- Getting Started and Completing the Forms
- What exactly qualifies as human subjects research (and thus requires IRB approval)?
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. See our manual or webpage "What is human subjects research?"
- My professor says I need to fill out some paperwork in order to do my project. What is she talking about?
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.
- How do I submit documents for review?
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 RSC. 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. 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.
- The application says I can apply for Expedited Review. Does this mean that my proposal will be reviewed and approved quicker?
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 "IRB Forms" heading on our web site.
**You can only apply for one type of review. Your study cannot be both Exempt and Expedited.
- I will be conducting interviews which I will audio tape and later transcribe. Does my study qualify for Exempt Review?
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.
- Do I need to list in my protocol application all of the research faculty that might be asked to participate on my approved research project?
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.
- Do I need to include my research staff on the protocol application? Also, what about "student" researchers?
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.
- Do students' academic research projects require IRB approval?
If human subjects are involved, yes. Student research that involves human subjects requires approval by the IRB prior to initiation. Note: student researchers are required to obtain a faculty sponsor for each research project.
- What is the fastest way to find out what happened to my study at an IRB meeting?
IRBaccess is the quickest way to check the results from an IRB meeting. 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.
- When should I submit my proposal?
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.
- What is required for off-campus research?
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.
- Consent & Recruitment
- Is informed consent required even if the data/specimens will be collected from my friends and colleagues?
Yes. All research involving interaction with human subjects (including collection of specimens) requires informed consent regardless of who the subjects are. In some cases, written informed consent may be waived.
- Who can consent on behalf of a subject for participation in a research study?
If an adult subject is unable to consent on his/her own behalf due to medical incapacity, the subject's legally authorized representative (a court appointed conservator or guardian, an attorney-in-fact pursuant to a durable power of attorney) may consent on his/her behalf. Family members (also called "next-of-kin") who do not meet the definition of legally authorized representative may not provide consent for a related adult to be enrolled in research. If there is no legally authorized representative, and the adult subject cannot consent, the subject may not become a human subject in an experiment unless the federal requirements for waiver of consent have been met. If a minor is unable to consent on his/her own behalf due to medical incapacity, a parent or legal guardian may provide consent for research. (Note: under normal circumstances, enrollment of minors as subjects requires consent by the parent or legal guardian as well as assent by the minor.)
- Does "Waiver of Informed Consent" or "Waiver of Documentation of Consent" mean that I don't have to get consent from the participant?
A waiver of documentation of consent means that a subject's physical signature on the informed consent form is not required. However, you must always get consent from your participants and you must always provide them with enough information about your study so that they can make an informed decision as to whether or not they wish to participate. You can get verbal consent from your participants, but you have to mention this in your research proposal. In cases where a waiver of documentation of informed consent is granted cover letters are typically used to inform subjects. The cover letter is given to the subject (either physically, displayed on a website in HTML, or sent in the mail) but is not signed. A waiver of informed consent means that
- the research involves no more than minimal risk to subjects;
- the waiver will not adversely affect the rights or welfare of subjects;
- the research could not practically be carried out without the waiver;
- whenever appropriate the subjects will be provided with additional pertinent information after participation. Waivers of informed consent are usually granted for retrospective data analysis. For more information on how you may qualify for either of these waivers, see 45 CFR 46.116 and 45 CFR 46.117.
- Can I recruit students for my research from my own class?
We prefer that you do not use students from your own class because it is difficult to avoid giving the perception to your students that they have an obligation to participate. In other words, there is a potential for a conflict of interest. However, it can be done if recruitment is done in such a way that there is no hint of undue influence. The students shouldn't be made to feel pressured to participate, and if they refuse, their refusal shouldn't influence their grades for the course. Alternatives to research participation should be used in the consent form.
- I want to amend my study to compensate subjects. Do I need to reimburse subjects which have already participated?
The choice is yours. You may go back and "retrospectively" compensate subjects for their participation or you may begin to once the amendment is approved.
- After You Submit Your Proposal
- I disagree with the IRB decision. What can I do now?
The Vice President for Research and the IRB advisory committee recognize that actions of the IRB are subject to scrutiny by the research community. The Institutional Review Board evaluates a wide range of research, and RSC wants researchers to know there is an avenue to address disagreements regarding committee decisions.
Principal investigators wishing to raise concerns with IRB decisions should first clarify their understanding of the recommendations or requirements with the RSC assigned staff member (512-471-8871 or firstname.lastname@example.org). It is also recommended that researchers familiarize themselves with the specific regulation requirements related to the committee concerns. These references can most often be found on the IRB website.
- I'm really busy, can I have my research coordinator or my assistant respond to requests from the IRB on my behalf?
Federal regulations require that the IRB to communicate directly with the Primary Investigator regarding protocol-related issues. Accordingly, all correspondence from (or on behalf of) the Primary Investigator must be submitted to the IRB with the Primary Investigator's signature. The IRB may return any protocol-related correspondence that is received without evidence of the Primary Investigator's approval.
- Why was I given less than a 12-month approval?
It is mandated by federal regulations that the IRB grant approvals for a period not to exceed 365 days. However, if your protocol is reviewed, and changes have to be made before your granted approval, you will only be granted approval from the day the IRB receives the changes up till 12 months from the initial review. For example, your protocol is reviewed at the November 25thmeeting and the IRB finds that changes have to be made to the protocol and consent forms before they will approve your protocol. Your changes are submitted to the IRB on January 16th Your approval time period will be from January 16th, the day your turned in the changes through November 25th, one year from the day of the initial review.
- I received Exempt approval for my study. Do I still need to submit a continuation every year at The University of Texas at Austin?
No. A continuing review must be submitted in three years after initial determination expires. Failure to submit a continuation in a timely manner will result in your study being in "cessation." The study will be kept in cessation status for 30 days after which it will be "inactive."
- Okay, so you have my UT EID in your database, does that mean that the database will notify me of my studies expiration date and I don't have to worry about it?
No. The database, like any other software, may have glitches that our programmer doesn't yet know about. While the database is programmed to notify the investigator of the expiration of their study, it is still the investigator's responsibility to submit a continuing review before the study expires and in time to meet the agenda deadline (if it's Full Board).
- I received a "Cessation Notice." What does this mean?
A "Cessation Notice" is sent out to the Primary Investigator when their study has expired and the investigator has failed to submit a continuation. During the period of cessation, the investigator is prohibited from collecting further data and from recruiting more participants. The investigator should submit a continuing review application as soon as possible.
- I received an "Inactive Notice." What does this mean?
An "Inactive Notice" means that your study has lapsed its expiration date by 30 days and the IRB has now terminated it. Further research is prohibited. You will need to resubmit a new protocol for review. You may also have received a "Inactive Notice" even if you submitted a closure after receiving your "Cessation Notice." You cannot close a study once it has been suspended.
- Is the difference between closure and termination?
A study is terminated when it has lapsed its expiration date by 30 days. This is an automatic action taken by the IRB. A closure is an action taken by the PI to end the study. The closure can be submitted at any point prior to the suspension of the study. Once a study is suspended it cannot be closed.
- What If . . . ?
- I want to do a study, which will involve me observing conversations in a cyber chat room. I will be observing the dialogue only, but will not participate. Do I still need IRB approval?
"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 about living humans, qualifies as human subjects research. " While some researchers may argue some cyber chat rooms are "public" space, still have an ethical and moral responsibility to the protection of human subjects. A study that will use existing data, whether public or private must still get human subjects approval. Privacy and autonomy are important principles to We will post more information and ethical guidelines regarding internet research as they are developed.
- I am working on my thesis/dissertation and have complete access to everyone's records as part of my job. I want to use information gathered from their records and from asking them questions. Surely I don't have to follow the guidelines on account that I have complete access to these records, right?
Wrong. While your job duties may allow you full access to their records, you are not allowed to use information contained in their records or to gather information from them as a researcher without prior IRB approval and the consent of the subject. As a researcher you are still required to submit an IRB application along with the supporting documents for review prior to beginning your study.
- I want to distribute some surveys to gather feedback on how to improve the services offered at the Student Health Services. Do I still need IRB approval?
If the information being gathered is not going to be published and will be used only to improve the services offered by your department, then you do not need IRB approval.
- What if I carried out my research without IRB approval?
If you are conducting human subject research without IRB approval, you are in violation of Federal Regulations and subject to non-compliance reporting both to University officials as well as OHRP in Washington, D.C. You also put the University at risk of having its research privileges shut down. If the research is being done for a Master's Thesis or a Doctoral Dissertation, the Graduate School will require that you submit proof of IRB approval with your paper. If you didn't receive approval from the IRB prior to starting your project, you will not receive approval once it is completed.
- Additional Information and What is Considered Human Subjects Research
- Where can I read more on the regulations governing human subject research?
You can find a lot of information governing human subject research at the following sites:
- 45 CFR 46
- Office of Human Research Protections
- FDA Title 21, Part 50
- FDA Title 21, Part 56
- FDA Information Sheets
- What happens when a non-research activity becomes research?
Research using data collected for non-research purposes requires IRB to determine if the research:
- Is exempt because it already exists, and the sources are publicly available or the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants;
- May be reviewed using the expedited procedure if risks are minimal;
- Requires full IRB review if data are identifiable and risks cannot be minimized
- What questions should you ask yourself about what is research?
Is the activity a routine operation in the setting?
If yes, then it probably isn't research.
Do the data gatherers normally have regular and routine contact with the data or the subjects?
If yes, then it probably isn't research.
Does the activity require additional procedures?
If no, then it probably isn't research.
Does the activity alter the timing or frequency of standard procedures?
If no, then it probably isn't research.
Is the responsible agency sponsoring the activity?
If yes, then it probably isn't research.
Is the goal of the activity to test a hypothesis or answer a research question?
If yes, then it probably is research.
- Is there anything else I should know?
All communication concerning IRB submissions should be submitted directly to the RSC office, and not to individual committee members or to other University of Texas officials. Per federal regulations, 45 CFR 46.112 and 21 CFR 56.112, officials may not approve the research if it has not been approved by an IRB. These regulations prevent University of Texas officials such as the RSC Director, the Institutional Official, and the Vice President of Research from overruling a decision by the IRB.