Humans as Subjects in Research
The University of Arkansas is committed to ensuring that researchers use safe, ethical practices when engaging in human subjects research. In accordance with Federal Regulations and University of Arkansas Policies and Procedures Governing Research with Human Subjects, 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.
What is Human Subjects Research?
- 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 professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.
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 are required to submit a completed Protocol to the IRB Coordinator. Investigators may not engage in HSR prior to submission and approval of the protocol. HSR is reviewed according to three categories: 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).
IRB Fall 2017 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. Since a quorum of voting members is required to review protocols, investigators are encouraged to plan ahead and submit protocols for summer research in time for the April or May meetings. It is very difficult to get a quorum together during the summer months.
All meetings will be held in 107 MLKG on the following dates:
- Wednesday, September 13, at 12:00 Noon
- Wednesday, October 11, at 12:00 Noon
- Wednesday, November 15, at 12:00 Noon
- Wednesday, December 13, at 12:00 Noon
Types of Review
Exempt - Protocols which are exempt from federal regulations do not need the approval of the IRB. They are reviewed and approved administratively.
Expedited - Some protocols can be approved through the Expedited review process. These protocols are reviewed and approved by a single, voting member of the IRB. Any voting member can request that a project approved through expedited review be brought to the consideration of the full IRB.
Full Board- Some protocols must be reviewed and approved by a quorum of the voting members of the IRB at a regularly convened meeting.
Protocol Submission Form
Submission and Deadlines
Protocols should be submitted to the IRB Coordinator and may be submitted in hard copy or electronically (FAX or email). Submission deadlines vary according to the type of review required. You may make your own preliminary determination using the key available through this link or request assistance from the IRB Coordinator (firstname.lastname@example.org).
- 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 must be sent to the IRB Coordinator with your completed Project Protocol Form. The agreement and protocol form will be reviewed and approved (signed by the authorized institutional official) concurrently. The signed agreement will be either returned to you or forwarded to the databank as requested.
Except for projects funded by the National Institutes of Health (NIH), training in the responsible conduct of human subjects research is voluntary at this time unless specifically required by the IRB as a condition of approval. 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 must establish a username 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.
Reporting Concerns About Human Research Activities
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, and/or the IRB Coordinator. 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 email@example.com.
- Department of Health and Human Services, Office for Human Research Protections
- Food and Drug Administration (FDA)
- 45 CFR 46 DHHS Protection of Human Subjects
- FDA Regulations
- 21 CFR part 50, Protection of Human Subjects
- 21 CFR part 56, Institutional Review Boards
- 21 CFR part 312, Investigational New Drug Application
- 21 CFR part 812, Investigational Device Exemptions
- Good Laboratory Practices Act
Policies and Principles
- UA Policies and Procedures Governing Research with Human Subjects
- NIH Policy for IRB Review of Human Subjects Protocols in Grant Applications
- NSF Policy for Proposals Involving Human Subjects
- USDA Policy on the Protection of Human Subjects
Resources for Investigators
- Sample Documents
Resources (Guidance) for IRB Members
Contact IRB Program Staff
|IRB Coordinator||Iroshi (Ro) Windwalker||
|IRB Chair||Douglas Adams||
|Director, Research Compliance||
RESEARCH COMPLIANCE ALERT
REMINDER: New IRB Protocol Submission Process Debuts. Please click here for details and a training schedule.
IACUC Submission Deadline Change: The next IACUC meeting will be held on Nov. 3. Deadline for submitting protocols for review at the meeting is Oct 27, 2017.
NOTE – Use only the current forms found under ‘Protocol Submission’ subheading on this page.