safety

11/19 - Animal Care and Use 

11/23 - Responsible Conduct of Research

11/24 - Conflict of Interest