I will be conducting interviews which I will audio tape and later transcribe. Does my study qualify for Exempt Review?
Any systematic investigation that is designed to develop or contribute to generalizable knowledge, and which involves living humans about whom an investigator obtains information through intervention or interaction or obtains identifiable private information, qualifies as human subjects research. Also, any activity whose data will be submitted to the FDA or held for their inspection, will likely qualify as human subjects research. Please see our manual or webpage "What is human subjects research?"
In order to conduct human subjects research at the University of Texas at Austin you need to have IRB approval. This entails completing the application process and receiving approval. Items required with your application are:
- "Application for DRC & IRB Review (exempt. non-exempt, & expedited),"
- "Required Proposal Form" This is a template that we prefer that you use when writing your research proposal,
- Your consent form should be written using the consent form template,
- "Documentation of Compliance with Educational Mandate. " This form should include the ethical training in human subject research that you, your faculty supervisor and other key personnel have completed. The different options in which you can meet this training requirement can be found under the "Policies" link on our web site, and
- "Faculty Supervisor Form." **Make sure that all the forms that require a signature have been signed. We require the application to be reviewed and signed by your faculty supervisor and the Departmental Review Chair (DRC) before being submitted to the IRB. The DRC is the person who has been appointed/designated by your department to review human subject research proposals to ensure that all the necessary material has been completed before being submitted to the IRB. Your faculty supervisor should know who the DRC is for your department, if your department doesn't have a designated DRC, then the signature of the department head will suffice. In the event that your faculty supervisor doesn't know who the DRC is, click here for a DRC list.
If researchers are unable to address concerns through these traditional methods, then a researcher may address controverted issues by meeting with the committee. Before meeting with the committee, researchers should describe their concern and forward any supporting materials to ORS. The submission should be a scientifically based position outlining the specific concerns, provide references, scientific rationale, and/or supporting material.
The submission will be referred to the committee for discussion. The process may include meeting with the committee at its next meeting if requested and appropriate. The process will include communication with all the relevant parties to collect additional information as well as the transmittal of the findings, recommendations and resultant actions back to the researcher.
The UT EID (UT Electronic Identification) is not your social security number. Please do not give us your social security number.The UT EID is the logon you use to sign on to the UT Direct web site, not your social security number. The software we use to track protocols uses the EID to locate the investigators Email address.
No. There are three categories of review, Exempt, Expedited and Full Board. Depending on the risk/benefit ratio of the study you plan to do, one of these three levels of review will be assigned. There are six categories that fall under the Exempt Review and nine categories under Expedited. A complete listing of these categories may be found in the "Forms & Templates" heading on our web site.
**You can only apply for one type of review. Your study cannot be both Exempt and Expedited.
No. The use of audio and video equipment is not allowed in Exempt studies. You may qualify for Expedited review if your study meets the criteria outlined in 45 CRF 46.110. This will not increase your approval time.
No. We need for you to list the type of ethical training you have received in the responsible conduct of human subject research and the date that you completed the training. You can find a listing of several ways that this training requirement can be met by clicking on the "IRB Policies and Procedures at UT" heading in the side navigation area.
Yes. All research faculty (including volunteer faculty) that participate in an approved research project, either by performing research procedures, collecting and reporting data, or receiving credit as an author on the published results must be included on the application as a co-investigator, sign the application, be listed on the consent form (unless doing statistical analysis only with no subject contact), and be listed on the Documentation of Compliance with Educational Mandate. If your research team should change once the project is approved, you must submit an Amendment modifying your protocol either adding the new investigator(s) or removing those no longer involved.
If the work performed on the research project would allow the staff person to receive credit in publications resulting from the research, then his or her name must be listed on the protocol. For large classroom projects, students can be listed on the Documentation of Compliance with the supervising faculty member listed as the Primary Investigator.
No. The IRB approves protocols with the understanding that only the investigators named in the protocol application will conduct the work. If your colleagues would like to work on your research project, you may modify your existing protocol to add them as co-investigators by submitting an Amendment application along with the changes you want to make. Otherwise, they must apply for their own IRB protocol approvals.
If human subjects are involved, yes. Student research that involves human subjects requires approval by the IRB prior to initiation. Please note: student researchers are required to obtain a faculty sponsor for each research project.
IRBaccess is the quickest way to check the results from an IRB meeting. https://utdirect.utexas.edu/vr/IRBsignoff_actions.WBX The fastest way for you to find out the status of your study is to provide us with an accurate address where you receive your correspondence. That can be your department mail code if you're faculty or staff. If you're a student, you should list your home mailing address on the application instead of your department.
If you are applying for Expedited or Exempt approval, you should submit your proposal at least 30 days before you intend to start your research. This allows the IRB time to review it. By submitting it that far in advance, it will also give you time to make any changes that the IRB requests in a timely manner and still meet your start date. For a Full Board review, your proposal should be submitted by the agenda deadline, prior to the monthly meeting.
The IRB committee consists of over 15 individuals who prepare for IRB meetings by reviewing each application, protocol, and consent form, along with additional materials such as recruitment flyers/advertisements, Email texts, surveys, questionnaires, etc. In order to ensure a thorough and detailed review, all members must receive a complete copy of these materials. The original copy will be maintained by the Office of Research Support.
Note: only one copy is needed for Expedited and Exempt review.
Research that is physically conducted on private property (schools, hospitals, community agencies, NGOs, businesses) requires documented approval from that site (site letter). A template site letter is located in the forms and templates page. All research conducting within schools requires district approval.