Frequently Asked Questions & Answers of the Human Subjects Research Process

What is the definition of “Human Subject”?

A living individual about whom an investigator … conducting research obtains

1. data through intervention or interaction with the individual, or
2. identifiable private information

What is the definition of “Research”?

A systematic investigation designed to develop or contribute to generalizable knowledge.

What is the difference between a Human Subjects proposal and an IRB proposal?

Nothing. Human Subjects proposals are also known as IRB proposals and refer to systematic investigations that involve human subjects.

What do the acronyms DRC and IRB represent?

DRC = Department Review Committee, which references the approval process at the department level.
IRB = Institutional Review Board, which references the approval process at the University level.

What types of studies need to be reviewed by the UT IRB Office, the Office of Research Support and Compliance?

Anything involving a living human being.

Why do I have to submit an IRB proposal?

Many research requirements are influenced by federal law. These requirements are in place to protect the researcher(s) and the subject(s) being researched. UT's Office of Research Support and Compliance keeps track of these requirements. UT's IRB proposal submission requirements are based on these federal regulations. Web resources for information on these federal requirements are listed below:

• Public Responsibility in Medicine & Research (PRIM&R) – http://www.primr.org/
• Applied Research Ethics National Association (ARENA) – http://www.primr.org/membership/overview.html
• U.S. Food & Drug Administration (FDA) – http://www.fda.gov/
• Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) – http://www.aahrpp.org/

Who can help me figure out what I am suppose to include in my IRB proposal?

First contact your Faculty Sponsor to discuss your proposal and to ask your questions. Contact the Office of Research Support and Compliance; NOA 5.200, (512) 471-8871, orsc@uts.cc.utexas.edu, in reference to the UT IRB Submission process and web site. Contact Gail Seale; SZB 340, (512) 232-6202, gails@mail.utexas.edu, if you have questions about the departmental approval process and have been unable to find answers to your questions on the research area of the C&I web site (www.edb.utexas.edu/CI/research/research).

To whom do I submit my IRB proposal?

There are two levels of approval for Human Subjects/IRB proposals:

1. Your Department Review Committee (DRC): Made up of department faculty – Forward it to the C&I Department Coordinator of Human Subjects Research Review in the Center for Science and Mathematics Education: SZB 340, (512) 232-6202.
2. The Institutional Review Board (IRB): Made up of faculty from across the university – The Office of Research Support and Compliance; NOA 5.200; (512) 471-8871, orsc@uts.cc.utexas.edu.
   NOTE: Proposals must be approved by the DRC prior to submitting them to the IRB.

How do I know if my IRB proposal is ready to be submitted?

You may download the procedure checklist for new, amended, or continuing review IRB studies. These checklists were designed to assist researchers in making sure all of the departmental procedures were followed. This will prevent the omission of important steps, therefore preventing delays in the approval process. You may download either of these checklists by clicking on the appropriate PDF icon below or by clicking on the PDF icons listed at the end of the appropriate procedure area on the Electronic Submission page.
View the Checklist for New IRB Proposal procedures in a new window
View the Checklist for Amended or Continuing Review IRB Proposal procedures in a new window

How long will it take to get my IRB proposal approved?

Allow:

• Two to four weeks for departmental approval.
• Two to four weeks, after receiving departmental approval, for UT IRB approval .

Processing times vary depending on the type of study submitted and the schedules of the individuals who approve the proposal.

Why are there different applications?

Human Subjects/IRB proposals are categorized as one of the following:

1. New Review
2. Amended Review
3. Continuing Review

Is there an electronic application available for on-line submission?

Yes. New, Amended, and Continuing IRB proposals should be submitted on-line. Contact your department office or the Office of Research Support and Compliance if you are unable to submit your proposal electronically.

What are the differences between the three types of IRB proposals?

There are three types of Human Subjects/IRB proposals:

1. Full Board – High risk
2. Expedited – Low or Moderate risk
3. Exempt – Low risk with adult subjects (Children cannot be subjects in exempt studies.)

For more detailed descriptions log onto the Human Subjects Research website at http://www.utexas.edu/research/rsc/humanresearch/

Having difficulty submitting your new proposal on-line?

You must have a High Assurance UTEID to submit your IRB Proposal on-line. Log on-line (https://utdirect.utexas.edu/nlogon/eid_suite/essentials/upgrade_sec_level.WBX) to apply for or upgrade to a High Assurance UTEID. For UTEID assistance contact the ITS Enterprise Information Center at (512) 471-7128.

Problems with the on-line application should be directed to the Office of Research Support and Compliance at (512) 471-8871.

Where do I find my faculty sponsor or DRC UTEID?

There is a UTEID hyperlink to the left of the faculty sponsor & DRC signature areas. Click on the UTEID link. A window with a list of all UT faculty, staff, and students will appear. You may conduct a search for a specific person or you may scroll through the list. You can also obtain the C&I DRC UTEID in the procedures areas on the DRC Submission Procedures page at www.edb.utexas.edu/CI/hs_submapproval.php#drceid.

Having difficulty accessing your faculty sponsor UTEID or the DRC UTEID?

UTEID access is restricted to individuals with High Assurance UTEIDs. Log on-line (https://utdirect.utexas.edu/nlogon/eid_suite/essentials/upgrade_sec_level.WBX) to apply for or upgrade to a High Assurance UTEID. For UTEID assistance contact the ITS Enterprise Information Center at (512) 471-7128.

What if my IRB proposal is a class project?

Class projects do not have to be approved by the DRC; however, they do have to be approved by the IRB. There is a special form for class projects that must be completed, signed by your facutly sponsor, and submitted to the UT IRB. This form is located in the Forms and Templates area of the IRB website listed under Special Documents. Contact your faculty sponsor for assistance if you are unsure of whether or not your IRB proposal is a class project.

Please refer to the following website for the complete IRB policy statements:
http://www.utexas.edu/research/rsc/humanresearch/special_topics/oral_history.php

What if I am using a public dataset for my research?

If you are using public datasets, or databases for which there are no restrictions on access (e.g., you don't have to be "cleared" to use the dataset), and the data are de-identified (e.g., U.S. Bureau of the Census), and this is your only "human subject data", then what you are doing is NOT human subjects research and does not have to go through the DRC/IRB review process.

Please refer to the following website for the complete IRB policy statements:
http://www.utexas.edu/research/rsc/humanresearch/special_topics/oral_history.php

What if my IRB proposal is an oral history project?

Oral history projects which only involve interviewing individuals to obtain a specific unique perspective on an event or person or practice, rather than contributing generalizable knowledge, are not subject to the DRC/IRB review process.

Please refer to the following website for the complete IRB policy statements:
http://www.utexas.edu/research/rsc/humanresearch/special_topics/oral_history.php

Are there any other things I should keep in mind when preparing my research paperwork?

1. For consent forms, follow the template closely with one exception - researchers can delete references to outside funding agencies if the study is unfunded.
2. Be clear about inclusion and exclusion criteria for participants.
3. Make sure the research proposal matches exactly the information in the consent forms in terms of numbers of participants, protocols, time required of the participants, etc. Proposals often get sent back to researchers because they are inconsisitent.
4. It's okay that some studies have no immediate benefit to the participants. Researchers shouldn't try to "squeeze out" benefits that don't really exist. If the research has merit in terms of the field but not the participants, it will be considered legitimate.

When may I begin my research?

You may begin your research after your proposal has been approved by the UT IRB Committee in the Office of Research Support and Compliance. There are penalties for begining your research prior to receiving approval from the UT IRB Committee office so make sure you allow sufficient time to obtain approval from your department, as well as the UT IRB Committee, prior to begining your research.

Please refer to the following website for the complete IRB policy statements:
http://www.utexas.edu/research/rsc/humanresearch/special_topics/oral_history.php

Do I need to keep a copy of my IRB proposal; and if so, how long do I have to keep it?

You need to keep a copy of the approval letter that you receive from the Office of Research Support and Compliance. Masters and Doctoral students must include a Statement on Research with Human Participants in their Graduation Packet. The approval letter can be used for this statement of research.

Whom do I contact to get a copy of my IRB proposal or approval letter if I have misplaced my personal copy?

You may contact your department office to see if they have a copy of your proposal. Proposals submitted to the department office in hard copy are kept up to three years after the expiration of the proposal. The department office may not have access to electronically submitted proposals. The Office of Research Support and Compliance keeps record of hard copy and electronically submitted proposals in their database for up to three years from the time the proposal was submitted. The timeframes listed are subject to change so check with your department office or the Office of RS&C for updated information.

For additional IRB questions contact Gail Seale in the Center for Science and Mathematics Education office (SZB 340), by phone at (512) 232-6202, or by email at gails@mail.utexas.edu.

Submit additional FAQs to be posted on this web page to Shawna Matteson by email at smatteson@teachnet.edb.utexas.edu.