IRB Frequently Asked Questions
1. Who serves on the IRB?
IRB members are appointed for one-year terms, and may be reappointed for successive periods. The IRB chair serves three-year terms. In accordance with applicable federal regulations, the Board must have a minimum of five members, including at least one individual who would be considered a non-scientist. Members are selected from faculty, staff, students, and community members. If necessary, non-voting consultants may be enlisted to review specific protocols for which there is no IRB member with sufficient knowledge of the research method or scientific discipline to conduct a substantive review.
2. What qualifies as human subjects research and therefore 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.
Individuals who provide information for research that is not about themselves are not considered to be human subjects in this context (e.g., interviews for a new story). While researchers should take steps to ensure that these individuals are not placed at risk, it is not necessary for the IRB to approve their participation.
3. What is required prior to submitting an IRB application?
Researchers must complete a short online course called CITI ethics training. Researchers may go to (https://about.citiprogram.org/en/homepage/) and register under “The University of Texas Permian Basin.” At the conclusion of the course you will receive a certificate that is valid for 3 years and this certificate must be attached to your IRB application.
4. Once the board reviews my study, when can I start enrolling participants?
You must wait for an approval letter from the IRB before your study may begin recruiting or enrolling participants.
5. What elements are required for consent procedures?
Informed consent is an ongoing process, not a piece of paper or a discrete moment in time. Informed consent assures that prospective participants will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. The prospective subject should be presented with the information, and then given an opportunity to ask questions and have them answered, prior to signing the consent document.
Participants can and should be allowed to withdraw consent and exit the study at any time.
For adult participants, the UTPB has a standardized consent form (available on our website) that we encourage researchers to use. It includes all elements of consent required by the Office for Human Research Protections.
For child participants, consent or verbal assent is required. A child consent or assent form must include: 1) a statement of the purpose of the research; 2) a description of the procedures to be applied to the minor; 3) a description of the potential risks and discomforts associated with the research; a description of any direct benefits to the minor; 4) a statement that the minor does not have to participate if he/she does not want to; 5) a statement that the minor is free to withdraw at any time; 6) a statement that the minor should discuss whether or not to participate with his/her parents prior to signing the form; 7) a statement that the parent(s)/guardian(s) of the minor will be asked for their permission on behalf of the minor; an offer to answer all questions.
6. Can I waive informed consent on my study?
Yes, the UTPB IRB considers requests to waive consent in circumstances where it is justified. Please provide ample detail or documentation as relevant to demonstrate why your research necessitates a waiver of informed consent. Requests for waiver of consent will be evaluated based on regulations outlined in Dept. of Health and Human Services 45 CFR 46.117.
7. Do I need to tell the IRB if I make changes to my study?
Yes. All changes must be documented and on record with the IRB. Researchers are asked to submit an update form (available on the UTPB IRB website) detailing changes. Once received, the IRB chair review changes. Researchers must receive approval for protocol changes prior to making them.
8. Do I qualify for exempt review? If my project is exempt, does that mean that I do not have to submit an application to IRB?
Applications will be classified by the IRB as requiring full IRB review, exempt IRB review, or expedited IRB review. Researchers must submit an IRB application for approval regardless of what kind of application is submitted. The exempt designation means only that the study is low risk and that it does not require full IRB board approval. Instead, the chair of the IRB or a small number of IRB members may review these applications. In short, an exempt review is one that is deemed to be of minimal risk and therefore does not merit a review by the full IRB.
9. What is the procedure for conducting research at a local public grade school or charter school?
The UTPB IRB welcomes research at neighboring schools, although it is imperative that we meet certain criteria to protect all individuals involved and maintain good relationships with all of these institutions.
First, you will be expected to provide approval from the district central office, either a superintendent or similar person with authority to permit research at a school. A school principal’s permission is not sufficient to authorize your research, although it is generally appropriate to provide principal’s permission as a supplement, because they should also approve of research taking place on their campus.
For private schools, a head administrator’s approval, including signature on letterhead, with full contact information should be provided.
If you will be conducting research on students, i.e., individuals under the age of 18, you will have to obtain parental consent for each participant. As such, make sure that your consent form is addressed to the parent, noting what the child will be expected to do should they consent to his/her participation. Ideally, you should also have an age appropriate script for minor participants to agree to participate (i.e., child asset). Research at a day care or childcare facility should generally follow the same protocol as schools, providing administrator or director’s approval. Again, use parental consent/child assent forms as appropriate. Many examples of these types of permission forms exist online, but the IRB can direct you to examples should you fail to find appropriate documentation.
10. What is the protocol for conducting research at a community organization or business?
Each case will be different, depending on the risk or nature of the study. However, similar to school research, we request written permission from a head administrator, manager, or owner (as appropriate), with full contact information. It will be your responsibility as the researcher to detail in your IRB application whether they will have access to your data or results.
If you work at this place of business, please outline your position there. We must consider issues of coercion and data security, and your place within that organization may be relevant to the degree to which individuals feel their participation is voluntary.
Similarly, if you do not work for the organization, but are accessing it for your research because of someone you know, e.g. a friend or family member, please outline his or her position with that organization as well.
11. I plan to collect data at universities/colleges other than UTPB, what is required for approval of this type of project?
Each IRB application is judged on specific elements of its research methodology and recruitment, and as such, there is no singular rule for this type of research. However, for the general case, we recommend the following:
Assuming you will collect data at UTPB, you should submit your IRB application with a primary focus upon how you will collect data at UTPB. You may mention that you eventually plan to collect data at other universities, but understand that UTPB IRB does not have jurisdiction over research carried out at other universities.
Once you have approval to collect data at UTPB, the IRB will provide you with documentation of your approved research. If your project requires a formal signed letter from the IRB chair, please request one. With that letter, you may then contact the IRB at other institutions where you want to collect data, noting your existing approval. Often you will need a faculty contact at each university who has volunteered to help you in your data collection. In some cases, other institutions may grant approval based on your existing IRB approval through UTPB. However, please note that each university IRB has the authority to govern research at their institution, and may require a full application or other documentation before approving your project.
14. I am a researcher at a university or institution other than UTPB, and I would like to survey UTPB students/faculty/staff, do I need approval from the UTPB IRB to collect my data?
Yes, although depending on the situation, procedures required for approval may differ. First, in most cases we would expect you to have a UTPB faculty or staff member who is serving as your representative or collaborator at UTPB. That is, we would expect in many cases that a faculty member at UTPB might be helping you collect data, and this relationship will aid the approval process.
If you have existing IRB approval at your own institution, you may provide that information to us, along with relevant details about your study, and from there, we will work with you to gain approval for your study. In some cases, we may ask for additional details to ensure protection of participants at UTPB or may require that you submit an application at UTPB.
If you do not have existing IRB approval at another institution, then you will need to have a faculty sponsor at UTPB whom you are working with, and through whom you will submit a full application to the UTPB IRB.
13. I plan to conduct a pilot study (or feasibility study) to guide a larger research project. Does this require IRB review?
If the pilot study uses human participants in some form, it should be reviewed by the IRB. It is in the best interests of all involved parties that all human subjects research be reviewed by the IRB.
14. I am a professor who intends to collect data for an assessment of one of my classes. Do I need IRB?
The answer may differ depending on your intentions. In general, if you are doing a classroom assessment for your own pedagogical assessment, or for institutional assessment purposes, this work traditionally is not considered human subjects research, and therefore would not need approval by the IRB. Conversely, if you would like to present, publish, or disseminate this information beyond the above parameters, you must submit an IRB before collecting the data.
15. I am a professor who has assigned a class to complete research activities that may include contact with human subjects. Do I need to complete an IRB application for the class as a whole, or must I require each student to complete one independently?
Given the spectrum of possibilities for such a project, there is no “rule” that can be applied to this question. However, we can provide some guidance.
For course projects that involve students individually performing similar human subjects research (e.g., everyone interviews a public sector worker, an entrepreneur or everyone conducts a short survey and analyzes the data), it may be best for the instructor to submit a single IRB application for the class detailing what information will be gathered.
It will often be appropriate for the instructor to create an informed consent template to be used by all class members. Secondly, you should describe what instructions you will give students to guide research, including any ethics training. You may ask students to complete the CITI online training module or other appropriate training for the project.
For classes where students will be doing projects using a variety of methodological approaches, it may be most appropriate for students to submit separate IRB applications.
The IRB will be glad to work with you to decide what approach best suits your class needs.
16. Does focus group research require IRB approval?
Yes, focus group research at UTPB qualifies as human subjects’ research. You should submit a standard IRB application detailing methods, recruitment, consent, etc. A common concern of the IRB often involves how disclosures of potentially sensitive information will be handled, given that focus groups are not anonymous. You should be prepared to consider management of such instances, depending on the subject matter of your proposed focus group. For example, if a focus group among workers in an organization brings out mention of illegal activity, how will you manage that information as a researcher?
17. Does oral history research require IRB approval?
It depends. Oral history activities that only document a specific historical event or the experiences of individuals without intent to draw conclusions or generalize findings would not constitute "research" as defined by HHS regulations 45 CFR part 46. Systematic investigations involving open-ended interviews used to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions, inform policy, or generalize findings) would constitute "research."
18. I will be talking with people as part of my project. Will I need IRB approval?
Recall that research is defined as a systematic investigation with human subjects in which identifiable information is obtained with the goal of developing or contributing to generalizable knowledge. This includes, surveys research, research development, testing, evaluation, and observational methods. However, some activities clearly are not considered “research.” This includes scholarly and journalistic activities (i.e., some oral history activities, journalism, biography, literary criticism, legal research, historical scholarship), which includes the collection and use of information that focuses directly on the specific individuals about whom the information is collected.
19. Where do I go to obtain training/certification on conducting ethical research with human participants?
Researchers must complete a short online course called CITI ethics training prior to submitting an application for review. Researchers may go to (https://about.citiprogram.org/en/homepage/) and register under “The University of Texas Permian Basin.” At the conclusion of the course you will receive a certificate that is valid for 3 years and this certificate must be attached to your IRB application.